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

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc. (Industry)

Overall Status

Terminated

CT.gov ID

NCT00202995

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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®

Condition or Disease	Intervention/Treatment	Phase
Relapsing Remitting Multiple Sclerosis	Drug: Glatiramer Acetate Drug: Betaseron Drug: Rebif	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

91 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jul 1, 2004

Actual Primary Completion Date :

Oct 1, 2007

Actual Study Completion Date :

Oct 1, 2007

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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