Phase IIIB-IV Long-Term Follow-up Study for Patients Who Participated
A Long-term Follow-up Study for Multiple Sclerosis Patients Who Have Completed the Alemtuzumab Extension Study (CAMMS03409)
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
- Alemtuzumab
CAMPATH-1 antigen inhibitor
Results by group
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), and Treatment-Emergent Serious Adverse Events (TESAEs)
From Baseline until the end of the study (up to a maximum duration of 5.6 years)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Delayed Alemtuzumab Treatment (DAT) | 204 Participants | 241 | |
| Initial Alemtuzumab Treatment (IAT) | 500 Participants | 598 | |
| Alemtuzumab | 879 Participants | 1062 | |
| Delayed Alemtuzumab Treatment (DAT) | 55 Participants | 241 | |
| Initial Alemtuzumab Treatment (IAT) | 133 Participants | 598 | |
| Alemtuzumab | 237 Participants | 1062 | |
| Delayed Alemtuzumab Treatment (DAT) | 0 Participants | 241 | |
| Initial Alemtuzumab Treatment (IAT) | 10 Participants | 598 | |
| Alemtuzumab | 11 Participants | 1062 | |
| Delayed Alemtuzumab Treatment (DAT) | 0 Participants | 241 | |
| Initial Alemtuzumab Treatment (IAT) | 2 Participants | 598 | |
| Alemtuzumab | 2 Participants | 1062 |
Number of Participants With Infusion-Associated Reactions (IAR)
Within 24 hours of any alemtuzumab infusion
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Delayed Alemtuzumab Treatment (DAT) | 48 Participants | 83 | |
| Initial Alemtuzumab Treatment (IAT) | 89 Participants | 164 | |
| Alemtuzumab | 164 Participants | 294 |
Delayed Alemtuzumab Treatment (DAT)
Initial Alemtuzumab Treatment (IAT)
Alemtuzumab
Number of Participants With Adverse Events of Special Interest (AESI)
From Baseline until the end of the study (up to a maximum duration of 5.6 years)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Delayed Alemtuzumab Treatment (DAT) | 12 Participants | 241 | |
| Initial Alemtuzumab Treatment (IAT) | 25 Participants | 598 | |
| Alemtuzumab | 44 Participants | 1062 | |
| Delayed Alemtuzumab Treatment (DAT) | 17 Participants | 241 | |
| Initial Alemtuzumab Treatment (IAT) | 42 Participants | 598 | |
| Alemtuzumab | 70 Participants | 1062 | |
| Delayed Alemtuzumab Treatment (DAT) | 0 Participants | 241 | |
| Initial Alemtuzumab Treatment (IAT) | 0 Participants | 598 | |
| Alemtuzumab | 0 Participants | 1062 | |
| Delayed Alemtuzumab Treatment (DAT) | 0 Participants | 241 | |
| Initial Alemtuzumab Treatment (IAT) | 0 Participants | 598 | |
| Alemtuzumab | 1 Participants | 1062 | |
| Delayed Alemtuzumab Treatment (DAT) | 27 Participants | 241 | |
| Initial Alemtuzumab Treatment (IAT) | 66 Participants | 598 | |
| Alemtuzumab | 100 Participants | 1062 | |
| Delayed Alemtuzumab Treatment (DAT) | 0 Participants | 241 | |
| Initial Alemtuzumab Treatment (IAT) | 0 Participants | 598 | |
| Alemtuzumab | 0 Participants | 1062 | |
| Delayed Alemtuzumab Treatment (DAT) | 0 Participants | 241 | |
| Initial Alemtuzumab Treatment (IAT) | 0 Participants | 598 | |
| Alemtuzumab | 0 Participants | 1062 | |
| Delayed Alemtuzumab Treatment (DAT) | 2 Participants | 241 | |
| Initial Alemtuzumab Treatment (IAT) | 4 Participants | 598 | |
| Alemtuzumab | 9 Participants | 1062 | |
| Delayed Alemtuzumab Treatment (DAT) | 10 Participants | 241 | |
| Initial Alemtuzumab Treatment (IAT) | 35 Participants | 598 | |
| Alemtuzumab | 60 Participants | 1062 | |
| Delayed Alemtuzumab Treatment (DAT) | 6 Participants | 241 | |
| Initial Alemtuzumab Treatment (IAT) | 15 Participants | 598 | |
| Alemtuzumab | 27 Participants | 1062 | |
| Delayed Alemtuzumab Treatment (DAT) | 0 Participants | 241 | |
| Initial Alemtuzumab Treatment (IAT) | 0 Participants | 598 | |
| Alemtuzumab | 0 Participants | 1062 |
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities
From Baseline until the end of the study (up to a maximum duration of 5.6 years)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Delayed Alemtuzumab Treatment (DAT) | 11 Participants | 214 | |
| Initial Alemtuzumab Treatment (IAT) | 28 Participants | 316 | |
| Alemtuzumab (Overall) | 43 Participants | 619 | |
| Delayed Alemtuzumab Treatment (DAT) | 2 Participants | 214 | |
| Initial Alemtuzumab Treatment (IAT) | 6 Participants | 316 | |
| Alemtuzumab (Overall) | 12 Participants | 619 | |
| Delayed Alemtuzumab Treatment (DAT) | 32 Participants | 214 | |
| Initial Alemtuzumab Treatment (IAT) | 50 Participants | 316 | |
| Alemtuzumab (Overall) | 98 Participants | 619 | |
| Delayed Alemtuzumab Treatment (DAT) | 20 Participants | 214 | |
| Initial Alemtuzumab Treatment (IAT) | 42 Participants | 316 | |
| Alemtuzumab (Overall) | 70 Participants | 619 | |
| Delayed Alemtuzumab Treatment (DAT) | 6 Participants | 214 | |
| Initial Alemtuzumab Treatment (IAT) | 14 Participants | 316 | |
| Alemtuzumab (Overall) | 26 Participants | 619 | |
| Delayed Alemtuzumab Treatment (DAT) | 8 Participants | 214 | |
| Initial Alemtuzumab Treatment (IAT) | 7 Participants | 316 | |
| Alemtuzumab (Overall) | 21 Participants | 619 | |
| Delayed Alemtuzumab Treatment (DAT) | 5 Participants | 214 | |
| Initial Alemtuzumab Treatment (IAT) | 16 Participants | 316 | |
| Alemtuzumab (Overall) | 25 Participants | 619 | |
| Delayed Alemtuzumab Treatment (DAT) | 1 Participants | 214 | |
| Initial Alemtuzumab Treatment (IAT) | 0 Participants | 316 | |
| Alemtuzumab (Overall) | 1 Participants | 619 |
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Delayed Alemtuzumab Treatment (DAT) | 241 | 55 (22.8%) | 0 |
| Initial Alemtuzumab Treatment (IAT) | 598 | 133 (22.2%) | 10 |
| Alemtuzumab | 1062 | 237 (22.3%) | 11 |
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 Treatment-Emergent Adverse Events (TEAEs), and Treatment-Emergent Serious Adverse Events (TESAEs)
From Baseline until the end of the study (up to a maximum duration of 5.6 years)
SafetyNumber of Participants With Infusion-Associated Reactions (IAR)
Within 24 hours of any alemtuzumab infusion
SafetyNumber of Participants With Adverse Events of Special Interest (AESI)
From Baseline until the end of the study (up to a maximum duration of 5.6 years)
SafetyNumber of Participants With Potentially Clinically Significant Laboratory Abnormalities
From Baseline until the end of the study (up to a maximum duration of 5.6 years)
Safety- Incidence, duration, grade/intensity, relationship to study drug, and outcome of the following: Serious Adverse Events; Adverse Events
Safety
Other measures (23)
Annualized Relapse Rate
Up to a maximum duration of 5.6 years
RelapsesProportion of Participants Who Were Relapse Free
Up to a maximum duration of 5.6 years
RelapsesChange From Baseline in Expanded Disability Status Scale (EDSS) Score at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Baseline (Month 0 of LPS13649), Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Disability progressionBladder, bowel and sexual functionBrain Magnetic Resonance Imaging (MRI) Assessment: Number of Gadolinium Enhancing (Gd-enhancing) Lesions Per MRI Scan
Up to a maximum duration of 5.6 years
MRI lesionsBrain Magnetic Resonance Imaging (MRI) Assessment: Number of New or Enlarged T2 Lesions Per MRI Scan
Up to a maximum duration of 5.6 years
MRI lesionsBrain Magnetic Resonance Imaging (MRI) Assessment: Number of New T1 (and New Hypointense T1) Lesions Per MRI Scan
Up to a maximum duration of 5.6 years
MRI lesionsBrain Magnetic Resonance Imaging (MRI) Assessment: Percent Change From Baseline in Volume of T1 Lesions at Months 12, 24, 36, 48, and 60
Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
MRI lesionsBrain Magnetic Resonance Imaging (MRI) Assessment: Percent Change From Baseline in Volume of T2 Lesions at Months 12, 24, 36, 48, and 60
Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
MRI lesionsBrain Magnetic Resonance Imaging (MRI) Assessment: Percent Change From Baseline in Brain Parenchymal Fraction (BPF) at Month 12, 24, 36, 48, and 60
Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
MRI lesionsBrain volume lossChange From Baseline in Self-reported Quality of Life (QoL) as Assessed by the Medical Outcome Study (MOS) 36-Item Short-Form Health Survey (SF-36): Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Month 12, 24, 36, 48, and 60
Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
PainQuality of life (reported by participants)
Who could take part
Relapsing MS · 18 and over
Show the full criteria
Inclusion criteria
Participant had completed at least 48 months of the Extension Study CAMMS03409. Signed written informed consent form.
Exclusion criteria
Participant participating in another investigational interventional study. The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Primary Objective: To evaluate long-term safety of alemtuzumab. Secondary Objectives: * To evaluate long term efficacy of alemtuzumab. * To evaluate the safety profile of participants who received other Disease Modifying Treatment (DMT) following alemtuzumab treatment. * To evaluate participant-reported Quality of Life (QoL) outcomes and health resource utilization of participant who received alemtuzumab. * To evaluate as needed re-treatment with alemtuzumab and other DMTs.
Papers
Results
Efficacy and Safety of Alemtuzumab Through 9 Years of Follow-up in Patients with Highly Active Disease: Post Hoc Analysis of CARE-MS I and II Patients in the TOPAZ Extension Study.CNS Drugs · 2020
Results
Pregnancy outcomes and postpartum relapse rates in women with RRMS treated with alemtuzumab in the phase 2 and 3 clinical development program over 16 years.Mult Scler Relat Disord · 2020
Results
Lymphocyte pharmacodynamics are not associated with autoimmunity or efficacy after alemtuzumab.Neurol Neuroimmunol Neuroinflamm · 2020
Results
Ziemssen T, Bass AD, Van Wijmeersch B, Eichau S, Richter S, Hoffmann F, Armstrong NM, Chirieac M, Cunha-Santos J, Singer BA. Long-term efficacy and safety of alemtuzumab in participants with highly active MS: TOPAZ clinical trial and interim analysis of TREAT-MS real-world study. Ther Adv Neurol Disord. 2025 Feb 10;18:17562864241306575. doi: 10.1177/17562864241306575. eCollection 2025.Results
Coles AJ, Achiron A, Traboulsee A, Singer BA, Pozzilli C, Oreja-Guevara C, Giovannoni G, Comi G, Freedman MS, Ziemssen T, Shiota D, Rawlings AM, Wong AT, Chirieac M, Montalban X. Safety and efficacy with alemtuzumab over 13 years in relapsing-remitting multiple sclerosis: final results from the open-label TOPAZ study. Ther Adv Neurol Disord. 2023 Sep 21;16:17562864231194823. doi: 10.1177/175628642Results
Coles AJ, Jones JL, Vermersch P, Traboulsee A, Bass AD, Boster A, Chan A, Comi G, Fernandez O, Giovannoni G, Kubala Havrdova E, LaGanke C, Montalban X, Oreja-Guevara C, Piehl F, Wiendl H, Ziemssen T. Autoimmunity and long-term safety and efficacy of alemtuzumab for multiple sclerosis: Benefit/risk following review of trial and post-marketing data. Mult Scler. 2022 Apr;28(5):842-846. doi: 10.1177/1Results
Kuhle J, Daizadeh N, Benkert P, Maceski A, Barro C, Michalak Z, Sormani MP, Godin J, Shankara S, Samad TA, Jacobs A, Chung L, Rӧsch N, Kaiser C, Mitchell CP, Leppert D, Havari E, Kappos L. Sustained reduction of serum neurofilament light chain over 7 years by alemtuzumab in early relapsing-remitting MS. Mult Scler. 2022 Apr;28(4):573-582. doi: 10.1177/13524585211032348. Epub 2021 Aug 11.Results
Bass AD, Arroyo R, Boster AL, Boyko AN, Eichau S, Ionete C, Limmroth V, Navas C, Pelletier D, Pozzilli C, Ravenscroft J, Sousa L, Tintore M, Uitdehaag BMJ, Baker DP, Daizadeh N, Choudhry Z, Rog D; CARE-MS I, CARE-MS II, CAMMS03409, and TOPAZ investigators. Alemtuzumab outcomes by age: Post hoc analysis from the randomized CARE-MS studies over 8 years. Mult Scler Relat Disord. 2021 Apr;49:102717. dResults
Steingo B, Al Malik Y, Bass AD, Berkovich R, Carraro M, Fernandez O, Ionete C, Massacesi L, Meuth SG, Mitsikostas DD, Pardo G, Simm RF, Traboulsee A, Choudhry Z, Daizadeh N, Compston DAS; CAMMS223, CAMMS03409, and TOPAZ Investigators. Long-term efficacy and safety of alemtuzumab in patients with RRMS: 12-year follow-up of CAMMS223. J Neurol. 2020 Nov;267(11):3343-3353. doi: 10.1007/s00415-020-0998Results
Comi G, Alroughani R, Boster AL, Bass AD, Berkovich R, Fernandez O, Kim HJ, Limmroth V, Lycke J, Macdonell RA, Sharrack B, Singer BA, Vermersch P, Wiendl H, Ziemssen T, Jacobs A, Daizadeh N, Rodriguez CE, Traboulsee A; CARE-MS I, CARE-MS II, CAMMS03409, and TOPAZ Investigators. Efficacy of alemtuzumab in relapsing-remitting MS patients who received additional courses after the initial two courses:
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History
Started
Jan 2015
Main results due
Jul 2020
Finished
Jul 2020
Results posted
Jul 2021