Health Condition 1: null- Arthritis, Rheumatoid
Conditions
Interventions
Intervention1: Drug: CP-690,550
Open-Label Active Treatment Enrolled from Phase 2: Experimental Patients enrolling from Phase 2 studies: CP-690,550
5 mg PO BID open label
may increase to 10 mg PO BID to provide greater control of RA if no related AEs are present. May be off study drug temporarily for up to 28 days for mild to moderate AEs.
Intervention2: Drug: CP-690
Open-Label Active Treatment Enrolled from Phase 3: Experimental Patients enrolling from Phase 3 studies: CP-690,550
10 mg PO BID open label
may decrease to 5 mg PO BID for mild to moderate AEs. May be off study drug temporarily for up to 28 days for mild to moderate AEs.
Control Intervention1: NILL: NILL
Sponsors
Pfizer Limited
Eligibility
Inclusion criteria
Inclusion criteria: a. Ages Eligible for Study: 18 Years and older, b. Genders Eligible for Study: Both, c. Accepts Healthy Volunteers: No, 1. Subjects who have participated in a randomized "qualifying" study of CP-690,550 for the treatment of rheumatoid arthritis Note: There is no upper age limit specified for inclusion criteria in this trial
Exclusion criteria
Exclusion criteria: Serious medical conditions that would make treatment with CP-690,550 potentially unsafe
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints will be standard laboratory safety data (chemistry, hematology, etc.) and adverse event (AE) reportsTimepoint: Every visit until last observation.;The long-term safety and tolerability of CP-690,550 5 mg BID and 10 mg BID for the treatment of rheumatoid arthritisTimepoint: Every visit until last observation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Area under ACR n curveTimepoint: Every visit until last observation.;DAS 28-3 (CRP) and DAS 28-4 (ESR).Also incidence of Disease Activity Score <2.6 and 3.2.Timepoint: Every visit until last observation.;FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization QuestionnaireTimepoint: Every visit until last observation.;HAQ DI scoreTimepoint: Every visit until last observation.;Percent of patients with ACR 20, 50, and 70 responsesTimepoint: Every visit until last observation.;Preservation of joint structure in patients who had baseline radiographs obtained in their qualifying index studyTimepoint: Every 6 months until last observation.;SF 36 scoreTimepoint: Every visit until last observation | — |
Countries
Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Malaysia, Mexico, New Zealand, Other, Philippines, Poland, Republic of Korea, Romania, Russian Federation, Slovakia, Spain, Sweden, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States of America
Contacts
Public ContactSwapnali Raut
Representing Pfizer Limited
Outcome results
None listed