Conditions: Relapsing Remitting Multiple Sclerosis
Keywords: MS
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 84
Healthy volunteers: no

Brief summary:
This was a multicenter, randomized, open-label, parallel-group, active-controlled study. Prior to randomization, participants were to have been treated with glatiramer acetate or interferon β-1a (44 μg). Participants were to be randomized to receive natalizumab, interferon β-1a 44 μg, or glatiramer acetate.

Detailed description:
The protocol was amended in 15 March 2011 to discontinue participants' enrollment and efficacy assessments, and to offer the opportunity for participants already enrolled to continue receiving study treatment for their planned participation in the study. The study had been active in several countries for approximately 1 year, and enrollment had been significantly slower than expected. Thus, the decision was made by the Sponsor to terminate the study since current and projected future enrollment rates would not have provided valuable information in a reasonable timeframe. All clinical efficacy and magnetic resonance imaging (MRI) procedures were removed from the protocol, and safety assessments were to be managed through standard of care activities.

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: BG00002 (natalizumab) intervention 2: interferon beta-1a intervention 3: glatiramer acetate
Intervention descriptions: intervention 1: 300 mg intravenous injection every 4 weeks intervention 2: 44 mcg subcutaneous injection 3 times per week intervention 3: 20 mg subcutaneous injection once daily

Protocol document: