Status:
COMPLETED
Safety Study of Combination Therapy With Intramuscular Avonex and Oral Cellcept in Patients With Multiple Sclerosis
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
Roche Pharma AG
Biogen
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
21-45 years
Phase:
PHASE2
PHASE3
Brief 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...
Detailed Description
Design: Uni-center, double-blind, randomized, placebo-controlled study of Avonex + placebo vs Avonex + Cellcept Rationale: A number of immunopathogenic mechanisms have been hypothesized to figure pro...
Eligibility Criteria
Inclusion
- Between the ages of 21-45 inclusive
- Clinically definite, laboratory supported definite relapsing MS of less than or equal to two years in duration or monosymptomatic MS meeting CHAMPS criteria ref .
- At least one exacerbation in the preceding two years
- Written informed consent.
Exclusion
- Primary progressive, secondary progressive or progressive relapsing MS.
- Corticosteroids during the 60 days prior to study entry.
- Treatment with plasma exchange within 90 days of preenrollment.
- No prior exposure to total lymphoid irradiation.
- No prior use of interferons, monoclonal antibodies, glatiramer acetate, methotrexate or other immunomodulatory drugs
- A clinical relapse within 60 days prior to enrollment.
- Pregnant/breastfeeding.
- Patients with major medical illnesses.
- Cognitive impairment interfering with ability to comply with the protocol.
- Patients who need to remain on any contraindicated medication.
- Diabetic
- Inability to undergo MRI scan
- On intravenous immunoglobulin protocol
- HIV+ or RPR+
- Females of childbearing age who have not undergone a sterilization procedure must be willing to practice effective birth control.
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
End Date :
March 1 2007
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00223301
Start Date
July 1 2004
End Date
March 1 2007
Last Update
April 22 2013
Active Locations (1)
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1
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390-8806