Safety Study of Combination Therapy With Intramuscular Avonex and Oral Cellcept in Patients With Multiple Sclerosis
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|ClinicalTrials.gov Identifier: NCT00223301|
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : April 22, 2013
- To determine the safety and tolerability of oral Cellcept when used in combination with weekly intramuscular Avonex in early MS.
- To document changes in exacerbation frequency,
- To document the incidence of mild, moderate, and severe exacerbations in the treated groups (categorical analysis),
- To document changes in the level of sustained disability as measured by the expanded disability status score (EDSS) and ambulation index (AI),
- To document changes in quality of life measures,
- To assess fatigue with the validated fatigue assessment inventory,
- Neuroimmunological studies:At baseline, 6 and 12 months after treatment
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Drug: Mycophenolate Mofetil (cellcept)||Phase 2 Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|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|
|Study Start Date :||July 2004|
|Actual Primary Completion Date :||March 2007|
|Actual Study Completion Date :||March 2007|
- The primary objective of this safety/mechanistic study is to determine the safety and tolerability of oral Cellcept when used in combination with weekly intramuscular Avonex in early MS. Early MS for this study is defined at a definite diagnosis of less
- To document changes in exacerbation frequency
- To document the incidence of mild, moderate, and severe exacerbations in the treated groups.
- To document changes in the level of sustained disability as measured by the expanded disability status score (EDSS) and ambulation index (AI) as assessed by the Kaplan-Meier methodology.
- To document changes in quality of life measures (MSQOL-54, SF-36, and Beck's Depression Index).
- To assess fatigue with the validated fatigue assessment inventory
- Neuroimmunological studies:At baseline, 6 and 12 months after treatment.
- Genetic Studies.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00223301
|United States, Texas|
|University of Texas Southwestern Medical Center|
|Dallas, Texas, United States, 75390-8806|
|Principal Investigator:||Elliot Frohman, MD/PhD||UT Southwestern Medical Center|