Clinical trial NCT00414661: Long-Term Safety Follow-Up Of Subjects Previously Enrolled In Rheumatoid Arthritis Studies Of CP-690,550
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis, Rheumatoid
Keywords: Observational non-interventional long-term safety
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-12-21
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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

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.

Primary outcomes:
measure: Incidence of Lymphoproliferative Disorders (LPD)
timeFrame: Up to Month 24
measure: Incidence of Lymphoma
timeFrame: Up to Month 24
measure: Incidence of Important Infections
timeFrame: Up to Month 24
Secondary outcomes:
Other outcomes:
measure: Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
timeFrame: Baseline, Month 6, 12, 18, 24
Locations:
city: Gilbert
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Palo Alto
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Stanford
country: United States
facility: Pfizer Investigational Site
state: California
city: Upland
country: United States
facility: Pfizer Investigational Site
state: California
city: Ocala
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Orlando
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Sarasota
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Venice
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Rockford
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Lincoln
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Albany
country: United States
facility: Pfizer Investigational Site
state: New York
city: Hickory
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Hickory
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Wyomissing
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Mesquite
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Tacoma
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Tacoma
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Goiania
country: Brazil
facility: Pfizer Investigational Site
state: GO
city: Rio de Janeiro
country: Brazil
facility: Pfizer Investigational Site
state: RJ
city: Sao Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Sao Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Sofia
country: Bulgaria
facility: Pfizer Investigational Site
city: Victoria
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Santiago
country: Chile
facility: Pfizer Investigational Site
state: RM
city: Santiago
country: Chile
facility: Pfizer Investigational Site
state: RM
city: Providencia
country: Chile
facility: Pfizer Investigational Site
state: Santiago, RM
city: Brno
country: Czech Republic
facility: Pfizer Investigational Site
city: Ceske Budejovice
country: Czech Republic
facility: Pfizer Investigational Site
city: Praha 11 - Chodov
country: Czech Republic
facility: Pfizer Investigational Site
city: Praha 2
country: Czech Republic
facility: Pfizer Investigational Site
city: Praha 4
country: Czech Republic
facility: Pfizer Investigational Site
city: Santo Domingo
country: Dominican Republic
facility: Pfizer Investigational Site
city: Hyvinkaa
country: Finland
facility: Pfizer Investigational Site
city: Athens
country: Greece
facility: Pfizer Investigational Site
state: Goudi
city: Thessaloniki
country: Greece
facility: Pfizer Investigational Site
city: Budapest
country: Hungary
facility: Pfizer Investigational Site
city: Szolnok
country: Hungary
facility: Pfizer Investigational Site
city: Veszprem
country: Hungary
facility: Pfizer Investigational Site
city: Ahmedabad
country: India
facility: Pfizer Investigational Site
state: Gujarat
city: Mangalore
country: India
facility: Pfizer Investigational Site
state: Karnataka
city: Pune
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Firenze
country: Italy
facility: Pfizer Investigational Site
city: Genova
country: Italy
facility: Pfizer Investigational Site
city: Kitakyusyu
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka
city: Higashihiroshima
country: Japan
facility: Pfizer Investigational Site
state: Hiroshima
city: Sagamihara
country: Japan
facility: Pfizer Investigational Site
state: Kanagawa
city: Shinjyuku-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Daejeon
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Gwangju
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Incheon
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Mexico
country: Mexico
facility: Pfizer Investigational Site
state: D.f.
city: Mexico
country: Mexico
facility: Pfizer Investigational Site
state: DF
city: Bialystok
country: Poland
facility: Pfizer Investigational Site
city: Poznan
country: Poland
facility: Pfizer Investigational Site
city: Sopot
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Wroclaw
country: Poland
facility: Pfizer Investigational Site
city: San Juan
country: Puerto Rico
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Piestany
country: Slovakia
facility: Pfizer Investigational Site
city: Zilina
country: Slovakia
facility: Pfizer Investigational Site
city: Guadalajara
country: Spain
facility: Pfizer Investigational Site
city: Vinnitsa
country: Ukraine
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: