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

Phase 4

Terminated

• Conditions: Relapsing Remitting Multiple Sclerosis
• Interventions: Drug: Glatiramer Acetate; Drug: Betaseron; Drug: Rebif

• Registration Number: NCT00202995
• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-20
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-14
• Last Update Posted: 2010-10-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

1. Patients must have a diagnosis of clinically definite MS with a relapsing disease course as determined by the Poser criteria
2. Patients must be on high dose interferon therapy (Betaseron® 250 µg or Rebif® 44 µg) for at least 1 year prior to study entry
3. 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.
4. Patients must be ambulatory, with a Kurtzke EDSS score between 0-5 inclusive
5. Patients must be between the ages of 18 and 50 years inclusive
6. 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
7. Patients must be relapse-free and off corticosteroids (IV or oral) for at least 30 days prior to the screening visit
8. Patients must be relapse-free and off corticosteroids between the screening and baseline visits
9. Patients must be willing and able to give written informed consent

Exclusion Criteria

1. Use of experimental or investigational drugs, and/or participation in an investigational drug study within 6 months prior to study entry
2. Previous treatment with glatiramer acetate (injectable)
3. 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
4. Previous total body irradiation or total lymphoid irradiation
5. Chronic corticosteroid (IV, IM, and/or PO) treatment (more than 30 consecutive days) in the 6 months prior to study entry
6. Pregnancy or breastfeeding
7. Life-threatening or other clinically significant disease
8. Any condition which the investigator feels may interfere with participation in the study, including alcohol and/or drug abuse
9. A known sensitivity to gadolinium (gadolinium acid)
10. A known history of sensitivity to mannitol
11. Inability to successfully undergo MRI scanning

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Glatiramer Acetate	Glatiramer Acetate 20 mg s.c. daily
2	Rebif	Betaseron 250 ug every other day or Rebif 44 ug 3 times a week
2	Betaseron	Betaseron 250 ug every other day or Rebif 44 ug 3 times a week

Primary Outcome Measures

Name	Time	Method
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.