Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2025-12-26 @ 12:12 PM
Study NCT ID:
NCT01786668
Status:
COMPLETED
Last Update Posted:
2016-06-10
First Post:
2013-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dose-Ranging Study Of Tofacitinib In Adults With Active Ankylosing Spondylitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013167', 'term': 'Spondylitis, Ankylosing'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D025242', 'term': 'Spondylarthropathies'}], 'ancestors': [{'id': 'D000089183', 'term': 'Axial Spondyloarthritis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000844', 'term': 'Ankylosis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D001850', 'term': 'Bone Diseases, Infectious'}, {'id': 'D007239', 'term': 'Infections'}]}, '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': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From informed consent through and including 28 calendar days after the last administration of the investigational product.', 'description': 'The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Tofacitinib 2 mg BID', 'description': 'Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.', 'otherNumAtRisk': 52, 'otherNumAffected': 15, 'seriousNumAtRisk': 52, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Tofacitinib 5 mg BID', 'description': 'Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.', 'otherNumAtRisk': 52, 'otherNumAffected': 10, 'seriousNumAtRisk': 52, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Tofacitinib 10 mg BID', 'description': 'Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.', 'otherNumAtRisk': 52, 'otherNumAffected': 13, 'seriousNumAtRisk': 52, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Placebo BID', 'description': 'Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.', 'otherNumAtRisk': 51, 'otherNumAffected': 14, 'seriousNumAtRisk': 51, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.0'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.0'}, {'term': 'Vaginitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.0'}, {'term': 'Vulvovaginal mycotic infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.0'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.0'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.0'}, {'term': 'Pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.0'}, {'term': 'Balanoposthitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.0'}], 'seriousEvents': [{'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.0'}, {'term': 'Iridocyclitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.0'}, {'term': 'Tendon injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.0'}, {'term': 'Foetal death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.0'}, {'term': 'Uterine spasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.0'}, {'term': 'Vaginal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v18.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving 20 Percent (%) Improvement in Assessment of SpondyloArthritis International Society (ASAS) Score (ASAS 20) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib 2 mg BID', 'description': 'Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib 5 mg BID', 'description': 'Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG002', 'title': 'Tofacitinib 10 mg BID', 'description': 'Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG003', 'title': 'Placebo BID', 'description': 'Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '56.0', 'groupId': 'OG000'}, {'value': '63.0', 'groupId': 'OG001'}, {'value': '67.4', 'groupId': 'OG002'}, {'value': '40.1', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.8', 'ciLowerLimit': '5.0', 'ciUpperLimit': '30.3', 'groupDescription': 'Emax model - 95% Confidence Interval represents 95% Credible Interval', 'statisticalMethod': 'Emax Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '22.9', 'ciLowerLimit': '8.4', 'ciUpperLimit': '37.7', 'groupDescription': 'Emax model - 95% Confidence Interval represents 95% Credible Interval', 'statisticalMethod': 'Emax Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '27.3', 'ciLowerLimit': '10.7', 'ciUpperLimit': '43.4', 'groupDescription': 'Emax model - 95% Confidence Interval represents 95% Credible Interval', 'statisticalMethod': 'Emax Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': "The primary analysis of this outcome measure was performed using the Emax model. Clinical response to treatment was assessed according to ASAS20 criteria. ASAS20 responder had improvement of greater than or equal to (≥) 20% and ≥1 unit in at least 3 domains (on a scale of 0 \\[least\\] to 10 \\[worst\\]) and no worsening of ≥20% and less than or equal to (≤)1 unit in the remaining domain. The domains are: Patient's Global Assessment of Disease Activity, spinal pain, function and inflammation (from Bath Ankylosing Spondylitis Disease Activity Index \\[BASDAI\\]). Missing data were handled by nonresponsive (NRI)/ last observation carried forward (LOCF). Missing values due to a subject dropping out from the study were handled by setting the ASAS20 value to NRI. The LOCF approach was applied to missing components, if just some of the components of the ASAS20 were missing.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): included all participants who were randomized to the study and received at least one dose of the randomized study drug (Tofacitinib or placebo).'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving ASAS20 at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib 2 mg BID', 'description': 'Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib 5 mg BID', 'description': 'Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG002', 'title': 'Tofacitinib 10 mg BID', 'description': 'Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG003', 'title': 'Placebo BID', 'description': 'Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '51.92', 'groupId': 'OG000'}, {'value': '80.77', 'groupId': 'OG001'}, {'value': '55.77', 'groupId': 'OG002'}, {'value': '41.18', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.271', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.75', 'ciLowerLimit': '-8.41', 'ciUpperLimit': '29.90', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.77', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '39.59', 'ciLowerLimit': '22.35', 'ciUpperLimit': '56.83', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.80', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.134', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.59', 'ciLowerLimit': '-4.50', 'ciUpperLimit': '33.69', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.74', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 12', 'description': "The supportive analysis of this outcome measure was performed using the normal approximation for two proportions. Clinical response to treatment was assessed according to ASAS20 criteria. ASAS20 responder had improvement of ≥ 20% and ≥1 unit in at least 3 domains (on a scale of 0 \\[least\\] to 10 \\[worst\\]) and no worsening of ≥20% and ≤1 unit in the remaining domain. The domains are: Patient's Global Assessment of Disease Activity, spinal pain, function and inflammation (from Bath Ankylosing Spondylitis Disease Activity Index \\[BASDAI\\]). Missing data were handled by NRI/LOCF. Missing values due to a subject dropping out from the study were handled by setting the ASAS20 value to NRI. The LOCF approach was applied to missing components, if just some of the components of the ASAS20 were missing.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving 20% Improvement in ASAS Score at Weeks 2, 4 and 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib 2 mg BID', 'description': 'Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib 5 mg BID', 'description': 'Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG002', 'title': 'Tofacitinib 10 mg BID', 'description': 'Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG003', 'title': 'Placebo BID', 'description': 'Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.'}], 'classes': [{'title': 'Week 2 (n=21,17,18,14)', 'categories': [{'measurements': [{'value': '40.38', 'groupId': 'OG000'}, {'value': '32.69', 'groupId': 'OG001'}, {'value': '34.62', 'groupId': 'OG002'}, {'value': '27.45', 'groupId': 'OG003'}]}]}, {'title': 'Week 4 (n=25,29,25,17)', 'categories': [{'measurements': [{'value': '48.08', 'groupId': 'OG000'}, {'value': '55.77', 'groupId': 'OG001'}, {'value': '48.08', 'groupId': 'OG002'}, {'value': '33.33', 'groupId': 'OG003'}]}]}, {'title': 'Week 8 (n=30, 37, 28, 22)', 'categories': [{'measurements': [{'value': '57.69', 'groupId': 'OG000'}, {'value': '71.15', 'groupId': 'OG001'}, {'value': '53.85', 'groupId': 'OG002'}, {'value': '43.14', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.162', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.93', 'ciLowerLimit': '-5.17', 'ciUpperLimit': '31.04', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.24', 'groupDescription': 'Week 2', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.561', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.24', 'ciLowerLimit': '-12.44', 'ciUpperLimit': '22.92', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.02', 'groupDescription': 'Week 2', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.430', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.16', 'ciLowerLimit': '-10.65', 'ciUpperLimit': '24.97', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.09', 'groupDescription': 'Week 2', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.123', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.74', 'ciLowerLimit': '-4.01', 'ciUpperLimit': '33.50', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.57', 'groupDescription': 'Week 4', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.019', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '22.44', 'ciLowerLimit': '3.74', 'ciUpperLimit': '41.13', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.54', 'groupDescription': 'Week 4', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.123', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.74', 'ciLowerLimit': '-4.01', 'ciUpperLimit': '33.50', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.57', 'groupDescription': 'Week 4', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.135', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.56', 'ciLowerLimit': '-4.55', 'ciUpperLimit': '33.66', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.75', 'groupDescription': 'Week 8', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.003', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '28.02', 'ciLowerLimit': '9.68', 'ciUpperLimit': '46.36', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.36', 'groupDescription': 'Week 8', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.274', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.71', 'ciLowerLimit': '-8.48', 'ciUpperLimit': '29.90', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.79', 'groupDescription': 'Week 8', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8', 'description': "Clinical response to treatment was assessed according to ASAS20 criteria. ASAS20 responder had improvement of ≥ 20% and ≥1 unit in at least 3 domains (on a scale of 0 \\[least\\] to 10 \\[worst\\]) and no worsening of ≥20% and ≤1 unit in the remaining domain. The domains are: Patient's Global Assessment of Disease Activity, spinal pain, function and inflammation (from Bath Ankylosing Spondylitis Disease Activity Index \\[BASDAI\\]). Missing data were handled by NRI/LOCF. Missing values due to a subject dropping out from the study were handled by setting the ASAS20 value to NRI. The LOCF approach was applied to missing components, if just some of the components of the ASAS20 were missing.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS - n=number of responders at each visit.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Index of Disease Activity Score of the Sacroiliac (SI) Joints at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib 2 mg BID', 'description': 'Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib 5 mg BID', 'description': 'Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG002', 'title': 'Tofacitinib 10 mg BID', 'description': 'Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG003', 'title': 'Placebo BID', 'description': 'Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.70', 'spread': '0.779', 'groupId': 'OG000'}, {'value': '-3.15', 'spread': '0.788', 'groupId': 'OG001'}, {'value': '-3.55', 'spread': '0.795', 'groupId': 'OG002'}, {'value': '-0.81', 'spread': '0.806', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.427', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.89', 'ciLowerLimit': '-3.11', 'ciUpperLimit': '1.32', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.123', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.039', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.35', 'ciLowerLimit': '-4.58', 'ciUpperLimit': '-0.12', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.130', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.016', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.74', 'ciLowerLimit': '-4.97', 'ciUpperLimit': '-0.51', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.131', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'SPARCC scoring consists of assessing six SI joint MRI image coronal slices representing the largest proportion of the synovial compartment of the SI joints for edema. The maximum score per slice was 2 and 12 for all 6 slices. The total minimum and maximum score for all SI joints across 6 slices is 0 to 72 and higher scores indicate more inflammation. A negative change from baseline indicates improvement. Missing data at Week 12 were imputed by LOCF if data at an early visit (discontinuation visit) were available.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in SPARCC MRI Index of Disease Activity Score of the Spine at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib 2 mg BID', 'description': 'Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib 5 mg BID', 'description': 'Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG002', 'title': 'Tofacitinib 10 mg BID', 'description': 'Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG003', 'title': 'Placebo BID', 'description': 'Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.09', 'spread': '1.061', 'groupId': 'OG000'}, {'value': '-5.51', 'spread': '1.063', 'groupId': 'OG001'}, {'value': '-6.57', 'spread': '1.073', 'groupId': 'OG002'}, {'value': '-0.09', 'spread': '1.085', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.050', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.00', 'ciLowerLimit': '-5.99', 'ciUpperLimit': '-0.00', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.517', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.42', 'ciLowerLimit': '-8.42', 'ciUpperLimit': '-2.42', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.520', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.47', 'ciLowerLimit': '-9.48', 'ciUpperLimit': '-3.46', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.525', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'SPARCC scoring of the magnetic resonance imaging (MRI) of the spine consists of assessing six disco-vertebral units (DVU) with 3 consecutive sagittal slices at each DVU. The minimum and maximum SPARCC score for all 6 DVUs is 0 to 108, with higher scores indicating more damage. A negative change from baseline indicates improvement. Missing data at Week 12 were imputed by LOCF if data at an early visit (discontinuation visit) were available.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Modified Berlin Ankylosing Spondylitis Spine Magnetic Resonance Imaging Activity Score (ASspiMRI) of the Spine at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib 2 mg BID', 'description': 'Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib 5 mg BID', 'description': 'Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG002', 'title': 'Tofacitinib 10 mg BID', 'description': 'Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG003', 'title': 'Placebo BID', 'description': 'Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.05', 'spread': '0.364', 'groupId': 'OG000'}, {'value': '-2.22', 'spread': '0.364', 'groupId': 'OG001'}, {'value': '-2.13', 'spread': '0.368', 'groupId': 'OG002'}, {'value': '-0.41', 'spread': '0.372', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.221', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.64', 'ciLowerLimit': '-1.66', 'ciUpperLimit': '0.39', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.520', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.80', 'ciLowerLimit': '-2.83', 'ciUpperLimit': '-0.78', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.520', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.71', 'ciLowerLimit': '-2.75', 'ciUpperLimit': '-0.68', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.523', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'Berlin modification of the ASspiMRI is a measure of acute lesion as determined by short-tau inversion recovery (STIR) sequences. All 23 disco-vertebral units (DVU) of the spine (from C2 to S1), defined as the region between 2 virtual lines through the middle of each vertebra, were scored in a single dimension, which is represented the highest level of inflammation in that particular DVU. Total spine ASspiMRI scores can range from 0-69 with higher scores indicating more disease activity. A negative change from baseline indicates improvement. Missing data at Week 12 were imputed by LOCF if data at an early visit (discontinuation visit) were available.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving 40% Improvement in ASAS Score at Weeks 2, 4, 8 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib 2 mg BID', 'description': 'Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib 5 mg BID', 'description': 'Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG002', 'title': 'Tofacitinib 10 mg BID', 'description': 'Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG003', 'title': 'Placebo BID', 'description': 'Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.'}], 'classes': [{'title': 'Week 2 (n=7, 7, 9, 8)', 'categories': [{'measurements': [{'value': '13.46', 'groupId': 'OG000'}, {'value': '13.46', 'groupId': 'OG001'}, {'value': '17.31', 'groupId': 'OG002'}, {'value': '15.69', 'groupId': 'OG003'}]}]}, {'title': 'Week 4 (n=15, 17, 11, 8)', 'categories': [{'measurements': [{'value': '28.85', 'groupId': 'OG000'}, {'value': '32.69', 'groupId': 'OG001'}, {'value': '21.15', 'groupId': 'OG002'}, {'value': '15.69', 'groupId': 'OG003'}]}]}, {'title': 'Week 8 (n=15, 18, 19, 14)', 'categories': [{'measurements': [{'value': '28.85', 'groupId': 'OG000'}, {'value': '34.62', 'groupId': 'OG001'}, {'value': '36.54', 'groupId': 'OG002'}, {'value': '27.45', 'groupId': 'OG003'}]}]}, {'title': 'Week 12 (n=22, 24, 20, 10)', 'categories': [{'measurements': [{'value': '42.31', 'groupId': 'OG000'}, {'value': '46.15', 'groupId': 'OG001'}, {'value': '38.46', 'groupId': 'OG002'}, {'value': '19.61', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.749', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.22', 'ciLowerLimit': '-15.85', 'ciUpperLimit': '11.40', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.95', 'groupDescription': 'Week 2', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.749', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.22', 'ciLowerLimit': '-15.85', 'ciUpperLimit': '11.40', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.95', 'groupDescription': 'Week 2', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.824', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.62', 'ciLowerLimit': '-12.71', 'ciUpperLimit': '15.95', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.31', 'groupDescription': 'Week 2', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.104', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.16', 'ciLowerLimit': '-2.69', 'ciUpperLimit': '29.01', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.09', 'groupDescription': 'Week 4', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.040', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.01', 'ciLowerLimit': '0.81', 'ciUpperLimit': '33.20', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.26', 'groupDescription': 'Week 4', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.473', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.47', 'ciLowerLimit': '-9.46', 'ciUpperLimit': '20.40', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.62', 'groupDescription': 'Week 4', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.875', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.40', 'ciLowerLimit': '-15.97', 'ciUpperLimit': '18.76', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.86', 'groupDescription': 'Week 8', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.430', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.16', 'ciLowerLimit': '-10.65', 'ciUpperLimit': '24.97', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.09', 'groupDescription': 'Week 8', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.320', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.09', 'ciLowerLimit': '-8.84', 'ciUpperLimit': '27.01', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.15', 'groupDescription': 'Week 8', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.010', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '22.70', 'ciLowerLimit': '5.41', 'ciUpperLimit': '39.99', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.82', 'groupDescription': 'Week 12', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.003', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '26.55', 'ciLowerLimit': '9.16', 'ciUpperLimit': '43.93', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.87', 'groupDescription': 'Week 12', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.031', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.85', 'ciLowerLimit': '1.72', 'ciUpperLimit': '35.99', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.74', 'groupDescription': 'Week 12', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, Week 12', 'description': 'ASAS 40 is defined as ≥40% and absolute change of ≥2 units in at least 3 domains on a 0-10 scale (0=no disease activity, 10=high disease activity), and no worsening in the remaining domain. Missing data were handled by NRI/LOCF.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS - n=number of responders at each visit.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving ASAS5/6 Response at Weeks 2, 4, 8 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib 2 mg BID', 'description': 'Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib 5 mg BID', 'description': 'Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG002', 'title': 'Tofacitinib 10 mg BID', 'description': 'Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG003', 'title': 'Placebo BID', 'description': 'Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.'}], 'classes': [{'title': 'Week 2 (n=12, 7, 11, 4)', 'categories': [{'measurements': [{'value': '23.08', 'groupId': 'OG000'}, {'value': '13.46', 'groupId': 'OG001'}, {'value': '21.15', 'groupId': 'OG002'}, {'value': '7.84', 'groupId': 'OG003'}]}]}, {'title': 'Week 4 (n=10, 16, 15, 4)', 'categories': [{'measurements': [{'value': '19.23', 'groupId': 'OG000'}, {'value': '30.77', 'groupId': 'OG001'}, {'value': '28.85', 'groupId': 'OG002'}, {'value': '7.84', 'groupId': 'OG003'}]}]}, {'title': 'Week 8 (n=11, 22, 15, 5)', 'categories': [{'measurements': [{'value': '21.15', 'groupId': 'OG000'}, {'value': '42.31', 'groupId': 'OG001'}, {'value': '28.85', 'groupId': 'OG002'}, {'value': '9.80', 'groupId': 'OG003'}]}]}, {'title': 'Week 12 (n=10, 26, 20, 8)', 'categories': [{'measurements': [{'value': '19.23', 'groupId': 'OG000'}, {'value': '50.00', 'groupId': 'OG001'}, {'value': '38.46', 'groupId': 'OG002'}, {'value': '15.69', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.028', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.23', 'ciLowerLimit': '1.61', 'ciUpperLimit': '28.86', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.95', 'groupDescription': 'Week 2', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.353', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.62', 'ciLowerLimit': '-6.23', 'ciUpperLimit': '17.47', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.05', 'groupDescription': 'Week 2', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.050', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.31', 'ciLowerLimit': '-0.02', 'ciUpperLimit': '26.64', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.80', 'groupDescription': 'Week 2', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.086', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.39', 'ciLowerLimit': '-1.62', 'ciUpperLimit': '24.39', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.64', 'groupDescription': 'Week 4', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.002', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '22.93', 'ciLowerLimit': '8.37', 'ciUpperLimit': '37.48', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.43', 'groupDescription': 'Week 4', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.004', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '21.00', 'ciLowerLimit': '6.65', 'ciUpperLimit': '35.36', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.32', 'groupDescription': 'Week 4', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.106', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.35', 'ciLowerLimit': '-2.43', 'ciUpperLimit': '25.13', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.03', 'groupDescription': 'Week 8', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '32.50', 'ciLowerLimit': '16.79', 'ciUpperLimit': '48.22', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.02', 'groupDescription': 'Week 8', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.012', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.04', 'ciLowerLimit': '4.27', 'ciUpperLimit': '33.81', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.54', 'groupDescription': 'Week 8', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.635', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.54', 'ciLowerLimit': '-11.10', 'ciUpperLimit': '18.19', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.47', 'groupDescription': 'Week 12', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '34.31', 'ciLowerLimit': '17.45', 'ciUpperLimit': '51.18', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.60', 'groupDescription': 'Week 12', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.007', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '22.78', 'ciLowerLimit': '6.21', 'ciUpperLimit': '39.34', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.45', 'groupDescription': 'Week 12', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, Week 12', 'description': "ASAS5/6 consists of 6 domains: the 4 used in ASAS20 (Patient's Global Assessment of Disease Activity, spinal pain, function, inflammation plus spinal mobility and an acute phase reactant, C Reactive Protein (CRP). ASAS 5/6 is defined as ≥20% improvement in at least 5 domains and no worsening in the remaining domain. Missing data were handled by NRI/LOCF.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS - n=number of responders at each visit'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein ASDAS(CRP) at Weeks 2, 4, 8 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib 2 mg BID', 'description': 'Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib 5 mg BID', 'description': 'Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG002', 'title': 'Tofacitinib 10 mg BID', 'description': 'Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG003', 'title': 'Placebo BID', 'description': 'Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '-0.68', 'spread': '0.096', 'groupId': 'OG000', 'lowerLimit': '15.20', 'upperLimit': '39.70'}, {'value': '-1.00', 'spread': '0.096', 'groupId': 'OG001'}, {'value': '-0.97', 'spread': '0.096', 'groupId': 'OG002'}, {'value': '-0.50', 'spread': '0.097', 'groupId': 'OG003'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-1.01', 'spread': '0.099', 'groupId': 'OG000'}, {'value': '-1.20', 'spread': '0.099', 'groupId': 'OG001'}, {'value': '-1.17', 'spread': '0.099', 'groupId': 'OG002'}, {'value': '-0.58', 'spread': '0.100', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-1.08', 'spread': '0.111', 'groupId': 'OG000'}, {'value': '-1.36', 'spread': '0.111', 'groupId': 'OG001'}, {'value': '-1.32', 'spread': '0.112', 'groupId': 'OG002'}, {'value': '-0.73', 'spread': '0.112', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-1.23', 'spread': '0.119', 'groupId': 'OG000'}, {'value': '-1.41', 'spread': '0.119', 'groupId': 'OG001'}, {'value': '-1.37', 'spread': '0.121', 'groupId': 'OG002'}, {'value': '-0.68', 'spread': '0.123', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.175', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.19', 'ciLowerLimit': '-0.46', 'ciUpperLimit': '0.08', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.136', 'groupDescription': 'Week 2', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.51', 'ciLowerLimit': '-0.77', 'ciUpperLimit': '-0.24', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.136', 'groupDescription': 'Week 2', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.47', 'ciLowerLimit': '-0.74', 'ciUpperLimit': '-0.20', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.136', 'groupDescription': 'Week 2', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.43', 'ciLowerLimit': '-0.70', 'ciUpperLimit': '-0.15', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.141', 'groupDescription': 'Week 4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.62', 'ciLowerLimit': '-0.90', 'ciUpperLimit': '-0.34', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.141', 'groupDescription': 'Week 4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.59', 'ciLowerLimit': '-0.86', 'ciUpperLimit': '-0.31', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.141', 'groupDescription': 'Week 4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.026', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.35', 'ciLowerLimit': '-0.66', 'ciUpperLimit': '-0.04', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.158', 'groupDescription': 'Week 8', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.63', 'ciLowerLimit': '-0.94', 'ciUpperLimit': '-0.32', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.157', 'groupDescription': 'Week 8', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.59', 'ciLowerLimit': '-0.90', 'ciUpperLimit': '-0.27', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.159', 'groupDescription': 'Week 8', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.55', 'ciLowerLimit': '-0.89', 'ciUpperLimit': '-0.21', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.171', 'groupDescription': 'Week 12', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.73', 'ciLowerLimit': '-1.07', 'ciUpperLimit': '-0.39', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.171', 'groupDescription': 'Week 12', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.69', 'ciLowerLimit': '-1.03', 'ciUpperLimit': '-0.35', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.172', 'groupDescription': 'Week 12', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, Week 12', 'description': "The ASDAS(CRP) is a derived score that uses back pain, duration of morning stiffness, Patient's Global Assessment of their disease and peripheral pain/swelling. The formula used for calculating the ASDAS (CRP)is: 0.12 x Back Pain + 0.06 x Duration of Morning Stiffness + 0.11 x Patient Global + 0.07 x Peripheral Pain/Swelling + 0.58 x Ln(CRP+1). The calculated score can be from 0 to no defined upper limit. A negative number indicates a reduction in the score which indicates decrease in disease activity.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With ASDAS Clinically Important Improvement at Weeks 2, 4, 8 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib 2 mg BID', 'description': 'Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib 5 mg BID', 'description': 'Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG002', 'title': 'Tofacitinib 10 mg BID', 'description': 'Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG003', 'title': 'Placebo BID', 'description': 'Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.'}], 'classes': [{'title': 'Week 2 (n=14, 25, 21, 8)', 'categories': [{'measurements': [{'value': '26.92', 'groupId': 'OG000'}, {'value': '48.08', 'groupId': 'OG001'}, {'value': '40.38', 'groupId': 'OG002'}, {'value': '15.69', 'groupId': 'OG003'}]}]}, {'title': 'Week4 (n=22, 30, 27, 10)', 'categories': [{'measurements': [{'value': '42.31', 'groupId': 'OG000'}, {'value': '57.69', 'groupId': 'OG001'}, {'value': '51.92', 'groupId': 'OG002'}, {'value': '19.61', 'groupId': 'OG003'}]}]}, {'title': 'Week 8 (n=23, 31, 31, 15)', 'categories': [{'measurements': [{'value': '44.23', 'groupId': 'OG000'}, {'value': '59.62', 'groupId': 'OG001'}, {'value': '59.62', 'groupId': 'OG002'}, {'value': '29.41', 'groupId': 'OG003'}]}]}, {'title': 'Week 12 (n=27, 33, 29, 14)', 'categories': [{'measurements': [{'value': '51.92', 'groupId': 'OG000'}, {'value': '63.46', 'groupId': 'OG001'}, {'value': '55.77', 'groupId': 'OG002'}, {'value': '27.45', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.159', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.24', 'ciLowerLimit': '-4.41', 'ciUpperLimit': '26.89', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.99', 'groupDescription': 'Week 2', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '32.39', 'ciLowerLimit': '15.54', 'ciUpperLimit': '49.24', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.60', 'groupDescription': 'Week 2', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.004', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '24.70', 'ciLowerLimit': '8.04', 'ciUpperLimit': '41.36', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.50', 'groupDescription': 'Week 2', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.010', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '22.70', 'ciLowerLimit': '5.41', 'ciUpperLimit': '39.99', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.82', 'groupDescription': 'Week 4', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '38.08', 'ciLowerLimit': '20.79', 'ciUpperLimit': '55.38', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.82', 'groupDescription': 'Week 4', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '32.32', 'ciLowerLimit': '14.90', 'ciUpperLimit': '49.73', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.88', 'groupDescription': 'Week 4', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.114', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.82', 'ciLowerLimit': '-3.58', 'ciUpperLimit': '33.22', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.39', 'groupDescription': 'Week 8', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '30.20', 'ciLowerLimit': '11.92', 'ciUpperLimit': '48.49', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.33', 'groupDescription': 'Week 8', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '30.20', 'ciLowerLimit': '11.92', 'ciUpperLimit': '48.49', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.33', 'groupDescription': 'Week 8', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.009', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '24.47', 'ciLowerLimit': '6.18', 'ciUpperLimit': '42.76', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.33', 'groupDescription': 'Week 12', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '36.01', 'ciLowerLimit': '18.09', 'ciUpperLimit': '53.94', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.15', 'groupDescription': 'Week 12', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.002', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '28.32', 'ciLowerLimit': '10.09', 'ciUpperLimit': '46.55', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.30', 'groupDescription': 'Week 12', 'statisticalMethod': 'Normal 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{'id': 'OG002', 'title': 'Tofacitinib 10 mg BID', 'description': 'Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG003', 'title': 'Placebo BID', 'description': 'Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.'}], 'classes': [{'title': 'Week 2 (n=4, 4, 4, 1)', 'categories': [{'measurements': [{'value': '7.69', 'groupId': 'OG000'}, {'value': '7.69', 'groupId': 'OG001'}, {'value': '7.69', 'groupId': 'OG002'}, {'value': '1.96', 'groupId': 'OG003'}]}]}, {'title': 'Week 4 (n=6, 6, 8, 3)', 'categories': [{'measurements': [{'value': '11.54', 'groupId': 'OG000'}, {'value': '11.54', 'groupId': 'OG001'}, {'value': '15.38', 'groupId': 'OG002'}, {'value': '5.88', 'groupId': 'OG003'}]}]}, {'title': 'Week 8 (n=6, 14, 12, 5)', 'categories': [{'measurements': [{'value': '11.54', 'groupId': 'OG000'}, {'value': '26.92', 'groupId': 'OG001'}, {'value': '23.08', 'groupId': 'OG002'}, {'value': '9.80', 'groupId': 'OG003'}]}]}, {'title': 'Week 12 (n=10, 12, 13, 6)', 'categories': [{'measurements': [{'value': '19.23', 'groupId': 'OG000'}, {'value': '23.08', 'groupId': 'OG001'}, {'value': '25.00', 'groupId': 'OG002'}, {'value': '11.76', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.170', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.73', 'ciLowerLimit': '-2.45', 'ciUpperLimit': '13.91', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.17', 'groupDescription': 'Week 2', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.170', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.73', 'ciLowerLimit': '-2.45', 'ciUpperLimit': '13.91', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.17', 'groupDescription': 'Week 2', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.170', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.73', 'ciLowerLimit': '-2.45', 'ciUpperLimit': '13.91', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.17', 'groupDescription': 'Week 2', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.306', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.66', 'ciLowerLimit': '-5.17', 'ciUpperLimit': '16.48', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.52', 'groupDescription': 'Week 4', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.306', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.66', 'ciLowerLimit': '-5.17', 'ciUpperLimit': '16.48', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.52', 'groupDescription': 'Week 4', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.113', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.50', 'ciLowerLimit': '-2.24', 'ciUpperLimit': '21.24', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.99', 'groupDescription': 'Week 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'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.064', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.27', 'ciLowerLimit': '-0.79', 'ciUpperLimit': '27.34', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.17', 'groupDescription': 'Week 8', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.292', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.47', 'ciLowerLimit': '-6.42', 'ciUpperLimit': '21.36', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.09', 'groupDescription': 'Week 12', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.125', 'groupIds': 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[{'measurements': [{'value': '5.77', 'groupId': 'OG000'}, {'value': '1.92', 'groupId': 'OG001'}, {'value': '9.62', 'groupId': 'OG002'}, {'value': '1.96', 'groupId': 'OG003'}]}]}, {'title': 'Week 12 (n=7, 7, 8, 4)', 'categories': [{'measurements': [{'value': '13.46', 'groupId': 'OG000'}, {'value': '13.46', 'groupId': 'OG001'}, {'value': '15.38', 'groupId': 'OG002'}, {'value': '7.84', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.313', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.92', 'ciLowerLimit': '-1.81', 'ciUpperLimit': '5.66', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.90', 'groupDescription': 'Week 2', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.313', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.92', 'ciLowerLimit': '-1.81', 'ciUpperLimit': '5.66', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.90', 'groupDescription': 'Week 2', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.313', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.92', 'ciLowerLimit': '-1.81', 'ciUpperLimit': '5.66', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.90', 'groupDescription': 'Week 2', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.989', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.04', 'ciLowerLimit': '-5.37', 'ciUpperLimit': '5.29', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.72', 'groupDescription': 'Week 4', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.313', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.81', 'ciLowerLimit': '-3.58', 'ciUpperLimit': '11.20', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.77', 'groupDescription': 'Week 4', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.170', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.73', 'ciLowerLimit': '-2.45', 'ciUpperLimit': '13.91', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.17', 'groupDescription': 'Week 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'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.091', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.65', 'ciLowerLimit': '-1.22', 'ciUpperLimit': '16.52', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.53', 'groupDescription': 'Week 8', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.353', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.62', 'ciLowerLimit': '-6.23', 'ciUpperLimit': '17.47', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.05', 'groupDescription': 'Week 12', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': 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ASDAS inactive disease was calculated from the ASDAS data. The ASDAS inactive disease was defined as ASDAS \\<1.3 units. Missing data were handled by NRI/LOCF.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS - n=number of responders at each visit'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in BASDAI Total Score at Week 2, 4, 8 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib 2 mg BID', 'description': 'Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib 5 mg BID', 'description': 'Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG002', 'title': 'Tofacitinib 10 mg BID', 'description': 'Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG003', 'title': 'Placebo BID', 'description': 'Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '-1.45', 'spread': '0.219', 'groupId': 'OG000'}, {'value': '-1.53', 'spread': '0.217', 'groupId': 'OG001'}, {'value': '-1.24', 'spread': '0.219', 'groupId': 'OG002'}, {'value': '-1.42', 'spread': '0.219', 'groupId': 'OG003'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-1.90', 'spread': '0.242', 'groupId': 'OG000'}, {'value': '-1.93', 'spread': '0.240', 'groupId': 'OG001'}, {'value': '-1.84', 'spread': '0.242', 'groupId': 'OG002'}, {'value': '-1.60', 'spread': '0.243', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-2.16', 'spread': '0.268', 'groupId': 'OG000'}, {'value': '-2.39', 'spread': '0.267', 'groupId': 'OG001'}, {'value': '-2.35', 'spread': '0.271', 'groupId': 'OG002'}, {'value': '-1.87', 'spread': '0.271', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-2.75', 'spread': '0.277', 'groupId': 'OG000'}, {'value': '-2.88', 'spread': '0.276', 'groupId': 'OG001'}, {'value': '-2.68', 'spread': '0.281', 'groupId': 'OG002'}, {'value': '-1.85', 'spread': '0.283', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.926', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.64', 'ciUpperLimit': '0.58', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.310', 'groupDescription': 'Week 2', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.718', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.11', 'ciLowerLimit': '-0.72', 'ciUpperLimit': '0.50', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.308', 'groupDescription': 'Week 2', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.570', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.18', 'ciLowerLimit': '-0.43', 'ciUpperLimit': '0.79', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.310', 'groupDescription': 'Week 2', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.384', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.30', 'ciLowerLimit': '-0.97', 'ciUpperLimit': '0.38', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.343', 'groupDescription': 'Week 4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.334', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.33', 'ciLowerLimit': '-1.00', 'ciUpperLimit': '0.34', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.341', 'groupDescription': 'Week 4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.474', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.25', 'ciLowerLimit': '-0.92', 'ciUpperLimit': '0.43', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.343', 'groupDescription': 'Week 4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.445', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.29', 'ciLowerLimit': '-1.04', 'ciUpperLimit': '0.46', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.381', 'groupDescription': 'Week 8', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.174', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.52', 'ciLowerLimit': '-1.27', 'ciUpperLimit': '0.23', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.380', 'groupDescription': 'Week 8', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.217', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.47', 'ciLowerLimit': '-1.23', 'ciUpperLimit': '0.28', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.383', 'groupDescription': 'Week 8', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.024', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.90', 'ciLowerLimit': '-1.69', 'ciUpperLimit': '-0.12', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.396', 'groupDescription': 'Week 12', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.010', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.03', 'ciLowerLimit': '-1.81', 'ciUpperLimit': '-0.24', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.396', 'groupDescription': 'Week 12', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.038', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.83', 'ciLowerLimit': '-1.62', 'ciUpperLimit': '-0.04', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.399', 'groupDescription': 'Week 12', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, Week 12', 'description': "BASDAI is a validated self-assessment tool used to determine disease activity in participant with Ankylosing Spondylitis. Utilizing a Numerical Rating Scale (NRS) of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions (Q)1-4. This score is then divided by 5. BASDAI=Q1+Q2+Q3+Q4+\\[Q5+Q6/2\\]/5. The final BASDAI score averages the individual assessments for a final score range of 0-10. Negative values indicate improvement.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)50 Response at Weeks 2, 4, 8 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib 2 mg BID', 'description': 'Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib 5 mg BID', 'description': 'Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG002', 'title': 'Tofacitinib 10 mg BID', 'description': 'Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG003', 'title': 'Placebo BID', 'description': 'Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.'}], 'classes': [{'title': 'Week 2 (n=6, 11, 7, 8)', 'categories': [{'measurements': [{'value': '11.54', 'groupId': 'OG000', 'lowerLimit': '2.92', 'upperLimit': '20.61'}, {'value': '21.15', 'groupId': 'OG001'}, {'value': '13.46', 'groupId': 'OG002'}, {'value': '15.69', 'groupId': 'OG003'}]}]}, {'title': 'Week 4 (n=15, 12, 15, 11)', 'categories': [{'measurements': [{'value': '28.85', 'groupId': 'OG000'}, {'value': '23.08', 'groupId': 'OG001'}, {'value': '28.85', 'groupId': 'OG002'}, {'value': '21.57', 'groupId': 'OG003'}]}]}, {'title': 'Week 8 (n=18, 17, 21, 14)', 'categories': [{'measurements': [{'value': '34.62', 'groupId': 'OG000'}, {'value': '32.69', 'groupId': 'OG001'}, {'value': '40.38', 'groupId': 'OG002'}, {'value': '27.45', 'groupId': 'OG003'}]}]}, {'title': 'Week 12 (n=24, 22, 22, 12)', 'categories': [{'measurements': [{'value': '46.15', 'groupId': 'OG000'}, {'value': '42.31', 'groupId': 'OG001'}, {'value': '42.31', 'groupId': 'OG002'}, {'value': '23.53', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.539', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.15', 'ciLowerLimit': '-17.38', 'ciUpperLimit': '9.08', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.75', 'groupDescription': 'Week 2', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.473', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.47', 'ciLowerLimit': '-9.46', 'ciUpperLimit': '20.40', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.62', 'groupDescription': 'Week 2', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.749', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.22', 'ciLowerLimit': '-15.85', 'ciUpperLimit': '11.40', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.95', 'groupDescription': 'Week 2', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.393', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.28', 'ciLowerLimit': '-9.43', 'ciUpperLimit': '23.98', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.52', 'groupDescription': 'Week 4', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.854', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.51', 'ciLowerLimit': '-14.57', 'ciUpperLimit': '17.59', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.20', 'groupDescription': 'Week 4', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.393', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.28', 'ciLowerLimit': '-9.43', 'ciUpperLimit': '23.98', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.52', 'groupDescription': 'Week 4', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.430', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.16', 'ciLowerLimit': '-10.65', 'ciUpperLimit': '24.97', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.09', 'groupDescription': 'Week 8', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.561', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.24', 'ciLowerLimit': '-12.44', 'ciUpperLimit': '22.92', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.02', 'groupDescription': 'Week 8', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.162', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.93', 'ciLowerLimit': '-5.17', 'ciUpperLimit': '31.04', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.24', 'groupDescription': 'Week 8', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.013', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '22.62', 'ciLowerLimit': '4.76', 'ciUpperLimit': '40.49', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.11', 'groupDescription': 'Week 12', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.038', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.78', 'ciLowerLimit': '1.01', 'ciUpperLimit': '36.55', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.07', 'groupDescription': 'Week 12', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.038', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.78', 'ciLowerLimit': '1.01', 'ciUpperLimit': '36.55', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.07', 'groupDescription': 'Week 12', 'statisticalMethod': 'Normal approximation for two proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, Week 12', 'description': "BASDAI is a validated self-assessment tool used to determine disease activity in participant with Ankylosing Spondylitis. Utilizing a Numerical Rating Scale (NRS) of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions (Q)1-4. This score is then divided by 5. The final BASDAI score range from 0-10. A positive response was defined as a 50% improvement in the BASDAI from baseline.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS - n=number of responders at each visit'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, 8 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib 2 mg BID', 'description': 'Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib 5 mg BID', 'description': 'Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG002', 'title': 'Tofacitinib 10 mg BID', 'description': 'Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG003', 'title': 'Placebo BID', 'description': 'Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '-1.12', 'spread': '0.192', 'groupId': 'OG000'}, {'value': '-1.16', 'spread': '0.191', 'groupId': 'OG001'}, {'value': '-0.86', 'spread': '0.192', 'groupId': 'OG002'}, {'value': '-0.74', 'spread': '0.192', 'groupId': 'OG003'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-1.36', 'spread': '0.210', 'groupId': 'OG000'}, {'value': '-1.61', 'spread': '0.208', 'groupId': 'OG001'}, {'value': '-1.32', 'spread': '0.210', 'groupId': 'OG002'}, {'value': '-1.02', 'spread': '0.210', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-1.61', 'spread': '0.247', 'groupId': 'OG000'}, {'value': '-2.07', 'spread': '0.246', 'groupId': 'OG001'}, {'value': '-1.72', 'spread': '0.249', 'groupId': 'OG002'}, {'value': '-1.38', 'spread': '0.249', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-1.90', 'spread': '0.261', 'groupId': 'OG000'}, {'value': '-2.39', 'spread': '0.260', 'groupId': 'OG001'}, {'value': '-2.24', 'spread': '0.264', 'groupId': 'OG002'}, {'value': '-1.43', 'spread': '0.266', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.164', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.38', 'ciLowerLimit': '-0.92', 'ciUpperLimit': '0.16', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.272', 'groupDescription': 'Week 2', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.129', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.41', 'ciLowerLimit': '-0.95', 'ciUpperLimit': '0.12', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.271', 'groupDescription': 'Week 2', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.660', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.12', 'ciLowerLimit': '-0.66', 'ciUpperLimit': '0.42', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.272', 'groupDescription': 'Week 2', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.256', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.34', 'ciLowerLimit': '-0.92', 'ciUpperLimit': '0.25', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.297', 'groupDescription': 'Week 4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.048', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.59', 'ciLowerLimit': '-1.17', 'ciUpperLimit': '-0.00', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.296', 'groupDescription': 'Week 4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.318', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.30', 'ciLowerLimit': '-0.88', 'ciUpperLimit': '0.29', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.297', 'groupDescription': 'Week 4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.522', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.22', 'ciLowerLimit': '-0.92', 'ciUpperLimit': '0.47', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.350', 'groupDescription': 'Week 8', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.050', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.69', 'ciLowerLimit': '-1.38', 'ciUpperLimit': '0.00', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.350', 'groupDescription': 'Week 8', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.337', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.34', 'ciLowerLimit': '-1.03', 'ciUpperLimit': '0.36', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.352', 'groupDescription': 'Week 8', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.214', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.47', 'ciLowerLimit': '-1.20', 'ciUpperLimit': '0.27', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.373', 'groupDescription': 'Week 12', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.011', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.96', 'ciLowerLimit': '-1.69', 'ciUpperLimit': '-0.22', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.372', 'groupDescription': 'Week 12', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.031', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.81', 'ciLowerLimit': '-1.55', 'ciUpperLimit': '-0.08', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.375', 'groupDescription': 'Week 12', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, Week 12', 'description': 'BASFI is a validated self-assessment tool that determines the degree of physical functional limitation in Ankylosing Spondylitis. Utilizing a Numerical Rating Scale (NRS) of 0-10 (0=easy, 10=impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions with lower scores indicating better physical function. The higher the negative value the better the improvement.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 2, 4, 8 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib 2 mg BID', 'description': 'Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib 5 mg BID', 'description': 'Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG002', 'title': 'Tofacitinib 10 mg BID', 'description': 'Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG003', 'title': 'Placebo BID', 'description': 'Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '-0.09', 'spread': '0.075', 'groupId': 'OG000'}, {'value': '-0.24', 'spread': '0.075', 'groupId': 'OG001'}, {'value': '-0.22', 'spread': '0.075', 'groupId': 'OG002'}, {'value': '-0.09', 'spread': '0.075', 'groupId': 'OG003'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-0.15', 'spread': '0.083', 'groupId': 'OG000'}, {'value': '-0.24', 'spread': '0.083', 'groupId': 'OG001'}, {'value': '-0.26', 'spread': '0.084', 'groupId': 'OG002'}, {'value': '-0.14', 'spread': '0.084', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-0.34', 'spread': '0.095', 'groupId': 'OG000'}, {'value': '-0.40', 'spread': '0.095', 'groupId': 'OG001'}, {'value': '-0.48', 'spread': '0.096', 'groupId': 'OG002'}, {'value': '-0.19', 'spread': '0.096', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-0.33', 'spread': '0.109', 'groupId': 'OG000'}, {'value': '-0.42', 'spread': '0.109', 'groupId': 'OG001'}, {'value': '-0.55', 'spread': '0.111', 'groupId': 'OG002'}, {'value': '-0.16', 'spread': '0.112', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.982', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '-0.21', 'ciUpperLimit': '0.21', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.106', 'groupDescription': 'Week 2', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.151', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.15', 'ciLowerLimit': '-0.36', 'ciUpperLimit': '0.06', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.106', 'groupDescription': 'Week 2', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.205', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.13', 'ciLowerLimit': '-0.34', 'ciUpperLimit': '0.07', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.106', 'groupDescription': 'Week 2', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.898', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.25', 'ciUpperLimit': '0.22', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.118', 'groupDescription': 'Week 4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.370', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.11', 'ciLowerLimit': '-0.34', 'ciUpperLimit': '0.13', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.118', 'groupDescription': 'Week 4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.288', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.13', 'ciLowerLimit': '-0.36', 'ciUpperLimit': '0.11', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.119', 'groupDescription': 'Week 4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.242', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-0.42', 'ciUpperLimit': '0.11', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.135', 'groupDescription': 'Week 8', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.120', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.21', 'ciLowerLimit': '-0.48', 'ciUpperLimit': '0.06', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.135', 'groupDescription': 'Week 8', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.031', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.30', 'ciLowerLimit': '-0.56', 'ciUpperLimit': '-0.03', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.136', 'groupDescription': 'Week 8', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.280', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.17', 'ciLowerLimit': '-0.48', 'ciUpperLimit': '0.14', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.157', 'groupDescription': 'Week 12', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.099', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.26', 'ciLowerLimit': '-0.57', 'ciUpperLimit': '0.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.157', 'groupDescription': 'Week 12', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.014', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.39', 'ciLowerLimit': '-0.70', 'ciUpperLimit': '-0.08', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.158', 'groupDescription': 'Week 12', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, Week 12', 'description': "BASMI is an objective measure of spinal mobility and was completed by a blinded assessor. The BASMI score is composed of 5 clinical measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. The derived score used the average of the 5 assessments on a scale of 0-10 scale with higher scores indicating more impairment of spinal mobility. BASMI was analyzed using the linear function method. The higher the negative value the better the improvement.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Weeks 4, 8 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib 2 mg BID', 'description': 'Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib 5 mg BID', 'description': 'Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG002', 'title': 'Tofacitinib 10 mg BID', 'description': 'Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG003', 'title': 'Placebo BID', 'description': 'Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '-0.16', 'spread': '0.272', 'groupId': 'OG000'}, {'value': '-0.93', 'spread': '0.271', 'groupId': 'OG001'}, {'value': '-0.89', 'spread': '0.274', 'groupId': 'OG002'}, {'value': '-0.11', 'spread': '0.275', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-0.79', 'spread': '0.289', 'groupId': 'OG000'}, {'value': '-1.19', 'spread': '0.289', 'groupId': 'OG001'}, {'value': '-0.97', 'spread': '0.295', 'groupId': 'OG002'}, {'value': '-0.54', 'spread': '0.292', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-0.66', 'spread': '0.259', 'groupId': 'OG000'}, {'value': '-1.37', 'spread': '0.259', 'groupId': 'OG001'}, {'value': '-1.24', 'spread': '0.263', 'groupId': 'OG002'}, {'value': '-0.34', 'spread': '0.265', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.895', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.05', 'ciLowerLimit': '-0.81', 'ciUpperLimit': '0.71', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.387', 'groupDescription': 'Week 4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.033', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.83', 'ciLowerLimit': '-1.59', 'ciUpperLimit': '-0.07', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.386', 'groupDescription': 'Week 4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.044', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.79', 'ciLowerLimit': '-1.55', 'ciUpperLimit': '-0.02', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.388', 'groupDescription': 'Week 4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.530', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.26', 'ciLowerLimit': '-1.07', 'ciUpperLimit': '0.55', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.411', 'groupDescription': 'Week 8', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.114', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.65', 'ciLowerLimit': '-1.46', 'ciUpperLimit': '0.16', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.411', 'groupDescription': 'Week 8', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.297', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.43', 'ciLowerLimit': '-1.25', 'ciUpperLimit': '0.38', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.415', 'groupDescription': 'Week 8', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.377', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.33', 'ciLowerLimit': '-1.06', 'ciUpperLimit': '0.40', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.370', 'groupDescription': 'Week 12', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.006', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.04', 'ciLowerLimit': '-1.77', 'ciUpperLimit': '-0.31', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.370', 'groupDescription': 'Week 12', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.017', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.90', 'ciLowerLimit': '-1.64', 'ciUpperLimit': '-0.17', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.373', 'groupDescription': 'Week 12', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment 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'OG003'}]}]}, {'title': 'UVE: New Condition: Baseline (n=6, 9, 6, 4)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'UVE: Never: Week 4 (n=4, 7, 3, 2)', 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000'}, {'value': '71.4', 'groupId': 'OG001'}, {'value': '66.7', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}]}, {'title': 'UVE: Past But Not Active: Week 4 (n=4, 7, 3, 2)', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}, {'value': '28.6', 'groupId': 'OG001'}, {'value': '33.3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'UVE: Currently Active: Week 4 (n=4, 7, 3, 2)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'UVE: New Condition: Week 4 (n=4, 7, 3, 2)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'UVE: Never: Week 8 (n=2, 6, 2, 4)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}, {'value': '50.0', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}]}, {'title': 'UVE: Past But Not Active: Week 8 (n=2, 6, 2, 4)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}, {'value': '50.0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'UVE: Currenly Active: Week 8 (n=2, 6, 2, 4)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'UVE: New Condition: Week 8 (n=2, 6, 2, 4)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'UVE: Never: Week 12 (n=5, 6, 2, 3)', 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000'}, {'value': '66.7', 'groupId': 'OG001'}, {'value': '50.0', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}]}, {'title': 'UVE: Past But Not Active: Week 12 (n=5, 6, 2, 3)', 'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}, {'value': '50.0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'UVE: Currently Active: Week 12 (n=5, 6, 2, 3)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'UVE: New Condition: Week 12 (n=5, 6, 2, 3)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'UVE: Never: Follow-up (n=3, 6, 4, 2)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}, {'value': '50.0', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}]}, {'title': 'UVE: Past But Not Active: Follow-up (n=3, 6, 4, 2)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}, {'value': '25.0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'UVE: Currently Active: Follow-up (n=3, 6, 4, 2)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '16.7', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'UVE: New Condition: Follow-up (n=3, 6, 4, 2)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '25.0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 12 and Follow-up', 'description': 'Participants were assessed at Baseline, Week 12 and Week 16 (Follow-up) to determine if they had specific Ankylosing Spondylitis medical history or changes in specific Ankylosing Spondylitis medical history which included: Inflammatory Bowel Disease (IBD), Peripheral Articular Involvement (PAI; as assessed by swollen joint count), psoriasis (PSO) and uveitis (UVE).', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS - n=number of participants completing the Specific Medical History Assessment at each visit.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Total Swollen Joint Count at Weeks 2, 4 8 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib 2 mg BID', 'description': 'Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib 5 mg BID', 'description': 'Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG002', 'title': 'Tofacitinib 10 mg BID', 'description': 'Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG003', 'title': 'Placebo BID', 'description': 'Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '-0.53', 'spread': '0.293', 'groupId': 'OG000'}, {'value': '0.23', 'spread': '0.291', 'groupId': 'OG001'}, {'value': '-1.20', 'spread': '0.292', 'groupId': 'OG002'}, {'value': '-0.43', 'spread': '0.293', 'groupId': 'OG003'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-0.87', 'spread': '0.260', 'groupId': 'OG000'}, {'value': '-0.57', 'spread': '0.259', 'groupId': 'OG001'}, {'value': '-1.23', 'spread': '0.260', 'groupId': 'OG002'}, {'value': '-0.86', 'spread': '0.261', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-1.02', 'spread': '0.442', 'groupId': 'OG000'}, {'value': '-0.98', 'spread': '0.442', 'groupId': 'OG001'}, {'value': '-1.28', 'spread': '0.451', 'groupId': 'OG002'}, {'value': '-0.60', 'spread': '0.448', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-0.87', 'spread': '0.362', 'groupId': 'OG000'}, {'value': '-0.79', 'spread': '0.362', 'groupId': 'OG001'}, {'value': '-1.40', 'spread': '0.368', 'groupId': 'OG002'}, {'value': '-0.99', 'spread': '0.373', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.800', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.11', 'ciLowerLimit': '-0.92', 'ciUpperLimit': '0.71', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.414', 'groupDescription': 'Week 2', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.113', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.66', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '1.47', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.413', 'groupDescription': 'Week 2', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.064', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.77', 'ciLowerLimit': '-1.59', 'ciUpperLimit': '0.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.414', 'groupDescription': 'Week 2', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.972', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-0.74', 'ciUpperLimit': '0.71', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.368', 'groupDescription': 'Week 4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.440', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.28', 'ciLowerLimit': '-0.44', 'ciUpperLimit': '1.01', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.368', 'groupDescription': 'Week 4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.311', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.37', 'ciLowerLimit': '-1.10', 'ciUpperLimit': '0.35', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.369', 'groupDescription': 'Week 4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.501', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.42', 'ciLowerLimit': '-1.66', 'ciUpperLimit': '0.82', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.629', 'groupDescription': 'Week 8', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.543', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.38', 'ciLowerLimit': '-1.63', 'ciUpperLimit': '0.86', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.629', 'groupDescription': 'Week 8', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.287', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.68', 'ciLowerLimit': '-1.93', 'ciUpperLimit': '0.57', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.636', 'groupDescription': 'Week 8', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.820', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.12', 'ciLowerLimit': '-0.91', 'ciUpperLimit': '1.14', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.519', 'groupDescription': 'Week 12', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.711', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.19', 'ciLowerLimit': '-0.83', 'ciUpperLimit': '1.22', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.520', 'groupDescription': 'Week 12', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.424', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.42', 'ciLowerLimit': '-1.45', 'ciUpperLimit': '0.61', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.524', 'groupDescription': 'Week 12', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, Week 12', 'description': 'This assessment was performed by the blinded assessor using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints) for determination of the total number of swollen joints. Forty-four joints were assessed for swelling on left and right side and included the following: sternoclaviculars, acromioclaviculars, shoulders, elbows, wrists, metacarpophalangeals (I, II, III, IV, V), thumb interphalangeal, proximal interphalangeals (II, III, IV, V), knees, ankles, and metatarsophalangeals (I, II, III, IV, V). Artificial joints were not assessed. A negative change means improvement.', 'unitOfMeasure': 'Swollen Joints', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Mean Spinal Mobility (Chest Expansion) at Week 2, 4, 8 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib 2 mg BID', 'description': 'Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib 5 mg BID', 'description': 'Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG002', 'title': 'Tofacitinib 10 mg BID', 'description': 'Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG003', 'title': 'Placebo BID', 'description': 'Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '0.30', 'spread': '0.144', 'groupId': 'OG000'}, {'value': '0.35', 'spread': '0.143', 'groupId': 'OG001'}, {'value': '-0.03', 'spread': '0.144', 'groupId': 'OG002'}, {'value': '0.24', 'spread': '0.144', 'groupId': 'OG003'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '0.54', 'spread': '0.164', 'groupId': 'OG000'}, {'value': '0.13', 'spread': '0.162', 'groupId': 'OG001'}, {'value': '0.13', 'spread': '0.164', 'groupId': 'OG002'}, {'value': '0.38', 'spread': '0.165', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '0.52', 'spread': '0.178', 'groupId': 'OG000'}, {'value': '0.35', 'spread': '0.178', 'groupId': 'OG001'}, {'value': '0.15', 'spread': '0.182', 'groupId': 'OG002'}, {'value': '0.13', 'spread': '0.181', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '0.69', 'spread': '0.187', 'groupId': 'OG000'}, {'value': '0.49', 'spread': '0.187', 'groupId': 'OG001'}, {'value': '0.13', 'spread': '0.190', 'groupId': 'OG002'}, {'value': '0.31', 'spread': '0.193', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.785', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.06', 'ciLowerLimit': '-0.34', 'ciUpperLimit': '0.46', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.203', 'groupDescription': 'Week 2', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.605', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.11', 'ciLowerLimit': '-0.30', 'ciUpperLimit': '0.51', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.203', 'groupDescription': 'Week 2', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.175', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.28', 'ciLowerLimit': '-0.68', 'ciUpperLimit': '0.12', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.204', 'groupDescription': 'Week 2', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.482', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.16', 'ciLowerLimit': '-0.29', 'ciUpperLimit': '0.62', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.232', 'groupDescription': 'Week 4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.288', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.25', 'ciLowerLimit': '-0.70', 'ciUpperLimit': '0.21', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.231', 'groupDescription': 'Week 4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.278', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.25', 'ciLowerLimit': '-0.71', 'ciUpperLimit': '0.21', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.233', 'groupDescription': 'Week 4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.134', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.38', 'ciLowerLimit': '-0.12', 'ciUpperLimit': '0.88', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.254', 'groupDescription': 'Week 8', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.397', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.22', 'ciLowerLimit': '-0.29', 'ciUpperLimit': '0.72', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.254', 'groupDescription': 'Week 8', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.964', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.01', 'ciLowerLimit': '-0.50', 'ciUpperLimit': '0.52', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.257', 'groupDescription': 'Week 8', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.155', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.38', 'ciLowerLimit': '-0.15', 'ciUpperLimit': '0.91', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.269', 'groupDescription': 'Week 12', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.491', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.19', 'ciLowerLimit': '-0.34', 'ciUpperLimit': '0.72', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.269', 'groupDescription': 'Week 12', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.515', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.18', 'ciLowerLimit': '-0.71', 'ciUpperLimit': '0.36', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.271', 'groupDescription': 'Week 12', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, Week 12', 'description': 'Chest expansion, measured in centimeters (cm), is defined as the difference in the thoracic circumference during full expiration versus full inspiration. This was measured at the 4th intercostal space. The difference between maximal inspiration and expiration of the two attempts was recorded. The better of the two attempts was used to calculate chest expansion. Missing data at Week 12 were imputed by LOCF if data at an early visit (discontinuation visit) were available.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Short-Form-36 Health Survey (SF-36) Physical and Mental Health Scores at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib 2 mg BID', 'description': 'Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib 5 mg BID', 'description': 'Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG002', 'title': 'Tofacitinib 10 mg BID', 'description': 'Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG003', 'title': 'Placebo BID', 'description': 'Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.'}], 'classes': [{'title': 'Week 12 Physical Health Score', 'categories': [{'measurements': [{'value': '6.34', 'spread': '0.923', 'groupId': 'OG000'}, {'value': '6.49', 'spread': '0.914', 'groupId': 'OG001'}, {'value': '7.05', 'spread': '0.943', 'groupId': 'OG002'}, {'value': '2.69', 'spread': '0.932', 'groupId': 'OG003'}]}]}, {'title': 'Week 12 Mental Health Score', 'categories': [{'measurements': [{'value': '2.08', 'spread': '1.306', 'groupId': 'OG000'}, {'value': '4.15', 'spread': '1.294', 'groupId': 'OG001'}, {'value': '3.71', 'spread': '1.336', 'groupId': 'OG002'}, {'value': '2.41', 'spread': '1.318', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.006', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.65', 'ciLowerLimit': '1.06', 'ciUpperLimit': '6.24', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.312', 'groupDescription': 'Physical Health Score', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.', 'testedNonInferiority': False}, {'pValue': '0.004', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.80', 'ciLowerLimit': '1.23', 'ciUpperLimit': '6.37', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.305', 'groupDescription': 'Physical Health Score', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.', 'testedNonInferiority': False}, {'pValue': '0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.36', 'ciLowerLimit': '1.74', 'ciUpperLimit': '6.98', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.328', 'groupDescription': 'Physical Health Score', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.', 'testedNonInferiority': False}, {'pValue': '0.857', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.34', 'ciLowerLimit': '-4.00', 'ciUpperLimit': '3.33', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.857', 'groupDescription': 'Mental Health Score', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.', 'testedNonInferiority': False}, {'pValue': '0.350', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.73', 'ciLowerLimit': '-1.91', 'ciUpperLimit': '5.37', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.848', 'groupDescription': 'Mental Health Score', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.', 'testedNonInferiority': False}, {'pValue': '0.490', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.30', 'ciLowerLimit': '-2.40', 'ciUpperLimit': '5.00', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.876', 'groupDescription': 'Mental Health Score', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (0=no functioning, 100=highest level of functioning). Missing data at Week 12 were imputed by LOCF if data at an early visit (discontinuation visit) were available.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in EuroQol EQ-5D Health State Profile (EQ-5D) Utility Score at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib 2 mg BID', 'description': 'Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib 5 mg BID', 'description': 'Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG002', 'title': 'Tofacitinib 10 mg BID', 'description': 'Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG003', 'title': 'Placebo BID', 'description': 'Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.17', 'spread': '0.034', 'groupId': 'OG000'}, {'value': '0.16', 'spread': '0.034', 'groupId': 'OG001'}, {'value': '0.22', 'spread': '0.035', 'groupId': 'OG002'}, {'value': '0.10', 'spread': '0.034', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.125', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.07', 'ciLowerLimit': '-0.02', 'ciUpperLimit': '0.17', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.048', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.', 'testedNonInferiority': False}, {'pValue': '0.207', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.06', 'ciLowerLimit': '-0.03', 'ciUpperLimit': '0.16', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.048', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.', 'testedNonInferiority': False}, {'pValue': '0.013', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.12', 'ciLowerLimit': '0.03', 'ciUpperLimit': '0.22', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.049', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of single utility score. Health state profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression; Scale range 1 to 3 (1=better health state \\[no problems\\], 3=worst health state \\[confined to bed\\]).', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Weeks 2, 4, 8 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib 2 mg BID', 'description': 'Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib 5 mg BID', 'description': 'Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG002', 'title': 'Tofacitinib 10 mg BID', 'description': 'Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.'}, {'id': 'OG003', 'title': 'Placebo BID', 'description': 'Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '3.62', 'spread': '0.871', 'groupId': 'OG000'}, {'value': '1.97', 'spread': '0.871', 'groupId': 'OG001'}, {'value': '2.17', 'spread': '0.875', 'groupId': 'OG002'}, {'value': '1.90', 'spread': '0.872', 'groupId': 'OG003'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '4.25', 'spread': '0.931', 'groupId': 'OG000'}, {'value': '3.67', 'spread': '0.927', 'groupId': 'OG001'}, {'value': '2.80', 'spread': '0.937', 'groupId': 'OG002'}, {'value': '2.71', 'spread': '0.938', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '4.54', 'spread': '1.039', 'groupId': 'OG000'}, {'value': '4.81', 'spread': '1.039', 'groupId': 'OG001'}, {'value': '4.19', 'spread': '1.061', 'groupId': 'OG002'}, {'value': '2.85', 'spread': '1.053', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '4.74', 'spread': '1.145', 'groupId': 'OG000'}, {'value': '7.03', 'spread': '1.145', 'groupId': 'OG001'}, {'value': '7.58', 'spread': '1.166', 'groupId': 'OG002'}, {'value': '3.08', 'spread': '1.178', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.163', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.72', 'ciLowerLimit': '-0.71', 'ciUpperLimit': '4.15', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.232', 'groupDescription': 'Week 2', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.955', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.07', 'ciLowerLimit': '-2.36', 'ciUpperLimit': '2.50', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.232', 'groupDescription': 'Week 2', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.826', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.27', 'ciLowerLimit': '-2.17', 'ciUpperLimit': '2.71', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.237', 'groupDescription': 'Week 2', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.246', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.54', 'ciLowerLimit': '-1.07', 'ciUpperLimit': '4.14', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.322', 'groupDescription': 'Week 4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.467', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '-1.64', 'ciUpperLimit': '3.56', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.318', 'groupDescription': 'Week 4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.948', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.09', 'ciLowerLimit': '-2.53', 'ciUpperLimit': '2.70', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.328', 'groupDescription': 'Week 4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.255', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.69', 'ciLowerLimit': '-1.23', 'ciUpperLimit': '4.61', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.479', 'groupDescription': 'Week 8', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.187', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.96', 'ciLowerLimit': '-0.96', 'ciUpperLimit': '4.87', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.479', 'groupDescription': 'Week 8', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.373', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.34', 'ciLowerLimit': '-1.62', 'ciUpperLimit': '4.29', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.497', 'groupDescription': 'Week 8', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.313', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.66', 'ciLowerLimit': '-1.58', 'ciUpperLimit': '4.90', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.643', 'groupDescription': 'Week 12', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.017', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.95', 'ciLowerLimit': '0.71', 'ciUpperLimit': '7.19', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.642', 'groupDescription': 'Week 12', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}, {'pValue': '0.007', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.51', 'ciLowerLimit': '1.23', 'ciUpperLimit': '7.78', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.660', 'groupDescription': 'Week 12', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, Week 12', 'description': "FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tofacitinib 2 mg BID', 'description': 'Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the morning \\[AM\\] and afternoon \\[PM\\]) for a total of 12 weeks.'}, {'id': 'FG001', 'title': 'Tofacitinib 5 mg BID', 'description': 'Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.'}, {'id': 'FG002', 'title': 'Tofacitinib 10 mg BID', 'description': 'Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.'}, {'id': 'FG003', 'title': 'Placebo BID', 'description': 'Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '52'}, {'groupId': 'FG002', 'numSubjects': '52'}, {'groupId': 'FG003', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '51'}, {'groupId': 'FG002', 'numSubjects': '47'}, {'groupId': 'FG003', 'numSubjects': '47'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'In total 208 participants were randomized to double-blind treatment; 52 to each treatment group (tofacitinib 2 milligrams \\[mg\\] twice daily \\[BID\\], tofacitinib 5 mg BID, tofacitinib 10 mg BID, and placebo BID). One participant was randomized to the placebo group but did not receive study drug, as such only 207 participants received study treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}, {'value': '207', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Tofacitinib 2 mg BID', 'description': 'Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.'}, {'id': 'BG001', 'title': 'Tofacitinib 5 mg BID', 'description': 'Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.'}, {'id': 'BG002', 'title': 'Tofacitinib 10 mg BID', 'description': 'Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.'}, {'id': 'BG003', 'title': 'Placebo BID', 'description': 'Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Age', 'categories': [{'measurements': [{'value': '41.8', 'spread': '12.3', 'groupId': 'BG000'}, {'value': '41.2', 'spread': '10.3', 'groupId': 'BG001'}, {'value': '41.6', 'spread': '12.2', 'groupId': 'BG002'}, {'value': '41.9', 'spread': '12.9', 'groupId': 'BG003'}, {'value': '41.6', 'spread': '11.9', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '64', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '143', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety population - included participants who received at least 1 dose of study medication'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 208}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-04', 'studyFirstSubmitDate': '2013-02-06', 'resultsFirstSubmitDate': '2016-03-15', 'studyFirstSubmitQcDate': '2013-02-06', 'lastUpdatePostDateStruct': {'date': '2016-06-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-05-04', 'studyFirstPostDateStruct': {'date': '2013-02-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving 20 Percent (%) Improvement in Assessment of SpondyloArthritis International Society (ASAS) Score (ASAS 20) at Week 12', 'timeFrame': 'Week 12', 'description': "The primary analysis of this outcome measure was performed using the Emax model. Clinical response to treatment was assessed according to ASAS20 criteria. ASAS20 responder had improvement of greater than or equal to (≥) 20% and ≥1 unit in at least 3 domains (on a scale of 0 \\[least\\] to 10 \\[worst\\]) and no worsening of ≥20% and less than or equal to (≤)1 unit in the remaining domain. The domains are: Patient's Global Assessment of Disease Activity, spinal pain, function and inflammation (from Bath Ankylosing Spondylitis Disease Activity Index \\[BASDAI\\]). Missing data were handled by nonresponsive (NRI)/ last observation carried forward (LOCF). Missing values due to a subject dropping out from the study were handled by setting the ASAS20 value to NRI. The LOCF approach was applied to missing components, if just some of the components of the ASAS20 were missing."}, {'measure': 'Percentage of Participants Achieving ASAS20 at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': "The supportive analysis of this outcome measure was performed using the normal approximation for two proportions. Clinical response to treatment was assessed according to ASAS20 criteria. ASAS20 responder had improvement of ≥ 20% and ≥1 unit in at least 3 domains (on a scale of 0 \\[least\\] to 10 \\[worst\\]) and no worsening of ≥20% and ≤1 unit in the remaining domain. The domains are: Patient's Global Assessment of Disease Activity, spinal pain, function and inflammation (from Bath Ankylosing Spondylitis Disease Activity Index \\[BASDAI\\]). Missing data were handled by NRI/LOCF. Missing values due to a subject dropping out from the study were handled by setting the ASAS20 value to NRI. The LOCF approach was applied to missing components, if just some of the components of the ASAS20 were missing."}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving 20% Improvement in ASAS Score at Weeks 2, 4 and 8', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8', 'description': "Clinical response to treatment was assessed according to ASAS20 criteria. ASAS20 responder had improvement of ≥ 20% and ≥1 unit in at least 3 domains (on a scale of 0 \\[least\\] to 10 \\[worst\\]) and no worsening of ≥20% and ≤1 unit in the remaining domain. The domains are: Patient's Global Assessment of Disease Activity, spinal pain, function and inflammation (from Bath Ankylosing Spondylitis Disease Activity Index \\[BASDAI\\]). Missing data were handled by NRI/LOCF. Missing values due to a subject dropping out from the study were handled by setting the ASAS20 value to NRI. The LOCF approach was applied to missing components, if just some of the components of the ASAS20 were missing."}, {'measure': 'Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Index of Disease Activity Score of the Sacroiliac (SI) Joints at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'SPARCC scoring consists of assessing six SI joint MRI image coronal slices representing the largest proportion of the synovial compartment of the SI joints for edema. The maximum score per slice was 2 and 12 for all 6 slices. The total minimum and maximum score for all SI joints across 6 slices is 0 to 72 and higher scores indicate more inflammation. A negative change from baseline indicates improvement. Missing data at Week 12 were imputed by LOCF if data at an early visit (discontinuation visit) were available.'}, {'measure': 'Change From Baseline in SPARCC MRI Index of Disease Activity Score of the Spine at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'SPARCC scoring of the magnetic resonance imaging (MRI) of the spine consists of assessing six disco-vertebral units (DVU) with 3 consecutive sagittal slices at each DVU. The minimum and maximum SPARCC score for all 6 DVUs is 0 to 108, with higher scores indicating more damage. A negative change from baseline indicates improvement. Missing data at Week 12 were imputed by LOCF if data at an early visit (discontinuation visit) were available.'}, {'measure': 'Change From Baseline in Modified Berlin Ankylosing Spondylitis Spine Magnetic Resonance Imaging Activity Score (ASspiMRI) of the Spine at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'Berlin modification of the ASspiMRI is a measure of acute lesion as determined by short-tau inversion recovery (STIR) sequences. All 23 disco-vertebral units (DVU) of the spine (from C2 to S1), defined as the region between 2 virtual lines through the middle of each vertebra, were scored in a single dimension, which is represented the highest level of inflammation in that particular DVU. Total spine ASspiMRI scores can range from 0-69 with higher scores indicating more disease activity. A negative change from baseline indicates improvement. Missing data at Week 12 were imputed by LOCF if data at an early visit (discontinuation visit) were available.'}, {'measure': 'Percentage of Participants Achieving 40% Improvement in ASAS Score at Weeks 2, 4, 8 and 12', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, Week 12', 'description': 'ASAS 40 is defined as ≥40% and absolute change of ≥2 units in at least 3 domains on a 0-10 scale (0=no disease activity, 10=high disease activity), and no worsening in the remaining domain. Missing data were handled by NRI/LOCF.'}, {'measure': 'Percentage of Participants Achieving ASAS5/6 Response at Weeks 2, 4, 8 and 12', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, Week 12', 'description': "ASAS5/6 consists of 6 domains: the 4 used in ASAS20 (Patient's Global Assessment of Disease Activity, spinal pain, function, inflammation plus spinal mobility and an acute phase reactant, C Reactive Protein (CRP). ASAS 5/6 is defined as ≥20% improvement in at least 5 domains and no worsening in the remaining domain. Missing data were handled by NRI/LOCF."}, {'measure': 'Change From Baseline of Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein ASDAS(CRP) at Weeks 2, 4, 8 and 12', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, Week 12', 'description': "The ASDAS(CRP) is a derived score that uses back pain, duration of morning stiffness, Patient's Global Assessment of their disease and peripheral pain/swelling. The formula used for calculating the ASDAS (CRP)is: 0.12 x Back Pain + 0.06 x Duration of Morning Stiffness + 0.11 x Patient Global + 0.07 x Peripheral Pain/Swelling + 0.58 x Ln(CRP+1). The calculated score can be from 0 to no defined upper limit. A negative number indicates a reduction in the score which indicates decrease in disease activity."}, {'measure': 'Percentage of Participants With ASDAS Clinically Important Improvement at Weeks 2, 4, 8 and 12', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, Week 12', 'description': 'The ASDAS clinically important improvement was calculated from the ASDAS data. The ASDAS clinically important improvement is defined as change (decrease) from baseline of ≥1.1 units. Missing data were handled by NRI/LOCF.'}, {'measure': 'Percentage of Participants With ASDAS Major Improvement at Weeks 2, 4, 8 and 12', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, Week 12', 'description': 'The ASDAS major improvement was calculated from the ASDAS data. The ASDAS major improvement was defined as change (decrease) from baseline of ≥2.0 units. Missing data were handled by NRI/LOCF.'}, {'measure': 'Percentage of Participants Achieving ASDAS Inactive Disease at Weeks 2, 4, 8 and 12', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, Week 12', 'description': 'The ASDAS inactive disease was calculated from the ASDAS data. The ASDAS inactive disease was defined as ASDAS \\<1.3 units. Missing data were handled by NRI/LOCF.'}, {'measure': 'Change From Baseline in BASDAI Total Score at Week 2, 4, 8 and 12', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, Week 12', 'description': "BASDAI is a validated self-assessment tool used to determine disease activity in participant with Ankylosing Spondylitis. Utilizing a Numerical Rating Scale (NRS) of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions (Q)1-4. This score is then divided by 5. BASDAI=Q1+Q2+Q3+Q4+\\[Q5+Q6/2\\]/5. The final BASDAI score averages the individual assessments for a final score range of 0-10. Negative values indicate improvement."}, {'measure': 'Percentage of Participants Achieving a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)50 Response at Weeks 2, 4, 8 and 12', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, Week 12', 'description': "BASDAI is a validated self-assessment tool used to determine disease activity in participant with Ankylosing Spondylitis. Utilizing a Numerical Rating Scale (NRS) of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions (Q)1-4. This score is then divided by 5. The final BASDAI score range from 0-10. A positive response was defined as a 50% improvement in the BASDAI from baseline."}, {'measure': 'Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, 8 and 12', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, Week 12', 'description': 'BASFI is a validated self-assessment tool that determines the degree of physical functional limitation in Ankylosing Spondylitis. Utilizing a Numerical Rating Scale (NRS) of 0-10 (0=easy, 10=impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions with lower scores indicating better physical function. The higher the negative value the better the improvement.'}, {'measure': 'Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 2, 4, 8 and 12', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, Week 12', 'description': "BASMI is an objective measure of spinal mobility and was completed by a blinded assessor. The BASMI score is composed of 5 clinical measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. The derived score used the average of the 5 assessments on a scale of 0-10 scale with higher scores indicating more impairment of spinal mobility. BASMI was analyzed using the linear function method. The higher the negative value the better the improvement."}, {'measure': 'Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Weeks 4, 8 and 12', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12', 'description': 'Assessment of enthesitis of 13 sites was performed in the following, 1st costochondral joint left and right, 7th costochondral joint left and right, posterior superior iliac spine left and right, anterior superior iliac spine left and right, iliac crest left and right, 5th lumbar spinous process and proximal insertion of Achilles tendon left and right. Each site was graded for the presence (1) and absence (0) of tenderness yielding total MASES ranging from 0 (no tenderness) to 13 (worst possible score; severe tenderness).'}, {'measure': 'Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History', 'timeFrame': 'Baseline, Week 12 and Follow-up', 'description': 'Participants were assessed at Baseline, Week 12 and Week 16 (Follow-up) to determine if they had specific Ankylosing Spondylitis medical history or changes in specific Ankylosing Spondylitis medical history which included: Inflammatory Bowel Disease (IBD), Peripheral Articular Involvement (PAI; as assessed by swollen joint count), psoriasis (PSO) and uveitis (UVE).'}, {'measure': 'Change From Baseline of Total Swollen Joint Count at Weeks 2, 4 8 and 12', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, Week 12', 'description': 'This assessment was performed by the blinded assessor using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints) for determination of the total number of swollen joints. Forty-four joints were assessed for swelling on left and right side and included the following: sternoclaviculars, acromioclaviculars, shoulders, elbows, wrists, metacarpophalangeals (I, II, III, IV, V), thumb interphalangeal, proximal interphalangeals (II, III, IV, V), knees, ankles, and metatarsophalangeals (I, II, III, IV, V). Artificial joints were not assessed. A negative change means improvement.'}, {'measure': 'Change From Baseline of Mean Spinal Mobility (Chest Expansion) at Week 2, 4, 8 and 12', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, Week 12', 'description': 'Chest expansion, measured in centimeters (cm), is defined as the difference in the thoracic circumference during full expiration versus full inspiration. This was measured at the 4th intercostal space. The difference between maximal inspiration and expiration of the two attempts was recorded. The better of the two attempts was used to calculate chest expansion. Missing data at Week 12 were imputed by LOCF if data at an early visit (discontinuation visit) were available.'}, {'measure': 'Change From Baseline to Week 12 in Short-Form-36 Health Survey (SF-36) Physical and Mental Health Scores at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (0=no functioning, 100=highest level of functioning). Missing data at Week 12 were imputed by LOCF if data at an early visit (discontinuation visit) were available.'}, {'measure': 'Change From Baseline in EuroQol EQ-5D Health State Profile (EQ-5D) Utility Score at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of single utility score. Health state profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression; Scale range 1 to 3 (1=better health state \\[no problems\\], 3=worst health state \\[confined to bed\\]).'}, {'measure': 'Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Weeks 2, 4, 8 and 12', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, Week 12', 'description': "FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score)."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ankylosing Spondylitis', 'Spondylitis', 'Ankylosing', 'Spondyloarthritis', 'Spondyloarthropathy', 'Oral preparation'], 'conditions': ['Ankylosing Spondylitis']}, 'referencesModule': {'references': [{'pmid': '39695887', 'type': 'DERIVED', 'citation': 'Deodhar A, Akar S, Curtis JR, El-Zorkany B, Magrey M, Wang C, Wu J, Makgoeng SB, Vranic I, Menon S, Fleishaker DL, Diehl AM, Fallon L, Yndestad A, Landewe RBM. Integrated safety analysis of tofacitinib from Phase 2 and 3 trials of patients with ankylosing spondylitis. Adv Rheumatol. 2024 Dec 18;64(1):87. doi: 10.1186/s42358-024-00402-x.'}, {'pmid': '39636343', 'type': 'DERIVED', 'citation': 'Norton H, Sliwinska-Stanczyk P, Hala T, El-Zorkany B, Stockert L, Mundayat R, Wang L, Ritchlin CT. Tofacitinib Efficacy/Safety in Patients with Ankylosing Spondylitis by Baseline Body Mass Index: A Post Hoc Analysis of Phase 2/3 Trials. Rheumatol Ther. 2025 Feb;12(1):67-84. doi: 10.1007/s40744-024-00726-6. Epub 2024 Dec 5.'}, {'pmid': '38825359', 'type': 'DERIVED', 'citation': 'Deodhar A, Baraliakos X, Magrey M, Gensler LS, Thorat AV, Pemmaraju SK, Cadatal MJ, Nash P. Efficacy and Safety of Tofacitinib in Ankylosing Spondylitis by Baseline C-Reactive Protein Level: Post Hoc Analysis of Phase II and Phase III Clinical Trials. J Rheumatol. 2024 Aug 1;51(8):772-780. doi: 10.3899/jrheum.2023-1198.'}, {'pmid': '38696034', 'type': 'DERIVED', 'citation': 'Kristensen LE, Deodhar A, Leung YY, Vranic I, Mortezavi M, Fallon L, Yndestad A, Kinch CD, Gladman DD. Risk Stratification of Patients with Psoriatic Arthritis and Ankylosing Spondylitis for Treatment with Tofacitinib: A Review of Current Clinical Data. Rheumatol Ther. 2024 Jun;11(3):487-499. doi: 10.1007/s40744-024-00662-5. Epub 2024 May 2.'}, {'pmid': '37909386', 'type': 'DERIVED', 'citation': 'Magrey M, Wei JC, Yndestad A, Bushmakin AG, Cappelleri JC, Dina O, Deodhar A. Relationships of Work Productivity and Activity Impairment With Patient-Reported Outcomes in Ankylosing Spondylitis: Results From Two Trials. Arthritis Care Res (Hoboken). 2024 Mar;76(3):359-365. doi: 10.1002/acr.25267. Epub 2024 Jan 5.'}, {'pmid': '37331992', 'type': 'DERIVED', 'citation': 'Ostergaard M, Wu J, Fallon L, Sherlock SP, Wang C, Fleishaker D, Kanik KS, Maksymowych WP. Tofacitinib Reduces Spinal Inflammation in Vertebral Bodies and Posterolateral Elements in Ankylosing Spondylitis: Results from a Phase 2 Trial. Rheumatol Ther. 2023 Aug;10(4):1001-1020. doi: 10.1007/s40744-023-00564-y. Epub 2023 Jun 18.'}, {'pmid': '36138330', 'type': 'DERIVED', 'citation': 'Cella D, Lenderking WR, Chongpinitchai P, Bushmakin AG, Dina O, Wang L, Cappelleri JC, Navarro-Compan V. Functional Assessment of Chronic Illness Therapy-Fatigue is a reliable and valid measure in patients with active ankylosing spondylitis. J Patient Rep Outcomes. 2022 Sep 23;6(1):100. doi: 10.1186/s41687-022-00508-0.'}, {'pmid': '28130206', 'type': 'DERIVED', 'citation': 'van der Heijde D, Deodhar A, Wei JC, Drescher E, Fleishaker D, Hendrikx T, Li D, Menon S, Kanik KS. Tofacitinib in patients with ankylosing spondylitis: a phase II, 16-week, randomised, placebo-controlled, dose-ranging study. Ann Rheum Dis. 2017 Aug;76(8):1340-1347. doi: 10.1136/annrheumdis-2016-210322. Epub 2017 Jan 27.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921119&StudyName=Dose-Ranging%20Study%20Of%20Tofacitinib%20In%20Adults%20With%20Active%20Ankylosing%20Spondylitis', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This is the first study of oral tofacitinib in adults with active ankylosing spondylitis. It is designed to obtain information on the efficacy and safety of 3 different doses of tofacitinib.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documented diagnosis of Ankylosing Spondylitis\n* Has active disease despite concurrent nonsteroidal anti-inflammatory drugs (NSAIDs) treatment or is intolerant to NSAIDs\n\nExclusion Criteria:\n\n* Pregnant or lactating females\n* Currently receiving or previous use of a Tumor Necrosis Factor (TNF) inhibitor or any biological agent'}, 'identificationModule': {'nctId': 'NCT01786668', 'briefTitle': 'Dose-Ranging Study Of Tofacitinib In Adults With Active Ankylosing Spondylitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study Of The Efficacy And Safety Of Tofacitinib In Subjects With Active Ankylosing Spondylitis (as)', 'orgStudyIdInfo': {'id': 'A3921119'}, 'secondaryIdInfos': [{'id': '2011-005689-39', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tofacitinib 2 mg', 'interventionNames': ['Drug: Tofacitinib 2 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Tofacitinib 5 mg', 'interventionNames': ['Drug: Tofacitinib 5 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Tofacitinib 10 mg', 'interventionNames': ['Drug: Tofacitinib 10 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Tofacitinib 2 mg', 'type': 'DRUG', 'description': '4 blinded tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) will be administered orally twice a day (in the AM and PM) for 12 weeks', 'armGroupLabels': ['Tofacitinib 2 mg']}, {'name': 'Tofacitinib 5 mg', 'type': 'DRUG', 'description': '4 blinded tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 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