A Phase II Study Comparing Low- and High-Dose Alemtuzumab and High-Dose Rebif® in Patients With Early, Active Relapsing-Remitting Multiple Sclerosis
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 2

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
    

Intervention name(s): Interferon beta-1a; Alemtuzumab 12 mg; Alemtuzumab 24 mg
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 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).
Other intervention name(s): Rebif®; Lemtrada; Lemtrada
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a; Alemtuzumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; Active Relapsing-Remitting Multiple Sclerosis