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Combination Therapy Using Cellcept and Rebif in RRMS

NCT00618527 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2012-11-15

No results posted yet for this study

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.

Conditions

Interventions

DRUG

mycophenolate mofetil (Cellcept)

1 gram po, bid

DRUG

human interferon beta 1a (Rebif)

44mcg sq injection every other day

Sponsors & Collaborators

  • EMD Serono

    collaborator INDUSTRY

  • Pfizer

    collaborator INDUSTRY

  • Aaron Boster

    lead OTHER

Principal Investigators

  • Aaron L Boster, MD · Ohio State University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00618527 on ClinicalTrials.gov