Ignite Creation Date:
2025-12-24 @ 11:49 AM
Ignite Modification Date:
2025-12-30 @ 9:32 PM
Study NCT ID:
NCT00414661
Status:
COMPLETED
Last Update Posted:
2013-01-01
First Post:
2006-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Long-Term Safety Follow-Up Of Subjects Previously Enrolled In Rheumatoid Arthritis Studies Of CP-690,550
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia', 'Austria', 'Belgium', 'Costa Rica', 'Romania', 'Sweden']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C479163', 'term': 'tofacitinib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': '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.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': '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.', 'eventGroups': [{'id': 'EG000', 'title': 'CP-690,550 >=10 mg', 'description': '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.', 'otherNumAtRisk': 48, 'otherNumAffected': 3, 'seriousNumAtRisk': 48, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'CP-690,550 <10 mg', 'description': 'Participants who had received 1 dose CP-690,550 less than (\\<) 10 mg orally twice daily in any of the previous studies.', 'otherNumAtRisk': 89, 'otherNumAffected': 2, 'seriousNumAtRisk': 89, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Participants who had received 1 dose of matching-placebo in any of the previous studies.', 'otherNumAtRisk': 22, 'otherNumAffected': 1, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Adalimumab', 'description': 'Participants who had received 1 dose of adalimumab in any of the previous studies.', 'otherNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}], 'seriousEvents': [{'term': 'Tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Lymphoproliferative Disorders (LPD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-690,550 >=10 mg', 'description': '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.'}, {'id': 'OG001', 'title': 'CP-690,550 <10 mg', 'description': 'Participants who had received 1 dose CP-690,550 less than (\\<) 10 mg orally twice daily in any of the previous studies.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants who had received 1 dose of matching-placebo in any of the previous studies.'}, {'id': 'OG003', 'title': 'Adalimumab', 'description': 'Participants who had received 1 dose of adalimumab in any of the previous studies.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data was not analyzed as no LPD occurred.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not analyzed as no LPD occurred.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not analyzed as no LPD occurred.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not analyzed as no LPD occurred.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Month 24', 'description': '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.', 'unitOfMeasure': 'LPD per 100 person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Incidence of Lymphoma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-690,550 >=10 mg', 'description': '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.'}, {'id': 'OG001', 'title': 'CP-690,550 <10 mg', 'description': 'Participants who had received 1 dose CP-690,550 less than (\\<) 10 mg orally twice daily in any of the previous studies.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants who had received 1 dose of matching-placebo in any of the previous studies.'}, {'id': 'OG003', 'title': 'Adalimumab', 'description': 'Participants who had received 1 dose of adalimumab in any of the previous studies.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data was not analyzed as no lymphoma occurred.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not analyzed as no lymphoma occurred.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not analyzed as no lymphoma occurred.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not analyzed as no lymphoma occurred.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Month 24', 'description': '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.', 'unitOfMeasure': 'Lymphoma per 100 person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Incidence of Important Infections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-690,550 >=10 mg', 'description': '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.'}, {'id': 'OG001', 'title': 'CP-690,550 <10 mg', 'description': 'Participants who had received 1 dose CP-690,550 less than (\\<) 10 mg orally twice daily in any of the previous studies.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants who had received 1 dose of matching-placebo in any of the previous studies.'}, {'id': 'OG003', 'title': 'Adalimumab', 'description': 'Participants who had received 1 dose of adalimumab in any of the previous studies.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.000', 'comment': 'Upper limit of 95 percent (%) confidence interval (CI) was not estimable as no event occurred in this arm group.', 'groupId': 'OG000', 'lowerLimit': '0.000', 'upperLimit': 'NA'}, {'value': '0.607', 'groupId': 'OG001', 'lowerLimit': '0.086', 'upperLimit': '4.312'}, {'value': '0.000', 'comment': 'Upper limit of 95 percent (%) confidence interval (CI) was not estimable as no event occurred in this arm group.', 'groupId': 'OG002', 'lowerLimit': '0.000', 'upperLimit': 'NA'}, {'value': '0.000', 'comment': 'Upper limit of 95 percent (%) confidence interval (CI) was not estimable as no event occurred in this arm group.', 'groupId': 'OG003', 'lowerLimit': '0.000', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Month 24', 'description': '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.', 'unitOfMeasure': 'Infections per 100 person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Health Assessment Questionnaire-Disability Index (HAQ-DI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-690,550 >=10 mg', 'description': '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.'}, {'id': 'OG001', 'title': 'CP-690,550 <10 mg', 'description': 'Participants who had received 1 dose CP-690,550 less than (\\<) 10 mg orally twice daily in any of the previous studies.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants who had received 1 dose of matching-placebo in any of the previous studies.'}, {'id': 'OG003', 'title': 'Adalimumab', 'description': 'Participants who had received 1 dose of adalimumab in any of the previous studies.'}], 'classes': [{'title': 'Baseline (n= 48, 88, 22, 3)', 'categories': [{'measurements': [{'value': '1.32', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '1.42', 'spread': '0.67', 'groupId': 'OG001'}, {'value': '1.63', 'spread': '0.76', 'groupId': 'OG002'}, {'value': '1.13', 'spread': '0.13', 'groupId': 'OG003'}]}]}, {'title': 'Month 6 (n= 37, 81, 21, 2)', 'categories': [{'measurements': [{'value': '1.08', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '1.23', 'spread': '0.69', 'groupId': 'OG001'}, {'value': '1.21', 'spread': '0.82', 'groupId': 'OG002'}, {'value': '0.19', 'spread': '0.27', 'groupId': 'OG003'}]}]}, {'title': 'Month 12 (n= 39, 79, 21, 1)', 'categories': [{'measurements': [{'value': '1.16', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '1.12', 'spread': '0.76', 'groupId': 'OG001'}, {'value': '1.15', 'spread': '0.81', 'groupId': 'OG002'}, {'value': '0.88', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG003'}]}]}, {'title': 'Month 18 (n= 35, 76, 20, 0)', 'categories': [{'measurements': [{'value': '1.15', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '1.07', 'spread': '0.77', 'groupId': 'OG001'}, {'value': '1.12', 'spread': '0.86', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable in this arm group.', 'groupId': 'OG003'}]}]}, {'title': 'Month 24 (n= 31, 68, 20, 0)', 'categories': [{'measurements': [{'value': '1.15', 'spread': '0.69', 'groupId': 'OG000'}, {'value': '1.14', 'spread': '0.78', 'groupId': 'OG001'}, {'value': '1.07', 'spread': '0.87', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable in this arm group.', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6, 12, 18, 24', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "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."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CP-690,550 >=10 mg', 'description': '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.'}, {'id': 'FG001', 'title': 'CP-690,550 <10 mg', 'description': 'Participants who had received 1 dose CP-690,550 less than (\\<) 10 mg orally twice daily in any of the previous studies.'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Participants who had received 1 dose of matching-placebo in any of the previous studies.'}, {'id': 'FG003', 'title': 'Adalimumab', 'description': 'Participants who had received 1 dose of adalimumab in any of the previous studies.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '89'}, {'groupId': 'FG002', 'numSubjects': '22'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '75'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '162', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'CP-690,550 >=10 mg', 'description': '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.'}, {'id': 'BG001', 'title': 'CP-690,550 <10 mg', 'description': 'Participants who had received 1 dose CP-690,550 less than (\\<) 10 mg orally twice daily in any of the previous studies.'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Participants who had received 1 dose of matching-placebo in any of the previous studies.'}, {'id': 'BG003', 'title': 'Adalimumab', 'description': 'Participants who had received 1 dose of adalimumab in any of the previous studies.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.2', 'spread': '10.8', 'groupId': 'BG000'}, {'value': '54.7', 'spread': '11.6', 'groupId': 'BG001'}, {'value': '51.8', 'spread': '13.5', 'groupId': 'BG002'}, {'value': '52.3', 'spread': '16.0', 'groupId': 'BG003'}, {'value': '55.0', 'spread': '11.7', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '132', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 162}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-28', 'studyFirstSubmitDate': '2006-12-19', 'resultsFirstSubmitDate': '2012-11-28', 'studyFirstSubmitQcDate': '2006-12-20', 'lastUpdatePostDateStruct': {'date': '2013-01-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-11-28', 'studyFirstPostDateStruct': {'date': '2006-12-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-01-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Health Assessment Questionnaire-Disability Index (HAQ-DI) Score', 'timeFrame': 'Baseline, Month 6, 12, 18, 24', 'description': '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.'}], 'primaryOutcomes': [{'measure': 'Incidence of Lymphoproliferative Disorders (LPD)', 'timeFrame': 'Up to Month 24', 'description': '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.'}, {'measure': 'Incidence of Lymphoma', 'timeFrame': 'Up to Month 24', 'description': '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.'}, {'measure': 'Incidence of Important Infections', 'timeFrame': 'Up to Month 24', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Observational non-interventional long-term safety'], 'conditions': ['Arthritis, Rheumatoid']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921029&StudyName=Long-Term%20Safety%20Follow-Up%20Of%20Subjects%20Previously%20Enrolled%20In%20Rheumatoid%20Arthritis%20Studies%20Of%20CP-690%2C550', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'At their last visit of a qualifying study, eligible subjects will be given the opportunity to participate in this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who have completed all participation in any other Phase 2B or Phase 3 studies of CP-690,550 for rheumatoid arthritis.\n\nExclusion Criteria:\n\n* Any subject who refuses consent.'}, 'identificationModule': {'nctId': 'NCT00414661', 'briefTitle': 'Long-Term Safety Follow-Up Of Subjects Previously Enrolled In Rheumatoid Arthritis Studies Of CP-690,550', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'A3921029'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group', 'description': 'All enrolled subjects', 'interventionNames': ['Drug: CP-690,550']}], 'interventions': [{'name': 'CP-690,550', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85234', 'city': 'Gilbert', 'state': 'Arizona', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '85704', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '92108', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '91786', 'city': 'Upland', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 34.09751, 'lon': -117.64839}}, {'zip': '34474', 'city': 'Ocala', 'state': 'Florida', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'zip': '32804', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '34233', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33614', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '34292', 'city': 'Venice', 'state': 'Florida', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 27.09978, 'lon': -82.45426}}, {'zip': '61107', 'city': 'Rockford', 'state': 'Illinois', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 42.27113, 'lon': -89.094}}, {'zip': '68516', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '12206-1043', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '28601', 'city': 'Hickory', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.73319, 'lon': -81.3412}}, {'zip': '28602', 'city': 'Hickory', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.73319, 'lon': -81.3412}}, {'zip': '19610', 'city': 'Wyomissing', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 40.32954, 'lon': -75.96521}}, {'zip': '75150', 'city': 'Mesquite', 'state': 'Texas', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 32.7668, 'lon': -96.59916}}, {'zip': '98405-2308', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}, {'zip': 'C1034ACO', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1114AAH', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '74110-120', 'city': 'Goiânia', 'state': 'Goiás', 'country': 'Brazil', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -16.67861, 'lon': -49.25389}}, {'zip': '22271-100', 'city': 'Rio de Janeiro', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'zip': '01323-903', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '04266-010', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '1612', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': 'V8V 3P9', 'city': 'Victoria', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 48.4359, 'lon': -123.35155}}, {'zip': '7500922', 'city': 'Santiago', 'state': 'RM', 'country': 'Chile', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '7501126', 'city': 'Santiago', 'state': 'RM', 'country': 'Chile', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '7500710', 'city': 'Providencia', 'state': 'Santiago, RM', 'country': 'Chile', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -33.43107, 'lon': -70.60454}}, {'zip': '656 91', 'city': 'Brno', 'country': 'Czechia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '370 01', 'city': 'České Budějovice', 'country': 'Czechia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 48.97447, 'lon': 14.47434}}, {'zip': '128 50', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '140 00', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '148 00', 'city': 'Praha 11 - Chodov', 'country': 'Czechia', 'facility': 'Pfizer Investigational Site'}, {'zip': '00000', 'city': 'Santo Domingo', 'state': 'Santo Domingo Province', 'country': 'Dominican Republic', 'facility': 'Pfizer Investigational Site'}, {'zip': '05800', 'city': 'Hyvinkää', 'country': 'Finland', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 60.63195, 'lon': 24.8606}}, {'zip': '11527', 'city': 'Athens', 'state': 'Goudi', 'country': 'Greece', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '54 636', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': 'H-1036', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': 'H-5000', 'city': 'Szolnok', 'country': 'Hungary', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 47.18066, 'lon': 20.19835}}, {'zip': 'H-8200', 'city': 'Veszprém', 'country': 'Hungary', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 47.09327, 'lon': 17.91149}}, {'zip': '380 015', 'city': 'Ahmedabad', 'state': 'Gujarat', 'country': 'India', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'zip': '575 001', 'city': 'Mangalore', 'state': 'Karnataka', 'country': 'India', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 12.91723, 'lon': 74.85603}}, {'zip': '411 001', 'city': 'Pune', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'zip': '50139', 'city': 'Florence', 'country': 'Italy', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '16132', 'city': 'Genova', 'country': 'Italy', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'city': 'Kitakyushu', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.85181, 'lon': 130.85034}}, {'city': 'Higashihiroshima', 'state': 'Hiroshima', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 34.40861, 'lon': 132.73682}}, {'city': 'Sagamihara', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.56707, 'lon': 139.24167}}, {'city': 'Shinjyuku-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Pfizer Investigational Site'}, {'zip': '06726', 'city': 'México', 'state': 'D.f.', 'country': 'Mexico', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 31.00435, 'lon': -108.15213}}, {'zip': '14000', 'city': 'Mexico City', 'state': 'Mexico City', 'country': 'Mexico', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '15-950', 'city': 'Bialystok', 'country': 'Poland', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'zip': '60-773', 'city': 'Poznan', 'country': 'Poland', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '81-759', 'city': 'Sopot', 'country': 'Poland', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 54.4418, 'lon': 18.56003}}, {'zip': '02-256', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '50-088', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '00918', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}, {'zip': '81109', 'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}, {'zip': '921 01', 'city': 'Piešťany', 'country': 'Slovakia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 48.59479, 'lon': 17.82591}}, {'zip': '012 07', 'city': 'Žilina', 'country': 'Slovakia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 49.22315, 'lon': 18.73941}}, {'zip': '302-799', 'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'zip': '501-757', 'city': 'Gwangju', 'country': 'South Korea', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'zip': '400-711', 'city': 'Incheon', 'country': 'South Korea', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '133-792', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '19002', 'city': 'Guadalajara', 'state': 'Guadalajara', 'country': 'Spain', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 40.62862, 'lon': -3.16185}}, {'zip': '21018', 'city': 'Vinnitsa', 'country': 'Ukraine', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 49.84639, 'lon': 37.71861}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}