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

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

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

Study Overview

• Status: Terminated
• Conditions: Relapsing Remitting Multiple Sclerosis
• Intervention / Treatment: Drug: Glatiramer Acetate; Drug: Betaseron; Drug: Rebif

• Study Type: Interventional
• Enrollment (Actual): 91
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
• Investigators: Study Director: Helene Brooks, Teva Neuroscience, Inc.

Study record dates

Study Major Dates

• Study Start: July 1, 2004
• Primary Completion (Actual): October 1, 2007
• Study Completion (Actual): October 1, 2007

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 20, 2005

Study Record Updates

• Last Update Posted (Estimate): October 18, 2010
• Last Update Submitted That Met QC Criteria: October 14, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Physiological Effects of Drugs; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Adjuvants, Immunologic; Interferon beta-1b; Glatiramer Acetate; (T,G)-A-L
• Other Study ID Numbers: 9013