Phase 4
Completed N=1,062
Phase IIIB-IV Long-Term Follow-up Study for Patients Who Participated in CAMMS03409
Source: ClinicalTrials.gov NCT02255656 ↗Enrolled (actual)
1,062
Serious AEs
22.4%
Results posted
Jul 2021
Primary outcomePrimary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), and Treatment-Emergent Serious Adverse Events (TESAEs) — 204; 500; 879; 55 Participants
◆ Published Evidence
Established
35citations · ~9 / year
Sustained reduction of serum neurofilament light chain over 7 years by alemtuzumab in early relapsing-remitting MS.
Summary
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.
Linked Publications (5)
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Sustained reduction of serum neurofilament light chain over 7 years by alemtuzumab in early relapsing-remitting MS.
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Autoimmunity and long-term safety and efficacy of alemtuzumab for multiple sclerosis: Benefit/risk following review of trial and post-marketing data.
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Safety and efficacy with alemtuzumab over 13 years in relapsing-remitting multiple sclerosis: final results from the open-label TOPAZ study.
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Alemtuzumab outcomes by age: Post hoc analysis from the randomized CARE-MS studies over 8 years.
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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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs), and Treatment-Emergent Serious Adverse Events (TESAEs) |
204; 500; 879; 55; 133; 237 | — |
| PRIMARY Number of Participants With Infusion-Associated Reactions (IAR) |
48; 89; 164 | — |
| PRIMARY Number of Participants With Adverse Events of Special Interest (AESI) |
12; 25; 44; 17; 42; 70 | — |
| PRIMARY Number of Participants With Potentially Clinically Significant Laboratory Abnormalities |
11; 28; 43; 2; 6; 12 | — |
| SECONDARY Annualized Relapse Rate |
0.1994; 0.1608 | — |
| SECONDARY Proportion of Participants Who Were Relapse Free |
29.59; 36.86 | — |
| SECONDARY Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 |
0.21; 0.03; 0.27; 0.08; 0.29; 0.10 | — |
| SECONDARY Brain Magnetic Resonance Imaging (MRI) Assessment: Number of Gadolinium Enhancing (Gd-enhancing) Lesions Per MRI Scan |
1.307; 1.558 | — |
| SECONDARY Brain Magnetic Resonance Imaging (MRI) Assessment: Number of New or Enlarged T2 Lesions Per MRI Scan |
8.033; 9.564 | — |
| SECONDARY Brain Magnetic Resonance Imaging (MRI) Assessment: Number of New T1 (and New Hypointense T1) Lesions Per MRI Scan |
1.719; 1.908 | — |
| SECONDARY Brain Magnetic Resonance Imaging (MRI) Assessment: Percent Change From Baseline in Volume of T1 Lesions at Months 12, 24, 36, 48, and 60 |
141.71; 64.73; 130.73; 67.48; 145.57; 104.41 | — |
| SECONDARY Brain Magnetic Resonance Imaging (MRI) Assessment: Percent Change From Baseline in Volume of T2 Lesions at Months 12, 24, 36, 48, and 60 |
21.44; 9.09; 17.53; 13.89; 24.24; 22.02 | — |
| SECONDARY Brain Magnetic Resonance Imaging (MRI) Assessment: Percent Change From Baseline in Brain Parenchymal Fraction (BPF) at Month 12, 24, 36, 48, and 60 |
-1.65; -1.49; -1.77; -1.68; -1.92; -1.84 | — |
| SECONDARY Change 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 |
0.54; 0.88; 0.20; 0.59; 0.08; 1.12 | — |
| SECONDARY Change From Baseline in Functional Assessment of Multiple Sclerosis (FAMS) Score at Month 12, 24, 36, 48, and 60 |
1.05; 2.83; -0.45; 2.73; 0.82; 2.70 | — |
| SECONDARY Change From Baseline in European Quality of Life -5 Dimension (EQ-5D) Score: Utility Scores at Month 12, 24, 36, 48, and 60 |
-0.01; -0.01; -0.02; -0.01; -0.04; -0.00 | — |
| SECONDARY Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Scores at Month 12, 24, 36, 48, and 60 |
-2.09; -1.05; -1.57; -0.39; 0.10; 1.42 | — |
| SECONDARY Modified Healthcare Resource Utilization Questionnaire (HRUQ): Number of Participants Who Reported Change in Employment Situation, Availing of Sick Leaves, Admissions and Stays in Hospital, Rehabilitation Centers or Nursing Homes Due to Multiple Sclerosis |
3; 7; 12; 11; 25; 44 | — |
| SECONDARY Modified HRUQ: Number of Participants Who Reported Other Changes/Changes in Lifestyle Due to Multiple Sclerosis |
0; 3; 7; 11; 21; 42 | — |
| SECONDARY Health Related Productivity Questionnaire (HRPQ): Number of Participants Reporting Current Employment Status (Part Time/Full Time/Not Employed) Due to Multiple Sclerosis |
127; 297; 528; 20; 54; 98 | — |
| SECONDARY HRPQ: Total Scheduled Working Hours and Number of Hours Missed From Work Due to Multiple Sclerosis |
34.0; 32.2; 32.9; 33.6; 32.3; 32.5 | — |
| SECONDARY HRPQ: Percentage Impact on Work Output Due to Multiple Sclerosis |
6.2; 10.2; 8.5; 8.7; 9.5; 9.0 | — |
| SECONDARY HRPQ: Total Scheduled Household Chores Hours; Number of Hours Missed From Household Chores Due to Multiple Sclerosis |
9.8; 11.0; 10.8; 10.3; 11.1; 10.9 | — |
| SECONDARY HRPQ: Percentage Impact on Work Output for Household Chores Due to Multiple Sclerosis |
16.0; 16.4; 16.8; 18.3; 16.6; 17.7 | — |
| SECONDARY HRPQ: Duration of Disease (in Months) Since Development of Multiple Sclerosis |
10.3; 10.2; 10.5 | — |
| SECONDARY HRPQ: Number of Participants Who Reported Impact on Work Due to Multiple Sclerosis |
22; 81; 125; 32; 88; 168 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02255656) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.