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Sponsored by: |
Teva Pharmaceutical Industries |
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Information provided by: | Teva Pharmaceutical Industries |
ClinicalTrials.gov Identifier: | NCT00203047 |
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: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Study Completion Date: | May 2011 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Study evaluating the effect of pulse oral steroids administered every 4 months, for a period of three years, as an add-on treatment to GA, given every day, in patients with relapsing remitting multiple sclerosis.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
University of Rochester | |
Rochester, New York, United States, 14642 | |
United States, Texas | |
Integra Clinical Research, LLC | |
San Antonio, Texas, United States, 78229 | |
Canada, Quebec | |
Complexe Hospitalier de la Sagamie | |
Chicoutimi, Quebec, Canada, G7H 5T6 | |
Centre Hospitalier Régional de Trois-Rivières, Pavillon St-Joseph | |
Trois-Rivières, Quebec, Canada, G9A 1Y1 |
Study Chair: | Carole Desforges | Teva Neuroscience Canada |
Responsible Party: | Teva Neuroscience ( J. Michael Nicholas, Ph.D., Sr. Director, US Regulatory Affairs ) |
Study ID Numbers: | TNC GA MS 2004_01 (ASSERT) |
Study First Received: | September 13, 2005 |
Last Updated: | March 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00203047 History of Changes |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; Australia: |
Multiple Sclerosis brain atrophy Glatiramer Acetate |
Copaxone Steroids Prednisone |
Prednisone Autoimmune Diseases Demyelinating Diseases Immunologic Factors Adjuvants, Immunologic Sclerosis Multiple Sclerosis, Relapsing-Remitting |
Immunosuppressive Agents Copolymer 1 Multiple Sclerosis Demyelinating Autoimmune Diseases, CNS Atrophy Autoimmune Diseases of the Nervous System |
Autoimmune Diseases Demyelinating Diseases Immune System Diseases Immunologic Factors Physiological Effects of Drugs Nervous System Diseases Adjuvants, Immunologic Sclerosis |
Multiple Sclerosis, Relapsing-Remitting Immunosuppressive Agents Pharmacologic Actions Copolymer 1 Multiple Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |