Ofatumumab Dose-finding in Relapsing Remitting Multiple Sclerosis (RRM
A Double-blind, Randomized, Placebo Controlled, Multicenter, Dose-finding Trial of Ofatumumab in Relapsing Remitting Multiple Sclerosis (RRMS) Patients
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Ofatumumab 100
- Ofatumumab 300
- Ofatumumab 700
Placebo
- Placebo
Results by group
Number of Participants With Any Adverse Event
First Treatment Period (FTP): From Visit 3 (Week 0) up to Visit 10 (Week 24); Second Treatment Period (STP): From Visit 10 (Week 24) up to Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 8 participants | 8 | |
| 300 mg Ofa/Matching Placebo | 10 participants | 11 | |
| 700 mg Ofa/Matching Placebo | 7 participants | 7 | |
| Matching Placebo/100 mg Ofa | 3 participants | 4 | |
| Matching Placebo/300 mg Ofa | 2 participants | 4 | |
| Matching Placebo/700 mg Ofa | 2 participants | 4 | |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 4 participants | 8 | |
| 300 mg Ofa/Matching Placebo | 5 participants | 11 | |
| 700 mg Ofa/Matching Placebo | 4 participants | 7 | |
| Matching Placebo/100 mg Ofa | 3 participants | 4 | |
| Matching Placebo/300 mg Ofa | 4 participants | 4 | |
| Matching Placebo/700 mg Ofa | 4 participants | 4 | |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 0 participants | 8 | |
| 300 mg Ofa/Matching Placebo | 0 participants | 11 | |
| 700 mg Ofa/Matching Placebo | 0 participants | 7 | |
| Matching Placebo/100 mg Ofa | 0 participants | 4 | |
| Matching Placebo/300 mg Ofa | 0 participants | 4 | |
| Matching Placebo/700 mg Ofa | 0 participants | 4 |
Number of Participants With the Indicated Critical Adverse Events (CAEs)
FTP: From Visit 3 (Week 0) up to Visit 10 (Week 24); STP: From Visit 10 (Week 24) up to Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 0 participants | 8 | |
| 300 mg Ofa/Matching Placebo | 0 participants | 11 | |
| 700 mg Ofa/Matching Placebo | 0 participants | 7 | |
| Matching Placebo/100 mg Ofa | 1 participants | 4 | |
| Matching Placebo/300 mg Ofa | 0 participants | 4 | |
| Matching Placebo/700 mg Ofa | 0 participants | 4 | |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 0 participants | 8 | |
| 300 mg Ofa/Matching Placebo | 1 participants | 11 | |
| 700 mg Ofa/Matching Placebo | 0 participants | 7 | |
| Matching Placebo/100 mg Ofa | 0 participants | 4 | |
| Matching Placebo/300 mg Ofa | 0 participants | 4 | |
| Matching Placebo/700 mg Ofa | 0 participants | 4 | |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 0 participants | 8 | |
| 300 mg Ofa/Matching Placebo | 1 participants | 11 | |
| 700 mg Ofa/Matching Placebo | 0 participants | 7 | |
| Matching Placebo/100 mg Ofa | 0 participants | 4 | |
| Matching Placebo/300 mg Ofa | 0 participants | 4 | |
| Matching Placebo/700 mg Ofa | 0 participants | 4 | |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 0 participants | 8 | |
| 300 mg Ofa/Matching Placebo | 1 participants | 11 | |
| 700 mg Ofa/Matching Placebo | 0 participants | 7 | |
| Matching Placebo/100 mg Ofa | 0 participants | 4 | |
| Matching Placebo/300 mg Ofa | 0 participants | 4 | |
| Matching Placebo/700 mg Ofa | 0 participants | 4 | |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 0 participants | 8 | |
| 300 mg Ofa/Matching Placebo | 0 participants | 11 | |
| 700 mg Ofa/Matching Placebo | 0 participants | 7 | |
| Matching Placebo/100 mg Ofa | 0 participants | 4 | |
| Matching Placebo/300 mg Ofa | 0 participants | 4 | |
| Matching Placebo/700 mg Ofa | 0 participants | 4 | |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 0 participants | 8 | |
| 300 mg Ofa/Matching Placebo | 0 participants | 11 | |
| 700 mg Ofa/Matching Placebo | 0 participants | 7 | |
| Matching Placebo/100 mg Ofa | 0 participants | 4 | |
| Matching Placebo/300 mg Ofa | 0 participants | 4 | |
| Matching Placebo/700 mg Ofa | 0 participants | 4 |
Number of Participants With Negative or Unconfirmed Human Anti-human Antibodies (HAHA) in Which Concentrations of Ofa Were Below 500 Nanograms Per Milliliter (ng/ml)
Visit 3 (Week 0), Visit 10 (Week 24), Visit 17 (Week 48) or early withdrawal (EW), and Visit 26 (Week 104)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 8 participants | 8 | |
| 300 mg Ofa/Matching Placebo | 8 participants | 11 | |
| 700 mg Ofa/Matching Placebo | 2 participants | 7 | |
| Matching Placebo/100 mg Ofa | 4 participants | 4 | |
| Matching Placebo/300 mg Ofa | 3 participants | 4 | |
| Matching Placebo/700 mg Ofa | 4 participants | 4 | |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 8 participants | 8 | |
| 300 mg Ofa/Matching Placebo | 9 participants | 11 | |
| 700 mg Ofa/Matching Placebo | 1 participants | 7 | |
| Matching Placebo/100 mg Ofa | 4 participants | 4 | |
| Matching Placebo/300 mg Ofa | 4 participants | 4 | |
| Matching Placebo/700 mg Ofa | 4 participants | 4 | |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 8 participants | 8 | |
| 300 mg Ofa/Matching Placebo | 11 participants | 11 | |
| 700 mg Ofa/Matching Placebo | 7 participants | 7 | |
| Matching Placebo/100 mg Ofa | 4 participants | 4 | |
| Matching Placebo/300 mg Ofa | 3 participants | 4 | |
| Matching Placebo/700 mg Ofa | 1 participants | 4 | |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 0 participants | 8 | |
| 300 mg Ofa/Matching Placebo | 0 participants | 11 | |
| 700 mg Ofa/Matching Placebo | 0 participants | 7 | |
| Matching Placebo/100 mg Ofa | 0 participants | 4 | |
| Matching Placebo/300 mg Ofa | 0 participants | 4 | |
| Matching Placebo/700 mg Ofa | 3 participants | 4 | |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 0 participants | 8 | |
| 300 mg Ofa/Matching Placebo | 0 participants | 11 | |
| 700 mg Ofa/Matching Placebo | 0 participants | 7 | |
| Matching Placebo/100 mg Ofa | 0 participants | 4 | |
| Matching Placebo/300 mg Ofa | 0 participants | 4 | |
| Matching Placebo/700 mg Ofa | 0 participants | 4 |
Number of Participants With Abnormal Physical Examination Findings
FTP: From Visit 3 (Week 0) up to Visit 10 (Week 24); STP: From Visit 10 (Week 24) up to Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 1 participants | 8 | |
| 300 mg Ofa/Matching Placebo | 0 participants | 11 | |
| 700 mg Ofa/Matching Placebo | 0 participants | 7 | |
| Matching Placebo/100 mg Ofa | 0 participants | 4 | |
| Matching Placebo/300 mg Ofa | 0 participants | 4 | |
| Matching Placebo/700 mg Ofa | 0 participants | 4 | |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 1 participants | 8 | |
| 300 mg Ofa/Matching Placebo | 0 participants | 11 | |
| 700 mg Ofa/Matching Placebo | 0 participants | 7 | |
| Matching Placebo/100 mg Ofa | 0 participants | 4 | |
| Matching Placebo/300 mg Ofa | 0 participants | 4 | |
| Matching Placebo/700 mg Ofa | 0 participants | 4 | |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 1 participants | 8 | |
| 300 mg Ofa/Matching Placebo | 0 participants | 11 | |
| 700 mg Ofa/Matching Placebo | 0 participants | 7 | |
| Matching Placebo/100 mg Ofa | 0 participants | 4 | |
| Matching Placebo/300 mg Ofa | 0 participants | 4 | |
| Matching Placebo/700 mg Ofa | 0 participants | 4 | |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 0 participants | 8 | |
| 300 mg Ofa/Matching Placebo | 0 participants | 11 | |
| 700 mg Ofa/Matching Placebo | 1 participants | 7 | |
| Matching Placebo/100 mg Ofa | 0 participants | 4 | |
| Matching Placebo/300 mg Ofa | 0 participants | 4 | |
| Matching Placebo/700 mg Ofa | 0 participants | 4 | |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 0 participants | 8 | |
| 300 mg Ofa/Matching Placebo | 0 participants | 11 | |
| 700 mg Ofa/Matching Placebo | 1 participants | 7 | |
| Matching Placebo/100 mg Ofa | 0 participants | 4 | |
| Matching Placebo/300 mg Ofa | 0 participants | 4 | |
| Matching Placebo/700 mg Ofa | 0 participants | 4 | |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 0 participants | 8 | |
| 300 mg Ofa/Matching Placebo | 0 participants | 11 | |
| 700 mg Ofa/Matching Placebo | 0 participants | 7 | |
| Matching Placebo/100 mg Ofa | 0 participants | 4 | |
| Matching Placebo/300 mg Ofa | 0 participants | 4 | |
| Matching Placebo/700 mg Ofa | 1 participants | 4 | |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 1 participants | 8 | |
| 300 mg Ofa/Matching Placebo | 0 participants | 11 | |
| 700 mg Ofa/Matching Placebo | 0 participants | 7 | |
| Matching Placebo/100 mg Ofa | 0 participants | 4 | |
| Matching Placebo/300 mg Ofa | 0 participants | 4 | |
| Matching Placebo/700 mg Ofa | 0 participants | 4 | |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 1 participants | 8 | |
| 300 mg Ofa/Matching Placebo | 0 participants | 11 | |
| 700 mg Ofa/Matching Placebo | 0 participants | 7 | |
| Matching Placebo/100 mg Ofa | 0 participants | 4 | |
| Matching Placebo/300 mg Ofa | 0 participants | 4 | |
| Matching Placebo/700 mg Ofa | 0 participants | 4 | |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 1 participants | 8 | |
| 300 mg Ofa/Matching Placebo | 0 participants | 11 | |
| 700 mg Ofa/Matching Placebo | 0 participants | 7 | |
| Matching Placebo/100 mg Ofa | 0 participants | 4 | |
| Matching Placebo/300 mg Ofa | 0 participants | 4 | |
| Matching Placebo/700 mg Ofa | 0 participants | 4 | |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 0 participants | 8 | |
| 300 mg Ofa/Matching Placebo | 1 participants | 11 | |
| 700 mg Ofa/Matching Placebo | 0 participants | 7 | |
| Matching Placebo/100 mg Ofa | 0 participants | 4 | |
| Matching Placebo/300 mg Ofa | 0 participants | 4 | |
| Matching Placebo/700 mg Ofa | 0 participants | 4 | |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 0 participants | 8 | |
| 300 mg Ofa/Matching Placebo | 0 participants | 11 | |
| 700 mg Ofa/Matching Placebo | 1 participants | 7 | |
| Matching Placebo/100 mg Ofa | 0 participants | 4 | |
| Matching Placebo/300 mg Ofa | 0 participants | 4 | |
| Matching Placebo/700 mg Ofa | 0 participants | 4 | |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 0 participants | 8 | |
| 300 mg Ofa/Matching Placebo | 0 participants | 11 | |
| 700 mg Ofa/Matching Placebo | 0 participants | 7 | |
| Matching Placebo/100 mg Ofa | 0 participants | 4 | |
| Matching Placebo/300 mg Ofa | 0 participants | 4 | |
| Matching Placebo/700 mg Ofa | 0 participants | 4 |
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: Visit 26 (Week 104)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 0 Giga (10^9) per liter | 0 (Standard Deviation) | 8 |
| 300 mg Ofa/Matching Placebo | 0 Giga (10^9) per liter | 0 (Standard Deviation) | 10 |
| 700 mg Ofa/Matching Placebo | 0 Giga (10^9) per liter | 0 (Standard Deviation) | 7 |
| Matching Placebo/100 mg Ofa | 0 Giga (10^9) per liter | 0 (Standard Deviation) | 3 |
| Matching Placebo/300 mg Ofa | 0 Giga (10^9) per liter | 0 (Standard Deviation) | 4 |
| Matching Placebo/700 mg Ofa | 0 Giga (10^9) per liter | 0 (Standard Deviation) | 4 |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 0 Giga (10^9) per liter | 0.05 (Standard Deviation) | 8 |
| 300 mg Ofa/Matching Placebo | -0.05 Giga (10^9) per liter | 0.13 (Standard Deviation) | 10 |
| 700 mg Ofa/Matching Placebo | 0.02 Giga (10^9) per liter | 0.15 (Standard Deviation) | 7 |
| Matching Placebo/100 mg Ofa | 0 Giga (10^9) per liter | 0 (Standard Deviation) | 3 |
| Matching Placebo/300 mg Ofa | -0.23 Giga (10^9) per liter | 0.21 (Standard Deviation) | 4 |
| Matching Placebo/700 mg Ofa | 0.03 Giga (10^9) per liter | 0.05 (Standard Deviation) | 4 |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 0.7 Giga (10^9) per liter | 1.6 (Standard Deviation) | 8 |
| 300 mg Ofa/Matching Placebo | 0.6 Giga (10^9) per liter | 2.4 (Standard Deviation) | 10 |
| 700 mg Ofa/Matching Placebo | -0.1 Giga (10^9) per liter | 3.3 (Standard Deviation) | 7 |
| Matching Placebo/100 mg Ofa | -0.3 Giga (10^9) per liter | 1.6 (Standard Deviation) | 3 |
| Matching Placebo/300 mg Ofa | 0.7 Giga (10^9) per liter | 5.9 (Standard Deviation) | 4 |
| Matching Placebo/700 mg Ofa | 0.4 Giga (10^9) per liter | 0.7 (Standard Deviation) | 4 |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 0.15 Giga (10^9) per liter | 1.03 (Standard Deviation) | 8 |
| 300 mg Ofa/Matching Placebo | -0.36 Giga (10^9) per liter | 0.67 (Standard Deviation) | 10 |
| 700 mg Ofa/Matching Placebo | -0.19 Giga (10^9) per liter | 0.78 (Standard Deviation) | 7 |
| Matching Placebo/100 mg Ofa | -0.37 Giga (10^9) per liter | 0.31 (Standard Deviation) | 3 |
| Matching Placebo/300 mg Ofa | -0.60 Giga (10^9) per liter | 0.79 (Standard Deviation) | 4 |
| Matching Placebo/700 mg Ofa | 0.12 Giga (10^9) per liter | 0.21 (Standard Deviation) | 4 |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 0.20 Giga (10^9) per liter | 0.31 (Standard Deviation) | 8 |
| 300 mg Ofa/Matching Placebo | -0.07 Giga (10^9) per liter | 0.23 (Standard Deviation) | 10 |
| 700 mg Ofa/Matching Placebo | 0.00 Giga (10^9) per liter | 0.2 (Standard Deviation) | 7 |
| Matching Placebo/100 mg Ofa | 0.07 Giga (10^9) per liter | 0.06 (Standard Deviation) | 3 |
| Matching Placebo/300 mg Ofa | -0.40 Giga (10^9) per liter | 0.17 (Standard Deviation) | 4 |
| Matching Placebo/700 mg Ofa | 0.05 Giga (10^9) per liter | 0.1 (Standard Deviation) | 4 |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 0.4 Giga (10^9) per liter | 0.9 (Standard Deviation) | 8 |
| 300 mg Ofa/Matching Placebo | 1 Giga (10^9) per liter | 2.2 (Standard Deviation) | 10 |
| 700 mg Ofa/Matching Placebo | 0 Giga (10^9) per liter | 3.8 (Standard Deviation) | 7 |
| Matching Placebo/100 mg Ofa | -0.1 Giga (10^9) per liter | 1.5 (Standard Deviation) | 3 |
| Matching Placebo/300 mg Ofa | -0.8 Giga (10^9) per liter | 1.7 (Standard Deviation) | 4 |
| Matching Placebo/700 mg Ofa | 0.2 Giga (10^9) per liter | 0.7 (Standard Deviation) | 4 |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 0.8 Giga (10^9) per liter | 33.3 (Standard Deviation) | 8 |
| 300 mg Ofa/Matching Placebo | 10.8 Giga (10^9) per liter | 44 (Standard Deviation) | 10 |
| 700 mg Ofa/Matching Placebo | 7.6 Giga (10^9) per liter | 39.7 (Standard Deviation) | 7 |
| Matching Placebo/100 mg Ofa | 0.3 Giga (10^9) per liter | 29.5 (Standard Deviation) | 3 |
| Matching Placebo/300 mg Ofa | 5.8 Giga (10^9) per liter | 36.2 (Standard Deviation) | 4 |
| Matching Placebo/700 mg Ofa | -4.8 Giga (10^9) per liter | 34.8 (Standard Deviation) | 4 |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 0 Giga (10^9) per liter | 0 (Standard Deviation) | 8 |
| 300 mg Ofa/Matching Placebo | 0 Giga (10^9) per liter | 0 (Standard Deviation) | 10 |
| 700 mg Ofa/Matching Placebo | 0 Giga (10^9) per liter | 0 (Standard Deviation) | 7 |
| Matching Placebo/100 mg Ofa | 0 Giga (10^9) per liter | 0 (Standard Deviation) | 3 |
| Matching Placebo/300 mg Ofa | 0 Giga (10^9) per liter | 0 (Standard Deviation) | 4 |
| Matching Placebo/700 mg Ofa | 0 Giga (10^9) per liter | 0 (Standard Deviation) | 4 |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 0 Giga (10^9) per liter | 0.05 (Standard Deviation) | 8 |
| 300 mg Ofa/Matching Placebo | -0.04 Giga (10^9) per liter | 0.16 (Standard Deviation) | 10 |
| 700 mg Ofa/Matching Placebo | 0.04 Giga (10^9) per liter | 0.09 (Standard Deviation) | 7 |
| Matching Placebo/100 mg Ofa | -0.07 Giga (10^9) per liter | 0.06 (Standard Deviation) | 3 |
| Matching Placebo/300 mg Ofa | -0.20 Giga (10^9) per liter | 0.28 (Standard Deviation) | 4 |
| Matching Placebo/700 mg Ofa | 0.03 Giga (10^9) per liter | 0.13 (Standard Deviation) | 4 |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 0.5 Giga (10^9) per liter | 1.1 (Standard Deviation) | 8 |
| 300 mg Ofa/Matching Placebo | -0.1 Giga (10^9) per liter | 1.7 (Standard Deviation) | 10 |
| 700 mg Ofa/Matching Placebo | -0.3 Giga (10^9) per liter | 1.1 (Standard Deviation) | 7 |
| Matching Placebo/100 mg Ofa | -0.9 Giga (10^9) per liter | 0.6 (Standard Deviation) | 3 |
| Matching Placebo/300 mg Ofa | -3.7 Giga (10^9) per liter | 1.7 (Standard Deviation) | 4 |
| Matching Placebo/700 mg Ofa | 0.9 Giga (10^9) per liter | 0.9 (Standard Deviation) | 4 |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | -0.11 Giga (10^9) per liter | 0.36 (Standard Deviation) | 8 |
| 300 mg Ofa/Matching Placebo | -0.28 Giga (10^9) per liter | 0.47 (Standard Deviation) | 10 |
| 700 mg Ofa/Matching Placebo | 0.15 Giga (10^9) per liter | 0.36 (Standard Deviation) | 7 |
| Matching Placebo/100 mg Ofa | -0.50 Giga (10^9) per liter | 0.2 (Standard Deviation) | 3 |
| Matching Placebo/300 mg Ofa | -0.65 Giga (10^9) per liter | 0.78 (Standard Deviation) | 4 |
| Matching Placebo/700 mg Ofa | -0.25 Giga (10^9) per liter | 0.45 (Standard Deviation) | 4 |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | -0.20 Giga (10^9) per liter | 0.07 (Standard Deviation) | 8 |
| 300 mg Ofa/Matching Placebo | -0.01 Giga (10^9) per liter | 0.12 (Standard Deviation) | 10 |
| 700 mg Ofa/Matching Placebo | 0.02 Giga (10^9) per liter | 0.17 (Standard Deviation) | 7 |
| Matching Placebo/100 mg Ofa | 0.03 Giga (10^9) per liter | 0.06 (Standard Deviation) | 3 |
| Matching Placebo/300 mg Ofa | -0.04 Giga (10^9) per liter | 0.28 (Standard Deviation) | 4 |
| Matching Placebo/700 mg Ofa | 0.13 Giga (10^9) per liter | 0.25 (Standard Deviation) | 4 |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 0.7 Giga (10^9) per liter | 1.2 (Standard Deviation) | 8 |
| 300 mg Ofa/Matching Placebo | 0.2 Giga (10^9) per liter | 1.8 (Standard Deviation) | 10 |
| 700 mg Ofa/Matching Placebo | -0.4 Giga (10^9) per liter | 1 (Standard Deviation) | 7 |
| Matching Placebo/100 mg Ofa | -0.4 Giga (10^9) per liter | 0.4 (Standard Deviation) | 3 |
| Matching Placebo/300 mg Ofa | -2.9 Giga (10^9) per liter | 1.3 (Standard Deviation) | 4 |
| Matching Placebo/700 mg Ofa | 1.0 Giga (10^9) per liter | 0.7 (Standard Deviation) | 4 |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | -6.5 Giga (10^9) per liter | 17.3 (Standard Deviation) | 8 |
| 300 mg Ofa/Matching Placebo | -16.3 Giga (10^9) per liter | 74.2 (Standard Deviation) | 10 |
| 700 mg Ofa/Matching Placebo | -10.1 Giga (10^9) per liter | 14.7 (Standard Deviation) | 7 |
| Matching Placebo/100 mg Ofa | -13.7 Giga (10^9) per liter | 20.6 (Standard Deviation) | 3 |
| Matching Placebo/300 mg Ofa | -34.3 Giga (10^9) per liter | 47.3 (Standard Deviation) | 4 |
| Matching Placebo/700 mg Ofa | -11.0 Giga (10^9) per liter | 38.4 (Standard Deviation) | 4 |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 0 Giga (10^9) per liter | 8 | |
| 300 mg Ofa/Matching Placebo | Not reached | 10 | |
| 700 mg Ofa/Matching Placebo | Not reached | 7 | |
| Matching Placebo/100 mg Ofa | Not reached | 3 | |
| Matching Placebo/300 mg Ofa | Not reached | 4 | |
| Matching Placebo/700 mg Ofa | Not reached | 4 | |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 0 Giga (10^9) per liter | 8 | |
| 300 mg Ofa/Matching Placebo | Not reached | 10 | |
| 700 mg Ofa/Matching Placebo | Not reached | 7 | |
| Matching Placebo/100 mg Ofa | Not reached | 3 | |
| Matching Placebo/300 mg Ofa | Not reached | 4 | |
| Matching Placebo/700 mg Ofa | Not reached | 4 | |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 1.30 Giga (10^9) per liter | 8 | |
| 300 mg Ofa/Matching Placebo | Not reached | 10 | |
| 700 mg Ofa/Matching Placebo | Not reached | 7 | |
| Matching Placebo/100 mg Ofa | Not reached | 3 | |
| Matching Placebo/300 mg Ofa | Not reached | 4 | |
| Matching Placebo/700 mg Ofa | Not reached | 4 | |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | -0.60 Giga (10^9) per liter | 8 | |
| 300 mg Ofa/Matching Placebo | Not reached | 10 | |
| 700 mg Ofa/Matching Placebo | Not reached | 7 | |
| Matching Placebo/100 mg Ofa | Not reached | 3 | |
| Matching Placebo/300 mg Ofa | Not reached | 4 | |
| Matching Placebo/700 mg Ofa | Not reached | 4 | |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 0 Giga (10^9) per liter | 8 | |
| 300 mg Ofa/Matching Placebo | Not reached | 10 | |
| 700 mg Ofa/Matching Placebo | Not reached | 7 | |
| Matching Placebo/100 mg Ofa | Not reached | 3 | |
| Matching Placebo/300 mg Ofa | Not reached | 4 | |
| Matching Placebo/700 mg Ofa | Not reached | 4 | |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 1.90 Giga (10^9) per liter | 8 | |
| 300 mg Ofa/Matching Placebo | Not reached | 10 | |
| 700 mg Ofa/Matching Placebo | Not reached | 7 | |
| Matching Placebo/100 mg Ofa | Not reached | 3 | |
| Matching Placebo/300 mg Ofa | Not reached | 4 | |
| Matching Placebo/700 mg Ofa | Not reached | 4 | |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | -20.0 Giga (10^9) per liter | 8 | |
| 300 mg Ofa/Matching Placebo | Not reached | 10 | |
| 700 mg Ofa/Matching Placebo | Not reached | 7 | |
| Matching Placebo/100 mg Ofa | Not reached | 3 | |
| Matching Placebo/300 mg Ofa | Not reached | 4 | |
| Matching Placebo/700 mg Ofa | Not reached | 4 |
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Erythrocyte Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: Visit 26 (Week 104)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 0.06 Pico (10^12) per liter | 0.25 (Standard Deviation) | 8 |
| 300 mg Ofa/Matching Placebo | -0.11 Pico (10^12) per liter | 0.33 (Standard Deviation) | 10 |
| 700 mg Ofa/Matching Placebo | -0.02 Pico (10^12) per liter | 0.23 (Standard Deviation) | 7 |
| Matching Placebo/100 mg Ofa | -0.09 Pico (10^12) per liter | 0.2 (Standard Deviation) | 3 |
| Matching Placebo/300 mg Ofa | -0.06 Pico (10^12) per liter | 0.42 (Standard Deviation) | 4 |
| Matching Placebo/700 mg Ofa | 0.07 Pico (10^12) per liter | 0.12 (Standard Deviation) | 4 |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 0.05 Pico (10^12) per liter | 0.26 (Standard Deviation) | 8 |
| 300 mg Ofa/Matching Placebo | 0.12 Pico (10^12) per liter | 0.34 (Standard Deviation) | 10 |
| 700 mg Ofa/Matching Placebo | 0.12 Pico (10^12) per liter | 0.25 (Standard Deviation) | 7 |
| Matching Placebo/100 mg Ofa | 0.01 Pico (10^12) per liter | 0.43 (Standard Deviation) | 3 |
| Matching Placebo/300 mg Ofa | 0.06 Pico (10^12) per liter | 0.18 (Standard Deviation) | 4 |
| Matching Placebo/700 mg Ofa | 0.09 Pico (10^12) per liter | 0.04 (Standard Deviation) | 4 |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | -0.08 Pico (10^12) per liter | 8 | |
| 300 mg Ofa/Matching Placebo | Not reached | 10 | |
| 700 mg Ofa/Matching Placebo | Not reached | 7 | |
| Matching Placebo/100 mg Ofa | Not reached | 3 | |
| Matching Placebo/300 mg Ofa | Not reached | 4 | |
| Matching Placebo/700 mg Ofa | Not reached | 4 |
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hematocrit at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: Visit 26 (Week 104)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | -0.00 Percentage of BV occupied by RBCs | 0.03 (Standard Deviation) | 8 |
| 300 mg Ofa/Matching Placebo | 0.01 Percentage of BV occupied by RBCs | 0.03 (Standard Deviation) | 10 |
| 700 mg Ofa/Matching Placebo | -0.01 Percentage of BV occupied by RBCs | 0.02 (Standard Deviation) | 7 |
| Matching Placebo/100 mg Ofa | -0.02 Percentage of BV occupied by RBCs | 0.02 (Standard Deviation) | 3 |
| Matching Placebo/300 mg Ofa | 0.02 Percentage of BV occupied by RBCs | 0.04 (Standard Deviation) | 4 |
| Matching Placebo/700 mg Ofa | 0.01 Percentage of BV occupied by RBCs | 0.01 (Standard Deviation) | 4 |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 0.01 Percentage of BV occupied by RBCs | 0.02 (Standard Deviation) | 8 |
| 300 mg Ofa/Matching Placebo | 0.02 Percentage of BV occupied by RBCs | 0.03 (Standard Deviation) | 10 |
| 700 mg Ofa/Matching Placebo | 0.00 Percentage of BV occupied by RBCs | 0.03 (Standard Deviation) | 7 |
| Matching Placebo/100 mg Ofa | 0.01 Percentage of BV occupied by RBCs | 0.05 (Standard Deviation) | 3 |
| Matching Placebo/300 mg Ofa | 0.01 Percentage of BV occupied by RBCs | 0.01 (Standard Deviation) | 4 |
| Matching Placebo/700 mg Ofa | 0.02 Percentage of BV occupied by RBCs | 0.01 (Standard Deviation) | 4 |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 0.01 Percentage of BV occupied by RBCs | 8 | |
| 300 mg Ofa/Matching Placebo | Not reached | 10 | |
| 700 mg Ofa/Matching Placebo | Not reached | 7 | |
| Matching Placebo/100 mg Ofa | Not reached | 3 | |
| Matching Placebo/300 mg Ofa | Not reached | 4 | |
| Matching Placebo/700 mg Ofa | Not reached | 4 |
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hemoglobin Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: Visit 26 (Week 104)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 0.1 Millimoles/liter | 0.5 (Standard Deviation) | 8 |
| 300 mg Ofa/Matching Placebo | -0.3 Millimoles/liter | 0.7 (Standard Deviation) | 10 |
| 700 mg Ofa/Matching Placebo | -0.0 Millimoles/liter | 0.5 (Standard Deviation) | 7 |
| Matching Placebo/100 mg Ofa | -0.4 Millimoles/liter | 0.4 (Standard Deviation) | 3 |
| Matching Placebo/300 mg Ofa | -0.1 Millimoles/liter | 0.8 (Standard Deviation) | 4 |
| Matching Placebo/700 mg Ofa | 0.2 Millimoles/liter | 0.2 (Standard Deviation) | 4 |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 0.1 Millimoles/liter | 0.5 (Standard Deviation) | 8 |
| 300 mg Ofa/Matching Placebo | 0.1 Millimoles/liter | 0.7 (Standard Deviation) | 10 |
| 700 mg Ofa/Matching Placebo | 0.2 Millimoles/liter | 0.5 (Standard Deviation) | 7 |
| Matching Placebo/100 mg Ofa | -0.3 Millimoles/liter | 1.1 (Standard Deviation) | 3 |
| Matching Placebo/300 mg Ofa | 0.0 Millimoles/liter | 0.3 (Standard Deviation) | 4 |
| Matching Placebo/700 mg Ofa | 0.5 Millimoles/liter | 0.3 (Standard Deviation) | 4 |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 0.10 Millimoles/liter | 8 | |
| 300 mg Ofa/Matching Placebo | Not reached | 10 | |
| 700 mg Ofa/Matching Placebo | Not reached | 7 | |
| Matching Placebo/100 mg Ofa | Not reached | 3 | |
| Matching Placebo/300 mg Ofa | Not reached | 4 | |
| Matching Placebo/700 mg Ofa | Not reached | 4 |
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Albumin at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: VIsit 26 (Week 104)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | -0.6 grams per liter | 2.5 (Standard Deviation) | 8 |
| 300 mg Ofa/Matching Placebo | -0.5 grams per liter | 2.5 (Standard Deviation) | 11 |
| 700 mg Ofa/Matching Placebo | 1.3 grams per liter | 1.2 (Standard Deviation) | 7 |
| Matching Placebo/100 mg Ofa | -1.6 grams per liter | 3.4 (Standard Deviation) | 4 |
| Matching Placebo/300 mg Ofa | -1.2 grams per liter | 6.1 (Standard Deviation) | 4 |
| Matching Placebo/700 mg Ofa | 2.0 grams per liter | 2.4 (Standard Deviation) | 4 |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 0.1 grams per liter | 2.5 (Standard Deviation) | 8 |
| 300 mg Ofa/Matching Placebo | -0.2 grams per liter | 3.1 (Standard Deviation) | 11 |
| 700 mg Ofa/Matching Placebo | 1.4 grams per liter | 3 (Standard Deviation) | 7 |
| Matching Placebo/100 mg Ofa | -1.1 grams per liter | 5.7 (Standard Deviation) | 4 |
| Matching Placebo/300 mg Ofa | 0.4 grams per liter | 4 (Standard Deviation) | 4 |
| Matching Placebo/700 mg Ofa | 1.1 grams per liter | 1.5 (Standard Deviation) | 4 |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | -2.00 grams per liter | 8 | |
| 300 mg Ofa/Matching Placebo | Not reached | 11 | |
| 700 mg Ofa/Matching Placebo | Not reached | 7 | |
| Matching Placebo/100 mg Ofa | Not reached | 4 | |
| Matching Placebo/300 mg Ofa | Not reached | 4 | |
| Matching Placebo/700 mg Ofa | Not reached | 4 |
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 4.8 Units per liter | 9 (Standard Deviation) | 8 |
| 300 mg Ofa/Matching Placebo | 3.8 Units per liter | 11.9 (Standard Deviation) | 11 |
| 700 mg Ofa/Matching Placebo | 2.7 Units per liter | 8.3 (Standard Deviation) | 7 |
| Matching Placebo/100 mg Ofa | 13.0 Units per liter | 20.2 (Standard Deviation) | 4 |
| Matching Placebo/300 mg Ofa | 2.3 Units per liter | 10.6 (Standard Deviation) | 4 |
| Matching Placebo/700 mg Ofa | 8.8 Units per liter | 8.3 (Standard Deviation) | 4 |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 3.6 Units per liter | 5.1 (Standard Deviation) | 8 |
| 300 mg Ofa/Matching Placebo | 1.6 Units per liter | 6.3 (Standard Deviation) | 11 |
| 700 mg Ofa/Matching Placebo | -0.2 Units per liter | 3.1 (Standard Deviation) | 7 |
| Matching Placebo/100 mg Ofa | -9.5 Units per liter | 28.6 (Standard Deviation) | 4 |
| Matching Placebo/300 mg Ofa | 4.3 Units per liter | 3.2 (Standard Deviation) | 4 |
| Matching Placebo/700 mg Ofa | -1.0 Units per liter | 6.1 (Standard Deviation) | 4 |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 7.1 Units per liter | 10.2 (Standard Deviation) | 8 |
| 300 mg Ofa/Matching Placebo | 4.7 Units per liter | 10 (Standard Deviation) | 11 |
| 700 mg Ofa/Matching Placebo | -1.7 Units per liter | 6.4 (Standard Deviation) | 7 |
| Matching Placebo/100 mg Ofa | 7.3 Units per liter | 24.4 (Standard Deviation) | 4 |
| Matching Placebo/300 mg Ofa | 5.3 Units per liter | 5.4 (Standard Deviation) | 4 |
| Matching Placebo/700 mg Ofa | 0 Units per liter | 13 (Standard Deviation) | 4 |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 7.6 Units per liter | 10.7 (Standard Deviation) | 8 |
| 300 mg Ofa/Matching Placebo | 3.1 Units per liter | 8.8 (Standard Deviation) | 11 |
| 700 mg Ofa/Matching Placebo | 9.1 Units per liter | 12.6 (Standard Deviation) | 7 |
| Matching Placebo/100 mg Ofa | 5.3 Units per liter | 17.7 (Standard Deviation) | 4 |
| Matching Placebo/300 mg Ofa | 5.7 Units per liter | 7.6 (Standard Deviation) | 4 |
| Matching Placebo/700 mg Ofa | 12.5 Units per liter | 12.9 (Standard Deviation) | 4 |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 0.6 Units per liter | 2.6 (Standard Deviation) | 8 |
| 300 mg Ofa/Matching Placebo | 1.5 Units per liter | 3 (Standard Deviation) | 11 |
| 700 mg Ofa/Matching Placebo | 0.3 Units per liter | 2.5 (Standard Deviation) | 7 |
| Matching Placebo/100 mg Ofa | -13.3 Units per liter | 28.5 (Standard Deviation) | 4 |
| Matching Placebo/300 mg Ofa | 0.7 Units per liter | 4.7 (Standard Deviation) | 4 |
| Matching Placebo/700 mg Ofa | 3.3 Units per liter | 10.7 (Standard Deviation) | 4 |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 2.8 Units per liter | 5.3 (Standard Deviation) | 8 |
| 300 mg Ofa/Matching Placebo | 0.6 Units per liter | 4.7 (Standard Deviation) | 11 |
| 700 mg Ofa/Matching Placebo | 0.6 Units per liter | 7.4 (Standard Deviation) | 7 |
| Matching Placebo/100 mg Ofa | -4.3 Units per liter | 9.3 (Standard Deviation) | 4 |
| Matching Placebo/300 mg Ofa | 0.7 Units per liter | 8.1 (Standard Deviation) | 4 |
| Matching Placebo/700 mg Ofa | 8.0 Units per liter | 20.4 (Standard Deviation) | 4 |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 16.0 Units per liter | 8 | |
| 300 mg Ofa/Matching Placebo | Not reached | 11 | |
| 700 mg Ofa/Matching Placebo | Not reached | 7 | |
| Matching Placebo/100 mg Ofa | Not reached | 4 | |
| Matching Placebo/300 mg Ofa | Not reached | 4 | |
| Matching Placebo/700 mg Ofa | Not reached | 4 | |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 2.0 Units per liter | 8 | |
| 300 mg Ofa/Matching Placebo | Not reached | 11 | |
| 700 mg Ofa/Matching Placebo | Not reached | 7 | |
| Matching Placebo/100 mg Ofa | Not reached | 4 | |
| Matching Placebo/300 mg Ofa | Not reached | 4 | |
| Matching Placebo/700 mg Ofa | Not reached | 4 | |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 2.0 Units per liter | 8 | |
| 300 mg Ofa/Matching Placebo | Not reached | 11 | |
| 700 mg Ofa/Matching Placebo | Not reached | 7 | |
| Matching Placebo/100 mg Ofa | Not reached | 4 | |
| Matching Placebo/300 mg Ofa | Not reached | 4 | |
| Matching Placebo/700 mg Ofa | Not reached | 4 |
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 0.6 millimoles per liter | 2.2 (Standard Deviation) | 8 |
| 300 mg Ofa/Matching Placebo | -1.1 millimoles per liter | 2.6 (Standard Deviation) | 11 |
| 700 mg Ofa/Matching Placebo | -0.6 millimoles per liter | 2.5 (Standard Deviation) | 7 |
| Matching Placebo/100 mg Ofa | 1.5 millimoles per liter | 3.2 (Standard Deviation) | 4 |
| Matching Placebo/300 mg Ofa | -2.0 millimoles per liter | 1.3 (Standard Deviation) | 4 |
| Matching Placebo/700 mg Ofa | -0.6 millimoles per liter | 4 (Standard Deviation) | 4 |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | -0.12 millimoles per liter | 0.59 (Standard Deviation) | 8 |
| 300 mg Ofa/Matching Placebo | 0.39 millimoles per liter | 1.37 (Standard Deviation) | 11 |
| 700 mg Ofa/Matching Placebo | 0.64 millimoles per liter | 1.23 (Standard Deviation) | 7 |
| Matching Placebo/100 mg Ofa | 0.21 millimoles per liter | 0.42 (Standard Deviation) | 4 |
| Matching Placebo/300 mg Ofa | 0.08 millimoles per liter | 0.63 (Standard Deviation) | 4 |
| Matching Placebo/700 mg Ofa | -0.22 millimoles per liter | 0.5 (Standard Deviation) | 4 |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | -0.07 millimoles per liter | 0.35 (Standard Deviation) | 8 |
| 300 mg Ofa/Matching Placebo | 0.06 millimoles per liter | 0.52 (Standard Deviation) | 11 |
| 700 mg Ofa/Matching Placebo | 0.03 millimoles per liter | 0.27 (Standard Deviation) | 7 |
| Matching Placebo/100 mg Ofa | -0.63 millimoles per liter | 1.01 (Standard Deviation) | 4 |
| Matching Placebo/300 mg Ofa | -0.20 millimoles per liter | 0.63 (Standard Deviation) | 4 |
| Matching Placebo/700 mg Ofa | -0.00 millimoles per liter | 0.16 (Standard Deviation) | 4 |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 0.4 millimoles per liter | 2.7 (Standard Deviation) | 8 |
| 300 mg Ofa/Matching Placebo | -0.5 millimoles per liter | 2.8 (Standard Deviation) | 11 |
| 700 mg Ofa/Matching Placebo | -1.2 millimoles per liter | 1.3 (Standard Deviation) | 7 |
| Matching Placebo/100 mg Ofa | 0.5 millimoles per liter | 1.7 (Standard Deviation) | 4 |
| Matching Placebo/300 mg Ofa | 0.8 millimoles per liter | 2.1 (Standard Deviation) | 4 |
| Matching Placebo/700 mg Ofa | 0.5 millimoles per liter | 2.1 (Standard Deviation) | 4 |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 0.5 millimoles per liter | 1.6 (Standard Deviation) | 8 |
| 300 mg Ofa/Matching Placebo | -0.8 millimoles per liter | 1.6 (Standard Deviation) | 11 |
| 700 mg Ofa/Matching Placebo | 0.4 millimoles per liter | 1.5 (Standard Deviation) | 7 |
| Matching Placebo/100 mg Ofa | -0.6 millimoles per liter | 0.8 (Standard Deviation) | 4 |
| Matching Placebo/300 mg Ofa | -0.7 millimoles per liter | 2.1 (Standard Deviation) | 4 |
| Matching Placebo/700 mg Ofa | -0.1 millimoles per liter | 0.4 (Standard Deviation) | 4 |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | -0.0 millimoles per liter | 2.9 (Standard Deviation) | 8 |
| 300 mg Ofa/Matching Placebo | -0.7 millimoles per liter | 2.8 (Standard Deviation) | 11 |
| 700 mg Ofa/Matching Placebo | 0.6 millimoles per liter | 1.3 (Standard Deviation) | 7 |
| Matching Placebo/100 mg Ofa | 0.6 millimoles per liter | 0.2 (Standard Deviation) | 4 |
| Matching Placebo/300 mg Ofa | 1.9 millimoles per liter | 3.1 (Standard Deviation) | 4 |
| Matching Placebo/700 mg Ofa | 1.0 millimoles per liter | 2.3 (Standard Deviation) | 4 |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 0.10 millimoles per liter | 0.5 (Standard Deviation) | 8 |
| 300 mg Ofa/Matching Placebo | 0.25 millimoles per liter | 0.95 (Standard Deviation) | 11 |
| 700 mg Ofa/Matching Placebo | -0.05 millimoles per liter | 0.51 (Standard Deviation) | 7 |
| Matching Placebo/100 mg Ofa | 0.09 millimoles per liter | 0.56 (Standard Deviation) | 4 |
| Matching Placebo/300 mg Ofa | -0.64 millimoles per liter | 0.44 (Standard Deviation) | 4 |
| Matching Placebo/700 mg Ofa | 0.27 millimoles per liter | 0.79 (Standard Deviation) | 4 |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 4.21 millimoles per liter | 0.11 (Standard Deviation) | 8 |
| 300 mg Ofa/Matching Placebo | 4.43 millimoles per liter | 0.44 (Standard Deviation) | 11 |
| 700 mg Ofa/Matching Placebo | 4.18 millimoles per liter | 0.34 (Standard Deviation) | 7 |
| Matching Placebo/100 mg Ofa | 4.23 millimoles per liter | 0.32 (Standard Deviation) | 4 |
| Matching Placebo/300 mg Ofa | 3.98 millimoles per liter | 0.1 (Standard Deviation) | 4 |
| Matching Placebo/700 mg Ofa | 4.20 millimoles per liter | 0.32 (Standard Deviation) | 4 |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | -2.3 millimoles per liter | 1.6 (Standard Deviation) | 8 |
| 300 mg Ofa/Matching Placebo | -0.07 millimoles per liter | 3.1 (Standard Deviation) | 11 |
| 700 mg Ofa/Matching Placebo | 0.7 millimoles per liter | 1 (Standard Deviation) | 7 |
| Matching Placebo/100 mg Ofa | -0.5 millimoles per liter | 3.7 (Standard Deviation) | 4 |
| Matching Placebo/300 mg Ofa | -0.7 millimoles per liter | 1.2 (Standard Deviation) | 4 |
| Matching Placebo/700 mg Ofa | 0.8 millimoles per liter | 1 (Standard Deviation) | 4 |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 0.13 millimoles per liter | 1.4 (Standard Deviation) | 8 |
| 300 mg Ofa/Matching Placebo | -0.05 millimoles per liter | 1.32 (Standard Deviation) | 11 |
| 700 mg Ofa/Matching Placebo | -0.19 millimoles per liter | 0.68 (Standard Deviation) | 7 |
| Matching Placebo/100 mg Ofa | -0.30 millimoles per liter | 1.04 (Standard Deviation) | 4 |
| Matching Placebo/300 mg Ofa | 1.00 millimoles per liter | 2.2 (Standard Deviation) | 4 |
| Matching Placebo/700 mg Ofa | -0.17 millimoles per liter | 0.46 (Standard Deviation) | 4 |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | -1.00 millimoles per liter | 8 | |
| 300 mg Ofa/Matching Placebo | Not reached | 11 | |
| 700 mg Ofa/Matching Placebo | Not reached | 7 | |
| Matching Placebo/100 mg Ofa | Not reached | 4 | |
| Matching Placebo/300 mg Ofa | Not reached | 4 | |
| Matching Placebo/700 mg Ofa | Not reached | 4 | |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 1.77 millimoles per liter | 8 | |
| 300 mg Ofa/Matching Placebo | Not reached | 11 | |
| 700 mg Ofa/Matching Placebo | Not reached | 7 | |
| Matching Placebo/100 mg Ofa | Not reached | 4 | |
| Matching Placebo/300 mg Ofa | Not reached | 4 | |
| Matching Placebo/700 mg Ofa | Not reached | 4 | |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 0.00 millimoles per liter | 8 | |
| 300 mg Ofa/Matching Placebo | Not reached | 11 | |
| 700 mg Ofa/Matching Placebo | Not reached | 7 | |
| Matching Placebo/100 mg Ofa | Not reached | 4 | |
| Matching Placebo/300 mg Ofa | Not reached | 4 | |
| Matching Placebo/700 mg Ofa | Not reached | 4 | |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 1.00 millimoles per liter | 8 | |
| 300 mg Ofa/Matching Placebo | Not reached | 11 | |
| 700 mg Ofa/Matching Placebo | Not reached | 7 | |
| Matching Placebo/100 mg Ofa | Not reached | 4 | |
| Matching Placebo/300 mg Ofa | Not reached | 4 | |
| Matching Placebo/700 mg Ofa | Not reached | 4 | |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 1.00 millimoles per liter | 8 | |
| 300 mg Ofa/Matching Placebo | Not reached | 11 | |
| 700 mg Ofa/Matching Placebo | Not reached | 7 | |
| Matching Placebo/100 mg Ofa | Not reached | 4 | |
| Matching Placebo/300 mg Ofa | Not reached | 4 | |
| Matching Placebo/700 mg Ofa | Not reached | 4 |
Change From Baseline (Week 0 for the FTP,Week 24 for the STP, and Week 0 for the IFUP) in Bilirubin and Creatinine at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 0.7 Micromoles per liter (µmol/L) | 5.2 (Standard Deviation) | 8 |
| 300 mg Ofa/Matching Placebo | -0.0 Micromoles per liter (µmol/L) | 4 (Standard Deviation) | 11 |
| 700 mg Ofa/Matching Placebo | 1.2 Micromoles per liter (µmol/L) | 2.2 (Standard Deviation) | 7 |
| Matching Placebo/100 mg Ofa | 0.5 Micromoles per liter (µmol/L) | 4 (Standard Deviation) | 4 |
| Matching Placebo/300 mg Ofa | -2.6 Micromoles per liter (µmol/L) | 3.5 (Standard Deviation) | 4 |
| Matching Placebo/700 mg Ofa | 0.3 Micromoles per liter (µmol/L) | 5.3 (Standard Deviation) | 4 |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 3.2 Micromoles per liter (µmol/L) | 11.8 (Standard Deviation) | 8 |
| 300 mg Ofa/Matching Placebo | -0.1 Micromoles per liter (µmol/L) | 7.6 (Standard Deviation) | 11 |
| 700 mg Ofa/Matching Placebo | 2.5 Micromoles per liter (µmol/L) | 4.7 (Standard Deviation) | 7 |
| Matching Placebo/100 mg Ofa | 2.5 Micromoles per liter (µmol/L) | 5.7 (Standard Deviation) | 4 |
| Matching Placebo/300 mg Ofa | -2.9 Micromoles per liter (µmol/L) | 7.8 (Standard Deviation) | 4 |
| Matching Placebo/700 mg Ofa | -1.2 Micromoles per liter (µmol/L) | 4 (Standard Deviation) | 4 |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 1.5 Micromoles per liter (µmol/L) | 4.9 (Standard Deviation) | 8 |
| 300 mg Ofa/Matching Placebo | -0.1 Micromoles per liter (µmol/L) | 4.8 (Standard Deviation) | 11 |
| 700 mg Ofa/Matching Placebo | 1.5 Micromoles per liter (µmol/L) | 3.5 (Standard Deviation) | 7 |
| Matching Placebo/100 mg Ofa | 0.7 Micromoles per liter (µmol/L) | 3.4 (Standard Deviation) | 4 |
| Matching Placebo/300 mg Ofa | -2.8 Micromoles per liter (µmol/L) | 1 (Standard Deviation) | 4 |
| Matching Placebo/700 mg Ofa | 0.6 Micromoles per liter (µmol/L) | 2.8 (Standard Deviation) | 4 |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 3.0 Micromoles per liter (µmol/L) | 8.7 (Standard Deviation) | 8 |
| 300 mg Ofa/Matching Placebo | -1.9 Micromoles per liter (µmol/L) | 5.3 (Standard Deviation) | 11 |
| 700 mg Ofa/Matching Placebo | -0.3 Micromoles per liter (µmol/L) | 4.1 (Standard Deviation) | 7 |
| Matching Placebo/100 mg Ofa | 3.5 Micromoles per liter (µmol/L) | 6.7 (Standard Deviation) | 4 |
| Matching Placebo/300 mg Ofa | -5.0 Micromoles per liter (µmol/L) | 6.5 (Standard Deviation) | 4 |
| Matching Placebo/700 mg Ofa | 2.0 Micromoles per liter (µmol/L) | 12.5 (Standard Deviation) | 4 |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | -4.70 Micromoles per liter (µmol/L) | 8 | |
| 300 mg Ofa/Matching Placebo | Not reached | 11 | |
| 700 mg Ofa/Matching Placebo | Not reached | 7 | |
| Matching Placebo/100 mg Ofa | Not reached | 4 | |
| Matching Placebo/300 mg Ofa | Not reached | 4 | |
| Matching Placebo/700 mg Ofa | Not reached | 4 | |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 11.5 Micromoles per liter (µmol/L) | 8 | |
| 300 mg Ofa/Matching Placebo | Not reached | 11 | |
| 700 mg Ofa/Matching Placebo | Not reached | 7 | |
| Matching Placebo/100 mg Ofa | Not reached | 4 | |
| Matching Placebo/300 mg Ofa | Not reached | 4 | |
| Matching Placebo/700 mg Ofa | Not reached | 4 |
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 0.05 grams per liter | 0.16 (Standard Deviation) | 8 |
| 300 mg Ofa/Matching Placebo | 0.08 grams per liter | 0.16 (Standard Deviation) | 10 |
| 700 mg Ofa/Matching Placebo | 0.40 grams per liter | 0.4 (Standard Deviation) | 7 |
| Matching Placebo/100 mg Ofa | -0.07 grams per liter | 0.18 (Standard Deviation) | 4 |
| Matching Placebo/300 mg Ofa | 0 grams per liter | 0.44 (Standard Deviation) | 4 |
| Matching Placebo/700 mg Ofa | 0.49 grams per liter | 0.35 (Standard Deviation) | 4 |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | -0.6 grams per liter | 1 (Standard Deviation) | 8 |
| 300 mg Ofa/Matching Placebo | -0.1 grams per liter | 0.8 (Standard Deviation) | 10 |
| 700 mg Ofa/Matching Placebo | 1.2 grams per liter | 1 (Standard Deviation) | 7 |
| Matching Placebo/100 mg Ofa | -0.5 grams per liter | 1 (Standard Deviation) | 4 |
| Matching Placebo/300 mg Ofa | -0.3 grams per liter | 0.9 (Standard Deviation) | 4 |
| Matching Placebo/700 mg Ofa | 1.4 grams per liter | 0.9 (Standard Deviation) | 4 |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | -0.09 grams per liter | 0.14 (Standard Deviation) | 8 |
| 300 mg Ofa/Matching Placebo | -0.13 grams per liter | 0.39 (Standard Deviation) | 10 |
| 700 mg Ofa/Matching Placebo | -0.19 grams per liter | 0.09 (Standard Deviation) | 7 |
| Matching Placebo/100 mg Ofa | 0.25 grams per liter | 0.25 (Standard Deviation) | 4 |
| Matching Placebo/300 mg Ofa | -0.07 grams per liter | 0.19 (Standard Deviation) | 4 |
| Matching Placebo/700 mg Ofa | 0.04 grams per liter | 0.08 (Standard Deviation) | 4 |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 0.08 grams per liter | 0.24 (Standard Deviation) | 8 |
| 300 mg Ofa/Matching Placebo | -0.03 grams per liter | 0.39 (Standard Deviation) | 10 |
| 700 mg Ofa/Matching Placebo | 0.13 grams per liter | 0.11 (Standard Deviation) | 7 |
| Matching Placebo/100 mg Ofa | -0.00 grams per liter | 0.24 (Standard Deviation) | 4 |
| Matching Placebo/300 mg Ofa | 0.05 grams per liter | 0.21 (Standard Deviation) | 4 |
| Matching Placebo/700 mg Ofa | 0.29 grams per liter | 0.26 (Standard Deviation) | 4 |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | -0.8 grams per liter | 1.2 (Standard Deviation) | 8 |
| 300 mg Ofa/Matching Placebo | 0.5 grams per liter | 1.6 (Standard Deviation) | 10 |
| 700 mg Ofa/Matching Placebo | 1.0 grams per liter | 0.7 (Standard Deviation) | 7 |
| Matching Placebo/100 mg Ofa | -0.6 grams per liter | 1.2 (Standard Deviation) | 4 |
| Matching Placebo/300 mg Ofa | 0.2 grams per liter | 1.6 (Standard Deviation) | 4 |
| Matching Placebo/700 mg Ofa | 1.2 grams per liter | 0.6 (Standard Deviation) | 4 |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | -0.17 grams per liter | 0.24 (Standard Deviation) | 8 |
| 300 mg Ofa/Matching Placebo | -0.21 grams per liter | 0.22 (Standard Deviation) | 10 |
| 700 mg Ofa/Matching Placebo | -0.18 grams per liter | 0.24 (Standard Deviation) | 7 |
| Matching Placebo/100 mg Ofa | -0.24 grams per liter | 0.24 (Standard Deviation) | 4 |
| Matching Placebo/300 mg Ofa | -0.40 grams per liter | 0.17 (Standard Deviation) | 4 |
| Matching Placebo/700 mg Ofa | -0.13 grams per liter | 0.04 (Standard Deviation) | 4 |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | -0.23 grams per liter | 8 | |
| 300 mg Ofa/Matching Placebo | Not reached | 10 | |
| 700 mg Ofa/Matching Placebo | Not reached | 7 | |
| Matching Placebo/100 mg Ofa | Not reached | 4 | |
| Matching Placebo/300 mg Ofa | Not reached | 4 | |
| Matching Placebo/700 mg Ofa | Not reached | 4 | |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | -0.60 grams per liter | 8 | |
| 300 mg Ofa/Matching Placebo | Not reached | 10 | |
| 700 mg Ofa/Matching Placebo | Not reached | 7 | |
| Matching Placebo/100 mg Ofa | Not reached | 4 | |
| Matching Placebo/300 mg Ofa | Not reached | 4 | |
| Matching Placebo/700 mg Ofa | Not reached | 4 | |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | -0.07 grams per liter | 8 | |
| 300 mg Ofa/Matching Placebo | Not reached | 10 | |
| 700 mg Ofa/Matching Placebo | Not reached | 7 | |
| Matching Placebo/100 mg Ofa | Not reached | 4 | |
| Matching Placebo/300 mg Ofa | Not reached | 4 | |
| Matching Placebo/700 mg Ofa | Not reached | 4 |
Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Blood Pressure (BP) at Week 24 (FTP) and Week 48 (STP)
FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 5.3 millimeters of mercury | 11.2 (Standard Deviation) | 8 |
| 300 mg Ofa/Matching Placebo | -2.3 millimeters of mercury | 11.1 (Standard Deviation) | 11 |
| 700 mg Ofa/Matching Placebo | -5.4 millimeters of mercury | 9.7 (Standard Deviation) | 7 |
| Matching Placebo/100 mg Ofa | -3.5 millimeters of mercury | 7.2 (Standard Deviation) | 4 |
| Matching Placebo/300 mg Ofa | 4.0 millimeters of mercury | 4.9 (Standard Deviation) | 4 |
| Matching Placebo/700 mg Ofa | -1.8 millimeters of mercury | 2.2 (Standard Deviation) | 4 |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 11.0 millimeters of mercury | 19.7 (Standard Deviation) | 8 |
| 300 mg Ofa/Matching Placebo | -2.5 millimeters of mercury | 12.3 (Standard Deviation) | 11 |
| 700 mg Ofa/Matching Placebo | -3.1 millimeters of mercury | 14.2 (Standard Deviation) | 7 |
| Matching Placebo/100 mg Ofa | 1.5 millimeters of mercury | 11.3 (Standard Deviation) | 4 |
| Matching Placebo/300 mg Ofa | 1.0 millimeters of mercury | 9 (Standard Deviation) | 4 |
| Matching Placebo/700 mg Ofa | -6.5 millimeters of mercury | 9.5 (Standard Deviation) | 4 |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 6.6 millimeters of mercury | 4.6 (Standard Deviation) | 8 |
| 300 mg Ofa/Matching Placebo | 2.1 millimeters of mercury | 12 (Standard Deviation) | 11 |
| 700 mg Ofa/Matching Placebo | 0.1 millimeters of mercury | 7.8 (Standard Deviation) | 7 |
| Matching Placebo/100 mg Ofa | 3.0 millimeters of mercury | 4.7 (Standard Deviation) | 4 |
| Matching Placebo/300 mg Ofa | 3.3 millimeters of mercury | 5.8 (Standard Deviation) | 4 |
| Matching Placebo/700 mg Ofa | 6.0 millimeters of mercury | 5.8 (Standard Deviation) | 4 |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 2.0 millimeters of mercury | 14.5 (Standard Deviation) | 8 |
| 300 mg Ofa/Matching Placebo | -2.5 millimeters of mercury | 13.9 (Standard Deviation) | 11 |
| 700 mg Ofa/Matching Placebo | -4.9 millimeters of mercury | 8.2 (Standard Deviation) | 7 |
| Matching Placebo/100 mg Ofa | -2.3 millimeters of mercury | 7.4 (Standard Deviation) | 4 |
| Matching Placebo/300 mg Ofa | 1.7 millimeters of mercury | 10.4 (Standard Deviation) | 4 |
| Matching Placebo/700 mg Ofa | 4.5 millimeters of mercury | 1 (Standard Deviation) | 4 |
Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Pulse Rate at Week 24 (FTP) and Week 48 (STP)
FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | -0.3 beats per minute | 11.5 (Standard Deviation) | 8 |
| 300 mg Ofa/Matching Placebo | 1.6 beats per minute | 8.4 (Standard Deviation) | 11 |
| 700 mg Ofa/Matching Placebo | 0.6 beats per minute | 10.7 (Standard Deviation) | 7 |
| Matching Placebo/100 mg Ofa | 1.3 beats per minute | 13.8 (Standard Deviation) | 4 |
| Matching Placebo/300 mg Ofa | 2.0 beats per minute | 8 (Standard Deviation) | 4 |
| Matching Placebo/700 mg Ofa | 3.8 beats per minute | 8.1 (Standard Deviation) | 4 |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | -0.1 beats per minute | 9.8 (Standard Deviation) | 8 |
| 300 mg Ofa/Matching Placebo | 0.4 beats per minute | 11.9 (Standard Deviation) | 11 |
| 700 mg Ofa/Matching Placebo | -3.0 beats per minute | 10.7 (Standard Deviation) | 7 |
| Matching Placebo/100 mg Ofa | -5.5 beats per minute | 10 (Standard Deviation) | 4 |
| Matching Placebo/300 mg Ofa | -0.3 beats per minute | 9.5 (Standard Deviation) | 4 |
| Matching Placebo/700 mg Ofa | 8.0 beats per minute | 5 (Standard Deviation) | 4 |
Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Temperature at Week 24 (FTP) and Week 48 (STP)
FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | -0.1 Degrees Celsius | 0.5 (Standard Deviation) | 8 |
| 300 mg Ofa/Matching Placebo | 0.1 Degrees Celsius | 0.2 (Standard Deviation) | 11 |
| 700 mg Ofa/Matching Placebo | -0.2 Degrees Celsius | 0.5 (Standard Deviation) | 7 |
| Matching Placebo/100 mg Ofa | -0.1 Degrees Celsius | 0.4 (Standard Deviation) | 4 |
| Matching Placebo/300 mg Ofa | 0.3 Degrees Celsius | 0.5 (Standard Deviation) | 4 |
| Matching Placebo/700 mg Ofa | -0.3 Degrees Celsius | 0.3 (Standard Deviation) | 4 |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | -0.1 Degrees Celsius | 0.4 (Standard Deviation) | 8 |
| 300 mg Ofa/Matching Placebo | 0.1 Degrees Celsius | 0.2 (Standard Deviation) | 11 |
| 700 mg Ofa/Matching Placebo | 0.1 Degrees Celsius | 0.5 (Standard Deviation) | 7 |
| Matching Placebo/100 mg Ofa | -0.1 Degrees Celsius | 0.2 (Standard Deviation) | 4 |
| Matching Placebo/300 mg Ofa | 0.2 Degrees Celsius | 0.3 (Standard Deviation) | 4 |
| Matching Placebo/700 mg Ofa | 0.1 Degrees Celsius | 0.3 (Standard Deviation) | 4 |
Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Complement Activation (CH50) at Week 24 (FTP) and Week 48 (STP)
FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | -0.6 Units per milliliter | 4.1 (Standard Deviation) | 8 |
| 300 mg Ofa/Matching Placebo | -7.1 Units per milliliter | 12.9 (Standard Deviation) | 7 |
| Matching Placebo/100 mg Ofa | 2.8 Units per milliliter | 9.1 (Standard Deviation) | 4 |
| Matching Placebo/300 mg Ofa | -19.5 Units per milliliter | 24.7 (Standard Deviation) | 2 |
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 3.8 Units per milliliter | 7.8 (Standard Deviation) | 8 |
| 300 mg Ofa/Matching Placebo | Not reached | 7 | |
| Matching Placebo/100 mg Ofa | -31.0 Units per milliliter | 0 (Standard Deviation) | 4 |
| Matching Placebo/300 mg Ofa | Not reached | 2 |
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| 100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo | 8 | 0 (0.0%) | |
| 300 mg Ofa/Matching Placebo | 11 | 2 (18.2%) | |
| 700 mg Ofa/Matching Placebo | 7 | 0 (0.0%) | |
| Matching Placebo/100 mg Ofa | 4 | 1 (25.0%) | |
| Matching Placebo/300 mg Ofa | 4 | 0 (0.0%) | |
| Matching Placebo/700 mg Ofa | 4 | 0 (0.0%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Number of Participants With Any Adverse Event
First Treatment Period (FTP): From Visit 3 (Week 0) up to Visit 10 (Week 24); Second Treatment Period (STP): From Visit 10 (Week 24) up to Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)
SafetyNumber of Participants With the Indicated Critical Adverse Events (CAEs)
FTP: From Visit 3 (Week 0) up to Visit 10 (Week 24); STP: From Visit 10 (Week 24) up to Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)
SpasticitySafetyNumber of Participants With Negative or Unconfirmed Human Anti-human Antibodies (HAHA) in Which Concentrations of Ofa Were Below 500 Nanograms Per Milliliter (ng/ml)
Visit 3 (Week 0), Visit 10 (Week 24), Visit 17 (Week 48) or early withdrawal (EW), and Visit 26 (Week 104)
Number of Participants With Abnormal Physical Examination Findings
FTP: From Visit 3 (Week 0) up to Visit 10 (Week 24); STP: From Visit 10 (Week 24) up to Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: Visit 26 (Week 104)
Immune responseChange From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Erythrocyte Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: Visit 26 (Week 104)
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hematocrit at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: Visit 26 (Week 104)
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hemoglobin Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: Visit 26 (Week 104)
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Albumin at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: VIsit 26 (Week 104)
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)
Change From Baseline (Week 0 for the FTP,Week 24 for the STP, and Week 0 for the IFUP) in Bilirubin and Creatinine at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)
Immune responseChange From Baseline (Week 0 for the FTP and Week 24 for the STP) in Blood Pressure (BP) at Week 24 (FTP) and Week 48 (STP)
FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48)
Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Pulse Rate at Week 24 (FTP) and Week 48 (STP)
FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48)
Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Temperature at Week 24 (FTP) and Week 48 (STP)
FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48)
Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Complement Activation (CH50) at Week 24 (FTP) and Week 48 (STP)
FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48)
Immune response
Other measures (9)
Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)
FTP: From Visit 3 (Week 0) up to Visit 10 (Week 24); STP: From Visit 10 (Week 24) up to Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)
RelapsesMRI lesionsTotal Volume of T2 Lesions at Week 24 and Week 48
Visit 10 (Week 24) and Visit 17 (Week 48)
MRI lesionsOfa Drug Concentration After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) Intravenous (i.v.) Infusions
Visit 3 (Week 0), Visit 4 (Week 2), Visit 10 (Week 24), and Visit 11 (Week 26). Samples were drawn predose, immediately following the end of infusion, 10 minutes after infusion, 1 hour after infusion,
The Maximum Observed Plasma Concentration (Cmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions
Visit 3 (Week 0), Visit 4, (Week 2), Visit 10 (Week 24), and Visit 11 (Week 26). Samples were drawn predose, immediately following the end of infusion, 10 minutes after infusion, 1 hour after infusion
How the body handles the medicineThe Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point (AUC(0-t)) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions
Visit 3 (Week 0), Visit 4 (Week 2), Visit 10 (Week 24), and Visit 11 (Week 26). Samples were drawn predose, immediately following the end of infusion, 10 minutes after infusion, 1 hour (hr) after infu
How the body handles the medicineTime to Reach Cmax (Tmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions
Visit 3 (Week 0), Visit 4 (Week 2),Visit 10 (Week 24), and Visit 11 (Week 26). Samples were drawn predose, immediately following the end of infusion, 10 minutes after infusion, 1 hour after infusion,
How the body handles the medicineClearance of Ofa Over the Course of Weeks 0-2 and 24-26
Weeks 0-2 and 24-26
How the body handles the medicineThe Volume of Distribution at Steady State (Vss) of Ofatumumab Over the Course of Weeks 0-2 and 24-26
Weeks 0-2 and 24-26
How the body handles the medicineHalf Life (t1/2) of Ofatumumab in the Terminal Elimination Phase Over the Course of Weeks 0-2 and 24-26
Weeks 0-2 and 24-26
MRI lesionsHow the body handles the medicine
Who could take part
Relapsing MS · 18 to 55 · EDSS 0 to 5.0
Show the full criteria
Inclusion criteria
* Patients with definite diagnosis of relapsing-remitting MS according to McDonald criteria * Patients with: * At least two confirmed relapses within the last 24 months or * At least one confirmed relapse within the last 12 months or * One confirmed relapse between 12 and 24 months prior to screening, and at least one documented T1 Gd-enhancing lesion on an MRI performed within 12 months prior to screening. * Patients with disability equivalent to Expanded Disability Status Scale (EDSS) score of 0-5.0 (both included) at screening * Neurologically stable patients with no evidence of relapse for at least 30 days prior to start of Screening and during the Screening Phase * Female patients must be either post-menopausal, surgically incapable of bearing children or practicing an acceptable method of birth control e.g. hormonal contraceptives, intrauterine device, spermicide and barrier as long as they are on trial medication and for a period of 1 year following the last infusion of trial drug. Females of childbearing potential must have a negative pregnancy test at screening visit prior to entry into the treatment period * Following receipt of verbal and written information about the trial, the patient must provide signed informed consent before any trial related activity is carried out.
Exclusion criteria
* Diagnosis of Secondary Progressive Multiple Sclerosis (SPMS), Primary Progressive Multiple Sclerosis (PPMS) or Progressive Relapsing Multiple Sclerosis (PRMS) or Neuromyelitis optica * Neurological findings consistent with Progressive Multifocal Leukoencephalopathy (PML) or confirmed PML * Findings on brain MRI scan indicating any other clinically significant brain abnormality other than MS * Patients unable to undergo MRI scans (e.g. due to pacemaker, severe claustrophobia, hypersensitivity to contrast media) or who lack adequate peripheral venous access * Patients who have had the following treatments: * Lymphocyte-depleting therapies (e.g. alemtuzumab (Campath®), anti-Cluster of Differentiation (CD4), cladribine, total body irradiation, bone marrow transplantation), mitoxantrone or cyclophosphamide at any time * Anti-CD20 treatments or any monoclonal antibodies at any time * Immunoglobulin, azathioprine, cyclosporine, tacrolimus or other immunosuppressive agents, immunomodulatory agents or plasma exchange within six months prior to randomization in the trial apart from Glatiramer Acetate and Interferon Beta (IFN-b). * Glatiramer Acetate or IFN-b within three months prior to the randomization in the trial. * Glucocorticoids or Adrenocorticotropic Hormone (ACTH) within one month prior to the screening in the trial. * Receipt of a live vaccine within one month prior to screening in the trial. * Plasmapheresis for treatment of relapses within 2 months prior to randomization in the trial. * Initiation of therapy with Statins or hormone replacement treatment within one month or less prior to screening in the trial. * Patients who have received other disease modifying therapies for MS may be allowed on a case to case basis after discussion with the sponsors medical monitor * Past or current history of medically significant adverse effects (including allergic reactions) from: * Cetirizine * Prednisolone * Paracetamol/acetaminophen * Plasma proteins or a known hypersensitivity to components of the investigational product. * Past or current malignancy, except for * Cervical carcinoma Stage 1B or less * Non-invasive basal cell and squamous cell skin carcinoma * Cancer diagnoses with a complete response of a duration of > 5 years. Patients with a prior history of hematological malignancies are excluded regardless of response * Clinically significant cardiac disease, including acute myocardial infarction within six months from screening, unstable angina, congestive heart failure, previous venous or arterial thrombosis or arrhythmia requiring therapy. * Electrocardiogram (ECG) showing significant abnormality that the treating investigator determines may jeopardize the subject's health (i.e. acute ischemia, left bundle branch or bifascicular block) * Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, immunodeficiency syndrome, pulmonary, cerebral, psychiatric or neurological disease which may impair their reliable participation in the trial or necessitate the use of medication not allowed by this protocol. * History of severe, clinically significant Central Nervous System (CNS) trauma (e.g. cerebral contusion, spinal cord compression) or a history or presence of myelopathy due to spinal cord compression by disk or vertebral disease * Chronic or ongoing active infectious disease requiring systemic treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active Hepatitis C. Any previous serious infections should be discussed with the sponsors medical monitor (e.g. opportunistic or atypical infections) * Female patients who are pregnant or nursing. * Use of an investigational drug or other experimental therapy for a condition other than MS within 4 weeks prior to screening. Any prior use of an investigational drug or other experimental therapy for MS at any time should be discussed with the medical monitor. * Current participation in any other interventional clinical trial. Participation in non-interventional trial requires approval of the protocol by the sponsor * Serum vitamin B12 below lower limit of normal * Positive polymerase chain reaction (PCR) screening for John Cunningham Virus (JC Virus) as measured by qualitative plasma and/or white blood cell JCV DNA * Serologic evidence of Hepatitis B (HB) infection based on the results of testing for Hepatitis B Surface Antigen (HBsAg), anti- Hepatitis B Core (HBc) and anti- Hepatitis B Surface (HBs) antibodies with eligibility based on the results as follows: * Patients positive for HBsAg are excluded * Patients negative for HBsAg but positive for both anti-HBc and anti-HBs antibodies (indicating past infection) are eligible * Patients negative for HBsAg and anti-HBc antibody but positive for anti-HBs antibody (indicating past vaccination) are eligible * Patients negative for HBsAg and anti-HBs antibody but positive for anti-HBc antibody will require clarification of their status by testing for HB DNA, which if positive will exclude the patient from participation * Patient with documented vaccination against Hepatitis B (primary and secondary immunization and booster) will be considered eligible for the trial. * Positive serology for HIV * Screening laboratory values: * White Blood Cell (WBC) \< 3.0 x 109/L * Neutrophils \< 2 x 109/L * Platelets \< 100 x 109/L * Circulating IgG level \< lower limit of normal (according to central laboratory range) * Serum Alanine Aminotransferase (S-ALAT) > 2.5 times the upper limit of normal (according to central laboratory range) * Serum Alpha Fetoprotein (S-AP) > 2.0 times the upper limit of normal (according to central laboratory range) * Serum Aspartate Aminotransferase (ASAT) >3.0 times the upper limit of normal (according to central laboratory range) * Bilirubin > 1.5 times the upper limit of normal (according to central laboratory range) * S-creatinine > the upper limit of normal (according to central laboratory range) * CD4 count \<500 cells/mm3, CD4:CD8 \<0.9 * Patients known or suspected of not being able to comply with a trial protocol (e.g. due to alcoholism, drug dependency or psychological disorder). * Positive test for Hepatitis C antibody confirmed with a Hepatitis C real time (RT) PCR assay. Patients who are positive for Hepatitis C antibody and negative when the Hepatitis C RT PCR assay is performed will be eligible for the study. Patients who are positive for Hepatitis C antibody and have a positive or indeterminate result when the Hepatitis C RT PCR assay is performed w
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The trial consists of a dose escalation, to establish the safety of ofatumumab in RRMS patients. A 48-week treatment period followed by an individualized follow-up period until normalization of peripheral B-cell counts or Immunoglobulin G (IgG) levels.
Papers
Loading reviews and guidelines…
Related trials
- A Study to Evaluate Pharmacokinetics, Safety, Tolerability, Immunogeni
Phase 2 · Not yet recruiting
Still running
- Switch to Ofatumumab and Level of Immunoglobulins
Recruiting
Still running
- Non-interventional Study of Subcutaneous Ocrelizumab in Persons With R
Recruiting
Still running
- The HIt HArd and hiT Early in Multiple Sclerosis Trial
Phase 2 · Recruiting
Still running
- Brain Imaging and Immune Changes During Remibrutinib Treatment in Mult
Recruiting
Still running
- Study to Assess Effects of Ublituximab in Pediatric Participants With
Phase 2 / Phase 3 · Recruiting
Still running
History
Started
May 2008
Main results due
May 2010
Finished
Oct 2011
Results posted
Dec 2012