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

Completed · Phase 2/Phase 3

Conditions studied: Multiple Sclerosis

In brief

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

Key facts

Study ID

NCT00223301

Run by

University of Texas Southwestern Medical Center

People needed

24

Starts

2004-07-01

Expected to finish

2007-03-01

Last updated by the study team

2013-04-22

Who can join

Age: 21 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Texas Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.