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| Sponsor: | University of Texas Southwestern Medical Center |
|---|---|
| Collaborators: |
Hoffmann-La Roche Biogen Idec |
| Information provided by: | University of Texas Southwestern Medical Center |
| ClinicalTrials.gov Identifier: | NCT00223301 |
Purpose
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Sclerosis |
Drug: Mycophenolate Mofetil (cellcept) |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 24 |
| Study Start Date: | July 2004 |
| Study Completion Date: | March 2007 |
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).
Eligibility| Ages Eligible for Study: | 21 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| Study ID Numbers: | 1103-716 |
| Study First Received: | September 19, 2005 |
| Last Updated: | February 12, 2009 |
| ClinicalTrials.gov Identifier: | NCT00223301 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Autoimmune Diseases Molecular Mechanisms of Pharmacological Action Demyelinating Diseases Immune System Diseases Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Nervous System Diseases Mycophenolic Acid Enzyme Inhibitors |
Sclerosis Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions Multiple Sclerosis Pathologic Processes Therapeutic Uses Mycophenolate mofetil Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |