At a glance
ClinicalIndex Comparison Record- ✓Age 18–50 years at ICF signing
- ✓Diagnosed with RRMS per McDonald criteria with cranial MRI consistent with criteria
- ✓MS symptom onset within 3 years prior to screening
- ✓EDSS score 0.0–3.0 at screening and baseline
- ✕Prior MS immunotherapy other than steroids, including interferons, IVIG, glatiramer acetate, or mitoxantrone
- ✕Personal history of thyroid autoimmune disease
- ✕Personal history of clinically significant autoimmune disease (inflammatory bowel disease, diabetes, lupus, severe asthma)
- ✕History of thyroid carcinoma or malignancy (except basal cell skin carcinoma if disease-free ≥5 years)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II, Randomized, Open-Label, Three-Arm Study Comparing Low- and High-Dose Alemtuzumab and High-Dose Subcutaneous Interferon Beta-1a (Rebif®) in Patients With Early, Active Relapsing-Remitting Multiple Sclerosis
In Brief
A Phase 2 clinical trial evaluating Interferon beta-1a, Alemtuzumab 12 mg, and 1 other intervention for Multiple Sclerosis, Relapsing-Remitting. Completed, enrolled 334 participants across 49 sites in 5 countries.
Detailed Summary
This was a Phase II, randomized, open-label, rater-blinded, three-arm study comparing two different doses of alemtuzumab (Lemtrada™) and one dose of subcutaneous (SC) interferon beta-1a (Rebif®) in participants with early, active relapsing-remitting multiple sclerosis (MS) who had not been previously treated with MS therapies other than steroids. The study was conducted for an initial period of 3 years and a follow-up to 5 years or more.
Study Details
Timeline
Interventions
Interferon beta-1a 44 microgram (mcg) subcutaneously 3-times weekly for 36 months.
Alemtuzumab 12 milligram per day (mg/day) was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians' discretion if the cluster of differentiation 4+ \[CD4+\] T-cell count was \>=100\*10\^6 cells per liter).
Alemtuzumab 24 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians' discretion if the CD4+ T-cell count was \>=100\*10\^6 cells per liter).