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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.
At their last visit of a qualifying study, eligible subjects will be given the opportunity to participate in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | All enrolled subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Gilbert | Arizona | 85234 | United States | ||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Participants who received at least 1 dose of CP-690,550, placebo or adalimumab for the treatment of Rheumatoid Arthritis (RA) in previous studies and had ceased participation in other Phase 2B or 3 randomized, controlled or open-label study of CP-690,550 were eligible for this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | CP-690,550 >=10 mg | Participants who had received 1 dose CP-690,550 greater than or equal to (>=) 10 milligram (mg) orally twice daily in any of the previous studies. |
| FG001 | CP-690,550 <10 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Baseline, Month 6, 12, 18, 24 |
| Tucson |
| Arizona |
| 85704 |
| United States |
| Pfizer Investigational Site | Palo Alto | California | 94304 | United States |
| Pfizer Investigational Site | San Diego | California | 92108 | United States |
| Pfizer Investigational Site | Stanford | California | 94305 | United States |
| Pfizer Investigational Site | Upland | California | 91786 | United States |
| Pfizer Investigational Site | Ocala | Florida | 34474 | United States |
| Pfizer Investigational Site | Orlando | Florida | 32804 | United States |
| Pfizer Investigational Site | Sarasota | Florida | 34233 | United States |
| Pfizer Investigational Site | Tampa | Florida | 33613 | United States |
| Pfizer Investigational Site | Tampa | Florida | 33614 | United States |
| Pfizer Investigational Site | Venice | Florida | 34292 | United States |
| Pfizer Investigational Site | Rockford | Illinois | 61107 | United States |
| Pfizer Investigational Site | Lincoln | Nebraska | 68516 | United States |
| Pfizer Investigational Site | Albany | New York | 12206-1043 | United States |
| Pfizer Investigational Site | Hickory | North Carolina | 28601 | United States |
| Pfizer Investigational Site | Hickory | North Carolina | 28602 | United States |
| Pfizer Investigational Site | Wyomissing | Pennsylvania | 19610 | United States |
| Pfizer Investigational Site | Mesquite | Texas | 75150 | United States |
| Pfizer Investigational Site | Tacoma | Washington | 98405-2308 | United States |
| Pfizer Investigational Site | Tacoma | Washington | 98405 | United States |
| Pfizer Investigational Site | Buenos Aires | C1034ACO | Argentina |
| Pfizer Investigational Site | Buenos Aires | C1114AAH | Argentina |
| Pfizer Investigational Site | Goiânia | Goiás | 74110-120 | Brazil |
| Pfizer Investigational Site | Rio de Janeiro | Rio de Janeiro | 22271-100 | Brazil |
| Pfizer Investigational Site | São Paulo | São Paulo | 01323-903 | Brazil |
| Pfizer Investigational Site | São Paulo | São Paulo | 04266-010 | Brazil |
| Pfizer Investigational Site | Sofia | 1612 | Bulgaria |
| Pfizer Investigational Site | Victoria | British Columbia | V8V 3P9 | Canada |
| Pfizer Investigational Site | Santiago | RM | 7500922 | Chile |
| Pfizer Investigational Site | Santiago | RM | 7501126 | Chile |
| Pfizer Investigational Site | Providencia | Santiago, RM | 7500710 | Chile |
| Pfizer Investigational Site | Brno | 656 91 | Czechia |
| Pfizer Investigational Site | České Budějovice | 370 01 | Czechia |
| Pfizer Investigational Site | Prague | 128 50 | Czechia |
| Pfizer Investigational Site | Prague | 140 00 | Czechia |
| Pfizer Investigational Site | Praha 11 - Chodov | 148 00 | Czechia |
| Pfizer Investigational Site | Santo Domingo | Santo Domingo Province | 00000 | Dominican Republic |
| Pfizer Investigational Site | Hyvinkää | 05800 | Finland |
| Pfizer Investigational Site | Athens | Goudi | 11527 | Greece |
| Pfizer Investigational Site | Thessaloniki | 54 636 | Greece |
| Pfizer Investigational Site | Budapest | H-1036 | Hungary |
| Pfizer Investigational Site | Szolnok | H-5000 | Hungary |
| Pfizer Investigational Site | Veszprém | H-8200 | Hungary |
| Pfizer Investigational Site | Ahmedabad | Gujarat | 380 015 | India |
| Pfizer Investigational Site | Mangalore | Karnataka | 575 001 | India |
| Pfizer Investigational Site | Pune | Maharashtra | 411 001 | India |
| Pfizer Investigational Site | Florence | 50139 | Italy |
| Pfizer Investigational Site | Genova | 16132 | Italy |
| Pfizer Investigational Site | Kitakyushu | Fukuoka | Japan |
| Pfizer Investigational Site | Higashihiroshima | Hiroshima | Japan |
| Pfizer Investigational Site | Sagamihara | Kanagawa | Japan |
| Pfizer Investigational Site | Shinjyuku-ku | Tokyo | Japan |
| Pfizer Investigational Site | México | D.f. | 06726 | Mexico |
| Pfizer Investigational Site | Mexico City | Mexico City | 14000 | Mexico |
| Pfizer Investigational Site | Bialystok | 15-950 | Poland |
| Pfizer Investigational Site | Poznan | 60-773 | Poland |
| Pfizer Investigational Site | Sopot | 81-759 | Poland |
| Pfizer Investigational Site | Warsaw | 02-256 | Poland |
| Pfizer Investigational Site | Wroclaw | 50-088 | Poland |
| Pfizer Investigational Site | San Juan | 00918 | Puerto Rico |
| Pfizer Investigational Site | Bratislava | 81109 | Slovakia |
| Pfizer Investigational Site | Piešťany | 921 01 | Slovakia |
| Pfizer Investigational Site | Žilina | 012 07 | Slovakia |
| Pfizer Investigational Site | Daejeon | 302-799 | South Korea |
| Pfizer Investigational Site | Gwangju | 501-757 | South Korea |
| Pfizer Investigational Site | Incheon | 400-711 | South Korea |
| Pfizer Investigational Site | Seoul | 110-744 | South Korea |
| Pfizer Investigational Site | Seoul | 120-752 | South Korea |
| Pfizer Investigational Site | Seoul | 133-792 | South Korea |
| Pfizer Investigational Site | Guadalajara | Guadalajara | 19002 | Spain |
| Pfizer Investigational Site | Vinnitsa | 21018 | Ukraine |
Participants who had received 1 dose CP-690,550 less than (<) 10 mg orally twice daily in any of the previous studies.
| FG002 | Placebo | Participants who had received 1 dose of matching-placebo in any of the previous studies. |
| FG003 | Adalimumab | Participants who had received 1 dose of adalimumab in any of the previous studies. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CP-690,550 >=10 mg | Participants who had received 1 dose CP-690,550 greater than or equal to (>=) 10 milligram (mg) orally twice daily in any of the previous studies. |
| BG001 | CP-690,550 <10 mg | Participants who had received 1 dose CP-690,550 less than (<) 10 mg orally twice daily in any of the previous studies. |
| BG002 | Placebo | Participants who had received 1 dose of matching-placebo in any of the previous studies. |
| BG003 | Adalimumab | Participants who had received 1 dose of adalimumab in any of the previous studies. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Safety analysis set included all participants who were previously enrolled in either randomized, controlled or open-label studies of CP-690,550 and had signed the informed consent form for this study. | Posted | Number | 95% Confidence Interval | LPD per 100 person-years | Up to Month 24 |
|
|
| ||||||||||||||||||||||||||||||||||
| 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. | Safety analysis set included all participants who were previously enrolled in either randomized, controlled or open-label studies of CP-690,550 and had signed the informed consent form for this study. | Posted | Number | 95% Confidence Interval | Lymphoma per 100 person-years | Up to Month 24 |
| ||||||||||||||||||||||||||||||||||||
| 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. | Safety analysis set included all participants who were previously enrolled in either randomized, controlled or open-label studies of CP-690,550 and had signed the informed consent form for this study. | Posted | Number | 95% Confidence Interval | Infections per 100 person-years | Up to Month 24 |
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | 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. | Safety analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for the measure and 'n' signifies participants evaluable at each time point for each arm respectively. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 6, 12, 18, 24 |
|
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CP-690,550 >=10 mg | Participants who had received 1 dose CP-690,550 greater than or equal to (>=) 10 milligram (mg) orally twice daily in any of the previous studies. | 0 | 48 | 3 | 48 | ||
| EG001 | CP-690,550 <10 mg | Participants who had received 1 dose CP-690,550 less than (<) 10 mg orally twice daily in any of the previous studies. | 1 | 89 | 2 | 89 | ||
| EG002 | Placebo | Participants who had received 1 dose of matching-placebo in any of the previous studies. | 0 | 22 | 1 | 22 | ||
| EG003 | Adalimumab | Participants who had received 1 dose of adalimumab in any of the previous studies. | 0 | 3 | 0 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tuberculosis | Infections and infestations | MedDRA v14.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Herpes zoster | Infections and infestations | MedDRA v14.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v14.1 | Non-systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA v14.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v14.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C479163 | tofacitinib |
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| Male |
|
| OG003 |
| Adalimumab |
Participants who had received 1 dose of adalimumab in any of the previous studies. |
|
|
| OG003 |
| Adalimumab |
Participants who had received 1 dose of adalimumab in any of the previous studies. |
|
|
Participants who had received 1 dose of matching-placebo in any of the previous studies.
| OG003 | Adalimumab | Participants who had received 1 dose of adalimumab in any of the previous studies. |
|
|