A Phase 2/3 interventional study of Mycophenolate Mofetil (cellcept) in Multiple Sclerosis, sponsored by University of Texas Southwestern Medical Center. Completed at 1 site in United States. Open to participants aged 21 Years to 45 Years. Per ClinicalTrials.gov, last updated 2013-04-22.
Sponsored by University of Texas Southwestern Medical Center · Phase 2/3, Interventional, and Treatment
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.
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).
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 24 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.
Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Pharmacodynamics.
Genetic Studies.
This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Texas Southwestern Medical Center