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| Sponsors and Collaborators: |
Ohio State University EMD Serono Pfizer |
|---|---|
| Information provided by: | Ohio State University |
| ClinicalTrials.gov Identifier: | NCT00618527 |
Purpose
The purpose of this trial is to examine the benefits of early combination of CellCept® with Rebif® in long-term management of patients with multiple sclerosis. Quantitation of mRNA for MxA gene from ex-vivo lymphocytes obtained from patients receiving both drugs or interferon alone will be used to gauge the usefulness of this combination therapy. In addition we will examine the safety of combination of mycophenylate mofetil and interferon beta 1a in treatment of multiple sclerosis.
This is a pilot study to examine if the combination of CellCept® with Rebif® will prove to be useful in the early treatment of patients with MS. Up-regulation of the MxA gene following the administration of Rebif® will be used as a surrogate marker of interferon bioactivity. This in turn could serve as a surrogate marker of interferon efficacy in these patients.
The null hypothesis is that there will not be any difference in the proportion of patients that produce MxA gene transcripts in the Rebif® group as compared to the group that received Rebif® with CellCept® at the end of this study (1 year).
The alternate hypothesis is that the combination of CellCept® with Rebif® will prove to be useful in prolonging the efficacy of interferon. In other words, the combination will result in a significant proportion of patients in the treatment group continuing to produce MxA as compared to the proportion of patients producing MxA in the Rebif® arm.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Sclerosis |
Drug: mycophenalate mofetil (Cellcept) Drug: human interferon beta 1a (Rebif) |
Phase 0 |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Combination Therapy Using Mycophenylate Mofetil (CellCept) and Human Interferon beta1a (Rebif) in Early Treatment of Multiple Sclerosis |
| Estimated Enrollment: | 30 |
| Study Start Date: | August 2006 |
| Estimated Study Completion Date: | August 2009 |
| Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Rebif with Cellcept
|
Drug: mycophenalate mofetil (Cellcept)
1 gram po, bid
Drug: human interferon beta 1a (Rebif)
44mcg sq injection every other day
|
|
2: Placebo Comparator
Rebif alone
|
Drug: human interferon beta 1a (Rebif)
44mcg sq injection every other day
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Jessi Fleck, CCRC | 614-293-6486 | jessi.fleck@osumc.edu |
| United States, Ohio | |
| The Ohio State University Multiple Sclerosis Center | Recruiting |
| Columbus, Ohio, United States, 43221 | |
| Principal Investigator: Kottil W. Rammohan, MD | |
| Principal Investigator: | Kottil W Rammohan, MD | The Ohio State University Medical Center |
More Information
| Responsible Party: | The Ohio State University Medical Center ( Kottil W. Rammohan, MD ) |
| Study ID Numbers: | 2006H0039 |
| Study First Received: | February 6, 2008 |
| Last Updated: | February 19, 2008 |
| ClinicalTrials.gov Identifier: | NCT00618527 |
| Health Authority: | United States: Institutional Review Board |
|
relapsing remitting multiple sclerosis multiple sclerosis |
|
Interferon Type I, Recombinant Autoimmune Diseases Demyelinating Diseases Interferons Interferon-beta Sclerosis Demyelinating diseases |
Multiple Sclerosis, Relapsing-Remitting Multiple Sclerosis Interferon beta 1a Mycophenolate mofetil Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |
|
Anti-Infective Agents Immune System Diseases Immunologic Factors Antineoplastic Agents Growth Substances Nervous System Diseases Physiological Effects of Drugs Adjuvants, Immunologic |
Immunosuppressive Agents Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Pathologic Processes Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents |
