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Ignite Creation Date: 2025-12-24 @ 4:59 PM

Ignite Modification Date: 2025-12-26 @ 7:57 PM

Study NCT ID: NCT01359150

Status: COMPLETED

Last Update Posted: 2013-03-29

First Post: 2011-05-11

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: A Study To Assess the Immune Response Following Administration Of Influenza and Pneumococcal Vaccines To Subjects With Rheumatoid Arthritis Receiving CP-690,550 Or Placebo

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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 + Influenza and Pneumococcal Vaccine', 'description': 'CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.', 'otherNumAtRisk': 112, 'otherNumAffected': 17, 'seriousNumAtRisk': 112, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Placebo + Influenza and Pneumococcal Vaccine', 'description': 'Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.', 'otherNumAtRisk': 111, 'otherNumAffected': 17, 'seriousNumAtRisk': 111, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'seriousEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Satisfactory Humoral Response to the Pneumococcal Vaccine at Visit 3 (Day 64)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-690,550 + Influenza and Pneumococcal Vaccine', 'description': 'CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.'}, {'id': 'OG001', 'title': 'Placebo + Influenza and Pneumococcal Vaccine', 'description': 'Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.'}], 'classes': [{'title': 'Regardless MTX use (n=102,98)', 'categories': [{'measurements': [{'value': '45.1', 'groupId': 'OG000', 'lowerLimit': '35.224', 'upperLimit': '55.264'}, {'value': '68.4', 'groupId': 'OG001', 'lowerLimit': '58.196', 'upperLimit': '77.394'}]}]}, {'title': 'With BG MTX use (n=57,55)', 'categories': [{'measurements': [{'value': '31.6', 'groupId': 'OG000', 'lowerLimit': '19.905', 'upperLimit': '45.243'}, {'value': '61.8', 'groupId': 'OG001', 'lowerLimit': '47.726', 'upperLimit': '74.591'}]}]}, {'title': 'Without BG MTX use (n=45,43)', 'categories': [{'measurements': [{'value': '62.2', 'groupId': 'OG000', 'lowerLimit': '46.541', 'upperLimit': '76.232'}, {'value': '76.7', 'groupId': 'OG001', 'lowerLimit': '61.369', 'upperLimit': '88.245'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 64 (End of Study [EOS])', 'description': 'Satisfactory humoral response to the pneumococcal vaccine was defined as greater than or equal to (\\>=) 2 fold increase in antibody concentrations from vaccination baseline (Day 29) in at least 6 of 12 pneumococcal antigens (1, 3, 4, 5, 6B, 7F, 9V, 14, 19A, 19F, 23F, 18C). Data was stratified by the background methotrexate use.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and \\>=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.n=participants evaluable at specified categories for each arm group.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Satisfactory Humoral Response to the Seasonal Influenza Vaccine at Visit 3 (Day 64)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-690,550 + Influenza and Pneumococcal Vaccine', 'description': 'CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.'}, {'id': 'OG001', 'title': 'Placebo + Influenza and Pneumococcal Vaccine', 'description': 'Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.'}], 'classes': [{'title': 'Regardless MTX use (n=102,98)', 'categories': [{'measurements': [{'value': '56.9', 'groupId': 'OG000', 'lowerLimit': '46.682', 'upperLimit': '66.634'}, {'value': '62.2', 'groupId': 'OG001', 'lowerLimit': '51.885', 'upperLimit': '71.844'}]}]}, {'title': 'With BG MTX use (n=57,55)', 'categories': [{'measurements': [{'value': '50.9', 'groupId': 'OG000', 'lowerLimit': '37.29', 'upperLimit': '64.37'}, {'value': '58.2', 'groupId': 'OG001', 'lowerLimit': '44.106', 'upperLimit': '71.345'}]}]}, {'title': 'Without BG MTX use (n=45,43)', 'categories': [{'measurements': [{'value': '64.4', 'groupId': 'OG000', 'lowerLimit': '48.78', 'upperLimit': '78.132'}, {'value': '67.4', 'groupId': 'OG001', 'lowerLimit': '51.456', 'upperLimit': '80.924'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 64 (EOS)', 'description': 'Satisfactory humoral response to the influenza vaccine was defined as \\>= 4 fold increase in antibody titers from vaccination baseline (Day 29) in at least 2 of 3 influenza antigens (B, H1N1, H3N2). Data was stratified by the background methotrexate use.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and \\>=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.n=participants evaluable at specified categories for each arm group.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-690,550 + Influenza and Pneumococcal Vaccine', 'description': 'CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.'}, {'id': 'OG001', 'title': 'Placebo + Influenza and Pneumococcal Vaccine', 'description': 'Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.'}], 'classes': [{'title': 'Regardless MTX use, 1 (n=102,98)', 'categories': [{'measurements': [{'value': '59.8', 'groupId': 'OG000', 'lowerLimit': '49.63', 'upperLimit': '69.393'}, {'value': '69.4', 'groupId': 'OG001', 'lowerLimit': '59.265', 'upperLimit': '78.302'}]}]}, {'title': 'Regardless MTX use, 14 (n=102,98)', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000', 'lowerLimit': '41.844', 'upperLimit': '61.961'}, {'value': '61.2', 'groupId': 'OG001', 'lowerLimit': '50.849', 'upperLimit': '70.903'}]}]}, {'title': 'Regardless MTX use, 18C (n=102,98)', 'categories': [{'measurements': [{'value': '59.8', 'groupId': 'OG000', 'lowerLimit': '49.63', 'upperLimit': '69.393'}, {'value': '70.4', 'groupId': 'OG001', 'lowerLimit': '60.338', 'upperLimit': '79.205'}]}]}, {'title': 'Regardless MTX use, 19A (n=102,98)', 'categories': [{'measurements': [{'value': '32.4', 'groupId': 'OG000', 'lowerLimit': '23.424', 'upperLimit': '42.337'}, {'value': '46.9', 'groupId': 'OG001', 'lowerLimit': '36.778', 'upperLimit': '57.289'}]}]}, {'title': 'Regardless MTX use, 19F (n=102,98)', 'categories': [{'measurements': [{'value': '35.3', 'groupId': 'OG000', 'lowerLimit': '26.086', 'upperLimit': '45.38'}, {'value': '56.1', 'groupId': 'OG001', 'lowerLimit': '45.732', 'upperLimit': '66.133'}]}]}, {'title': 'Regardless MTX use, 23F (n=102,98)', 'categories': [{'measurements': [{'value': '40.2', 'groupId': 'OG000', 'lowerLimit': '30.607', 'upperLimit': '50.37'}, {'value': '58.2', 'groupId': 'OG001', 'lowerLimit': '47.766', 'upperLimit': '68.054'}]}]}, {'title': 'Regardless MTX use, 3 (n=102,98)', 'categories': [{'measurements': [{'value': '38.2', 'groupId': 'OG000', 'lowerLimit': '28.787', 'upperLimit': '48.386'}, {'value': '54.1', 'groupId': 'OG001', 'lowerLimit': '43.714', 'upperLimit': '64.196'}]}]}, {'title': 'Regardless MTX use, 4 (n=102,98)', 'categories': [{'measurements': [{'value': '58.8', 'groupId': 'OG000', 'lowerLimit': '48.644', 'upperLimit': '68.477'}, {'value': '65.3', 'groupId': 'OG001', 'lowerLimit': '55.02', 'upperLimit': '74.64'}]}]}, {'title': 'Regardless MTX use, 5 (n=102,98)', 'categories': [{'measurements': [{'value': '28.4', 'groupId': 'OG000', 'lowerLimit': '19.938', 'upperLimit': '38.218'}, {'value': '38.8', 'groupId': 'OG001', 'lowerLimit': '29.097', 'upperLimit': '49.151'}]}]}, {'title': 'Regardless MTX use, 6B (n=102,98)', 'categories': [{'measurements': [{'value': '36.3', 'groupId': 'OG000', 'lowerLimit': '26.982', 'upperLimit': '46.386'}, {'value': '54.1', 'groupId': 'OG001', 'lowerLimit': '43.714', 'upperLimit': '64.196'}]}]}, {'title': 'Regardless MTX use, 7F (n=102,98)', 'categories': [{'measurements': [{'value': '58.8', 'groupId': 'OG000', 'lowerLimit': '48.644', 'upperLimit': '68.477'}, {'value': '65.3', 'groupId': 'OG001', 'lowerLimit': '55.02', 'upperLimit': '74.64'}]}]}, {'title': 'Regardless MTX use, 9V (n=102,98)', 'categories': [{'measurements': [{'value': '45.1', 'groupId': 'OG000', 'lowerLimit': '35.224', 'upperLimit': '55.264'}, {'value': '58.2', 'groupId': 'OG001', 'lowerLimit': '47.766', 'upperLimit': '68.054'}]}]}, {'title': 'With BG MTX use, 1 (n=57,55)', 'categories': [{'measurements': [{'value': '57.9', 'groupId': 'OG000', 'lowerLimit': '44.084', 'upperLimit': '70.857'}, {'value': '61.8', 'groupId': 'OG001', 'lowerLimit': '47.726', 'upperLimit': '74.591'}]}]}, {'title': 'With BG MTX use, 14 (n=57,55)', 'categories': [{'measurements': [{'value': '47.4', 'groupId': 'OG000', 'lowerLimit': '33.985', 'upperLimit': '61.035'}, {'value': '56.4', 'groupId': 'OG001', 'lowerLimit': '42.322', 'upperLimit': '69.696'}]}]}, {'title': 'With BG MTX use, 18C (n=57,55)', 'categories': [{'measurements': [{'value': '49.1', 'groupId': 'OG000', 'lowerLimit': '35.63', 'upperLimit': '62.71'}, {'value': '58.2', 'groupId': 'OG001', 'lowerLimit': '44.106', 'upperLimit': '71.345'}]}]}, {'title': 'With BG MTX use, 19A (n=57,55)', 'categories': [{'measurements': [{'value': '19.3', 'groupId': 'OG000', 'lowerLimit': '10.047', 'upperLimit': '31.911'}, {'value': '40', 'groupId': 'OG001', 'lowerLimit': '27.023', 'upperLimit': '54.093'}]}]}, {'title': 'With BG MTX use, 19F (n=57,55)', 'categories': [{'measurements': [{'value': '28.1', 'groupId': 'OG000', 'lowerLimit': '16.973', 'upperLimit': '41.543'}, {'value': '49.1', 'groupId': 'OG001', 'lowerLimit': '35.354', 'upperLimit': '62.929'}]}]}, {'title': 'With BG MTX use, 23F (n=57,55)', 'categories': [{'measurements': [{'value': '24.6', 'groupId': 'OG000', 'lowerLimit': '14.127', 'upperLimit': '37.761'}, {'value': '49.1', 'groupId': 'OG001', 'lowerLimit': '35.354', 'upperLimit': '62.929'}]}]}, {'title': 'With BG MTX use, 3 (n=57,55)', 'categories': [{'measurements': [{'value': '24.6', 'groupId': 'OG000', 'lowerLimit': '14.127', 'upperLimit': '37.761'}, {'value': '49.1', 'groupId': 'OG001', 'lowerLimit': '35.354', 'upperLimit': '62.929'}]}]}, {'title': 'With BG MTX use, 4 (n=57,55)', 'categories': [{'measurements': [{'value': '52.6', 'groupId': 'OG000', 'lowerLimit': '38.965', 'upperLimit': '66.015'}, {'value': '56.4', 'groupId': 'OG001', 'lowerLimit': '42.322', 'upperLimit': '69.696'}]}]}, {'title': 'With BG MTX use, 5 (n=57,55)', 'categories': [{'measurements': [{'value': '28.1', 'groupId': 'OG000', 'lowerLimit': '16.973', 'upperLimit': '41.543'}, {'value': '29.1', 'groupId': 'OG001', 'lowerLimit': '17.63', 'upperLimit': '42.898'}]}]}, {'title': 'With BG MTX use, 6B (n=57,55)', 'categories': [{'measurements': [{'value': '29.8', 'groupId': 'OG000', 'lowerLimit': '18.429', 'upperLimit': '43.403'}, {'value': '47.3', 'groupId': 'OG001', 'lowerLimit': '33.653', 'upperLimit': '61.196'}]}]}, {'title': 'With BG MTX use, 7F (n=57,55)', 'categories': [{'measurements': [{'value': '49.1', 'groupId': 'OG000', 'lowerLimit': '35.63', 'upperLimit': '62.71'}, {'value': '56.4', 'groupId': 'OG001', 'lowerLimit': '42.322', 'upperLimit': '69.696'}]}]}, {'title': 'With BG MTX use, 9V (n=57,55)', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000', 'lowerLimit': '21.401', 'upperLimit': '47.065'}, {'value': '49.1', 'groupId': 'OG001', 'lowerLimit': '35.354', 'upperLimit': '62.929'}]}]}, {'title': 'Without BG MTX use, 1 (n=45,43)', 'categories': [{'measurements': [{'value': '62.2', 'groupId': 'OG000', 'lowerLimit': '46.541', 'upperLimit': '76.232'}, {'value': '79.1', 'groupId': 'OG001', 'lowerLimit': '63.958', 'upperLimit': '89.956'}]}]}, {'title': 'Without BG MTX use, 14 (n=45,43)', 'categories': [{'measurements': [{'value': '57.8', 'groupId': 'OG000', 'lowerLimit': '42.15', 'upperLimit': '72.343'}, {'value': '67.4', 'groupId': 'OG001', 'lowerLimit': '51.456', 'upperLimit': '80.924'}]}]}, {'title': 'Without BG MTX use, 18C (n=45,43)', 'categories': [{'measurements': [{'value': '73.3', 'groupId': 'OG000', 'lowerLimit': '58.055', 'upperLimit': '85.396'}, {'value': '86', 'groupId': 'OG001', 'lowerLimit': '72.068', 'upperLimit': '94.702'}]}]}, {'title': 'Without BG MTX use, 19A (n=45,43)', 'categories': [{'measurements': [{'value': '48.9', 'groupId': 'OG000', 'lowerLimit': '33.703', 'upperLimit': '64.226'}, {'value': '55.8', 'groupId': 'OG001', 'lowerLimit': '39.875', 'upperLimit': '70.922'}]}]}, {'title': 'Without BG MTX use, 19F (n=45,43)', 'categories': [{'measurements': [{'value': '44.4', 'groupId': 'OG000', 'lowerLimit': '29.644', 'upperLimit': '60.003'}, {'value': '65.1', 'groupId': 'OG001', 'lowerLimit': '49.073', 'upperLimit': '78.992'}]}]}, {'title': 'Without BG MTX use, 23F (n=45,43)', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000', 'lowerLimit': '44.331', 'upperLimit': '74.302'}, {'value': '69.8', 'groupId': 'OG001', 'lowerLimit': '53.875', 'upperLimit': '82.818'}]}]}, {'title': 'Without BG MTX use, 3 (n=45,43)', 'categories': [{'measurements': [{'value': '55.6', 'groupId': 'OG000', 'lowerLimit': '39.997', 'upperLimit': '70.356'}, {'value': '60.5', 'groupId': 'OG001', 'lowerLimit': '44.41', 'upperLimit': '75.023'}]}]}, {'title': 'Without BG MTX use, 4 (n=45,43)', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000', 'lowerLimit': '51.05', 'upperLimit': '79.999'}, {'value': '76.7', 'groupId': 'OG001', 'lowerLimit': '61.369', 'upperLimit': '88.245'}]}]}, {'title': 'Without BG MTX use, 5 (n=45,43)', 'categories': [{'measurements': [{'value': '28.9', 'groupId': 'OG000', 'lowerLimit': '16.366', 'upperLimit': '44.315'}, {'value': '51.2', 'groupId': 'OG001', 'lowerLimit': '35.465', 'upperLimit': '66.695'}]}]}, {'title': 'Without BG MTX use, 6B (n=45,43)', 'categories': [{'measurements': [{'value': '44.4', 'groupId': 'OG000', 'lowerLimit': '29.644', 'upperLimit': '60.003'}, {'value': '62.8', 'groupId': 'OG001', 'lowerLimit': '46.725', 'upperLimit': '77.025'}]}]}, {'title': 'Without BG MTX use, 7F (n=45,43)', 'categories': [{'measurements': [{'value': '71.1', 'groupId': 'OG000', 'lowerLimit': '55.685', 'upperLimit': '83.634'}, {'value': '76.7', 'groupId': 'OG001', 'lowerLimit': '61.369', 'upperLimit': '88.245'}]}]}, {'title': 'Without BG MTX use, 9V (n=45,43)', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000', 'lowerLimit': '44.331', 'upperLimit': '74.302'}, {'value': '69.8', 'groupId': 'OG001', 'lowerLimit': '53.875', 'upperLimit': '82.818'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 64 (EOS)', 'description': 'Response to the pneumococcal vaccine (seroconversion) was defined as \\>= 2 fold increase in antibody concentrations from vaccination baseline (Day 29) in each of the 12 pneumococcal antigens (1, 3, 4, 5, 6B, 7F, 9V, 14, 19A, 19F, 23F, 18C). Data was stratified by the background methotrexate use.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and \\>=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.n=participants evaluable at specified categories for each arm group.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Responded to Each of the 3 Influenza Antigens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-690,550 + Influenza and Pneumococcal Vaccine', 'description': 'CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.'}, {'id': 'OG001', 'title': 'Placebo + Influenza and Pneumococcal Vaccine', 'description': 'Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.'}], 'classes': [{'title': 'Regardless MTX use, B (n=102,98)', 'categories': [{'measurements': [{'value': '38.2', 'groupId': 'OG000', 'lowerLimit': '28.787', 'upperLimit': '48.386'}, {'value': '52', 'groupId': 'OG001', 'lowerLimit': '41.712', 'upperLimit': '62.243'}]}]}, {'title': 'Regardless MTX use, H1N1 (n=102,98)', 'categories': [{'measurements': [{'value': '60.8', 'groupId': 'OG000', 'lowerLimit': '50.62', 'upperLimit': '70.305'}, {'value': '63.3', 'groupId': 'OG001', 'lowerLimit': '52.925', 'upperLimit': '72.781'}]}]}, {'title': 'Regardless MTX use, H3N2 (n=102,98)', 'categories': [{'measurements': [{'value': '60.8', 'groupId': 'OG000', 'lowerLimit': '50.62', 'upperLimit': '70.305'}, {'value': '69.4', 'groupId': 'OG001', 'lowerLimit': '59.265', 'upperLimit': '78.302'}]}]}, {'title': 'With BG MTX use, B (n=57,55)', 'categories': [{'measurements': [{'value': '35.1', 'groupId': 'OG000', 'lowerLimit': '22.915', 'upperLimit': '48.869'}, {'value': '41.8', 'groupId': 'OG001', 'lowerLimit': '28.655', 'upperLimit': '55.894'}]}]}, {'title': 'With BG MTX use, H1N1 (n=57,55)', 'categories': [{'measurements': [{'value': '52.6', 'groupId': 'OG000', 'lowerLimit': '38.965', 'upperLimit': '66.015'}, {'value': '58.2', 'groupId': 'OG001', 'lowerLimit': '44.106', 'upperLimit': '71.345'}]}]}, {'title': 'With BG MTX use, H3N2 (n=57,55)', 'categories': [{'measurements': [{'value': '57.9', 'groupId': 'OG000', 'lowerLimit': '44.084', 'upperLimit': '70.857'}, {'value': '65.5', 'groupId': 'OG001', 'lowerLimit': '51.419', 'upperLimit': '77.763'}]}]}, {'title': 'Without BG MTX use, B (n=45,43)', 'categories': [{'measurements': [{'value': '42.2', 'groupId': 'OG000', 'lowerLimit': '27.657', 'upperLimit': '57.85'}, {'value': '65.1', 'groupId': 'OG001', 'lowerLimit': '49.073', 'upperLimit': '78.992'}]}]}, {'title': 'Without BG MTX use, H1N1 (n=45,43)', 'categories': [{'measurements': [{'value': '71.1', 'groupId': 'OG000', 'lowerLimit': '55.685', 'upperLimit': '83.634'}, {'value': '69.8', 'groupId': 'OG001', 'lowerLimit': '53.875', 'upperLimit': '82.818'}]}]}, {'title': 'Without BG MTX use, H3N2 (n=45,43)', 'categories': [{'measurements': [{'value': '64.4', 'groupId': 'OG000', 'lowerLimit': '48.78', 'upperLimit': '78.132'}, {'value': '74.4', 'groupId': 'OG001', 'lowerLimit': '58.828', 'upperLimit': '86.481'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 64 (EOS)', 'description': 'Response to the influenza vaccine (seroconversion) was defined as \\>= 4 fold increase in antibody titers from vaccination baseline (Day 29) in each of 3 influenza antigens (B, H1N1, H3N2). Data was stratified by the background methotrexate use.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and \\>=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.n=participants evaluable at specified categories for each arm group.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Protective Antibody Titers to the Seasonal Influenza Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-690,550 + Influenza and Pneumococcal Vaccine', 'description': 'CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.'}, {'id': 'OG001', 'title': 'Placebo + Influenza and Pneumococcal Vaccine', 'description': 'Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.'}], 'classes': [{'title': 'Regardless MTX use (n=102,98)', 'categories': [{'measurements': [{'value': '76.5', 'groupId': 'OG000', 'lowerLimit': '67.043', 'upperLimit': '84.305'}, {'value': '91.8', 'groupId': 'OG001', 'lowerLimit': '84.547', 'upperLimit': '96.41'}]}]}, {'title': 'With BG MTX use (n=57,55)', 'categories': [{'measurements': [{'value': '64.9', 'groupId': 'OG000', 'lowerLimit': '51.131', 'upperLimit': '77.085'}, {'value': '92.7', 'groupId': 'OG001', 'lowerLimit': '82.413', 'upperLimit': '97.983'}]}]}, {'title': 'Without BG MTX use (n=45,43)', 'categories': [{'measurements': [{'value': '91.1', 'groupId': 'OG000', 'lowerLimit': '78.779', 'upperLimit': '97.525'}, {'value': '90.7', 'groupId': 'OG001', 'lowerLimit': '77.865', 'upperLimit': '97.407'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 64 (EOS)', 'description': 'Seroprotection was defined as achieving protective antibody titers to the influenza vaccine as measured by a hemagglutination inhibition (HAI) assay titer of \\>= 1:40 in at least 2 of 3 influenza antigens (B, H1N1, H3N2). Data was stratified by the background methotrexate use.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and \\>=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.n=participants evaluable at specified categories for each arm group.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-690,550 + Influenza and Pneumococcal Vaccine', 'description': 'CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.'}, {'id': 'OG001', 'title': 'Placebo + Influenza and Pneumococcal Vaccine', 'description': 'Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.'}], 'classes': [{'title': 'Regardless MTX use, 1 (n=89,92)', 'categories': [{'measurements': [{'value': '4.75', 'groupId': 'OG000', 'lowerLimit': '3.61', 'upperLimit': '6.24'}, {'value': '6.83', 'groupId': 'OG001', 'lowerLimit': '4.94', 'upperLimit': '9.46'}]}]}, {'title': 'Regardless MTX use, 14 (n=101,96)', 'categories': [{'measurements': [{'value': '2.68', 'groupId': 'OG000', 'lowerLimit': '2.19', 'upperLimit': '3.28'}, {'value': '3.90', 'groupId': 'OG001', 'lowerLimit': '3.05', 'upperLimit': '4.99'}]}]}, {'title': 'Regardless MTX use, 18C (n=101,98)', 'categories': [{'measurements': [{'value': '3.10', 'groupId': 'OG000', 'lowerLimit': '2.52', 'upperLimit': '3.81'}, {'value': '4.82', 'groupId': 'OG001', 'lowerLimit': '3.76', 'upperLimit': '6.18'}]}]}, {'title': 'Regardless MTX use, 19A (n=102,98)', 'categories': [{'measurements': [{'value': '1.80', 'groupId': 'OG000', 'lowerLimit': '1.56', 'upperLimit': '2.08'}, {'value': '2.34', 'groupId': 'OG001', 'lowerLimit': '1.99', 'upperLimit': '2.75'}]}]}, {'title': 'Regardless MTX use, 19F (n=102,95)', 'categories': [{'measurements': [{'value': '2.04', 'groupId': 'OG000', 'lowerLimit': '1.71', 'upperLimit': '2.42'}, {'value': '2.89', 'groupId': 'OG001', 'lowerLimit': '2.40', 'upperLimit': '3.49'}]}]}, {'title': 'Regardless MTX use, 23F (n=102,98)', 'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '1.64', 'upperLimit': '2.44'}, {'value': '2.81', 'groupId': 'OG001', 'lowerLimit': '2.34', 'upperLimit': '3.36'}]}]}, {'title': 'Regardless MTX use, 3 (n=101,94)', 'categories': [{'measurements': [{'value': '2.11', 'groupId': 'OG000', 'lowerLimit': '1.76', 'upperLimit': '2.54'}, {'value': '2.79', 'groupId': 'OG001', 'lowerLimit': '2.31', 'upperLimit': '3.38'}]}]}, {'title': 'Regardless MTX use, 4 (n=96,89)', 'categories': [{'measurements': [{'value': '3.10', 'groupId': 'OG000', 'lowerLimit': '2.49', 'upperLimit': '3.86'}, {'value': '5.13', 'groupId': 'OG001', 'lowerLimit': '3.94', 'upperLimit': '6.67'}]}]}, {'title': 'Regardless MTX use, 5 (n=101,98)', 'categories': [{'measurements': [{'value': '1.72', 'groupId': 'OG000', 'lowerLimit': '1.50', 'upperLimit': '1.97'}, {'value': '2.27', 'groupId': 'OG001', 'lowerLimit': '1.91', 'upperLimit': '2.70'}]}]}, {'title': 'Regardless MTX use, 6B (n=102,98)', 'categories': [{'measurements': [{'value': '1.90', 'groupId': 'OG000', 'lowerLimit': '1.61', 'upperLimit': '2.24'}, {'value': '2.56', 'groupId': 'OG001', 'lowerLimit': '2.12', 'upperLimit': '3.10'}]}]}, {'title': 'Regardless MTX use, 7F (n=102,97)', 'categories': [{'measurements': [{'value': '3.19', 'groupId': 'OG000', 'lowerLimit': '2.59', 'upperLimit': '3.93'}, {'value': '4.06', 'groupId': 'OG001', 'lowerLimit': '3.27', 'upperLimit': '5.04'}]}]}, {'title': 'Regardless MTX use, 9V (n=102,98)', 'categories': [{'measurements': [{'value': '2.27', 'groupId': 'OG000', 'lowerLimit': '1.85', 'upperLimit': '2.55'}, {'value': '3.16', 'groupId': 'OG001', 'lowerLimit': '2.59', 'upperLimit': '3.86'}]}]}, {'title': 'With BG MTX use, 1 (n=49,53)', 'categories': [{'measurements': [{'value': '3.92', 'groupId': 'OG000', 'lowerLimit': '2.77', 'upperLimit': '5.54'}, {'value': '4.51', 'groupId': 'OG001', 'lowerLimit': '3.00', 'upperLimit': '6.77'}]}]}, {'title': 'With BG MTX use, 14 (n=56,54)', 'categories': [{'measurements': [{'value': '2.37', 'groupId': 'OG000', 'lowerLimit': '1.84', 'upperLimit': '3.04'}, {'value': '2.85', 'groupId': 'OG001', 'lowerLimit': '2.19', 'upperLimit': '3.72'}]}]}, {'title': 'With BG MTX use, 18C (n=57,55)', 'categories': [{'measurements': [{'value': '2.64', 'groupId': 'OG000', 'lowerLimit': '2.05', 'upperLimit': '3.41'}, {'value': '3.23', 'groupId': 'OG001', 'lowerLimit': '2.45', 'upperLimit': '4.26'}]}]}, {'title': 'With BG MTX use, 19A (n=57,55)', 'categories': [{'measurements': [{'value': '1.51', 'groupId': 'OG000', 'lowerLimit': '1.30', 'upperLimit': '1.74'}, {'value': '2.08', 'groupId': 'OG001', 'lowerLimit': '1.67', 'upperLimit': '2.59'}]}]}, {'title': 'With BG MTX use, 19F (n=57,53)', 'categories': [{'measurements': [{'value': '1.92', 'groupId': 'OG000', 'lowerLimit': '1.51', 'upperLimit': '2.44'}, {'value': '2.29', 'groupId': 'OG001', 'lowerLimit': '1.88', 'upperLimit': '2.79'}]}]}, {'title': 'With BG MTX use, 23F (n=57,55)', 'categories': [{'measurements': [{'value': '1.66', 'groupId': 'OG000', 'lowerLimit': '1.32', 'upperLimit': '2.07'}, {'value': '2.34', 'groupId': 'OG001', 'lowerLimit': '1.88', 'upperLimit': '2.91'}]}]}, {'title': 'With BG MTX use, 3 (n=56,54)', 'categories': [{'measurements': [{'value': '1.78', 'groupId': 'OG000', 'lowerLimit': '1.39', 'upperLimit': '2.27'}, {'value': '2.43', 'groupId': 'OG001', 'lowerLimit': '1.90', 'upperLimit': '3.12'}]}]}, {'title': 'With BG MTX use, 4 (n=53,50)', 'categories': [{'measurements': [{'value': '2.92', 'groupId': 'OG000', 'lowerLimit': '2.22', 'upperLimit': '3.85'}, {'value': '3.27', 'groupId': 'OG001', 'lowerLimit': '2.51', 'upperLimit': '4.25'}]}]}, {'title': 'With BG MTX use, 5 (n=57,55)', 'categories': [{'measurements': [{'value': '1.62', 'groupId': 'OG000', 'lowerLimit': '1.35', 'upperLimit': '1.95'}, {'value': '1.99', 'groupId': 'OG001', 'lowerLimit': '1.59', 'upperLimit': '2.50'}]}]}, {'title': 'With BG MTX use, 6B (n=57,55)', 'categories': [{'measurements': [{'value': '1.60', 'groupId': 'OG000', 'lowerLimit': '1.37', 'upperLimit': '1.88'}, {'value': '2.24', 'groupId': 'OG001', 'lowerLimit': '1.79', 'upperLimit': '2.81'}]}]}, {'title': 'With BG MTX use, 7F (n=57,55)', 'categories': [{'measurements': [{'value': '2.38', 'groupId': 'OG000', 'lowerLimit': '1.89', 'upperLimit': '2.98'}, {'value': '3.46', 'groupId': 'OG001', 'lowerLimit': '2.57', 'upperLimit': '4.64'}]}]}, {'title': 'With BG MTX use, 9V (n=57,55)', 'categories': [{'measurements': [{'value': '1.87', 'groupId': 'OG000', 'lowerLimit': '1.53', 'upperLimit': '2.29'}, {'value': '2.72', 'groupId': 'OG001', 'lowerLimit': '2.08', 'upperLimit': '3.54'}]}]}, {'title': 'Without BG MTX use, 1 (n=40,39)', 'categories': [{'measurements': [{'value': '6.01', 'groupId': 'OG000', 'lowerLimit': '3.85', 'upperLimit': '9.37'}, {'value': '12.04', 'groupId': 'OG001', 'lowerLimit': '7.34', 'upperLimit': '19.74'}]}]}, {'title': 'Without BG MTX use, 14 (n=45,42)', 'categories': [{'measurements': [{'value': '3.14', 'groupId': 'OG000', 'lowerLimit': '2.25', 'upperLimit': '4.37'}, {'value': '5.85', 'groupId': 'OG001', 'lowerLimit': '3.81', 'upperLimit': '8.99'}]}]}, {'title': 'Without BG MTX use, 18C (n=44,43)', 'categories': [{'measurements': [{'value': '3.80', 'groupId': 'OG000', 'lowerLimit': '2.70', 'upperLimit': '5.35'}, {'value': '8.05', 'groupId': 'OG001', 'lowerLimit': '5.37', 'upperLimit': '12.08'}]}]}, {'title': 'Without BG MTX use, 19A (n=45,43)', 'categories': [{'measurements': [{'value': '2.27', 'groupId': 'OG000', 'lowerLimit': '1.75', 'upperLimit': '2.94'}, {'value': '2.72', 'groupId': 'OG001', 'lowerLimit': '2.13', 'upperLimit': '3.47'}]}]}, {'title': 'Without BG MTX use, 19F (n=45,42)', 'categories': [{'measurements': [{'value': '2.19', 'groupId': 'OG000', 'lowerLimit': '1.68', 'upperLimit': '2.85'}, {'value': '3.88', 'groupId': 'OG001', 'lowerLimit': '2.78', 'upperLimit': '5.43'}]}]}, {'title': 'Without BG MTX use, 23F (n=45,43)', 'categories': [{'measurements': [{'value': '2.54', 'groupId': 'OG000', 'lowerLimit': '1.81', 'upperLimit': '3.58'}, {'value': '3.55', 'groupId': 'OG001', 'lowerLimit': '2.63', 'upperLimit': '4.78'}]}]}, {'title': 'Without BG MTX use, 3 (n=45,40)', 'categories': [{'measurements': [{'value': '2.61', 'groupId': 'OG000', 'lowerLimit': '1.98', 'upperLimit': '3.44'}, {'value': '3.37', 'groupId': 'OG001', 'lowerLimit': '2.49', 'upperLimit': '4.55'}]}]}, {'title': 'Without BG MTX use, 4 (n=43,39)', 'categories': [{'measurements': [{'value': '3.32', 'groupId': 'OG000', 'lowerLimit': '2.31', 'upperLimit': '4.79'}, {'value': '9.15', 'groupId': 'OG001', 'lowerLimit': '5.85', 'upperLimit': '14.29'}]}]}, {'title': 'Without BG MTX use, 5 (n=44,43)', 'categories': [{'measurements': [{'value': '1.86', 'groupId': 'OG000', 'lowerLimit': '1.50', 'upperLimit': '2.29'}, {'value': '2.68', 'groupId': 'OG001', 'lowerLimit': '2.04', 'upperLimit': '3.52'}]}]}, {'title': 'Without BG MTX use, 6B (n=45,43)', 'categories': [{'measurements': [{'value': '2.36', 'groupId': 'OG000', 'lowerLimit': '1.73', 'upperLimit': '3.21'}, {'value': '3.04', 'groupId': 'OG001', 'lowerLimit': '2.19', 'upperLimit': '4.21'}]}]}, {'title': 'Without BG MTX use, 7F (n=45,42)', 'categories': [{'measurements': [{'value': '4.62', 'groupId': 'OG000', 'lowerLimit': '3.23', 'upperLimit': '6.60'}, {'value': '5.02', 'groupId': 'OG001', 'lowerLimit': '3.65', 'upperLimit': '6.90'}]}]}, {'title': 'Without BG MTX use, 9V (n=45,43)', 'categories': [{'measurements': [{'value': '2.63', 'groupId': 'OG000', 'lowerLimit': '2.03', 'upperLimit': '3.41'}, {'value': '3.83', 'groupId': 'OG001', 'lowerLimit': '2.82', 'upperLimit': '5.19'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 64 (EOS)', 'description': 'Geometric mean fold rises (GMFRs) for the 12 pneumococcal antigens (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) from pre-vaccination (Day 29) to Day 64 (Day 35 post-vaccination) were computed using the logarithmically transformed assay results. Confidence intervals (CIs) for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers. Data was stratified by the background methotrexate use.', 'unitOfMeasure': 'fold rise', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and \\>=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.n=participants evaluable at specified categories for each arm group.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Fold Rise (GMFR) of Anti-Influenza Antibody Levels to Each of the Influenza Antigens Above Vaccination Baseline Values (Day 29)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-690,550 + Influenza and Pneumococcal Vaccine', 'description': 'CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.'}, {'id': 'OG001', 'title': 'Placebo + Influenza and Pneumococcal Vaccine', 'description': 'Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.'}], 'classes': [{'title': 'Regardless MTX use, B (n=102,98)', 'categories': [{'measurements': [{'value': '2.95', 'groupId': 'OG000', 'lowerLimit': '2.32', 'upperLimit': '3.75'}, {'value': '3.90', 'groupId': 'OG001', 'lowerLimit': '3.06', 'upperLimit': '4.97'}]}]}, {'title': 'Regardless MTX use, H1N1 (n=102,98)', 'categories': [{'measurements': [{'value': '6.04', 'groupId': 'OG000', 'lowerLimit': '4.59', 'upperLimit': '7.95'}, {'value': '9.50', 'groupId': 'OG001', 'lowerLimit': '6.76', 'upperLimit': '13.35'}]}]}, {'title': 'Regardless MTX use, H3N2 (n=102,98)', 'categories': [{'measurements': [{'value': '7.11', 'groupId': 'OG000', 'lowerLimit': '5.18', 'upperLimit': '9.75'}, {'value': '9.06', 'groupId': 'OG001', 'lowerLimit': '6.61', 'upperLimit': '12.44'}]}]}, {'title': 'With BG MTX use, B (n=57,55)', 'categories': [{'measurements': [{'value': '2.84', 'groupId': 'OG000', 'lowerLimit': '2.02', 'upperLimit': '3.98'}, {'value': '3.11', 'groupId': 'OG001', 'lowerLimit': '2.27', 'upperLimit': '4.26'}]}]}, {'title': 'With BG MTX use, H1N1 (n=57,55)', 'categories': [{'measurements': [{'value': '4.90', 'groupId': 'OG000', 'lowerLimit': '3.43', 'upperLimit': '7.00'}, {'value': '7.54', 'groupId': 'OG001', 'lowerLimit': '4.80', 'upperLimit': '11.85'}]}]}, {'title': 'With BG MTX use, H3N2 (n=57,55)', 'categories': [{'measurements': [{'value': '5.69', 'groupId': 'OG000', 'lowerLimit': '3.88', 'upperLimit': '8.34'}, {'value': '6.04', 'groupId': 'OG001', 'lowerLimit': '4.18', 'upperLimit': '8.73'}]}]}, {'title': 'Without BG MTX use, B (n=45,43)', 'categories': [{'measurements': [{'value': '3.11', 'groupId': 'OG000', 'lowerLimit': '2.20', 'upperLimit': '4.40'}, {'value': '5.20', 'groupId': 'OG001', 'lowerLimit': '3.57', 'upperLimit': '7.57'}]}]}, {'title': 'Without BG MTX use, H1N1 (n=45,43)', 'categories': [{'measurements': [{'value': '7.88', 'groupId': 'OG000', 'lowerLimit': '5.13', 'upperLimit': '12.10'}, {'value': '12.76', 'groupId': 'OG001', 'lowerLimit': '7.56', 'upperLimit': '21.53'}]}]}, {'title': 'Without BG MTX use, H3N2 (n=45,43)', 'categories': [{'measurements': [{'value': '9.43', 'groupId': 'OG000', 'lowerLimit': '5.52', 'upperLimit': '16.09'}, {'value': '15.25', 'groupId': 'OG001', 'lowerLimit': '9.06', 'upperLimit': '25.66'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 64 (EOS)', 'description': 'GMFRs for the 3 influenza antigens (B, H1N1, H3N2) from pre-vaccination (Day 29) to Day 64 (Day 35 post-vaccination) were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers. Data was stratified by the background methotrexate use.', 'unitOfMeasure': 'fold rise', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and \\>=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.n=participants evaluable at specified categories for each arm group.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Concentrations (GMC) of Anti-Pneumococcal Antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-690,550 + Influenza and Pneumococcal Vaccine', 'description': 'CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.'}, {'id': 'OG001', 'title': 'Placebo + Influenza and Pneumococcal Vaccine', 'description': 'Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.'}], 'classes': [{'title': '1', 'categories': [{'measurements': [{'value': '1.81', 'groupId': 'OG000', 'lowerLimit': '1.32', 'upperLimit': '2.48'}, {'value': '3.27', 'groupId': 'OG001', 'lowerLimit': '2.34', 'upperLimit': '4.58'}]}]}, {'title': '14', 'categories': [{'measurements': [{'value': '5.24', 'groupId': 'OG000', 'lowerLimit': '3.85', 'upperLimit': '7.12'}, {'value': '6.40', 'groupId': 'OG001', 'lowerLimit': '4.63', 'upperLimit': '8.84'}]}]}, {'title': '18C', 'categories': [{'measurements': [{'value': '2.53', 'groupId': 'OG000', 'lowerLimit': '1.95', 'upperLimit': '3.29'}, {'value': '4.60', 'groupId': 'OG001', 'lowerLimit': '3.48', 'upperLimit': '6.09'}]}]}, {'title': '19A', 'categories': [{'measurements': [{'value': '5.21', 'groupId': 'OG000', 'lowerLimit': '4.15', 'upperLimit': '6.54'}, {'value': '8.57', 'groupId': 'OG001', 'lowerLimit': '6.86', 'upperLimit': '10.70'}]}]}, {'title': '19F', 'categories': [{'measurements': [{'value': '2.59', 'groupId': 'OG000', 'lowerLimit': '1.93', 'upperLimit': '3.47'}, {'value': '3.09', 'groupId': 'OG001', 'lowerLimit': '2.28', 'upperLimit': '4.19'}]}]}, {'title': '23F', 'categories': [{'measurements': [{'value': '2.41', 'groupId': 'OG000', 'lowerLimit': '1.86', 'upperLimit': '3.11'}, {'value': '3.55', 'groupId': 'OG001', 'lowerLimit': '2.78', 'upperLimit': '4.55'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '0.66', 'groupId': 'OG000', 'lowerLimit': '0.52', 'upperLimit': '0.86'}, {'value': '1.11', 'groupId': 'OG001', 'lowerLimit': '0.86', 'upperLimit': '1.43'}]}]}, {'title': '4', 'categories': [{'measurements': [{'value': '0.72', 'groupId': 'OG000', 'lowerLimit': '0.54', 'upperLimit': '0.97'}, {'value': '1.07', 'groupId': 'OG001', 'lowerLimit': '0.77', 'upperLimit': '1.48'}]}]}, {'title': '5', 'categories': [{'measurements': [{'value': '4.05', 'groupId': 'OG000', 'lowerLimit': '3.23', 'upperLimit': '5.09'}, {'value': '5.79', 'groupId': 'OG001', 'lowerLimit': '4.60', 'upperLimit': '7.30'}]}]}, {'title': '6B', 'categories': [{'measurements': [{'value': '2.99', 'groupId': 'OG000', 'lowerLimit': '2.34', 'upperLimit': '3.83'}, {'value': '4.75', 'groupId': 'OG001', 'lowerLimit': '3.71', 'upperLimit': '6.07'}]}]}, {'title': '7F', 'categories': [{'measurements': [{'value': '3.28', 'groupId': 'OG000', 'lowerLimit': '2.42', 'upperLimit': '4.45'}, {'value': '4.37', 'groupId': 'OG001', 'lowerLimit': '3.36', 'upperLimit': '5.67'}]}]}, {'title': '9V', 'categories': [{'measurements': [{'value': '2.61', 'groupId': 'OG000', 'lowerLimit': '2.11', 'upperLimit': '3.23'}, {'value': '4.06', 'groupId': 'OG001', 'lowerLimit': '3.29', 'upperLimit': '5.01'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 64 (EOS)', 'description': 'Antibody geometric mean concentration (GMC) for 12 pneumococcal antigens (1, 3, 4, 5, 6B, 7F, 9V, 14, 19A, 19F, 23F, 18C) as measured by geometric mean of three independent determinations of the antibody response of that antigen. GMC and corresponding 2-sided 95% confidence intervals (CI) were evaluated.', 'unitOfMeasure': 'microgram/milliliter (mcg/mL)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and \\>=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titer (GMT) of Anti-Influenza Antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-690,550 + Influenza and Pneumococcal Vaccine', 'description': 'CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.'}, {'id': 'OG001', 'title': 'Placebo + Influenza and Pneumococcal Vaccine', 'description': 'Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.'}], 'classes': [{'title': 'B', 'categories': [{'measurements': [{'value': '33.39', 'groupId': 'OG000', 'lowerLimit': '25.61', 'upperLimit': '43.54'}, {'value': '50.74', 'groupId': 'OG001', 'lowerLimit': '39.82', 'upperLimit': '64.64'}]}]}, {'title': 'H1N1', 'categories': [{'measurements': [{'value': '86.40', 'groupId': 'OG000', 'lowerLimit': '64.35', 'upperLimit': '116.0'}, {'value': '221.5', 'groupId': 'OG001', 'lowerLimit': '161.4', 'upperLimit': '304.0'}]}]}, {'title': 'H3N2', 'categories': [{'measurements': [{'value': '132.3', 'groupId': 'OG000', 'lowerLimit': '97.65', 'upperLimit': '179.1'}, {'value': '244.0', 'groupId': 'OG001', 'lowerLimit': '184.6', 'upperLimit': '322.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 64 (EOS)', 'description': 'Antibody geometric mean titer (GMT) for 3 influenza antigens antigens (B, H1N1, H3N2) as measured by geometric mean of three independent determinations of the antibody response of that antigen. GMT and corresponding 2-sided 95% confidence intervals (CI) were evaluated.', 'unitOfMeasure': 'titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and \\>=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CP-690,550 + Influenza and Pneumococcal Vaccine', 'description': 'CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.'}, {'id': 'FG001', 'title': 'Placebo + Influenza and Pneumococcal Vaccine', 'description': 'Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '112'}, {'groupId': 'FG001', 'numSubjects': '111'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '105'}, {'groupId': 'FG001', 'numSubjects': '106'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '223', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CP-690,550 + Influenza and Pneumococcal Vaccine', 'description': 'CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.'}, {'id': 'BG001', 'title': 'Placebo + Influenza and Pneumococcal Vaccine', 'description': 'Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.7', 'spread': '10.4', 'groupId': 'BG000'}, {'value': '52.2', 'spread': '11.1', 'groupId': 'BG001'}, {'value': '52.4', 'spread': '10.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '171', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants With Background (BG) Methotrexate (MTX) use', 'classes': [{'title': 'With Background MTX use', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}]}]}, {'title': 'Without Background MTX use', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 223}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-20', 'studyFirstSubmitDate': '2011-05-11', 'resultsFirstSubmitDate': '2013-01-07', 'studyFirstSubmitQcDate': '2011-05-20', 'lastUpdatePostDateStruct': {'date': '2013-03-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-02-20', 'studyFirstPostDateStruct': {'date': '2011-05-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-03-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Satisfactory Humoral Response to the Pneumococcal Vaccine at Visit 3 (Day 64)', 'timeFrame': 'Day 64 (End of Study [EOS])', 'description': 'Satisfactory humoral response to the pneumococcal vaccine was defined as greater than or equal to (\\>=) 2 fold increase in antibody concentrations from vaccination baseline (Day 29) in at least 6 of 12 pneumococcal antigens (1, 3, 4, 5, 6B, 7F, 9V, 14, 19A, 19F, 23F, 18C). Data was stratified by the background methotrexate use.'}, {'measure': 'Percentage of Participants With Satisfactory Humoral Response to the Seasonal Influenza Vaccine at Visit 3 (Day 64)', 'timeFrame': 'Day 64 (EOS)', 'description': 'Satisfactory humoral response to the influenza vaccine was defined as \\>= 4 fold increase in antibody titers from vaccination baseline (Day 29) in at least 2 of 3 influenza antigens (B, H1N1, H3N2). Data was stratified by the background methotrexate use.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens', 'timeFrame': 'Day 64 (EOS)', 'description': 'Response to the pneumococcal vaccine (seroconversion) was defined as \\>= 2 fold increase in antibody concentrations from vaccination baseline (Day 29) in each of the 12 pneumococcal antigens (1, 3, 4, 5, 6B, 7F, 9V, 14, 19A, 19F, 23F, 18C). Data was stratified by the background methotrexate use.'}, {'measure': 'Percentage of Participants Who Responded to Each of the 3 Influenza Antigens', 'timeFrame': 'Day 64 (EOS)', 'description': 'Response to the influenza vaccine (seroconversion) was defined as \\>= 4 fold increase in antibody titers from vaccination baseline (Day 29) in each of 3 influenza antigens (B, H1N1, H3N2). Data was stratified by the background methotrexate use.'}, {'measure': 'Percentage of Participants With Protective Antibody Titers to the Seasonal Influenza Vaccine', 'timeFrame': 'Day 64 (EOS)', 'description': 'Seroprotection was defined as achieving protective antibody titers to the influenza vaccine as measured by a hemagglutination inhibition (HAI) assay titer of \\>= 1:40 in at least 2 of 3 influenza antigens (B, H1N1, H3N2). Data was stratified by the background methotrexate use.'}, {'measure': 'Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29)', 'timeFrame': 'Day 64 (EOS)', 'description': 'Geometric mean fold rises (GMFRs) for the 12 pneumococcal antigens (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) from pre-vaccination (Day 29) to Day 64 (Day 35 post-vaccination) were computed using the logarithmically transformed assay results. Confidence intervals (CIs) for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers. Data was stratified by the background methotrexate use.'}, {'measure': 'Geometric Mean Fold Rise (GMFR) of Anti-Influenza Antibody Levels to Each of the Influenza Antigens Above Vaccination Baseline Values (Day 29)', 'timeFrame': 'Day 64 (EOS)', 'description': 'GMFRs for the 3 influenza antigens (B, H1N1, H3N2) from pre-vaccination (Day 29) to Day 64 (Day 35 post-vaccination) were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers. Data was stratified by the background methotrexate use.'}, {'measure': 'Geometric Mean Concentrations (GMC) of Anti-Pneumococcal Antibody', 'timeFrame': 'Day 64 (EOS)', 'description': 'Antibody geometric mean concentration (GMC) for 12 pneumococcal antigens (1, 3, 4, 5, 6B, 7F, 9V, 14, 19A, 19F, 23F, 18C) as measured by geometric mean of three independent determinations of the antibody response of that antigen. GMC and corresponding 2-sided 95% confidence intervals (CI) were evaluated.'}, {'measure': 'Geometric Mean Titer (GMT) of Anti-Influenza Antibody', 'timeFrame': 'Day 64 (EOS)', 'description': 'Antibody geometric mean titer (GMT) for 3 influenza antigens antigens (B, H1N1, H3N2) as measured by geometric mean of three independent determinations of the antibody response of that antigen. GMT and corresponding 2-sided 95% confidence intervals (CI) were evaluated.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '39192350', 'type': 'DERIVED', 'citation': 'Hetland ML, Strangfeld A, Bonfanti G, Soudis D, Deuring JJ, Edwards RA. Machine learning prediction and explanatory models of serious infections in patients with rheumatoid arthritis treated with tofacitinib. Arthritis Res Ther. 2024 Aug 27;26(1):153. doi: 10.1186/s13075-024-03376-9.'}, {'pmid': '38958913', 'type': 'DERIVED', 'citation': 'Wright GC, Mysler E, Kwok K, Cadatal MJ, Germino R, Yndestad A, Kinch CD, Ogdie A. Impact of Race on the Efficacy and Safety of Tofacitinib in Rheumatoid Arthritis: Post Hoc Analysis of Pooled Clinical Trials. Rheumatol Ther. 2024 Oct;11(5):1135-1164. doi: 10.1007/s40744-024-00677-y. Epub 2024 Jul 3.'}, {'pmid': '36931693', 'type': 'DERIVED', 'citation': 'Kristensen LE, Danese S, Yndestad A, Wang C, Nagy E, Modesto I, Rivas J, Benda B. Identification of two tofacitinib subpopulations with different relative risk versus TNF inhibitors: an analysis of the open label, randomised controlled study ORAL Surveillance. Ann Rheum Dis. 2023 Jul;82(7):901-910. doi: 10.1136/ard-2022-223715. Epub 2023 Mar 17.'}, {'pmid': '36601090', 'type': 'DERIVED', 'citation': 'Hansen KE, Mortezavi M, Nagy E, Wang C, Connell CA, Radi Z, Litman HJ, Adami G, Rossini M. Fracture in clinical studies of tofacitinib in rheumatoid arthritis. Ther Adv Musculoskelet Dis. 2022 Dec 27;14:1759720X221142346. doi: 10.1177/1759720X221142346. eCollection 2022.'}, {'pmid': '36600185', 'type': 'DERIVED', 'citation': 'Curtis JR, Yamaoka K, Chen YH, Bhatt DL, Gunay LM, Sugiyama N, Connell CA, Wang C, Wu J, Menon S, Vranic I, Gomez-Reino JJ. Malignancy risk with tofacitinib versus TNF inhibitors in rheumatoid arthritis: results from the open-label, randomised controlled ORAL Surveillance trial. Ann Rheum Dis. 2023 Mar;82(3):331-343. doi: 10.1136/ard-2022-222543. Epub 2022 Dec 5.'}, {'pmid': '36526796', 'type': 'DERIVED', 'citation': 'Winthrop KL, Yndestad A, Henrohn D, Danese S, Marsal S, Galindo M, Woolcott JC, Jo H, Kwok K, Shapiro AB, Jones TV, Diehl A, Su C, Panes J, Cohen SB. Influenza Adverse Events in Patients with Rheumatoid Arthritis, Ulcerative Colitis, or Psoriatic Arthritis in the Tofacitinib Clinical Development Programs. Rheumatol Ther. 2023 Apr;10(2):357-373. doi: 10.1007/s40744-022-00507-z. Epub 2022 Dec 17.'}, {'pmid': '34870800', 'type': 'DERIVED', 'citation': 'Winthrop KL, Curtis JR, Yamaoka K, Lee EB, Hirose T, Rivas JL, Kwok K, Burmester GR. Clinical Management of Herpes Zoster in Patients With Rheumatoid Arthritis or Psoriatic Arthritis Receiving Tofacitinib Treatment. Rheumatol Ther. 2022 Feb;9(1):243-263. doi: 10.1007/s40744-021-00390-0. Epub 2021 Dec 6.'}, {'pmid': '33127856', 'type': 'DERIVED', 'citation': 'Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Wang L, Chen C, Kwok K, Biswas P, Shapiro A, Madsen A, Wollenhaupt J. Long-term safety of tofacitinib up to 9.5 years: a comprehensive integrated analysis of the rheumatoid arthritis clinical development programme. RMD Open. 2020 Oct;6(3):e001395. doi: 10.1136/rmdopen-2020-001395.'}, {'pmid': '32816215', 'type': 'DERIVED', 'citation': 'Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20.'}, {'pmid': '28143815', 'type': 'DERIVED', 'citation': 'Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Thirunavukkarasu K, DeMasi R, Geier J, Kwok K, Wang L, Riese R, Wollenhaupt J. Long-term safety of tofacitinib for the treatment of rheumatoid arthritis up to 8.5 years: integrated analysis of data from the global clinical trials. Ann Rheum Dis. 2017 Jul;76(7):1253-1262. doi: 10.1136/annrheumdis-2016-210457. Epub 2017 Jan 31.'}, {'pmid': '25795907', 'type': 'DERIVED', 'citation': 'Winthrop KL, Silverfield J, Racewicz A, Neal J, Lee EB, Hrycaj P, Gomez-Reino J, Soma K, Mebus C, Wilkinson B, Hodge J, Fan H, Wang T, Bingham CO 3rd. The effect of tofacitinib on pneumococcal and influenza vaccine responses in rheumatoid arthritis. Ann Rheum Dis. 2016 Apr;75(4):687-95. doi: 10.1136/annrheumdis-2014-207191. Epub 2015 Mar 20.'}, {'pmid': '25047021', 'type': 'DERIVED', 'citation': 'Cohen S, Radominski SC, Gomez-Reino JJ, Wang L, Krishnaswami S, Wood SP, Soma K, Nduaka CI, Kwok K, Valdez H, Benda B, Riese R. Analysis of infections and all-cause mortality in phase II, phase III, and long-term extension studies of tofacitinib in patients with rheumatoid arthritis. Arthritis Rheumatol. 2014 Nov;66(11):2924-37. doi: 10.1002/art.38779.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921129&StudyName=A%20Study%20To%20Assess%20the%20Immune%20Response%20Following%20Administration%20Of%20Influenza%20and%20Pneumococcal%20Vaccines%20To%20Subjects%20with%20Rheumatoid%20Arthriti', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'A Randomized, Double Blind, Placebo Controlled Phase 2 Study To assess the Immune Response Following Administration of Influenza and Pneumococcal Vaccines to Subjects with Rheumatoid Arthritis receiving CP-690,550 with and Without background Methotrexate'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The subject must meet the American College of Rheumatology (ACR) classification criteria for the diagnosis of RA by satisfying at least four of the seven criteria.\n* The subject must have active disease at both screening and baseline\n\nExclusion Criteria:\n\n* History of any documented influenza or pneumococcal infection within the last 3 months.\n* Receipt of any vaccine within 1 month prior to the initial study drug administration (CP-690,550 or placebo CP-690,550).\n* If a subject has received an influenza vaccine within 6 months or a pneumococcal vaccine within 5 years of initial study drug administration.'}, 'identificationModule': {'nctId': 'NCT01359150', 'briefTitle': 'A Study To Assess the Immune Response Following Administration Of Influenza and Pneumococcal Vaccines To Subjects With Rheumatoid Arthritis Receiving CP-690,550 Or Placebo', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Randomized, Double Blind, Placebo Controlled Phase 2 Study To Assess The Immune Response Following Administration Of Influenza And Pneumococcal Vaccines To Subjects With Rheumatoid Arthritis Receiving Cp-690,550 Or Placebo Cp-690,550 With And Without Background Methotrexate', 'orgStudyIdInfo': {'id': 'A3921129'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group 1: 10 mg BID CP-690,550 (100 subjects).', 'description': 'CP-690,550 will be administered for 4 weeks, vaccines will be administered at week 4. CP-690,550 will then continue for another 5 weeks at which point the immune response will be evaluated.', 'interventionNames': ['Drug: CP-690,550']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Treatment Group 2:Placebo CP-690,550 (100 subjects).', 'description': 'Placebo will be administered for 4 weeks, vaccines will be administered at week 4. Placebo will then continue for another 5 weeks at which point the immune response will be evaluated.', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'CP-690,550', 'type': 'DRUG', 'description': 'Treatment Group 1: 10 mg BID CP-690,550 (100 subjects). Strata 1: 10 mg BID CP-690,550 on background methotrexate (50 subjects); Strata 2: 10 mg BID CP-690,550 monotherapy (50 subjects).', 'armGroupLabels': ['Treatment Group 1: 10 mg BID CP-690,550 (100 subjects).']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Placebo CP-690,550 (100 subjects). 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