AVONEX® Combination Trial - "ACT"
The purpose of this study is to determine the efficacy and safety of combination therapy with AVONEX plus low dose oral methotrexate (MTX), every other month courses of intravenous methylprednisolone (IVMP), or both in patients with continued disease activity on AVONEX monotherapy.
Multiple Sclerosis, Relapsing-Remitting
Drug: IV methylprednisolone
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
|Official Title:||A Multi-Center, Randomized, Blinded, Parallel-Group Study of AVONEX Compared With AVONEX in Combination With Oral Methotrexate, Intravenous Methylprednisolone, or Both in Subjects With Relapsing Remitting MS Who Have Breakthrough Disease on AVONEX Monotherapy.|
- Brain MRI lesion activity measured by the combined number of T2-hyperintense lesions at Month 12 that are new or enlarged since Baseline
- effectiveness of AVONEX® and IVMP plus MTX in trying to reduce lesion activity on brain MRI
- Gadolinium enhancing lesion number on brain MRI, relapse rate, MS Functional Composite change, whole brain atrophy progression
|Study Start Date:||June 2003|
|Study Completion Date:||May 2007|
|Primary Completion Date:||June 2006 (Final data collection date for primary outcome measure)|