Clinical Trial: A Study of Rebif® Compared With Avonex® in the Treatment of Relapsing-remitting Multiple Sclerosis (MS)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: An Open Label, Randomized, Multicenter, Comparative, Parallel Group Study of Rebif® 44 Mcg Administered Three Times Per Week by Subcutaneous Injection, Compared With Avonex® 30 Mcg Administe
Brief Summary: This is an open-label, randomized, multicenter, comparative, and parallel-group study comparing the therapeutic effects of two interferon-beta-1a regimens in relapsing-remitting multiple sclerosis (MS). The primary objective is to demonstrate the superiority of Rebif® 44 microgram (mcg) subcutaneous injection given three times a week (132 mcg per week) to that of Avonex® 30 mcg intramuscular injection given once a week.
Detailed Summary:
Sponsor: EMD Serono
Current Primary Outcome:
- Percentage of exacerbation-free subjects [ Time Frame: Week 24 ]
- Percentage of exacerbation-free subjects [ Time Frame: Week 48 ]
- Percentage of exacerbation-free subjects [ Time Frame: Week 72 ]
Original Primary Outcome:
Current Secondary Outcome:
- Mean number of combined unique (CU) active lesions per subject per scan [ Time Frame: Week 24 ]
- Total exacerbation count per subject [ Time Frame: Week 24, 48 and 72 ]
- Mean Number of Time constant 2 (T2) active lesions per subject per scan [ Time Frame: Week 24, 48 and 72 ]
Original Secondary Outcome:
Information By: EMD Serono
Dates:
Date Received: February 13, 2006
Date Started: November 1999
Date Completion:
Last Updated: August 2, 2013
Last Verified: August 2013
