Conditions: Relapsing Remitting Multiple Sclerosis
Keywords: Multiple Sclerosis Clinical trial treatment trial autoimmune disease Relapsing Remitting MS Treatment interferon beta-1a glatiramer acetate
Allocation: RANDOMIZED | Intervention model: FACTORIAL
Enrollment: 1008
Healthy volunteers: no

Brief summary:
This is for a randomized clinical trial (RCT) to determine if the combined use of interferon beta-1a (IFN) and glatiramer acetate (GA) is a measurably better therapy than either agent used individually in patients with relapsing-remitting (RR) multiple sclerosis (MS).

Detailed description:
This is a multicenter, double blind, randomized trial examining combination therapy versus single agent therapy with three-year follow-up on the last patient randomized. All patients will remain on therapy until the last patient completes the study. All patients will then be transitioned, based on the findings, to open label of combination with continued follow-up or some recommendation about single agent therapy. While the study design benefits from having two arms of single agent therapy to examine the important question of whether there are differences between the single agents, the primary interest is in combination therapy. Therefore, a two-group combination versus single agent concept was used - splitting the population into single agent and combination therapy equally. The single agent arm is divided into two groups, IFN and GA providing for 3 treatment arms: IFN intramuscularly (IM) and GA subcutaneously (SC) (50% of the patients), IFN IM and placebo SC (25% of the patients) and GA SC and placebo IM (25% of the patients).

Arms:
arm 1: Active Interferon B1a Weekly vs. Placebo Glatiramer Acetate

Interferon b-1a (IFN) intramuscularly weekly arm 2: Placebo Interferon B1a Weekly vs. Active Glatiramer Acetate

Glatiramer acetate 20mg daily arm 3: Active Interferon B1a Weekly and Active Glatiramer Acetate

Interventions: intervention 1: Interferon beta 1-a intervention 2: glatiramer acetate intervention 3: placebo
Intervention descriptions: intervention 1: The single agent arm is divided into two groups, IFN and GA providing for 3 treatment arms: IFN IM and GA SC (50% of the patients), IFN IM and placebo SC (25% of the patients) and GA SC and placebo IM (25% of the patients). intervention 2: The single agent arm is divided into two groups, IFN and GA providing for 3 treatment arms: IFN IM and GA SC (50% of the patients), IFN IM and placebo SC (25% of the patients) and GA SC and placebo IM (25% of the patients). intervention 3: an inactive substance

Protocol document: