Randomized Study Designed to Look at Disease Progression Using 2 Currently FDA Approved Drugs for the Treatment of RRMS

Study Overview
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Brief Summary
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Randomized study designed to look at the difference in relapse rates between patients remaining on their current interferon medication and those switched to Copaxone®

Official Title
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A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to That of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients

Conditions
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Relapsing Remitting Multiple Sclerosis

Intervention / Treatment
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* Drug: Glatiramer Acetate
* Drug: Betaseron
* Drug: Rebif


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must have a diagnosis of clinically definite MS with a relapsing disease course as determined by the Poser criteria Patients must be on high dose interferon therapy (Betaseron® 250 µg or Rebif® 44 µg) for at least 1 year prior to study entry Patients must have experienced at least one documented relapse during the past year prior to screening. Pseudo-relapses must be ruled out. A gadolinium enhancing lesion is not required. Patients must be ambulatory, with a Kurtzke EDSS score between 0-5 inclusive Patients must be between the ages of 18 and 50 years inclusive Women of childbearing potential must practice an acceptable method of birth control. Acceptable methods include oral contraceptive, contraceptive patch, long-acting injectable contraceptive, double-barrier method (condom or IUD with spermicide), or partner's vasectomy Patients must be relapse-free and off corticosteroids (IV or oral) for at least 30 days prior to the screening visit Patients must be relapse-free and off corticosteroids between the screening and baseline visits Patients must be willing and able to give written informed consent Exclusion Criteria: Use of experimental or investigational drugs, and/or participation in an investigational drug study within 6 months prior to study entry Previous treatment with glatiramer acetate (injectable) Previous treatment with immunomodulators (except IFNβ), immunosuppressive agents, IVIG, or plasma exchange in the 6 months prior to screening; previous treatment with cladribine in the past 2 years Previous total body irradiation or total lymphoid irradiation Chronic corticosteroid (IV, IM, and/or PO) treatment (more than 30 consecutive days) in the 6 months prior to study entry Pregnancy or breastfeeding Life-threatening or other clinically significant disease Any condition which the investigator feels may interfere with participation in the study, including alcohol and/or drug abuse A known sensitivity to gadolinium (gadolinium acid) A known history of sensitivity to mannitol Inability to successfully undergo MRI scanning

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Glatiramer Acetate 20 mg s.c. daily | Drug: Glatiramer Acetate<br>* 20 mg s.c. daily<br>|
| Active Comparator: 2<br>Betaseron 250 ug every other day or Rebif 44 ug 3 times a week | Drug: Betaseron<br>* 250 mg every other day<br>Drug: Rebif<br>* 44 ug 3 times a week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of the study is to compare the total number of confirmed relapses experienced by patients randomized to maintain treatment on high dose IFN therapy compared to those who were switched to Copaxone® treatment. |  |  |