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

November 28, 2012 updated by: Pfizer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

162

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1034ACO
        • Pfizer Investigational Site
      • Buenos Aires, Argentina, C1114AAH
        • Pfizer Investigational Site
  • Brazil
    • GO
      • Goiania, GO, Brazil, 74110-120
        • Pfizer Investigational Site
    • RJ
      • Rio de Janeiro, RJ, Brazil, 22271-100
        • Pfizer Investigational Site
    • SP
      • Sao Paulo, SP, Brazil, 04266-010
        • Pfizer Investigational Site
      • Sao Paulo, SP, Brazil, 01323-903
        • Pfizer Investigational Site
  • Bulgaria
      • Sofia, Bulgaria, 1612
        • Pfizer Investigational Site
  • Canada
    • British Columbia
      • Victoria, British Columbia, Canada, V8V 3P9
        • Pfizer Investigational Site
  • Chile
    • RM
      • Santiago, RM, Chile, 7500922
        • Pfizer Investigational Site
      • Santiago, RM, Chile, 7501126
        • Pfizer Investigational Site
    • Santiago, RM
      • Providencia, Santiago, RM, Chile, 7500710
        • Pfizer Investigational Site
  • Czech Republic
      • Brno, Czech Republic, 656 91
        • Pfizer Investigational Site
      • Ceske Budejovice, Czech Republic, 370 01
        • Pfizer Investigational Site
      • Praha 11 - Chodov, Czech Republic, 148 00
        • Pfizer Investigational Site
      • Praha 2, Czech Republic, 128 50
        • Pfizer Investigational Site
      • Praha 4, Czech Republic, 140 00
        • Pfizer Investigational Site
  • Dominican Republic
      • Santo Domingo, Dominican Republic, 00000
        • Pfizer Investigational Site
  • Finland
      • Hyvinkaa, Finland, 05800
        • Pfizer Investigational Site
  • Greece
      • Thessaloniki, Greece, 54 636
        • Pfizer Investigational Site
    • Goudi
      • Athens, Goudi, Greece, 11527
        • Pfizer Investigational Site
  • Hungary
      • Budapest, Hungary, H-1036
        • Pfizer Investigational Site
      • Szolnok, Hungary, H-5000
        • Pfizer Investigational Site
      • Veszprem, Hungary, H-8200
        • Pfizer Investigational Site
  • India
    • Gujarat
      • Ahmedabad, Gujarat, India, 380 015
        • Pfizer Investigational Site
    • Karnataka
      • Mangalore, Karnataka, India, 575 001
        • Pfizer Investigational Site
    • Maharashtra
      • Pune, Maharashtra, India, 411 001
        • Pfizer Investigational Site
  • Italy
      • Firenze, Italy, 50139
        • Pfizer Investigational Site
      • Genova, Italy, 16132
        • Pfizer Investigational Site
  • Japan
    • Fukuoka
      • Kitakyusyu, Fukuoka, Japan
        • Pfizer Investigational Site
    • Hiroshima
      • Higashihiroshima, Hiroshima, Japan
        • Pfizer Investigational Site
    • Kanagawa
      • Sagamihara, Kanagawa, Japan
        • Pfizer Investigational Site
    • Tokyo
      • Shinjyuku-ku, Tokyo, Japan
        • Pfizer Investigational Site
  • Korea, Republic of
      • Daejeon, Korea, Republic of, 302-799
        • Pfizer Investigational Site
      • Gwangju, Korea, Republic of, 501-757
        • Pfizer Investigational Site
      • Incheon, Korea, Republic of, 400-711
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 120-752
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 110-744
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 133-792
        • Pfizer Investigational Site
  • Mexico
    • D.f.
      • Mexico, D.f., Mexico, 06726
        • Pfizer Investigational Site
    • DF
      • Mexico, DF, Mexico, 14000
        • Pfizer Investigational Site
  • Poland
      • Bialystok, Poland, 15-950
        • Pfizer Investigational Site
      • Poznan, Poland, 60-773
        • Pfizer Investigational Site
      • Sopot, Poland, 81-759
        • Pfizer Investigational Site
      • Warszawa, Poland, 02-256
        • Pfizer Investigational Site
      • Wroclaw, Poland, 50-088
        • Pfizer Investigational Site
  • Puerto Rico
      • San Juan, Puerto Rico, 00918
        • Pfizer Investigational Site
  • Slovakia
      • Bratislava, Slovakia, 81109
        • Pfizer Investigational Site
      • Piestany, Slovakia, 921 01
        • Pfizer Investigational Site
      • Zilina, Slovakia, 012 07
        • Pfizer Investigational Site
  • Spain
      • Guadalajara, Spain, 19002
        • Pfizer Investigational Site
  • Ukraine
      • Vinnitsa, Ukraine, 21018
        • Pfizer Investigational Site
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Pfizer Investigational Site
      • Tucson, Arizona, United States, 85704
        • Pfizer Investigational Site
    • California
      • Palo Alto, California, United States, 94304
        • Pfizer Investigational Site
      • San Diego, California, United States, 92108
        • Pfizer Investigational Site
      • Stanford, California, United States, 94305
        • Pfizer Investigational Site
      • Upland, California, United States, 91786
        • Pfizer Investigational Site
    • Florida
      • Ocala, Florida, United States, 34474
        • Pfizer Investigational Site
      • Orlando, Florida, United States, 32804
        • Pfizer Investigational Site
      • Sarasota, Florida, United States, 34233
        • Pfizer Investigational Site
      • Tampa, Florida, United States, 33614
        • Pfizer Investigational Site
      • Tampa, Florida, United States, 33613
        • Pfizer Investigational Site
      • Venice, Florida, United States, 34292
        • Pfizer Investigational Site
    • Illinois
      • Rockford, Illinois, United States, 61107
        • Pfizer Investigational Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68516
        • Pfizer Investigational Site
    • New York
      • Albany, New York, United States, 12206-1043
        • Pfizer Investigational Site
    • North Carolina
      • Hickory, North Carolina, United States, 28601
        • Pfizer Investigational Site
      • Hickory, North Carolina, United States, 28602
        • Pfizer Investigational Site
    • Pennsylvania
      • Wyomissing, Pennsylvania, United States, 19610
        • Pfizer Investigational Site
    • Texas
      • Mesquite, Texas, United States, 75150
        • Pfizer Investigational Site
    • Washington
      • Tacoma, Washington, United States, 98405
        • Pfizer Investigational Site
      • Tacoma, Washington, United States, 98405-2308
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Lymphoproliferative Disorders (LPD)
Time Frame: 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.
Up to Month 24
Incidence of Lymphoma
Time Frame: 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.
Up to Month 24
Incidence of Important Infections
Time Frame: 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.
Up to Month 24

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
Time Frame: Baseline, Month 6, 12, 18, 24
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.
Baseline, Month 6, 12, 18, 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

December 19, 2006

First Submitted That Met QC Criteria

December 20, 2006

First Posted (Estimate)

December 21, 2006

Study Record Updates

Last Update Posted (Estimate)

January 1, 2013

Last Update Submitted That Met QC Criteria

November 28, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A3921029

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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