Safety Study of Combination Therapy With Intramuscular Avonex and Oral Cellcept in Patients With Multiple Sclerosis

Summary

1. To determine the safety and tolerability of oral Cellcept when used in combination with weekly intramuscular Avonex in early MS. 2. To document changes in exacerbation frequency, 3. To document the incidence of mild, moderate, and severe exacerbations in the treated groups (categorical analysis), 4. To document changes in the level of sustained disability as measured by the expanded disability status score (EDSS) and ambulation index (AI), 5. To document changes in quality of life measures, 6. To assess fatigue with the validated fatigue assessment inventory, 7. Neuroimmunological studies:At baseline, 6 and 12 months after treatment

Timeline

Start

2004-07

Primary completion

2007-03

Completion

2007-03

Drugs

Indications