Long-Term Safety Follow-Up Of Subjects Previously Enrolled In Rheumatoid Arthritis Studies Of CP-690,550

Completed

• Conditions: Arthritis, Rheumatoid
• Interventions: Drug: CP-690,550

• Registration Number: NCT00414661
• Lead Sponsor: Pfizer

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2006-12-19
• Study First Submitted QC: 2006-12-20
• Study First Posted: 2006-12-21
• Study Start: 2007-04
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2012-11
• Results First Submitted: 2012-11-28
• Results First Submitted QC: 2012-11-28
• Last Update Submitted: 2012-11-28
• Results First Posted: 2013-01-01
• Last Update Posted: 2013-01-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

Inclusion Criteria

• Subjects who have completed all participation in any other Phase 2B or Phase 3 studies of CP-690,550 for rheumatoid arthritis.

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Exclusion Criteria

• Any subject who refuses consent.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study group	CP-690,550	All enrolled subjects

Primary Outcome Measures

Name	Time	Method
Incidence of Lymphoproliferative Disorders (LPD)	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	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	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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇦 Vinnitsa, Ukraine