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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00814307 |
This Phase 3 study is intended to provide evidence of the efficacy and safety of CP 690,550 when dosed 5 mg and 10 mg twice a day as monotherapy in adult patients with moderate to severe Rheumatoid Arthritis. It is intended to confirm the benefits of CP-690,550 in improving signs and symptoms and physical function that were observed in the Phase 2 Rheumatoid Arthritis studies.
Condition | Intervention | Phase |
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Arthritis, Rheumatoid |
Drug: CP 690,550 Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of The Efficacy And Safety Of 2 Doses Of CP-690,550 Monotherapy In Patients With Active Rheumatoid Arthritis |
Estimated Enrollment: | 500 |
Study Start Date: | February 2009 |
Estimated Study Completion Date: | November 2010 |
Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Active 5mg: Experimental |
Drug: CP 690,550
5mg CP 690,550 BID PO for 6 months
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Active 10 mg: Experimental |
Drug: CP 690,550
10 mg CP 690,550 BID PO for 6 months
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Placebo Sequence 1: Placebo Comparator |
Drug: Placebo
Placebo nonresponders advance to 5mg CP 690,550 BID at Month 3 visit
Drug: Placebo
Placebo responders do not advance at Month 3 but remain on placebo for duration of study (6 months)
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Placebo Sequence 2: Placebo Comparator |
Drug: Placebo
Placebo nonresponders advance to 10mg CP 690,550 BID at Month 3 visit
Drug: Placebo
Placebo responders do not advance at Month 3 but remain on placebo for duration of study (6 months)
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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: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A3921045 |
Study First Received: | December 22, 2008 |
Last Updated: | January 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00814307 |
Health Authority: | United States: Food and Drug Administration |
Arthritis, Rheumatoid, Antirheumatic Agents, Clinical Trial |
Autoimmune Diseases Musculoskeletal Diseases Joint Diseases Arthritis |
Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases |
Immune System Diseases |