Status:
COMPLETED
Combination Therapy Using Cellcept and Rebif in RRMS
Lead Sponsor:
Aaron Boster
Collaborating Sponsors:
EMD Serono
Pfizer
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Phase:
EARLY_PHASE1
Brief 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 e...
Detailed Description
A total of 30 patients will be studied, fifteen in each arm. Proportional analysis for sample size estimation could not be done since the proportion of MxA positive patients at 1 year in the Rebif® tr...
Eligibility Criteria
Inclusion
- diagnosed with relapsing remitting multiple sclerosis
- eligible to initiate interferon therapy
- between he ages of 18-65, inclusive
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00618527
Start Date
August 1 2006
End Date
May 1 2012
Last Update
November 15 2012
Active Locations (1)
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1
The Ohio State University Multiple Sclerosis Center
Columbus, Ohio, United States, 43221