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Sponsored by: |
Synta Pharmaceuticals, Corp. |
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Information provided by: | Synta Pharmaceuticals, Corp. |
ClinicalTrials.gov Identifier: | NCT00642629 |
It is not fully clear how rheumatoid arthritis originates and develops, but it is understood that multiple genetic and environmental factors interact to trigger its onset. The immune system attacks the joint synovium, which damages the cartilage and bone in the joint by increasing the number of inflammatory cells and forming new blood vessels in the joint space. STA-5326 mesylate inhibits the production of IL-12 and IL-23 and therefore may inhibit Th-1 cytokine production. A reduction in the Th-1 response has the potential to minimize or eliminate joint damage caused by the immune response in rheumatoid arthritis. This study is designed to assess whether the proposed mechanism of action is associated with a reduction in inflammation in the synovium of patients who have rheumatoid arthritis.
Condition | Intervention | Phase |
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Active, Moderate to Severe Rheumatoid Arthritis |
Drug: STA 5326 mesylate Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Estimated Enrollment: | 35 |
Study Start Date: | December 2005 |
Arms | Assigned Interventions |
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1: Active Comparator
STA-5326 mesylate
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Drug: STA 5326 mesylate
STA 5326 mesylate 100mg taken orally twice a day for 8 weeks with the option to continue at the same dose and frequency for an additional 4 weeks.
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2: Placebo Comparator
Placebo
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Drug: Placebo
Placebo taken orally twice a day for 8 weeks with the option to continue at the same dose and frequency for an additional 4 weeks.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Synta Pharmaceuticals ( David Hynds, Clinical Trial manager ) |
Study ID Numbers: | 5326-09 |
Study First Received: | March 20, 2008 |
Last Updated: | March 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00642629 History of Changes |
Health Authority: | Netherlands: Independent Ethics Committee |
Interleukin-12 Autoimmune Diseases Musculoskeletal Diseases Joint Diseases |
Arthritis Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases |
Autoimmune Diseases Immune System Diseases Musculoskeletal Diseases Joint Diseases |
Arthritis Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases |