Safety Study of Combination Therapy With Intramuscular Avonex and Oral Cellcept in Patients With Multiple Sclerosis
Status:
Completed
Trial end date:
2007-03-01
Target enrollment:
Participant gender:
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