A Prospective Observational Study To Evaluate Long-Term Safety And Functional Status Of Subjects With Rheumatoid Arthritis Previously Enrolled In Studies Of CP-690,550
Overview
- Phase
- N/A
- Intervention
- CP-690,550
- Conditions
- Arthritis, Rheumatoid
- Sponsor
- Pfizer
- Enrollment
- 162
- Locations
- 1
- Primary Endpoint
- Incidence of Lymphoproliferative Disorders (LPD)
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
The purpose of this study is to follow the health of subjects who have previously been enrolled in studies of CP-690,550 for treatment of their rheumatoid arthritis. Subjects are only eligible for this study after they have completed all participation in other studies of CP-690,550.
Detailed Description
At their last visit of a qualifying study, eligible subjects will be given the opportunity to participate in this study.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects who have completed all participation in any other Phase 2B or Phase 3 studies of CP-690,550 for rheumatoid arthritis.
Exclusion Criteria
- •Any subject who refuses consent.
Arms & Interventions
Study group
All enrolled subjects
Intervention: CP-690,550
Outcomes
Primary Outcomes
Incidence of Lymphoproliferative Disorders (LPD)
Time Frame: Up to Month 24
Incidence rate was calculated separately for active treatment period and follow-up period in previous studies as number of participants with LPD by number of days while on active treatment or during follow-up period per 100 person-years. Standardization of incidence rates was based upon the age and sex distribution of the entire study population.
Incidence of Lymphoma
Time Frame: Up to Month 24
Incidence rate was calculated separately for active treatment period and follow-up period in previous studies as number of participants with lymphoma by number of days while on active treatment or during follow-up period per 100 person-years. Standardization of incidence rates was based upon the age and sex distribution of the entire study population.
Incidence of Important Infections
Time Frame: Up to Month 24
Incidence rate was calculated separately for active treatment period and follow-up period in previous studies as number of participants with important infections by number of days while on active treatment or during follow-up period per 100 person-years. Standardization of incidence rates was based upon the age and sex distribution of the entire study population.