Phase 3
Completed N=581
Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study One
Multiple Sclerosis, Relapsing-Remitting
Source: ClinicalTrials.gov NCT00530348 ↗
Enrolled (actual)
581
Serious AEs
17.1%
Results posted
Nov 2014
Primary outcomePrimary: Percentage of Participants With Sustained Accumulation of Disability (SAD) — 11.12; 8.00 percentage of participants with SAD — p=0.2173
Summary
The purpose of this study was to establish the efficacy and safety of alemtuzumab (Lemtrada™) as a treatment for relapsing-remitting multiple sclerosis (MS), in comparison with subcutaneous (SC) interferon beta-1a (Rebif®). The study had enrolled participants who had not previously received MS disease-modifying therapies. 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) |
11.12; 8.00 | 0.2173 |
| PRIMARY Annualized Relapse Rate |
0.39; 0.18 | <0.0001 sig |
| SECONDARY Percentage of Participants Who Were Relapse Free at Year 2 |
58.69; 77.59 | <0.0001 sig |
| SECONDARY Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Year 2 |
-0.2; -0.2 | 0.4188 |
| SECONDARY Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score at Year 2 |
0.05; -0.02; 0.07; 0.15 | 0.0115 sig |
| SECONDARY Percent Change From Baseline in Magnetic Resonance Imaging Time Constant 2 (MRI-T2) Hyperintense Lesion Volume at Year 2 |
-6.68; -10.28 | 0.3080 |
Eligibility Criteria
Inclusion Criteria
- Given written/signed informed consent
- Age 18 to 50 years old (inclusive) as of the date the informed consent form (ICF) was signed
- Diagnosis of MS per updated McDonald criteria, and cranial magnetic resonance imaging (MRI) scan demonstrating white matter lesions attributable to MS within 5 years of screening
- Onset of MS symptoms (as determined by a neurologist, either at screening or retrospectively) within 5 years of the date the ICF was signed
- Expanded Disability Status Scale (EDSS) score 0.0 to 3.0 (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
Exclusion Criteria
- Received prior therapy for MS other than corticosteroids, for example, alemtuzumab, interferons, intravenous immunoglobulin, glatiramer acetate, natalizumab, and mitoxantrone
- Exposure to azathioprine, cladribine, cyclophosphamide, cyclosporine A, methotrexate, or any other immunosuppressive agent other than systemic corticosteroid treatment
- Any progressive form of MS
- History of malignancy (except basal skin cell carcinoma)
- CD4 + , CD8 + count, B cell, or absolute neutrophil count less than (<) lower limit of normal (LLN) at screening
- 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 (NCT00530348). 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.