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NCT00414661 Clinical Trial

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

Arthritis, Rheumatoid Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00414661
Other study ID # A3921029
Secondary ID
Status Completed
Phase N/A
First received December 19, 2006
Last updated November 28, 2012
Start date April 2007
Est. completion date February 2012

Study information
Verified date November 2012
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 162
Est. completion date February 2012
Est. primary completion date February 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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.

Locations
Country Name City State
Argentina Pfizer Investigational Site Buenos Aires
Argentina Pfizer Investigational Site Buenos Aires
Brazil Pfizer Investigational Site Goiania GO
Brazil Pfizer Investigational Site Rio de Janeiro RJ
Brazil Pfizer Investigational Site Sao Paulo SP
Brazil Pfizer Investigational Site Sao Paulo SP
Bulgaria Pfizer Investigational Site Sofia
Canada Pfizer Investigational Site Victoria British Columbia
Chile Pfizer Investigational Site Providencia Santiago, RM
Chile Pfizer Investigational Site Santiago RM
Chile Pfizer Investigational Site Santiago RM
Czech Republic Pfizer Investigational Site Brno
Czech Republic Pfizer Investigational Site Ceske Budejovice
Czech Republic Pfizer Investigational Site Praha 11 - Chodov
Czech Republic Pfizer Investigational Site Praha 2
Czech Republic Pfizer Investigational Site Praha 4
Dominican Republic Pfizer Investigational Site Santo Domingo
Finland Pfizer Investigational Site Hyvinkaa
Greece Pfizer Investigational Site Athens Goudi
Greece Pfizer Investigational Site Thessaloniki
Hungary Pfizer Investigational Site Budapest
Hungary Pfizer Investigational Site Szolnok
Hungary Pfizer Investigational Site Veszprem
India Pfizer Investigational Site Ahmedabad Gujarat
India Pfizer Investigational Site Mangalore Karnataka
India Pfizer Investigational Site Pune Maharashtra
Italy Pfizer Investigational Site Firenze
Italy Pfizer Investigational Site Genova
Japan Pfizer Investigational Site Higashihiroshima Hiroshima
Japan Pfizer Investigational Site Kitakyusyu Fukuoka
Japan Pfizer Investigational Site Sagamihara Kanagawa
Japan Pfizer Investigational Site Shinjyuku-ku Tokyo
Korea, Republic of Pfizer Investigational Site Daejeon
Korea, Republic of Pfizer Investigational Site Gwangju
Korea, Republic of Pfizer Investigational Site Incheon
Korea, Republic of Pfizer Investigational Site Seoul
Korea, Republic of Pfizer Investigational Site Seoul
Korea, Republic of Pfizer Investigational Site Seoul
Mexico Pfizer Investigational Site Mexico D.f.
Mexico Pfizer Investigational Site Mexico DF
Poland Pfizer Investigational Site Bialystok
Poland Pfizer Investigational Site Poznan
Poland Pfizer Investigational Site Sopot
Poland Pfizer Investigational Site Warszawa
Poland Pfizer Investigational Site Wroclaw
Puerto Rico Pfizer Investigational Site San Juan
Slovakia Pfizer Investigational Site Bratislava
Slovakia Pfizer Investigational Site Piestany
Slovakia Pfizer Investigational Site Zilina
Spain Pfizer Investigational Site Guadalajara
Ukraine Pfizer Investigational Site Vinnitsa
United States Pfizer Investigational Site Albany New York
United States Pfizer Investigational Site Gilbert Arizona
United States Pfizer Investigational Site Hickory North Carolina
United States Pfizer Investigational Site Hickory North Carolina
United States Pfizer Investigational Site Lincoln Nebraska
United States Pfizer Investigational Site Mesquite Texas
United States Pfizer Investigational Site Ocala Florida
United States Pfizer Investigational Site Orlando Florida
United States Pfizer Investigational Site Palo Alto California
United States Pfizer Investigational Site Rockford Illinois
United States Pfizer Investigational Site San Diego California
United States Pfizer Investigational Site Sarasota Florida
United States Pfizer Investigational Site Stanford California
United States Pfizer Investigational Site Tacoma Washington
United States Pfizer Investigational Site Tacoma Washington
United States Pfizer Investigational Site Tampa Florida
United States Pfizer Investigational Site Tampa Florida
United States Pfizer Investigational Site Tucson Arizona
United States Pfizer Investigational Site Upland California
United States Pfizer Investigational Site Venice Florida
United States Pfizer Investigational Site Wyomissing Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  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, 

Outcome
Type Measure Description Time frame Safety issue
Other Health Assessment Questionnaire-Disability Index (HAQ-DI) Score 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 No
Primary Incidence of Lymphoproliferative Disorders (LPD) 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 Yes
Primary Incidence of Lymphoma 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 Yes
Primary Incidence of Important Infections 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 Yes
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Completed NCT00975130 - Subcutaneous Golimumab (GLM) Plus DMARDs for Rheumatoid Arthritis, Followed by Intravenous/Subcutaneous GLM Strategy (P06129 AM2) Phase 3
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Completed NCT00973479 - An Effectiveness and Safety Study of Intravenous Golimumab in Patients With Active Rheumatoid Arthritis Despite Treatment With Methotrexate Therapy Phase 3
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