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

NCT ID: NCT00202995

Last Updated: 2010-10-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-07-31
• Study Completion Date: 2007-10-31

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®

Conditions

Relapsing Remitting Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1

Glatiramer Acetate 20 mg s.c. daily

Group Type: EXPERIMENTAL

Glatiramer Acetate

Intervention Type: DRUG

20 mg s.c. daily

2

Betaseron 250 ug every other day or Rebif 44 ug 3 times a week

Group Type: ACTIVE_COMPARATOR

Betaseron

Intervention Type: DRUG

250 mg every other day

Rebif

Intervention Type: DRUG

44 ug 3 times a week

Interventions

Glatiramer Acetate

20 mg s.c. daily

Intervention Type: DRUG

Betaseron

250 mg every other day

Intervention Type: DRUG

Rebif

44 ug 3 times a week

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Teva Neuroscience

Principal Investigators

Helene Brooks

Role: STUDY_DIRECTOR

Teva Neuroscience, Inc.

Other Identifiers

9013

Identifier Type: -

Identifier Source: org_study_id