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

Sponsor:	Pfizer
Information provided by (Responsible Party):	Pfizer
ClinicalTrials.gov Identifier:	NCT00414661

Purpose

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.

Condition	Intervention	Phase
Arthritis, Rheumatoid	Other: CP-690,550	Phase II

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
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

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Incidence of lymphoproliferative disorders as confirmed by local pathologist and central pathologist [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Incidence of lymphoma as confirmed by local pathologist and central pathologist [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Incidence of important infections, defined as serious or opportunistic infections. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Functional status as assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI) score [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

New incidence of diabetes [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	300
Study Start Date:	February 2007
Estimated Study Completion Date:	February 2012
Estimated Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Study group All enrolled subjects	Other: 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.

Detailed Description:

At their last visit of a qualifying study, eligible subjects will be given the opportunity to participate in this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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.

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00414661

Show 72 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00414661 History of Changes
Other Study ID Numbers:	A3921029
Study First Received:	December 19, 2006
Last Updated:	December 14, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Observational non-interventional long-term safety

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases

Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on February 09, 2012