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

Last updated on October 11, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Gilbert, Arizona, 85234 United States
Contact
1-800-718-1021
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.

NCT00414661
Pfizer
Completed
Long-Term Safety Follow-Up Of Subjects Previously Enrolled In Rheumatoid Arthritis Studies Of CP-690,550

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Descriptive Information
Brief TitleLong-Term Safety Follow-Up Of Subjects Previously Enrolled In Rheumatoid Arthritis Studies Of CP-690,550
Official TitleA 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 SummaryThe 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 DescriptionAt their last visit of a qualifying study, eligible subjects will be given the opportunity to participate in this study.
Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationSubjects 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.
ConditionArthritis, Rheumatoid
InterventionDrug: 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/CohortsStudy 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 StatusCompleted
Actual Enrollment
 (submitted: March 28, 2012)
162
Original Enrollment
 (submitted: December 20, 2006)
300
Actual Study Completion DateFebruary 2012
Actual Primary Completion DateFebruary 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
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesArgentina,   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 CountriesAustralia,   Austria,   Belgium,   Costa Rica,   Romania,   Sweden
 
Administrative Information
NCT NumberNCT00414661
Other Study ID NumbersA3921029
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateNovember 2012

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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