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Sponsored by: |
Vertex Pharmaceuticals Incorporated |
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Information provided by: | Vertex Pharmaceuticals Incorporated |
ClinicalTrials.gov Identifier: | NCT00395577 |
The purpose of this study is to assess the safety and effects of VX-702 in subjects with moderate to severe rheumatoid arthritis and who are taking the drug methotrexate.
Condition | Intervention | Phase |
---|---|---|
Rheumatoid Arthritis |
Drug: VX-702 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment |
Official Title: | A Phase 2, 12-Week, Randomized, Placebo-Controlled Study to Evaluate the Antiinflammatory Effects of VX-702 When Administered Concomitantly With Methotrexate |
Estimated Enrollment: | 120 |
Study Start Date: | November 2006 |
Study Completion Date: | July 2007 |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Bulgaria | |
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Sofia, Bulgaria | |
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Dimitrovgrad, Bulgaria | |
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Pleven, Bulgaria | |
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Veliko Tarnovo, Bulgaria | |
Croatia | |
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Zagreb, Croatia | |
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Osijek, Croatia | |
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Zagreb, Croatia | |
Poland | |
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Krakow, Poland | |
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Bytom, Poland | |
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Zyrardow, Poland | |
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Torun, Poland | |
Russian Federation | |
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St. Petersburg, Russian Federation | |
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Novosibirsk, Russian Federation | |
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Saratov, Russian Federation | |
Serbia and Montenegro | |
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Zemun, Serbia and Montenegro | |
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Niska Banja, Serbia and Montenegro | |
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Belgrade, Serbia and Montenegro | |
Slovenia | |
Call For Information | |
Ljubljana, Slovenia |
Study Director: | Robert Kauffman, MD, PhD | Vertex Pharmaceuticals Incorporated |
Study ID Numbers: | VX06-702-304 |
Study First Received: | November 1, 2006 |
Last Updated: | December 5, 2007 |
ClinicalTrials.gov Identifier: | NCT00395577 History of Changes |
Health Authority: | Serbia and Montenegro: Agency for Drugs and Medicinal Devices; Poland: Ministry of Health; Slovenia: Ministry of Health; Croatia: Ministry of Health and Social Care; Bulgaria: Bulgarian Drug Agency; Russia: Pharmacological Committee, Ministry of Health |
Anti-Inflammatory Agents Autoimmune Diseases Musculoskeletal Diseases Joint Diseases Arthritis |
Connective Tissue Diseases Arthritis, Rheumatoid Methotrexate Rheumatic Diseases |
Autoimmune Diseases Immune System Diseases Musculoskeletal Diseases Joint Diseases |
Arthritis Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases |