NCT00050778

A Phase II Study Comparing Low- and High-Dose Alemtuzumab and High-Dose Rebif® in Patients With Early, Active Relapsing-Remitting Multiple Sclerosis

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 334 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The aims of MS therapy are to prevent the progression of disease and accumulation of long-term disability. The hypothesis underlying this study was that aggressive treatment of inflammation in the brain early in the course of MS would protect the participant from disease progression and accumulating disability. This protocol compared two different doses of alemtuzumab and high-dose, high frequency of SC interferon beta-1a to evaluate the safety profiles of the respective treatments and to evaluate efficacy in terms of: * Slowing the sustained accumulation of disability in participant with MS; * Reducing the frequency of relapses experienced by participant with MS; and * Reducing the harmful effects of MS on the brain, as assessed by magnetic resonance imaging (MRI) Participants who received alemtuzumab during the initial 36-month treatment period may have been eligible for re-treatment with alemtuzumab in the extension study CAMMS03409 (NCT00930553) to evaluate: * How long the effects of prior alemtuzumab treatment lasted; * If additional treatments with alemtuzumab continued to reduce the effects of MS; and * What kind of side effects participants experienced upon retreatment with alemtuzumab

Conditions

• Multiple Sclerosis, Relapsing-Remitting

Interventions

Type	Name	Description
BIOLOGICAL	Interferon beta-1a	Interferon beta-1a 44 microgram (mcg) subcutaneously 3-times weekly for 36 months.
BIOLOGICAL	Alemtuzumab 12 mg	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).
BIOLOGICAL	Alemtuzumab 24 mg	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).

Timeline

• Start date: 2002-12-01
• Primary completion: 2007-09-01
• Completion: 2010-01-01
• First posted: 2002-12-23
• Last updated: 2015-01-08
• Results posted: 2009-08-25

Locations

49 sites across 5 countries: United States, Croatia, Poland, Russia, United Kingdom