Phase 3
Completed N=840
Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study Two
Multiple Sclerosis, Relapsing-Remitting
Source: ClinicalTrials.gov NCT00548405 ↗
Enrolled (actual)
840
Serious AEs
19.7%
Results posted
Jan 2015
Primary outcomePrimary: Percentage of Participants With Sustained Accumulation of Disability (SAD) — 21.13; 12.71 percentage of participants — p=0.0084
Summary
The purpose of this study was to establish the efficacy and safety of two different doses of alemtuzumab (Lemtrada™) as a treatment for relapsing-remitting multiple sclerosis (MS), in comparison with subcutaneous interferon beta-1a (Rebif®). The study enrolled participants who had received an adequate trial of disease-modifying therapies but experienced at least 1 relapse during prior treatment, and who met a minimum severity of disease as measured by magnetic resonance imaging (MRI). Participants had monthly laboratory tests and comprehensive testing every 3 months.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Accumulation of Disability (SAD) |
21.13; 12.71 | 0.0084 sig |
| PRIMARY Annualized Relapse Rate |
0.52; 0.26 | <0.0001 sig |
| SECONDARY Percentage of Participants Who Were Relapse Free at Year 2 |
46.70; 65.38 | <0.0001 sig |
| SECONDARY Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Year 2 |
0.21; -0.20 | <0.0001 sig |
| SECONDARY Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score at Year 2 |
-0.03; 0.02; -0.04; 0.09 | 0.0022 sig |
| SECONDARY Percent Change From Baseline in Magnetic Resonance Imaging Time Constant 2 (MRI-T2) Hyperintense Lesion Volume at Year 2 |
2.41; -1.12 | 0.1371 |
Eligibility Criteria
Inclusion Criteria
- Signed informed consent form (ICF)
- Age 18 to 55 years (inclusive) as of the date the ICF was signed
- Diagnosis of MS per update of McDonald criteria
- Onset of MS symptoms (as determined by a neurologist; could be retrospectively) within 10 years of the date the ICF was signed
- Expanded Disability Status Scale (EDSS) score 0.0 to 5.0 (inclusive) at Screening
- Greater than or equal to (>=) 2 MS attacks (first episode or relapse) occurring in the 24 months prior to the date the ICF was signed, with >=1 attack in the 12 months prior to the date the ICF was signed, with objective neurological signs confirmed by a physician, nurse practitioner, or other Genzyme-approved health-care provider and the objective signs could be identified retrospectively
- >=1 MS relapse during treatment with a beta interferon therapy or glatiramer acetate after having been on that therapy for >=6 months within 10 years of the date the ICF was signed
- MRI scan demonstrating white matter lesions attributable to MS and meeting at least 1 of the following criteria, as determined by the neurologist or a radiologist: >=9 time constant 2 (T2) lesions at least 3 millimeter (mm) in any axis; a gadolinium- (Gd-) enhancing lesion at least 3 mm in any axis plus >=1 brain T2 lesions; and a spinal cord lesion consistent with MS plus >=1 brain T2 lesion
Exclusion Criteria
- Received prior therapy with alemtuzumab
- Current participation in another clinical study or previous participation in CAMMS323 (Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis, CARE-MS I)
- Treatment with natalizumab, methotrexate, azathioprine, or cyclosporine in the past 6 months. Participants who received one of these medications more than 6 months before the date the ICF was signed were eligible for study entry if approval was granted by Genzyme
- Any progressive form of MS
- History of malignancy (except basal skin cell carcinoma)
- CD4 +, CD8 +, CD19 + (that is, absolute CD3 + CD4 + , CD3 + CD8 + , or CD19 + /mm 3 ) count, absolute neutrophil count less than (<) lower limit of normal (LLN) at screening; if abnormal cell count(s) returned to within normal limits (WNL), eligibility could be reassessed
- Known bleeding disorder (for example, dysfibrinogenemia, factor IX deficiency, hemophilia, Von Willebrand's disease, disseminated intravascular coagulation, fibrinogen deficiency, or clotting factor deficiency)
- Significant autoimmune disease including but not limited to immune cytopenias, rheumatoid arthritis, systemic lupus erythematosus, other connective tissue disorders, vasculitis, inflammatory bowel disease, severe psoriasis
- Presence of anti-thyroid stimulating hormone (TSH) receptor (TSHR) antibodies (that is, above the LLN)
- Active infection or at high risk for infection
Data sourced from ClinicalTrials.gov (NCT00548405). 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.