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Sponsored by: |
Teva Pharmaceutical Industries |
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Information provided by: | Teva Pharmaceutical Industries |
ClinicalTrials.gov Identifier: | NCT00202995 |
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 | Intervention | Phase |
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Relapsing Remitting Multiple Sclerosis |
Drug: Glatiramer Acetate Drug: Betaseron Drug: Rebif |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Enrollment: | 91 |
Study Start Date: | July 2004 |
Study Completion Date: | October 2007 |
Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Glatiramer Acetate 20 mg s.c. daily
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Drug: Glatiramer Acetate
20 mg s.c. daily
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2: Active Comparator
Betaseron 250 ug every other day or Rebif 44 ug 3 times a week
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Drug: Betaseron
250 mg every other day
Drug: Rebif
44 ug 3 times a week
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This is a multi-center, randomized, single blind, parallel group study to compare the efficacy, tolerability and safety of injectable Copaxone®(GA) to that of high dose interferon (beta 1a or 1b) in relapsing MS patients.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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.
Exclusion Criteria:
Study Director: | Helene Brooks | Teva Pharmaceutical Industries |
Responsible Party: | Teva Neuroscience ( Siyu Liu, Vice President, North American IR&D and Head of Global Clinical Operations ) |
Study ID Numbers: | 9013 |
Study First Received: | September 13, 2005 |
Last Updated: | November 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00202995 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Autoimmune Diseases Immunologic Factors Demyelinating Diseases Interferons Adjuvants, Immunologic Disease Progression Interferon-beta Sclerosis |
Immunosuppressive Agents Multiple Sclerosis, Relapsing-Remitting Copolymer 1 Multiple Sclerosis Interferon beta 1a Interferon beta-1b Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |
Autoimmune Diseases Immunologic Factors Demyelinating Diseases Immune System Diseases Physiological Effects of Drugs Nervous System Diseases Adjuvants, Immunologic Sclerosis Immunosuppressive Agents |
Multiple Sclerosis, Relapsing-Remitting Pharmacologic Actions Copolymer 1 Multiple Sclerosis Pathologic Processes Interferon beta-1b Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |