Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2026-02-23 @ 7:48 AM
Study NCT ID:
NCT01808118
Status:
COMPLETED
Last Update Posted:
2018-05-30
First Post:
2013-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Continuing Versus Withdrawing Adalimumab in Maintaining Remission in Non-Radiographic Axial Spondyloarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia', 'Belgium', 'Brazil', 'Canada', 'Czechia', 'Denmark', 'Finland', 'France', 'Germany', 'Ireland', 'Italy', 'Mexico', 'Netherlands', 'New Zealand', 'Norway', 'Poland', 'Russia', 'Slovakia', 'South Korea', 'Spain', 'Sweden', 'Switzerland', 'United Kingdom', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000089183', 'term': 'Axial Spondyloarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D013167', 'term': 'Spondylitis, Ankylosing'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}], 'ancestors': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D000844', 'term': 'Ankylosis'}, {'id': 'D001850', 'term': 'Bone Diseases, Infectious'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068879', 'term': 'Adalimumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'abbvieclinicaltrials@abbvie.com', 'phone': '800-633-9110', 'title': 'Global Medical Services', 'organization': 'AbbVie'}, 'certainAgreement': {'otherDetails': 'AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 90 weeks).', 'description': 'TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.', 'eventGroups': [{'id': 'EG000', 'title': 'Open-label (OL) Adalimumab (Period 1), Full Analysis Set', 'description': '40 mg every other week (eow), Weeks 0-28. The Full Analysis Set included all participants who enrolled in the open-label period (Period 1) and received at least 1 dose of adalimumab.', 'otherNumAtRisk': 673, 'deathsNumAtRisk': 673, 'otherNumAffected': 221, 'seriousNumAtRisk': 673, 'deathsNumAffected': 0, 'seriousNumAffected': 19}, {'id': 'EG001', 'title': 'Placebo (Period 2)', 'description': 'Placebo every other week (eow), Weeks 28-68. Placebo was discontinued in participants who met the criteria for flare.', 'otherNumAtRisk': 153, 'deathsNumAtRisk': 153, 'otherNumAffected': 51, 'seriousNumAtRisk': 153, 'deathsNumAffected': 0, 'seriousNumAffected': 10}, {'id': 'EG002', 'title': 'Double-blind Adalimumab (Period 2)', 'description': 'Adalimumab 40 mg every other week (eow), Weeks 28-68. 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'numAffected': 117}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 673, 'numEvents': 70, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 25, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 673, 'numEvents': 114, 'numAffected': 80}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 673, 'numEvents': 39, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 673, 'numEvents': 48, 'numAffected': 42}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 673, 'numEvents': 50, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 673, 'numEvents': 62, 'numAffected': 54}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'AXIAL SPONDYLOARTHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 673, 'numEvents': 38, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 23, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 15, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 673, 'numEvents': 65, 'numAffected': 57}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}], 'seriousEvents': [{'term': 'VENTRICULAR FIBRILLATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 673, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 673, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'ILEUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 673, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 673, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'APPENDICITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 673, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 673, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'ATYPICAL PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 673, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 673, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'SEPSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 673, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 673, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'CLAVICLE FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 673, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 673, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'PROCEDURAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 673, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 673, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'BURSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 673, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 673, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'UTERINE LEIOMYOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 673, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 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'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'MYOCARDIAL ISCHAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 673, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 673, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'SINUS TACHYCARDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 673, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 673, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 673, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 673, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'CHOLECYSTITIS ACUTE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 673, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 673, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'PNEUMONIA', 'stats': 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'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 673, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 673, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'URETEROLITHIASIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 673, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 673, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'SUBCUTANEOUS ABSCESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 673, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 673, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'THYROID ADENOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 673, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 673, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'PULMONARY MASS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 673, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 673, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 673, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 673, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Did Not Experience a Flare During Period 2 by Week 68', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Period 2)', 'description': 'Placebo every other week (eow), Weeks 28-68. Placebo was discontinued in participants who met the criteria for flare.'}, {'id': 'OG001', 'title': 'Double-blind Adalimumab (Period 2)', 'description': 'Adalimumab 40 mg every other week (eow), Weeks 28-68. Blinded adalimumab was discontinued in participants who met the criteria for flare.'}], 'classes': [{'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': "2-sided Pearson's chi-square test", 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Week 28 through 68', 'description': 'The Ankylosing Spondylitis Disease Activity Score (ASDAS) tool is a self-administered questionnaire/objective laboratory evaluation. The questionnaire assesses disease activity, back pain, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and duration of morning stiffness on a numeric rating scale (from 0 to 10, with 0 being none and 10 representing a duration of ≥2 hours). The laboratory parameter is a measurement of high-sensitivity C-reactive protein (mg/L) (hs-CRP). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and hs-CRP) are combined to yield a score (0 to no defined upper limit). During Period 2 participants visited study sites at Weeks 28, 32, 36, 40, 44, 48, 52, 56, 60, 64 and 68 or if they discontinued early from the study. A flare was defined as having any 2 consecutive study visits with ASDAS ≥ 2.100.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-treat population: all participants who were randomized into double-blind Period 2 and received at least 1 dose of double-blind study medication; participants with missing data were inputed as nonresponders.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) Inactive Disease at 12 Weeks After Initiation of Rescue Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Period 2)', 'description': 'Placebo participants who flared during week 28-68 and received open-label adalimumab 40 mg every other week during the rescue period.'}, {'id': 'OG001', 'title': 'Double-blind Adalimumab (Period 2)', 'description': 'Double-blind adalimumab participants who flared during week 28-68 and received open-label adalimumab 40 mg every other week during the rescue period.'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Rescue Therapy Week 12', 'description': 'The Ankylosing Spondylitis Disease Activity Score (ASDAS) tool is a self-administered questionnaire/objective laboratory evaluation. The questionnaire assesses disease activity, back pain, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and duration of morning stiffness on a numeric rating scale (from 0 to 10, with 0 being none and 10 representing a duration of ≥2 hours). The laboratory parameter is a measurement of high-sensitivity C-reactive protein (mg/L) (hs-CRP). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and hs-CRP) are combined to yield a score (0 to no defined upper limit). ASDAS Inactive Disease is defined as a score of \\<1.300.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Rescued Population: participants with available data who received open-label rescue treatment after the double-blind period'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving ASDAS Major Improvement at 12 Weeks After Initiation of Rescue Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Period 2)', 'description': 'Placebo participants who flared during week 28-68 and received open-label adalimumab 40 mg every other week during the rescue period.'}, {'id': 'OG001', 'title': 'Double-blind Adalimumab (Period 2)', 'description': 'Double-blind adalimumab participants who flared during week 28-68 and received open-label adalimumab 40 mg every other week during the rescue period.'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and Rescue Therapy Week 12', 'description': 'The Ankylosing Spondylitis Disease Activity Score (ASDAS) tool is a self-administered questionnaire/objective laboratory evaluation. The questionnaire assesses disease activity, back pain, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and duration of morning stiffness on a numeric rating scale (from 0 to 10, with 0 being none and 10 representing a duration of ≥2 hours). The laboratory parameter is a measurement of high-sensitivity C-reactive protein (mg/L) (hs-CRP). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and hs-CRP) are combined to yield a score (0 to no defined upper limit). ASDAS Major Improvement is defined as a change from baseline ≤ -2.000.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Rescued Population: participants with available data who received open-label rescue treatment after the double-blind period'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving ASDAS Clinically Important Improvement at 12 Weeks After Initiation of Rescue Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Period 2)', 'description': 'Placebo participants who flared during week 28-68 and received open-label adalimumab 40 mg every other week during the rescue period.'}, {'id': 'OG001', 'title': 'Double-blind Adalimumab (Period 2)', 'description': 'Double-blind adalimumab participants who flared during week 28-68 and received open-label adalimumab 40 mg every other week during the rescue period.'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and Rescue Therapy Week 12', 'description': 'The Ankylosing Spondylitis Disease Activity Score (ASDAS) tool is a self-administered questionnaire/objective laboratory evaluation. The questionnaire assesses disease activity, back pain, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and duration of morning stiffness on a numeric rating scale (from 0 to 10, with 0 being none and 10 representing a duration of ≥2 hours). The laboratory parameter is a measurement of high-sensitivity C-reactive protein (mg/L) (hs-CRP). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and hs-CRP) are combined to yield a score (0 to no defined upper limit). ASDAS Clinically Important Improvement is defined as a change from baseline ≤ -1.100.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Rescued Population: participants with available data who received open-label rescue treatment after the double-blind period'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 20 Response at 12 Weeks After Initiation of Rescue Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Period 2)', 'description': 'Placebo participants who flared during week 28-68 and received open-label adalimumab 40 mg every other week during the rescue period.'}, {'id': 'OG001', 'title': 'Double-blind Adalimumab (Period 2)', 'description': 'Double-blind adalimumab participants who flared during week 28-68 and received open-label adalimumab 40 mg every other week during the rescue period.'}], 'classes': [{'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and Rescue Therapy Week 12', 'description': "ASAS20 response was defined as improvement of ≥ 20% relative to baseline and absolute improvement of ≥ 1 unit (on a scale from 0 to 10) in ≥ 3 of the following 4 domains with no deterioration (defined as a worsening of ≥ 20% and a net worsening of ≥ 1 unit) in the potential remaining domain:\n\n* Patient's Global Assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (none) to 10 (severe);\n* Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe);\n* Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);\n* Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 \\[level of stiffness\\] and 6 \\[duration of stiffness\\]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).", 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Rescued Population: participants with available data who received open-label rescue treatment after the double-blind period'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 40 Response at 12 Weeks After Initiation of Rescue Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Period 2)', 'description': 'Placebo participants who flared during week 28-68 and received open-label adalimumab 40 mg every other week during the rescue period.'}, {'id': 'OG001', 'title': 'Double-blind Adalimumab (Period 2)', 'description': 'Double-blind adalimumab participants who flared during week 28-68 and received open-label adalimumab 40 mg every other week during the rescue period.'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and Rescue Therapy Week 12', 'description': "ASAS40 response was defined as improvement of ≥ 40% relative to baseline and absolute improvement of ≥ 2 units (on a scale from 0 to 10) in ≥ 3 of the following 4 domains with no deterioration in the potential remaining domain:\n\n* Patient's Global Assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (none) to 10 (severe);\n* Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe);\n* Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);\n* Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 \\[level of stiffness\\] and 6 \\[duration of stiffness\\]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).", 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Rescued Population: participants with available data who received open-label rescue treatment after the double-blind period'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving an ASAS 5/6 Response at 12 Weeks After Initiation of Rescue Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Period 2)', 'description': 'Placebo participants who flared during week 28-68 and received open-label adalimumab 40 mg every other week during the rescue period.'}, {'id': 'OG001', 'title': 'Double-blind Adalimumab (Period 2)', 'description': 'Double-blind adalimumab participants who flared during week 28-68 and received open-label adalimumab 40 mg every other week during the rescue period.'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and Rescue Therapy Week 12', 'description': "An Assessment of Spondyloarthritis International Society (ASAS) 5/6 response is a 20% improvement in 5 out of the following 6 domains:\n\n* Patient's Global Assessment of disease activity, on a numeric rating scale (NRS) from 0 (none) to 10 (severe);\n* Pain, measured by total back pain NRS from 0 (no pain) to 10 (most severe);\n* Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which assesses participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);\n* Inflammation: the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 \\[level of stiffness\\] and 6 \\[duration of stiffness\\]) each on a scale from 0 (none) to 10 (very severe/2 hrs or more duration);\n* Spinal mobility: the lateral lumbar flexion score of the Bath AS Metrology Index (BASMI) on a scale from 0 (best mobility) to 10 (worst mobility);\n* High-sensitivity C-reactive protein level (lower levels = less inflammation).", 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Rescued Population: participants with available data who received open-label rescue treatment after the double-blind period'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving ASAS Partial Remission at 12 Weeks After Initiation of Rescue Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Period 2)', 'description': 'Placebo participants who flared during week 28-68 and received open-label adalimumab 40 mg every other week during the rescue period.'}, {'id': 'OG001', 'title': 'Double-blind Adalimumab (Period 2)', 'description': 'Double-blind adalimumab participants who flared during week 28-68 and received open-label adalimumab 40 mg every other week during the rescue period.'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Rescue Therapy Week 12', 'description': "Assessment in SpondyloArthritis International Society (ASAS) partial remission is defined as an absolute score of \\< 2 units on a 0 to 10 scale for each of the four following domains:\n\n* Patient's Global Assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (none) to 10 (severe);\n* Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe);\n* Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);\n* Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 \\[level of stiffness\\] and 6 \\[duration of stiffness\\]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).", 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Rescued Population: participants with available data who received open-label rescue treatment after the double-blind period'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response at 12 Weeks After Initiation of Rescue Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Period 2)', 'description': 'Placebo participants who flared during week 28-68 and received open-label adalimumab 40 mg every other week during the rescue period.'}, {'id': 'OG001', 'title': 'Double-blind Adalimumab (Period 2)', 'description': 'Placebo participants who flared during week 28-68 and received open-label adalimumab 40 mg every other week during the rescue period.'}], 'classes': [{'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and Rescue Therapy Week 12', 'description': 'The Bath Ankylosing Spondylitis (AS) Disease Activity Index assesses disease activity by asking the participant to answer 6 questions (each on a 10 point numeric rating scale \\[NRS\\]) pertaining to symptoms experienced for the past week. For 5 questions (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (≥ 2 hours). The overall BASDAI score ranges from 0 to 10. Lower scores indicate less disease activity. BASDAI50 is a 50% improvement from baseline in BASDAI score.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Rescued Population: participants with available data who received open-label rescue treatment after the double-blind period'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Disability Index of Health Assessment Questionnaire Modified for the Spondyloarthropathies (HAQ-S) at 12 Weeks After Initiation of Rescue Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Period 2)', 'description': 'Placebo participants who flared during week 28-68 and received open-label adalimumab 40 mg every other week during the rescue period.'}, {'id': 'OG001', 'title': 'Double-blind Adalimumab (Period 2)', 'description': 'Double-blind adalimumab participants who flared during week 28-68 and received open-label adalimumab 40 mg every other week during the rescue period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.60', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Rescue Therapy Week 12', 'description': "Health Assessment Questionnaire modified for spondyloarthropathies (HAQ-S) is a self-reported measure to assess the physical function and health-related quality of life. The Disability Index (DI) of HAQ-S is calculated as the mean of the following 8 category scores (range: 0 \\[without any difficulty\\] to 3 \\[unable to do\\]): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Five additional items in the functional status measure were included in the HAQ-S, including carrying heavy packages, sitting for long periods, able to work at a flat topped table, and (if the participant had a driver's license or a car) able to look in the rear view mirror and able to turn head to drive in reverse. The overall score ranges from 0 (no disability) to 3 (very severe, high-dependency disability). Negative mean changes from baseline in the overall score indicate improvement.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Rescued Population: participants with available data who received open-label rescue treatment after the double-blind period'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) Inactive Disease at Weeks 28 and 68', 'denoms': [{'units': 'Participants', 'counts': [{'value': '673', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-label (OL) Adalimumab (Period 1)', 'description': '40 mg every other week (eow), Weeks 0-28.'}, {'id': 'OG001', 'title': 'Placebo (Period 2)', 'description': 'Placebo every other week (eow), Weeks 28-68. Placebo was discontinued in participants who met the criteria for flare.'}, {'id': 'OG002', 'title': 'Double-blind Adalimumab (Period 2)', 'description': 'Adalimumab 40 mg every other week (eow), Weeks 28-68. Blinded adalimumab was discontinued in participants who met the criteria for flare.'}], 'classes': [{'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '295', 'groupId': 'OG000'}]}]}, {'title': 'Week 68', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Weeks 28 and 68', 'description': 'The Ankylosing Spondylitis Disease Activity Score (ASDAS) tool is a self-administered questionnaire/objective laboratory evaluation. The questionnaire assesses disease activity, back pain, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and duration of morning stiffness on a numeric rating scale (from 0 to 10, with 0 being none and 10 representing a duration of ≥2 hours). The laboratory parameter is a measurement of high-sensitivity C-reactive protein (mg/L) (hs-CRP). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and hs-CRP) are combined to yield a score (0 to no defined upper limit). ASDAS Inactive Disease is defined as a score of \\<1.300.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Period 1 (all enrolled participants who received at least 1 dose of adalimumab); Period 2 (mITT: all randomized participants who received at least 1 dose of double-blind study medication); participants with missing data were inputed as nonresponders.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving ASDAS Major Improvement at Weeks 28 and 68', 'denoms': [{'units': 'Participants', 'counts': [{'value': '673', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-label (OL) Adalimumab (Period 1)', 'description': '40 mg every other week (eow), Weeks 0-28.'}, {'id': 'OG001', 'title': 'Placebo (Period 2)', 'description': 'Placebo every other week (eow), Weeks 28-68. Placebo was discontinued in participants who met the criteria for flare.'}, {'id': 'OG002', 'title': 'Double-blind Adalimumab (Period 2)', 'description': 'Adalimumab 40 mg every other week (eow), Weeks 28-68. Blinded adalimumab was discontinued in participants who met the criteria for flare.'}], 'classes': [{'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '266', 'groupId': 'OG000'}]}]}, {'title': 'Week 68', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Weeks 28 and 68', 'description': 'The Ankylosing Spondylitis Disease Activity Score (ASDAS) tool is a self-administered questionnaire/objective laboratory evaluation. The questionnaire assesses disease activity, back pain, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and duration of morning stiffness on a numeric rating scale (from 0 to 10, with 0 being none and 10 representing a duration of ≥2 hours). The laboratory parameter is a measurement of high-sensitivity C-reactive protein (mg/L) (hs-CRP). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and hs-CRP) are combined to yield a score (0 to no defined upper limit). ASDAS Major Improvement is defined as a change from baseline ≤ -2.000.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Period 1 (all enrolled participants who received at least 1 dose of adalimumab); Period 2 (mITT: all randomized participants who received at least 1 dose of double-blind study medication); participants with missing data were inputed as nonresponders.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving ASDAS Clinically Important Improvement at Weeks 28 and 68', 'denoms': [{'units': 'Participants', 'counts': [{'value': '673', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-label (OL) Adalimumab (Period 1)', 'description': '40 mg every other week (eow), Weeks 0-28.'}, {'id': 'OG001', 'title': 'Placebo (Period 2)', 'description': 'Placebo every other week (eow), Weeks 28-68. Placebo was discontinued in participants who met the criteria for flare.'}, {'id': 'OG002', 'title': 'Double-blind Adalimumab (Period 2)', 'description': 'Adalimumab 40 mg every other week (eow), Weeks 28-68. Blinded adalimumab was discontinued in participants who met the criteria for flare.'}], 'classes': [{'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '316', 'groupId': 'OG000'}]}]}, {'title': 'Week 68', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Weeks 28 and 68', 'description': 'The Ankylosing Spondylitis Disease Activity Score (ASDAS) tool is a self-administered questionnaire/objective laboratory evaluation. The questionnaire assesses disease activity, back pain, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and duration of morning stiffness on a numeric rating scale (from 0 to 10, with 0 being none and 10 representing a duration of ≥2 hours). The laboratory parameter is a measurement of high-sensitivity C-reactive protein (mg/L) (hs-CRP). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and hs-CRP) are combined to yield a score (0 to no defined upper limit). ASDAS Clinically Important Improvement is defined as a change from baseline ≤ -1.100.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Period 1 (all enrolled participants who received at least 1 dose of adalimumab); Period 2 (mITT: all randomized participants who received at least 1 dose of double-blind study medication); participants with missing data were inputed as nonresponders.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 20 Response at Weeks 28 and 68', 'denoms': [{'units': 'Participants', 'counts': [{'value': '673', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-label (OL) Adalimumab (Period 1)', 'description': '40 mg every other week (eow), Weeks 0-28.'}, {'id': 'OG001', 'title': 'Placebo (Period 2)', 'description': 'Placebo every other week (eow), Weeks 28-68. Placebo was discontinued in participants who met the criteria for flare.'}, {'id': 'OG002', 'title': 'Double-blind Adalimumab (Period 2)', 'description': 'Adalimumab 40 mg every other week (eow), Weeks 28-68. Blinded adalimumab was discontinued in participants who met the criteria for flare.'}], 'classes': [{'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '324', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '315', 'groupId': 'OG000'}]}]}, {'title': 'Week 68', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Weeks 28 and 68', 'description': "ASAS20 response was defined as improvement of ≥ 20% relative to baseline and absolute improvement of ≥ 1 unit (on a scale from 0 to 10) in ≥ 3 of the following 4 domains with no deterioration (defined as a worsening of ≥ 20% and a net worsening of ≥ 1 unit) in the potential remaining domain:\n\n* Patient's Global Assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (none) to 10 (severe);\n* Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe);\n* Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);\n* Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 \\[level of stiffness\\] and 6 \\[duration of stiffness\\]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).", 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Period 1 (all enrolled participants who received at least 1 dose of adalimumab); Period 2 (mITT: all randomized participants who received at least 1 dose of double-blind study medication); participants with missing data were inputed as nonresponders.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 40 Response at Weeks 28 and 68', 'denoms': [{'units': 'Participants', 'counts': [{'value': '673', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-label (OL) Adalimumab (Period 1)', 'description': '40 mg every other week (eow), Weeks 0-28.'}, {'id': 'OG001', 'title': 'Placebo (Period 2)', 'description': 'Placebo every other week (eow), Weeks 28-68. Placebo was discontinued in participants who met the criteria for flare.'}, {'id': 'OG002', 'title': 'Double-blind Adalimumab (Period 2)', 'description': 'Adalimumab 40 mg every other week (eow), Weeks 28-68. Blinded adalimumab was discontinued in participants who met the criteria for flare.'}], 'classes': [{'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '324', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '302', 'groupId': 'OG000'}]}]}, {'title': 'Week 68', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Weeks 28 and 68', 'description': "ASAS40 response was defined as improvement of ≥ 40% relative to baseline and absolute improvement of ≥ 2 units (on a scale from 0 to 10) in ≥ 3 of the following 4 domains with no deterioration in the potential remaining domain:\n\n* Patient's Global Assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (none) to 10 (severe);\n* Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe);\n* Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);\n* Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 \\[level of stiffness\\] and 6 \\[duration of stiffness\\]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).", 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Period 1 (all enrolled participants who received at least 1 dose of adalimumab); Period 2 (mITT: all randomized participants who received at least 1 dose of double-blind study medication); participants with missing data were inputed as nonresponders.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving an ASAS 5/6 Response at Weeks 28 and 68', 'denoms': [{'units': 'Participants', 'counts': [{'value': '673', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-label (OL) Adalimumab (Period 1)', 'description': '40 mg every other week (eow), Weeks 0-28.'}, {'id': 'OG001', 'title': 'Placebo (Period 2)', 'description': 'Placebo every other week (eow), Weeks 28-68. Placebo was discontinued in participants who met the criteria for flare.'}, {'id': 'OG002', 'title': 'Double-blind Adalimumab (Period 2)', 'description': 'Adalimumab 40 mg every other week (eow), Weeks 28-68. Blinded adalimumab was discontinued in participants who met the criteria for flare.'}], 'classes': [{'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '324', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '253', 'groupId': 'OG000'}]}]}, {'title': 'Week 68', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Weeks 28 and 68', 'description': "An Assessment of Spondyloarthritis International Society (ASAS) 5/6 response is a 20% improvement in 5 out of the following 6 domains:\n\n* Patient's Global Assessment of disease activity, on a numeric rating scale (NRS) from 0 (none) to 10 (severe);\n* Pain, measured by total back pain NRS from 0 (no pain) to 10 (most severe);\n* Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which assesses participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);\n* Inflammation: the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 \\[level of stiffness\\] and 6 \\[duration of stiffness\\]) each on a scale from 0 (none) to 10 (very severe/2 hrs or more duration);\n* Spinal mobility: the lateral lumbar flexion score of the Bath AS Metrology Index (BASMI) on a scale from 0 (best mobility) to 10 (worst mobility);\n* High-sensitivity C-reactive protein level (lower levels = less inflammation).", 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Period 1 (all enrolled participants who received at least 1 dose of adalimumab); Period 2 (mITT: all randomized participants who received at least 1 dose of double-blind study medication); participants with missing data were inputed as nonresponders.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving ASAS Partial Remission at Weeks 28 and 68', 'denoms': [{'units': 'Participants', 'counts': [{'value': '673', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-label (OL) Adalimumab (Period 1)', 'description': '40 mg every other week (eow), Weeks 0-28.'}, {'id': 'OG001', 'title': 'Placebo (Period 2)', 'description': 'Placebo every other week (eow), Weeks 28-68. Placebo was discontinued in participants who met the criteria for flare.'}, {'id': 'OG002', 'title': 'Double-blind Adalimumab (Period 2)', 'description': 'Adalimumab 40 mg every other week (eow), Weeks 28-68. Blinded adalimumab was discontinued in participants who met the criteria for flare.'}], 'classes': [{'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '324', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '224', 'groupId': 'OG000'}]}]}, {'title': 'Week 68', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Weeks 28 and 68', 'description': "Assessment in SpondyloArthritis International Society (ASAS) partial remission is defined as an absolute score of \\< 2 units on a 0 to 10 scale for each of the four following domains:\n\n* Patient's Global Assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (none) to 10 (severe);\n* Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe);\n* Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);\n* Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 \\[level of stiffness\\] and 6 \\[duration of stiffness\\]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).", 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Period 1 (all enrolled participants who received at least 1 dose of adalimumab); Period 2 (mITT: all randomized participants who received at least 1 dose of double-blind study medication); participants with missing data were inputed as nonresponders.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response at Weeks 28 and 68', 'denoms': [{'units': 'Participants', 'counts': [{'value': '673', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-label (OL) Adalimumab (Period 1)', 'description': '40 mg every other week (eow), Weeks 0-28.'}, {'id': 'OG001', 'title': 'Placebo (Period 2)', 'description': 'Placebo every other week (eow), Weeks 28-68. Placebo was discontinued in participants who met the criteria for flare.'}, {'id': 'OG002', 'title': 'Double-blind Adalimumab (Period 2)', 'description': 'Adalimumab 40 mg every other week (eow), Weeks 28-68. Blinded adalimumab was discontinued in participants who met the criteria for flare.'}], 'classes': [{'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '324', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '317', 'groupId': 'OG000'}]}]}, {'title': 'Week 68', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Weeks 28 and 68', 'description': 'The Bath Ankylosing Spondylitis (AS) Disease Activity Index assesses disease activity by asking the participant to answer 6 questions (each on a 10 point numeric rating scale \\[NRS\\]) pertaining to symptoms experienced for the past week. For 5 questions (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (≥ 2 hours). The overall BASDAI score ranges from 0 to 10. Lower scores indicate less disease activity. BASDAI50 is a 50% improvement from baseline in BASDAI score.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Period 1 (all enrolled participants who received at least 1 dose of adalimumab); Period 2 (mITT: all randomized participants who received at least 1 dose of double-blind study medication); participants with missing data were inputed as nonresponders.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Disability Index of Health Assessment Questionnaire Modified for the Spondyloarthropathies (HAQ-S) at Weeks 28 and 68', 'denoms': [{'units': 'Participants', 'counts': [{'value': '673', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-label (OL) Adalimumab (Period 1)', 'description': '40 mg every other week (eow), Weeks 0-28.'}, {'id': 'OG001', 'title': 'Placebo (Period 2)', 'description': 'Placebo every other week (eow), Weeks 28-68. Placebo was discontinued in participants who met the criteria for flare.'}, {'id': 'OG002', 'title': 'Double-blind Adalimumab (Period 2)', 'description': 'Adalimumab 40 mg every other week (eow), Weeks 28-68. Blinded adalimumab was discontinued in participants who met the criteria for flare.'}], 'classes': [{'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '324', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.58', 'groupId': 'OG000'}]}]}, {'title': 'Week 68', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.59', 'groupId': 'OG001'}, {'value': '-0.8', 'spread': '0.63', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 28 and 68', 'description': "Health Assessment Questionnaire modified for spondyloarthropathies (HAQ-S) is a self-reported measure to assess the physical function and health-related quality of life. The Disability Index (DI) of HAQ-S is calculated as the mean of the following 8 category scores (range: 0 \\[without any difficulty\\] to 3 \\[unable to do\\]): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Five additional items in the functional status measure were included in the HAQ-S, including carrying heavy packages, sitting for long periods, able to work at a flat topped table, and (if the participant had a driver's license or a car) able to look in the rear view mirror and able to turn head to drive in reverse. The overall score ranges from 0 (no disability) to 3 (very severe, high-dependency disability). Negative mean changes from baseline in the overall score indicate improvement.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Period 1 (all enrolled participants who received at least 1 dose of adalimumab); Period 2 (mITT: all randomized participants who received at least 1 dose of double-blind study medication); participants with missing data were inputed as nonresponders.'}, {'type': 'SECONDARY', 'title': 'Time to Flare at Week 68', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Period 2)', 'description': 'Placebo every other week (eow), Weeks 28-68. Placebo was discontinued in participants who met the criteria for flare.'}, {'id': 'OG001', 'title': 'Double-blind Adalimumab (Period 2)', 'description': 'Adalimumab 40 mg every other week (eow), Weeks 28-68. Blinded adalimumab was discontinued in participants who met the criteria for flare.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'The survival function was \\>50%, with an insufficient number of participants with events to estimate median time to flare. The upper 95% CI limit was not estimable due to an insufficient number of participants with events, as indicated by NA.', 'groupId': 'OG000', 'lowerLimit': '41', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The survival function was \\>50%, with an insufficient number of participants with events to estimate median time to flare. The lower and upper 95% CI limits were not estimable due to an insufficient number of participants with events, indicated by NA.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The statistical test was performed at a 2-sided significance level of 0.05. Time to flare analysis showed statistically significant lower risk of flare in the adalimumab group than in the placebo group.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'From Week 28 through 68', 'description': 'The Ankylosing Spondylitis Disease Activity Score (ASDAS) tool is a self-administered questionnaire/objective laboratory evaluation. The questionnaire assesses disease activity, back pain, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and duration of morning stiffness on a numeric rating scale (from 0 to 10, with 0 being none and 10 representing a duration of ≥2 hours). The laboratory parameter is a measurement of high-sensitivity C-reactive protein (mg/L) (hs-CRP). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and hs-CRP) are combined to yield a score (0 to no defined upper limit). During Period 2 participants visited study sites at Weeks 28, 32, 36, 40, 44, 48, 52, 56, 60, 64 and 68 or if they discontinued early from the study. A flare was defined as having any 2 consecutive study visits with ASDAS ≥ 2.100.', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-treat population: all participants who were randomized into double-blind Period 2 and received at least 1 dose of double-blind study medication; participants with missing data were treated as missing.'}, {'type': 'SECONDARY', 'title': 'Time to Partial Flare at Week 68', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Period 2)', 'description': 'Placebo every other week (eow), Weeks 28-68. Placebo was discontinued in participants who met the criteria for flare.'}, {'id': 'OG001', 'title': 'Double-blind Adalimumab (Period 2)', 'description': 'Adalimumab 40 mg every other week (eow), Weeks 28-68. Blinded adalimumab was discontinued in participants who met the criteria for flare.'}], 'classes': [{'categories': [{'measurements': [{'value': '41', 'comment': 'The upper 95% CI limit was not estimable due to an insufficient number of participants with events, as indicated by NA.', 'groupId': 'OG000', 'lowerLimit': '41', 'upperLimit': 'NA'}, {'value': '42', 'comment': 'The upper 95% CI limit was not estimable due to an insufficient number of participants with events, as indicated by NA.', 'groupId': 'OG001', 'lowerLimit': '42', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Week 28 through 68', 'description': 'The Ankylosing Spondylitis Disease Activity Score (ASDAS) tool is a self-administered questionnaire/objective laboratory evaluation. The questionnaire assesses disease activity, back pain, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and duration of morning stiffness on a numeric rating scale (from 0 to 10, with 0 being none and 10 representing a duration of ≥2 hours). The laboratory parameter is a measurement of high-sensitivity C-reactive protein (mg/L) (hs-CRP). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and hs-CRP) are combined to yield a score (0 to no defined upper limit). During Period 2 participants visited study sites at Weeks 28, 32, 36, 40, 44, 48, 52, 56, 60, 64 and 68 or if they discontinued early from the study. A partial flare was defined as having any 2 consecutive study visits with ASDAS ≥ 1.300 but \\<2.100.', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-treat population: all participants who were randomized into double-blind Period 2 and received at least 1 dose of double-blind study medication; participants with missing data were treated as missing.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reaching Flare Definition by Week 68', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Period 2)', 'description': 'Placebo every other week (eow), Weeks 28-68. Placebo was discontinued in participants who met the criteria for flare.'}, {'id': 'OG001', 'title': 'Double-blind Adalimumab (Period 2)', 'description': 'Adalimumab 40 mg every other week (eow), Weeks 28-68. Blinded adalimumab was discontinued in participants who met the criteria for flare.'}], 'classes': [{'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Week 28 through 68', 'description': 'The Ankylosing Spondylitis Disease Activity Score (ASDAS) tool is a self-administered questionnaire/objective laboratory evaluation. The questionnaire assesses disease activity, back pain, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and duration of morning stiffness on a numeric rating scale (from 0 to 10, with 0 being none and 10 representing a duration of ≥2 hours). The laboratory parameter is a measurement of high-sensitivity C-reactive protein (mg/L) (hs-CRP). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and hs-CRP) are combined to yield a score (0 to no defined upper limit). During Period 2 participants visited study sites at Weeks 28, 32, 36, 40, 44, 48, 52, 56, 60, 64 and 68 or if they discontinued early from the study. A flare was defined as having any 2 consecutive study visits with ASDAS ≥ 2.100.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-treat population: all participants who were randomized into double-blind Period 2 and received at least 1 dose of double-blind study medication; participants with missing data were inputed as nonresponders.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reaching Partial Flare Definition by Week 68', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Period 2)', 'description': 'Placebo every other week (eow), Weeks 28-68. Placebo was discontinued in participants who met the criteria for flare.'}, {'id': 'OG001', 'title': 'Double-blind Adalimumab (Period 2)', 'description': 'Adalimumab 40 mg every other week (eow), Weeks 28-68. Blinded adalimumab was discontinued in participants who met the criteria for flare.'}], 'classes': [{'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Week 28 through 68', 'description': 'The Ankylosing Spondylitis Disease Activity Score (ASDAS) tool is a self-administered questionnaire/objective laboratory evaluation. The questionnaire assesses disease activity, back pain, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and duration of morning stiffness on a numeric rating scale (from 0 to 10, with 0 being none and 10 representing a duration of ≥2 hours). The laboratory parameter is a measurement of high-sensitivity C-reactive protein (mg/L) (hs-CRP). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and hs-CRP) are combined to yield a score (0 to no defined upper limit). During Period 2 participants visited study sites at Weeks 28, 32, 36, 40, 44, 48, 52, 56, 60, 64 and 68 or if they discontinued early from the study. A partial flare was defined as having any 2 consecutive study visits with ASDAS ≥ 1.300 but \\<2.100.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-treat population: all participants who were randomized into double-blind Period 2 and received at least 1 dose of double-blind study medication; participants with missing data were inputed as nonresponders.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Open-label (OL) Adalimumab (Period 1)', 'description': '40 mg every other week (eow), Weeks 0-28.'}, {'id': 'FG001', 'title': 'Placebo (Period 2)', 'description': 'Placebo every other week (eow), Weeks 28-68. Placebo was discontinued in participants who met the criteria for flare.'}, {'id': 'FG002', 'title': 'Double-blind Adalimumab (Period 2)', 'description': 'Adalimumab 40 mg every other week (eow), Weeks 28-68. Blinded adalimumab was discontinued in participants who met the criteria for flare.'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '673'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '305'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '368'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Did not meet criteria for remission', 'reasons': [{'groupId': 'FG000', 'numSubjects': '303'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Enrolled in error', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Did not meet inclusion criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Non-conformance with inclusion criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Investigator decision: site closure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Non-compliance per sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '153'}, {'groupId': 'FG002', 'numSubjects': '152'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '140'}, {'groupId': 'FG002', 'numSubjects': '144'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Investigator no longer conducting trials', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Switched to other therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'This study included a 42-day screening period.The Full Analysis Set (FAS) included all participants who enrolled in the open-label period (Period 1) and received at least 1 dose of adalimumab. The All Randomized Set included all Period 2 participants who were randomized to receive either placebo or 40 mg adalimumab every other week.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '673', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Open-label (OL) Adalimumab (Period 1)', 'description': '40 mg every other week (eow), Weeks 0-28.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.3', 'spread': '11.12', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '343', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '330', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '651', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full Analysis Set (FAS): all participants who enrolled in the open-label period (Period 1) and received at least 1 dose of adalimumab.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-03-02', 'size': 748531, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-02-02T12:35', 'hasProtocol': False}, {'date': '2015-01-15', 'size': 1337178, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-02-02T12:36', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 673}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2017-04-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-30', 'studyFirstSubmitDate': '2013-03-07', 'resultsFirstSubmitDate': '2018-02-16', 'studyFirstSubmitQcDate': '2013-03-07', 'lastUpdatePostDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-03-29', 'studyFirstPostDateStruct': {'date': '2013-03-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Did Not Experience a Flare During Period 2 by Week 68', 'timeFrame': 'From Week 28 through 68', 'description': 'The Ankylosing Spondylitis Disease Activity Score (ASDAS) tool is a self-administered questionnaire/objective laboratory evaluation. The questionnaire assesses disease activity, back pain, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and duration of morning stiffness on a numeric rating scale (from 0 to 10, with 0 being none and 10 representing a duration of ≥2 hours). The laboratory parameter is a measurement of high-sensitivity C-reactive protein (mg/L) (hs-CRP). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and hs-CRP) are combined to yield a score (0 to no defined upper limit). During Period 2 participants visited study sites at Weeks 28, 32, 36, 40, 44, 48, 52, 56, 60, 64 and 68 or if they discontinued early from the study. A flare was defined as having any 2 consecutive study visits with ASDAS ≥ 2.100.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) Inactive Disease at 12 Weeks After Initiation of Rescue Therapy', 'timeFrame': 'Rescue Therapy Week 12', 'description': 'The Ankylosing Spondylitis Disease Activity Score (ASDAS) tool is a self-administered questionnaire/objective laboratory evaluation. The questionnaire assesses disease activity, back pain, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and duration of morning stiffness on a numeric rating scale (from 0 to 10, with 0 being none and 10 representing a duration of ≥2 hours). The laboratory parameter is a measurement of high-sensitivity C-reactive protein (mg/L) (hs-CRP). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and hs-CRP) are combined to yield a score (0 to no defined upper limit). ASDAS Inactive Disease is defined as a score of \\<1.300.'}, {'measure': 'Number of Participants Achieving ASDAS Major Improvement at 12 Weeks After Initiation of Rescue Therapy', 'timeFrame': 'Baseline and Rescue Therapy Week 12', 'description': 'The Ankylosing Spondylitis Disease Activity Score (ASDAS) tool is a self-administered questionnaire/objective laboratory evaluation. The questionnaire assesses disease activity, back pain, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and duration of morning stiffness on a numeric rating scale (from 0 to 10, with 0 being none and 10 representing a duration of ≥2 hours). The laboratory parameter is a measurement of high-sensitivity C-reactive protein (mg/L) (hs-CRP). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and hs-CRP) are combined to yield a score (0 to no defined upper limit). ASDAS Major Improvement is defined as a change from baseline ≤ -2.000.'}, {'measure': 'Number of Participants Achieving ASDAS Clinically Important Improvement at 12 Weeks After Initiation of Rescue Therapy', 'timeFrame': 'Baseline and Rescue Therapy Week 12', 'description': 'The Ankylosing Spondylitis Disease Activity Score (ASDAS) tool is a self-administered questionnaire/objective laboratory evaluation. The questionnaire assesses disease activity, back pain, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and duration of morning stiffness on a numeric rating scale (from 0 to 10, with 0 being none and 10 representing a duration of ≥2 hours). The laboratory parameter is a measurement of high-sensitivity C-reactive protein (mg/L) (hs-CRP). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and hs-CRP) are combined to yield a score (0 to no defined upper limit). ASDAS Clinically Important Improvement is defined as a change from baseline ≤ -1.100.'}, {'measure': 'Number of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 20 Response at 12 Weeks After Initiation of Rescue Therapy', 'timeFrame': 'Baseline and Rescue Therapy Week 12', 'description': "ASAS20 response was defined as improvement of ≥ 20% relative to baseline and absolute improvement of ≥ 1 unit (on a scale from 0 to 10) in ≥ 3 of the following 4 domains with no deterioration (defined as a worsening of ≥ 20% and a net worsening of ≥ 1 unit) in the potential remaining domain:\n\n* Patient's Global Assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (none) to 10 (severe);\n* Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe);\n* Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);\n* Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 \\[level of stiffness\\] and 6 \\[duration of stiffness\\]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration)."}, {'measure': 'Number of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 40 Response at 12 Weeks After Initiation of Rescue Therapy', 'timeFrame': 'Baseline and Rescue Therapy Week 12', 'description': "ASAS40 response was defined as improvement of ≥ 40% relative to baseline and absolute improvement of ≥ 2 units (on a scale from 0 to 10) in ≥ 3 of the following 4 domains with no deterioration in the potential remaining domain:\n\n* Patient's Global Assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (none) to 10 (severe);\n* Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe);\n* Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);\n* Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 \\[level of stiffness\\] and 6 \\[duration of stiffness\\]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration)."}, {'measure': 'Number of Participants Achieving an ASAS 5/6 Response at 12 Weeks After Initiation of Rescue Therapy', 'timeFrame': 'Baseline and Rescue Therapy Week 12', 'description': "An Assessment of Spondyloarthritis International Society (ASAS) 5/6 response is a 20% improvement in 5 out of the following 6 domains:\n\n* Patient's Global Assessment of disease activity, on a numeric rating scale (NRS) from 0 (none) to 10 (severe);\n* Pain, measured by total back pain NRS from 0 (no pain) to 10 (most severe);\n* Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which assesses participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);\n* Inflammation: the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 \\[level of stiffness\\] and 6 \\[duration of stiffness\\]) each on a scale from 0 (none) to 10 (very severe/2 hrs or more duration);\n* Spinal mobility: the lateral lumbar flexion score of the Bath AS Metrology Index (BASMI) on a scale from 0 (best mobility) to 10 (worst mobility);\n* High-sensitivity C-reactive protein level (lower levels = less inflammation)."}, {'measure': 'Number of Participants Achieving ASAS Partial Remission at 12 Weeks After Initiation of Rescue Therapy', 'timeFrame': 'Rescue Therapy Week 12', 'description': "Assessment in SpondyloArthritis International Society (ASAS) partial remission is defined as an absolute score of \\< 2 units on a 0 to 10 scale for each of the four following domains:\n\n* Patient's Global Assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (none) to 10 (severe);\n* Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe);\n* Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);\n* Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 \\[level of stiffness\\] and 6 \\[duration of stiffness\\]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration)."}, {'measure': 'Number of Participants Achieving a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response at 12 Weeks After Initiation of Rescue Therapy', 'timeFrame': 'Baseline and Rescue Therapy Week 12', 'description': 'The Bath Ankylosing Spondylitis (AS) Disease Activity Index assesses disease activity by asking the participant to answer 6 questions (each on a 10 point numeric rating scale \\[NRS\\]) pertaining to symptoms experienced for the past week. For 5 questions (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (≥ 2 hours). The overall BASDAI score ranges from 0 to 10. Lower scores indicate less disease activity. BASDAI50 is a 50% improvement from baseline in BASDAI score.'}, {'measure': 'Change From Baseline in Disability Index of Health Assessment Questionnaire Modified for the Spondyloarthropathies (HAQ-S) at 12 Weeks After Initiation of Rescue Therapy', 'timeFrame': 'Baseline and Rescue Therapy Week 12', 'description': "Health Assessment Questionnaire modified for spondyloarthropathies (HAQ-S) is a self-reported measure to assess the physical function and health-related quality of life. The Disability Index (DI) of HAQ-S is calculated as the mean of the following 8 category scores (range: 0 \\[without any difficulty\\] to 3 \\[unable to do\\]): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Five additional items in the functional status measure were included in the HAQ-S, including carrying heavy packages, sitting for long periods, able to work at a flat topped table, and (if the participant had a driver's license or a car) able to look in the rear view mirror and able to turn head to drive in reverse. The overall score ranges from 0 (no disability) to 3 (very severe, high-dependency disability). Negative mean changes from baseline in the overall score indicate improvement."}, {'measure': 'Number of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) Inactive Disease at Weeks 28 and 68', 'timeFrame': 'Weeks 28 and 68', 'description': 'The Ankylosing Spondylitis Disease Activity Score (ASDAS) tool is a self-administered questionnaire/objective laboratory evaluation. The questionnaire assesses disease activity, back pain, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and duration of morning stiffness on a numeric rating scale (from 0 to 10, with 0 being none and 10 representing a duration of ≥2 hours). The laboratory parameter is a measurement of high-sensitivity C-reactive protein (mg/L) (hs-CRP). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and hs-CRP) are combined to yield a score (0 to no defined upper limit). ASDAS Inactive Disease is defined as a score of \\<1.300.'}, {'measure': 'Number of Participants Achieving ASDAS Major Improvement at Weeks 28 and 68', 'timeFrame': 'Baseline, Weeks 28 and 68', 'description': 'The Ankylosing Spondylitis Disease Activity Score (ASDAS) tool is a self-administered questionnaire/objective laboratory evaluation. The questionnaire assesses disease activity, back pain, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and duration of morning stiffness on a numeric rating scale (from 0 to 10, with 0 being none and 10 representing a duration of ≥2 hours). The laboratory parameter is a measurement of high-sensitivity C-reactive protein (mg/L) (hs-CRP). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and hs-CRP) are combined to yield a score (0 to no defined upper limit). ASDAS Major Improvement is defined as a change from baseline ≤ -2.000.'}, {'measure': 'Number of Participants Achieving ASDAS Clinically Important Improvement at Weeks 28 and 68', 'timeFrame': 'Baseline, Weeks 28 and 68', 'description': 'The Ankylosing Spondylitis Disease Activity Score (ASDAS) tool is a self-administered questionnaire/objective laboratory evaluation. The questionnaire assesses disease activity, back pain, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and duration of morning stiffness on a numeric rating scale (from 0 to 10, with 0 being none and 10 representing a duration of ≥2 hours). The laboratory parameter is a measurement of high-sensitivity C-reactive protein (mg/L) (hs-CRP). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and hs-CRP) are combined to yield a score (0 to no defined upper limit). ASDAS Clinically Important Improvement is defined as a change from baseline ≤ -1.100.'}, {'measure': 'Number of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 20 Response at Weeks 28 and 68', 'timeFrame': 'Baseline, Weeks 28 and 68', 'description': "ASAS20 response was defined as improvement of ≥ 20% relative to baseline and absolute improvement of ≥ 1 unit (on a scale from 0 to 10) in ≥ 3 of the following 4 domains with no deterioration (defined as a worsening of ≥ 20% and a net worsening of ≥ 1 unit) in the potential remaining domain:\n\n* Patient's Global Assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (none) to 10 (severe);\n* Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe);\n* Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);\n* Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 \\[level of stiffness\\] and 6 \\[duration of stiffness\\]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration)."}, {'measure': 'Number of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 40 Response at Weeks 28 and 68', 'timeFrame': 'Baseline, Weeks 28 and 68', 'description': "ASAS40 response was defined as improvement of ≥ 40% relative to baseline and absolute improvement of ≥ 2 units (on a scale from 0 to 10) in ≥ 3 of the following 4 domains with no deterioration in the potential remaining domain:\n\n* Patient's Global Assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (none) to 10 (severe);\n* Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe);\n* Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);\n* Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 \\[level of stiffness\\] and 6 \\[duration of stiffness\\]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration)."}, {'measure': 'Number of Participants Achieving an ASAS 5/6 Response at Weeks 28 and 68', 'timeFrame': 'Baseline, Weeks 28 and 68', 'description': "An Assessment of Spondyloarthritis International Society (ASAS) 5/6 response is a 20% improvement in 5 out of the following 6 domains:\n\n* Patient's Global Assessment of disease activity, on a numeric rating scale (NRS) from 0 (none) to 10 (severe);\n* Pain, measured by total back pain NRS from 0 (no pain) to 10 (most severe);\n* Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which assesses participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);\n* Inflammation: the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 \\[level of stiffness\\] and 6 \\[duration of stiffness\\]) each on a scale from 0 (none) to 10 (very severe/2 hrs or more duration);\n* Spinal mobility: the lateral lumbar flexion score of the Bath AS Metrology Index (BASMI) on a scale from 0 (best mobility) to 10 (worst mobility);\n* High-sensitivity C-reactive protein level (lower levels = less inflammation)."}, {'measure': 'Number of Participants Achieving ASAS Partial Remission at Weeks 28 and 68', 'timeFrame': 'Baseline, Weeks 28 and 68', 'description': "Assessment in SpondyloArthritis International Society (ASAS) partial remission is defined as an absolute score of \\< 2 units on a 0 to 10 scale for each of the four following domains:\n\n* Patient's Global Assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (none) to 10 (severe);\n* Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe);\n* Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);\n* Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 \\[level of stiffness\\] and 6 \\[duration of stiffness\\]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration)."}, {'measure': 'Number of Participants Achieving a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response at Weeks 28 and 68', 'timeFrame': 'Baseline, Weeks 28 and 68', 'description': 'The Bath Ankylosing Spondylitis (AS) Disease Activity Index assesses disease activity by asking the participant to answer 6 questions (each on a 10 point numeric rating scale \\[NRS\\]) pertaining to symptoms experienced for the past week. For 5 questions (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (≥ 2 hours). The overall BASDAI score ranges from 0 to 10. Lower scores indicate less disease activity. BASDAI50 is a 50% improvement from baseline in BASDAI score.'}, {'measure': 'Change From Baseline in Disability Index of Health Assessment Questionnaire Modified for the Spondyloarthropathies (HAQ-S) at Weeks 28 and 68', 'timeFrame': 'Baseline, Weeks 28 and 68', 'description': "Health Assessment Questionnaire modified for spondyloarthropathies (HAQ-S) is a self-reported measure to assess the physical function and health-related quality of life. The Disability Index (DI) of HAQ-S is calculated as the mean of the following 8 category scores (range: 0 \\[without any difficulty\\] to 3 \\[unable to do\\]): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Five additional items in the functional status measure were included in the HAQ-S, including carrying heavy packages, sitting for long periods, able to work at a flat topped table, and (if the participant had a driver's license or a car) able to look in the rear view mirror and able to turn head to drive in reverse. The overall score ranges from 0 (no disability) to 3 (very severe, high-dependency disability). Negative mean changes from baseline in the overall score indicate improvement."}, {'measure': 'Time to Flare at Week 68', 'timeFrame': 'From Week 28 through 68', 'description': 'The Ankylosing Spondylitis Disease Activity Score (ASDAS) tool is a self-administered questionnaire/objective laboratory evaluation. The questionnaire assesses disease activity, back pain, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and duration of morning stiffness on a numeric rating scale (from 0 to 10, with 0 being none and 10 representing a duration of ≥2 hours). The laboratory parameter is a measurement of high-sensitivity C-reactive protein (mg/L) (hs-CRP). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and hs-CRP) are combined to yield a score (0 to no defined upper limit). During Period 2 participants visited study sites at Weeks 28, 32, 36, 40, 44, 48, 52, 56, 60, 64 and 68 or if they discontinued early from the study. A flare was defined as having any 2 consecutive study visits with ASDAS ≥ 2.100.'}, {'measure': 'Time to Partial Flare at Week 68', 'timeFrame': 'From Week 28 through 68', 'description': 'The Ankylosing Spondylitis Disease Activity Score (ASDAS) tool is a self-administered questionnaire/objective laboratory evaluation. The questionnaire assesses disease activity, back pain, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and duration of morning stiffness on a numeric rating scale (from 0 to 10, with 0 being none and 10 representing a duration of ≥2 hours). The laboratory parameter is a measurement of high-sensitivity C-reactive protein (mg/L) (hs-CRP). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and hs-CRP) are combined to yield a score (0 to no defined upper limit). During Period 2 participants visited study sites at Weeks 28, 32, 36, 40, 44, 48, 52, 56, 60, 64 and 68 or if they discontinued early from the study. A partial flare was defined as having any 2 consecutive study visits with ASDAS ≥ 1.300 but \\<2.100.'}, {'measure': 'Number of Participants Reaching Flare Definition by Week 68', 'timeFrame': 'From Week 28 through 68', 'description': 'The Ankylosing Spondylitis Disease Activity Score (ASDAS) tool is a self-administered questionnaire/objective laboratory evaluation. The questionnaire assesses disease activity, back pain, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and duration of morning stiffness on a numeric rating scale (from 0 to 10, with 0 being none and 10 representing a duration of ≥2 hours). The laboratory parameter is a measurement of high-sensitivity C-reactive protein (mg/L) (hs-CRP). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and hs-CRP) are combined to yield a score (0 to no defined upper limit). During Period 2 participants visited study sites at Weeks 28, 32, 36, 40, 44, 48, 52, 56, 60, 64 and 68 or if they discontinued early from the study. A flare was defined as having any 2 consecutive study visits with ASDAS ≥ 2.100.'}, {'measure': 'Number of Participants Reaching Partial Flare Definition by Week 68', 'timeFrame': 'From Week 28 through 68', 'description': 'The Ankylosing Spondylitis Disease Activity Score (ASDAS) tool is a self-administered questionnaire/objective laboratory evaluation. The questionnaire assesses disease activity, back pain, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and duration of morning stiffness on a numeric rating scale (from 0 to 10, with 0 being none and 10 representing a duration of ≥2 hours). The laboratory parameter is a measurement of high-sensitivity C-reactive protein (mg/L) (hs-CRP). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and hs-CRP) are combined to yield a score (0 to no defined upper limit). During Period 2 participants visited study sites at Weeks 28, 32, 36, 40, 44, 48, 52, 56, 60, 64 and 68 or if they discontinued early from the study. A partial flare was defined as having any 2 consecutive study visits with ASDAS ≥ 1.300 but \\<2.100.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Spondylitis', 'Spondylarthropathy', 'Ankylosing Spondyloarthritis', 'Spondyloarthritis', 'Spinal Diseases', 'Musculoskeletal Diseases', 'Arthritis', 'Joint Diseases', 'Adalimumab', 'Antirheumatic Agents', 'Anti-Inflammatory Agents'], 'conditions': ['Axial Spondyloarthritis']}, 'referencesModule': {'references': [{'pmid': '29961640', 'type': 'DERIVED', 'citation': 'Landewe R, Sieper J, Mease P, Inman RD, Lambert RG, Deodhar A, Marzo-Ortega H, Magrey M, Kiltz U, Wang X, Li M, Zhong S, Mostafa NM, Lertratanakul A, Pangan AL, Anderson JK. Efficacy and safety of continuing versus withdrawing adalimumab therapy in maintaining remission in patients with non-radiographic axial spondyloarthritis (ABILITY-3): a multicentre, randomised, double-blind study. Lancet. 2018 Jul 14;392(10142):134-144. doi: 10.1016/S0140-6736(18)31362-X. Epub 2018 Jun 29.'}], 'seeAlsoLinks': [{'url': 'http://rxabbvie.com', 'label': 'Humira Prescribing Information'}]}, 'descriptionModule': {'briefSummary': 'The objective of this multicenter, randomized, double-blind study was to evaluate the efficacy and safety of continuing versus withdrawing therapy with adalimumab 40 mg given every other week SC in maintaining remission in subjects with moderate to severe non-radiographic axial spondyloarthritis.', 'detailedDescription': 'The study duration included a 42-day Screening Period, a 28-week open-label 40 mg adalimumab every other week (eow) treatment period (Period 1), a 40-week double-blind placebo controlled eow treatment period (Period 2) with an opportunity to receive at least 12 weeks of rescue therapy with open-label adalimumab (participants that flared at Weeks 60, 64 or 68 were allowed 12 weeks of rescue therapy and final visits were at Weeks 72, 76 or 80 respectively), plus a 70-day follow-up phone call. Participants in sustained Ankylosing Spondylitis Disease Activity Score (ASDAS) inactive disease were randomized at Week 28 at a 1:1 ratio to receive either blinded adalimumab 40 mg eow or matching placebo. The length of exposure to adalimumab depended on remission or flare status and ranged from 20 (first time Ankylosing Spondylitis Disease Activity Score \\[ASDAS\\] remission was calculated) to 80 weeks of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult participants with inadequate response to ≥2 nonsteroidal anti-inflammatory drugs (NSAIDs)\n* Participants with non-radiographic axial spondyloarthritis fulfilling the Assessment of Spondyloarthritis International Society (ASAS) axial SpA classification criteria, but not fulfilling the radiologic criterion of the modified New York criteria for ankylosing spondylitis\n* Participants must have baseline disease activity as defined by having an Ankylosing Spondylitis Disease Activity Score (ASDAS) ≥ 2.100, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥ 4 and Patient's Assessment of Total Back Pain score ≥ 4 based on a Numeric Rating Scale (NRS) at both the screening and baseline visits\n* Participants with evidence of active inflammation in the sacroiliac (SI) joints or spine on MRI, or elevated high sensitivity C-reactive protein (hs-CRP) at screening\n* Negative tuberculosis (TB) screening assessment\n* Ability to administer subcutaneous injections or have a qualified person available to administer injections\n* If female, either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy and/or hysterectomy) or of childbearing potential and practicing an approved method of birth control throughout the study and for 150 days after last dose of study drug.\n* Participant judged to be in good health as determined by the Principal Investigator based upon the results of medical history, laboratory profile, physical examination, chest X-ray, and a 12-lead electrocardiogram performed at screening\n\nExclusion Criteria:\n\n* Prior anti-Tumor Necrosis Factor (TNF) therapy; biologic therapy with a potential therapeutic impact on SpA or treated with an investigational drug of chemical or biologic nature within 30 days or 5 half-lives prior to the baseline visit.\n* Fulfillment of the radiologic criterion of the modified New York criteria for Ankylosing Spondylitis at or prior to the screening visit\n* Recent infection requiring treatment with intravenous (IV) anti-infectives within 30 days prior to the baseline visit or oral anti-infectives within 14 days prior to the baseline visit\n* Significant medical events or conditions that may put participants at risk for participation\n* Female participants who are pregnant or breast-feeding or considering becoming pregnant during the study\n* Known hypersensitivity to adalimumab or its excipients as stated in the label"}, 'identificationModule': {'nctId': 'NCT01808118', 'briefTitle': 'Continuing Versus Withdrawing Adalimumab in Maintaining Remission in Non-Radiographic Axial Spondyloarthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Study Comparing the Efficacy and Safety of Continuing Versus Withdrawing Adalimumab Therapy in Maintaining Remission in Subjects With Non-Radiographic Axial Spondyloarthritis', 'orgStudyIdInfo': {'id': 'M13-375'}, 'secondaryIdInfos': [{'id': '2012-000646-35', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Double-Blind Adalimumab', 'description': '40 mg every other week (eow), Weeks 28-68. Blinded adalimumab was discontinued in participants who met the criteria for flare.', 'interventionNames': ['Biological: adalimumab']}, {'type': 'EXPERIMENTAL', 'label': 'Open-label (OL) Adalimumab', 'description': '40 mg every other week (eow), Weeks 0-28. If participants flared during the double-blind period, they had an opportunity to receive at least 12 weeks of open-label adalimumab 40 mg eow.', 'interventionNames': ['Biological: adalimumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo every other week (eow), Weeks 28-68. Placebo was discontinued in participants who met the criteria for flare.', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'adalimumab', 'type': 'BIOLOGICAL', 'otherNames': ['Humira', 'ABT-D2E7'], 'description': '40 mg every other week', 'armGroupLabels': ['Double-Blind Adalimumab', 'Open-label (OL) Adalimumab']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'every other week', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'AbbVie Inc.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}