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

NCT00414661

Last updated date
Study Location
Pfizer Investigational Site
Gilbert, Arizona, 85234, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Any subject who refuses consent.

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Advanced Information
Descriptive Information
Brief Title Long-Term Safety Follow-Up Of Subjects Previously Enrolled In Rheumatoid Arthritis Studies Of CP-690,550
Official Title 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
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Subjects who have received at least one dose of study drug and ceased participation in any Phase 2B or 3 randomized, controlled or open-label (qualifying) study of CP-690,550 for the treatment of RA, but are no longer receiving CP-690,550.
Condition Arthritis, Rheumatoid
Intervention Drug: CP-690,550
Subjects had to have received CP-690,550 or other blinded study drug in index study. No intervention in this long-term follow-up trial.
Study Groups/Cohorts Study group
All enrolled subjects
Intervention: Drug: CP-690,550
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 28, 2012)
162
Original Enrollment
 (submitted: December 20, 2006)
300
Actual Study Completion Date February 2012
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Argentina,   Brazil,   Bulgaria,   Canada,   Chile,   Czech Republic,   Dominican Republic,   Finland,   Greece,   Hungary,   India,   Italy,   Japan,   Korea, Republic of,   Mexico,   Poland,   Puerto Rico,   Slovakia,   Spain,   Ukraine,   United States
Removed Location Countries Australia,   Austria,   Belgium,   Costa Rica,   Romania,   Sweden
 
Administrative Information
NCT Number NCT00414661
Other Study ID Numbers A3921029
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date November 2012