Combination Therapy Using Cellcept and Rebif in RRMS

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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 mycophenolate 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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aaron Boster
• Collaborators: EMD Serono; Pfizer
• Treatments: Interferon beta-1a; Interferon-beta; Interferons; Mycophenolate mofetil; Mycophenolic Acid

Criteria

Inclusion Criteria:

• diagnosed with relapsing remitting multiple sclerosis

• eligible to initiate interferon therapy

• between he ages of 18-65, inclusive

Exclusion Criteria:

• have received corticosteroids within 30 days prior to study start

• have ever received cyclophosphamide or mitoxantrone

• have received Imuran or methotrexate in the last 3 months

• females that are pregnant or breastfeeding are excluded