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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00414661
First received: December 19, 2006
Last updated: November 28, 2012
Last verified: November 2012
  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
Arthritis, Rheumatoid
Drug: CP-690,550

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:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Incidence of Lymphoproliferative Disorders (LPD) [ Time Frame: Up to Month 24 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Other Outcome Measures:
  • Health Assessment Questionnaire-Disability Index (HAQ-DI) Score [ Time Frame: Baseline, Month 6, 12, 18, 24 ] [ Designated as safety issue: No ]
    HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.


Enrollment: 162
Study Start Date: April 2007
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Study group
All enrolled subjects
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.

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:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00414661     History of Changes
Other Study ID Numbers: A3921029
Study First Received: December 19, 2006
Results First Received: November 28, 2012
Last Updated: November 28, 2012
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 April 15, 2014