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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00550446 |
The purpose of this study is to determine the effectiveness and safety, over 6 months, of 5 doses of CP-690,550 for the treatment of adults with active rheumatoid arthritis. Five out of seven subjects will receive CP-690,550. One out of seven will receive adalimumab (Humira®) and one out of seven will only receive inactive substances (placebo.)
Condition | Intervention | Phase |
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Arthritis, Rheumatoid |
Drug: Adalimumab Drug: CP-690-550 Drug: CP-690,550 Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2b, Randomized, Double Blind, Placebo Controlled Active Comparator, Multicenter Study To Compare 5 Dose Regimens Of CP- 690,550 And Adalimumab Versus Placebo, Administered For 6 Months In The Treatment Of Subjects With Active Rheumatoid Arthritis |
Estimated Enrollment: | 350 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | January 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator |
Drug: Adalimumab
40mg subcutaneous injections every other week for 6 injections during week 0-10 with oral placebo BID. Subjects switched to CP-690,550 at week 12.
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2: Experimental |
Drug: CP-690-550
15 mg BID oral plus 6 placebo subcutaneous injections (week 0-10)
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3: Experimental |
Drug: CP-690-550
10 mg BID oral plus 6 placebo subcutaneous injections (week 0-10)
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4: Experimental |
Drug: CP-690-550
5 mg BID oral plus 6 placebo subcutaneous injections (week 0-10)
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5: Experimental |
Drug: CP-690,550
3 mg BID PO plus 6 placebo subcutaneous injections (week 0-10)
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6: Experimental |
Drug: CP-690,550
1 mg BID PO plus 6 placebo subcutaneous injections (week 0-10)
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7: Placebo Comparator |
Drug: Placebo
Placebo by mouth plus 6 placebo subcutaneous injections (week 0-10)
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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:
Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer Inc. ( Director, Clinical Trial Disclosure ) |
Study ID Numbers: | A3921035 |
Study First Received: | October 25, 2007 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00550446 |
Health Authority: | United States: Food and Drug Administration |
Janus Kinase 3
Clinical Trial |
Autoimmune Diseases Musculoskeletal Diseases Joint Diseases Arthritis |
Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases Adalimumab |
Anti-Inflammatory Agents Immune System Diseases Therapeutic Uses Antirheumatic Agents Pharmacologic Actions |