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

NCT00414661 | Completed Results

• 1 other identifier: A3921029
• Study Type: observational
• Target: 162
• Locations: 21 countries
• Sites: 72

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.

Conditions

Arthritis, Rheumatoid

Keywords

Observational non-interventional long-term safety

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Other Outcomes (1)

• Health Assessment Questionnaire-Disability Index (HAQ-DI) Score

  Baseline, Month 6, 12, 18, 24

Study Arms (1)

Study group

All enrolled subjects

Drug: CP-690,550

Interventions

CP-690,550 DRUG

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.

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Subjects who have completed all participation in any other Phase 2B or Phase 3 studies of CP-690,550 for rheumatoid arthritis.

You may not qualify if:

• Any subject who refuses consent.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (72)

Pfizer Investigational Site

Gilbert, Arizona, 85234, United States

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Tucson, Arizona, 85704, United States

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Palo Alto, California, 94304, United States

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San Diego, California, 92108, United States

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Stanford, California, 94305, United States

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Upland, California, 91786, United States

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Ocala, Florida, 34474, United States

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Orlando, Florida, 32804, United States

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Sarasota, Florida, 34233, United States

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Tampa, Florida, 33613, United States

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Tampa, Florida, 33614, United States

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Venice, Florida, 34292, United States

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Rockford, Illinois, 61107, United States

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Lincoln, Nebraska, 68516, United States

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Albany, New York, 12206-1043, United States

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Hickory, North Carolina, 28601, United States

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Hickory, North Carolina, 28602, United States

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Wyomissing, Pennsylvania, 19610, United States

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Mesquite, Texas, 75150, United States

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Tacoma, Washington, 98405-2308, United States

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Tacoma, Washington, 98405, United States

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Buenos Aires, C1034ACO, Argentina

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Buenos Aires, C1114AAH, Argentina

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Goiânia, Goiás, 74110-120, Brazil

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Rio de Janeiro, Rio de Janeiro, 22271-100, Brazil

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São Paulo, São Paulo, 01323-903, Brazil

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São Paulo, São Paulo, 04266-010, Brazil

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Sofia, 1612, Bulgaria

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Victoria, British Columbia, V8V 3P9, Canada

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Santiago, RM, 7500922, Chile

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Santiago, RM, 7501126, Chile

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Providencia, Santiago, RM, 7500710, Chile

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Brno, 656 91, Czechia

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České Budějovice, 370 01, Czechia

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Prague, 128 50, Czechia

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Prague, 140 00, Czechia

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Praha 11 - Chodov, 148 00, Czechia

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Santo Domingo, Santo Domingo Province, 00000, Dominican Republic

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Hyvinkää, 05800, Finland

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Athens, Goudi, 11527, Greece

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Thessaloniki, 54 636, Greece

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Budapest, H-1036, Hungary

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Szolnok, H-5000, Hungary

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Veszprém, H-8200, Hungary

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Ahmedabad, Gujarat, 380 015, India

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Mangalore, Karnataka, 575 001, India

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Pune, Maharashtra, 411 001, India

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Florence, 50139, Italy

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Genova, 16132, Italy

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Kitakyushu, Fukuoka, Japan

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Higashihiroshima, Hiroshima, Japan

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Sagamihara, Kanagawa, Japan

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Shinjyuku-ku, Tokyo, Japan

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México, D.f., 06726, Mexico

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Mexico City, Mexico City, 14000, Mexico

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Bialystok, 15-950, Poland

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Poznan, 60-773, Poland

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Sopot, 81-759, Poland

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Warsaw, 02-256, Poland

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Wroclaw, 50-088, Poland

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San Juan, 00918, Puerto Rico

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Bratislava, 81109, Slovakia

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Piešťany, 921 01, Slovakia

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Žilina, 012 07, Slovakia

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Daejeon, 302-799, South Korea

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Gwangju, 501-757, South Korea

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Incheon, 400-711, South Korea

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Seoul, 110-744, South Korea

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Seoul, 120-752, South Korea

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Seoul, 133-792, South Korea

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Guadalajara, Guadalajara, 19002, Spain

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Vinnitsa, 21018, Ukraine

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tofacitinib

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2006
• First Posted: December 21, 2006
• Study Start: April 1, 2007
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: January 1, 2013
• Results First Posted: January 1, 2013

Record last verified: 2012-11

Locations

SL (3); DO (1); BU (1); JP (4); HU (3); BR (4); US (21); AR (2); PL (5); KR (6); ES (1); UA (1); GR (2); FI (1); CZ (5); IT (2); IN (3); CA (1); ME (2); CL (3); PR (1)