Efficacy and Safety of Ofatumumab Compared to Placebo in Patients With
A 24-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Ofatumumab in Patients With Relapsing Multiple Sclerosis Followed by an Extended Treatment of at Least 24 Weeks With Open-label Ofatumumab
What it found
The main measure showed a statistically significant benefit.
| Measure | Estimate | 95% CI | p |
|---|---|---|---|
| Number of Gadolinium-enhancing T1 Lesions Per MRI Scan - Core Part | Rate ratio 0.064 | 0.018–0.232 | <0.001 |
Statistical analysis as posted on ClinicalTrials.gov.
What was tested
Treatment tested
- Ofatumumab
B-lymphocyte antigen CD20 binding agent
Placebo
- Matching placebo of ofatumumab
Results by group
Number of Gadolinium-enhancing T1 Lesions Per MRI Scan - Core Part
Baseline up to Week 24
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| OMB 20 mg | 0.0670 lesions per scan | 0.027–0.167 | 39 |
| Placebo | 1.0413 lesions per scan | 0.465–2.331 | 20 |
OMB 20 mg
Placebo
p = <0.001; Rate ratio 0.064 (95% CI 0.018–0.232)
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| OMB 20mg Core | 43 | 1 (2.3%) | 0 |
| Placebo Core | 21 | 0 (0.0%) | 0 |
| OMB 20mg Continued | 40 | 1 (2.5%) | 0 |
| OMB 20mg Switched (From Placebo) | 19 | 0 (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 Gadolinium-enhancing T1 Lesions Per MRI Scan - Core Part
Baseline up to Week 24
MRI lesions
Other measures (11)
Number of Gadolinium-enhancing T1 Lesions Per MRI Scan - Japan vs Non-Japan - Core Part
Baseline up to Week 24
MRI lesionsNumber of New or Enlarging T2 Lesions on MRI Scans (Annualized T2 Lesion Rate) - Core Part
Baseline up to Week 24
MRI lesionsAnnualized Relapse Rate (ARR) - Core Part
Baseline up to Week 24
Disability progressionRelapsesBladder, bowel and sexual functionPharmacokinetic (PK) Concentrations of Ofatumumab - Core Part
Pre-dose at Baseline, Days 2, 5, 7, 14, Weeks 4, 12, 24
How the body handles the medicineB-cell Counts - Japan vs Non-Japan - Core Part
Baseline, Days 2, 5, 7, 14, Weeks 4, 12, 24
Immune responseNumber of Gadolinium-enhancing T1 Lesions Per MRI Scan - Extension Part
Week 24 up to Week 48
MRI lesionsNumber of New or Enlarging T2 Lesions on MRI Scans (Annualized T2 Lesion Rate) - Extension Part
Week 24 up to Week 48
MRI lesionsAnnualized Relapse Rate (ARR) - Extension Part
Week 24 up to Week 48
Disability progressionRelapsesBladder, bowel and sexual functionPharmacokinetic (PK) Concentrations of Ofatumumab - Extension Part
Weeks 24, 28, 36, 48
How the body handles the medicineB-cell Counts - Extension Part
Weeks 24, 36 and 48
Immune response
Who could take part
Relapsing MS · 18 to 55 · EDSS 0 to 5.5
Show the full criteria
Inclusion criteria
* Diagnosis of multiple sclerosis (MS) * Relapsing MS (RMS) * At least 1 appearance of a new neurological abnormality or worsening of pre-existing neurological abnormality during the previous 2 years prior to Screening AND an MRI activity (Gd-enhancing T1 lesions or new or enlarging T2 lesions) in brain during the previous 1 year prior to randomization * EDSS score of 0 to 5.5
Exclusion criteria
* Primary progressive MS or SPMS without disease activity * Patients with an active chronic disease of the immune system other than MS * Patients at risk of developing or having reactivation of hepatitis * Patients with active systemic infections or with neurological findings consistent with PML
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The study provided efficacy, safety, and pharmacokinetics (PK) data for patients with relapsing multiple sclerosis (RMS) in Japan and the other countries
Papers
Loading reviews and guidelines…
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History
Started
Mar 2018
Main results due
Dec 2019
Finished
Jul 2020
Results posted
Feb 2022