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: 0
• Participant gender: All

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Collaborators: Biogen; Roche Pharma AG
• Treatments: Mycophenolate mofetil; Mycophenolic Acid

Criteria

Inclusion Criteria:

1. Between the ages of 21-45 inclusive

2. Clinically definite, laboratory supported definite relapsing MS of less than or equal to two years in duration or monosymptomatic MS meeting CHAMPS criteria ref .

3. At least one exacerbation in the preceding two years

4. Written informed consent.

Exclusion Criteria:

1. Primary progressive, secondary progressive or progressive relapsing MS.

2. Corticosteroids during the 60 days prior to study entry.

3. Treatment with plasma exchange within 90 days of preenrollment.

4. No prior exposure to total lymphoid irradiation.

5. No prior use of interferons, monoclonal antibodies, glatiramer acetate, methotrexate or other immunomodulatory drugs

6. A clinical relapse within 60 days prior to enrollment.

7. Pregnant/breastfeeding.

8. Patients with major medical illnesses.

9. Cognitive impairment interfering with ability to comply with the protocol.

10. Patients who need to remain on any contraindicated medication.

11. Diabetic

12. Inability to undergo MRI scan

13. On intravenous immunoglobulin protocol

14. HIV+ or RPR+

15. Females of childbearing age who have not undergone a sterilization procedure must be willing to practice effective birth control.