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| Sponsor: | Teva Pharmaceutical Industries |
|---|---|
| Information provided by (Responsible Party): | Teva Pharmaceutical Industries |
| ClinicalTrials.gov Identifier: | NCT00203047 |
Purpose
This is a study evaluating the effect on brain volume of daily glatiramer acetate (GA) and add-on pulse steroids.
| Condition | Intervention | Phase |
|---|---|---|
|
Relapsing Remitting Multiple Sclerosis |
Drug: Glatiramer Acetate |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Multi-Centered, Randomized, Double-Blind, Placebo Controlled Study Assessing the Add-on Effect of Oral Steroids in Relapsing Remitting Multiple Sclerosis Subjects Treated With Glatiramer Acetate (GA) |
| Enrollment: | 414 |
| Study Start Date: | January 2005 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Teva Pharmaceutical Industries |
| ClinicalTrials.gov Identifier: | NCT00203047 History of Changes |
| Other Study ID Numbers: | TNC GA MS 2004_01 (ASSERT) |
| Study First Received: | September 13, 2005 |
| Last Updated: | February 1, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
Multiple Sclerosis brain atrophy Glatiramer Acetate |
Copaxone Steroids Prednisone |
|
Multiple Sclerosis Sclerosis Multiple Sclerosis, Relapsing-Remitting Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases |
Immune System Diseases Pathologic Processes Copolymer 1 Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Immunosuppressive Agents |