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

Multiple Sclerosis Clinical Trial

Official title: A One-Year Prospective, Randomized, Placebo-Controlled, Double-Blind, Phase II/III Safety Trial of Combination Therapy With IFN Beta-1a (Avonex) and Mycophenolate Mofetil (Cellcept) in Early Multiple Sclerosis

Status Completed

Clinical Trial 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

Clinical Trial 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 prominently in the processes that culminate in the characteristic plaque lesion. These include the role of cytokines, chemokines, excitatory amino acids, free radicals, superoxides, and nitric oxide synthetase products. Recognizing that the disease process in MS involves a cascade of biological events, sets the stage for strategically targeting specific immunopathogenetic steps through rational combination therapy regimens. We now propose a combination clinical trial utilizing Avonex and mycophenolate mofetil (MMF), a novel agent with a broad spectrum of anti- inflammatory mechanisms.

• Study population: MS patients who have been diagnosed with clinically definite, laboratory supported definite, or monosymptomatic MS meeting CHAMPS criteria ref , of either sex, who are between the ages of 21 and 50 inclusive.

• Treatment Groups: 12 patients in each group, ALL patients on Intramuscular Avonex. Cellcept/Placebo will be started at 250mg bid for one week and then escalated by 250mg bid until a target dose of 1000mg bid is achieved and Avonex 30 mcg IM q week

Patients also see an examining physician every three months, have brain MRI scans done every other month and donate WBCs through a procedure called leukapheresis (done every six months).

• Efficacy Parameters/Evaluations: EDSS, PSAT, MSFC and MRI, relapse rate and safety measures

• Safety Parameters/Evaluations: Safety will be assessed by virtue of changes in T2/FLAIR lesions (number and volume) and in gadolinium enhancements (measured at 6 and 12 months after treatment initiation) compared to baseline measurements derived from one pretreatment run- in scan. In addition, a variety of clinical assessments will be performed for the period of 12 months of treatment. We will enroll 12 patients in each group (24 total) ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

• NCT number: NCT00223301
• Study type: Interventional
• Source: University of Texas Southwestern Medical Center
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: July 2004
• Completion date: March 2007