2-Year Phase 3 Study Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate
Purpose
This study is designed to provide safety and efficacy data to support the development of CP-690,550 in patients with moderate to severe rheumatoid arthritis on background of methotrexate.
|
Condition |
Intervention |
Phase |
| Arthritis, Rheumatoid | Drug: CP-690,550 Drug: Placebo |
Phase 3 |
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 In Patients With Active Rheumatoid Arthritis On Background Methotrexate
Primary Outcome Measures:
- To compare the efficacy of 2 doses of CP-690,550 versus placebo for the treatment of signs and symptoms of rheumatoid arthritis as measured by ACR 20 response rates.
- To compare evidence of preservation of joint structure following administration of 2 doses CP-690,550 versus placebo as measured by changes from baseline.
- To compare physical function status of patients after administration of 2 doses of CP-690,550 versus placebo using the HAQ-DI.
- To evaluate the safety and tolerability of 2 doses of CP-690,550 versus placebo.
Secondary Outcome Measures:
- To compare the efficacy of 2 doses of CP-690,550 versus placebo measured by ACR20, ACR 50, ACR70 and DAS 28 response rates.
- To compare the durability of ACR20, ACR50, and ACR70 and DAS 28 response rates.
- To compare the incidence of DAS 28 remission and low disease activity state at each visit.
- To compare effects on all health outcomes measures in the study at each visit, as appropriate for the specific outcome, compared to baseline.
- To investigate possible associations between genomic and metabonomic variation in relation to interventions in an optional supplement requiring separate consent not required for participation in primary study.
Estimated Enrollment: 750
Study Start Date: April 2009
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
| Arms | Assigned Interventions |
| Sequence 1: Experimental |
Drug: CP-690,550 Oral tablets administered at 5 mg BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period. Drug: CP-690,550 Oral tablets administered at 5 mg BID daily through the end of the study during the double-blind, active-extension period. |
|
Sequence 2: Experimental |
Drug: CP-690,550 Oral tablets administered at 10 mg BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period. Drug: CP-690,550 Oral tablets administered at 10 mg BID daily through the end of the study during the double-blind, active-extension period. |
|
Sequence 3: Placebo Comparator |
Drug: Placebo Oral placebo tablets administered BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period. Drug: CP-690,550 Oral tablets administered at 5 mg BID daily through the end of the study during the double-blind, active-extension period. |
|
Sequence 4: Placebo Comparator |
Drug: Placebo Oral placebo tablets administered BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period. Drug: CP-690,550 Oral tablets administered at 10 mg BID daily through the end of the study during the double-blind, active-extension period. |
Eligibility
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:
- Adults with moderate to severe rheumatoid arthritis on a stable dose of methotrexate
Exclusion Criteria:
Pregnancy, severe acute or chronic medical conditions, including serious infections or clinically significant laboratory abnormalities.
This information is also available at www.clinicaltrials.gov Last updated September 29, 2009.
