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Ignite Creation Date: 2025-12-24 @ 1:53 PM

Ignite Modification Date: 2026-02-01 @ 7:18 AM

Study NCT ID: NCT02349295

Status: COMPLETED

Last Update Posted: 2020-07-01

First Post: 2014-10-10

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: A Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015535', 'term': 'Arthritis, Psoriatic'}], 'ancestors': [{'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C549079', 'term': 'ixekizumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov@lilly.com', 'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline Up To 2.55 Years', 'description': 'All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.', 'eventGroups': [{'id': 'EG000', 'title': 'Ixekizumab 80 mg Q2W (Ixe 80 mg Q2W)- Blinded Treatment Period', 'description': 'Participants received a starting dose of 160 mg of ixekizumab given as 2 subcutaneous (SC) injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab every 2 Weeks (Q2W) given on Weeks 2, 4, 6, 8, 10, 12,14, 16, 18, 20, 22, and 24.', 'otherNumAtRisk': 123, 'otherNumAffected': 58, 'seriousNumAtRisk': 123, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Ixekizumab 80 mg Q4W (Ixe 80 mg Q4W)- Blinded Treatment Period', 'description': 'Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14, 18, and 22.', 'otherNumAtRisk': 122, 'otherNumAffected': 58, 'seriousNumAtRisk': 122, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Placebo (PBO) - Blinded Treatment Period', 'description': 'Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24.', 'otherNumAtRisk': 118, 'otherNumAffected': 40, 'seriousNumAtRisk': 118, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'Ixe 80 mg Q2W - Blinded Treatment Period IR', 'description': 'Week 16 inadequate responders from the placebo treatment group who were re-randomized (1:1) to ixekizumab 80 mg Q2W and IR from ixekizumab 80 mg Q2W who continued on ixekizumab 80 mg Q2W. Patients receive rescue therapy while receiving ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20, 22, and 24.', 'otherNumAtRisk': 17, 'otherNumAffected': 5, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Ixe 80 mg Q4W - Blinded Treatment Period IR', 'description': 'Week 16 inadequate responders from the placebo treatment group who were re-randomized (1:1) to ixekizumab 80 mg Q4W and IR from ixekizumab 80 mg Q4W who continued on ixekizumab 80 mg Q4W. Patients receive rescue therapy while receiving ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22.', 'otherNumAtRisk': 15, 'otherNumAffected': 8, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'PBO IR / Ixe 80 mg Q2W - Blinded Treatment Period IR', 'description': 'Participants initially randomized to placebo treatment group in the double blind treatment period who were flagged as inadequate responders as week 16 were re-randomized to ixekizumab 80 mg Q2W for the remainder of the current period and following period.', 'otherNumAtRisk': 16, 'otherNumAffected': 11, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'PBO IR / Ixe 80 mg Q4W - Blinded Treatment Period IR', 'description': 'Participants initially randomized to placebo treatment group in the double blind treatment period who were flagged as inadequate responders as week 16 were re-randomized to ixekizumab 80 mg Q4W for the remainder of the current period and following period.', 'otherNumAtRisk': 16, 'otherNumAffected': 8, 'seriousNumAtRisk': 16, 'seriousNumAffected': 1}, {'id': 'EG007', 'title': 'Ixe 80 mg Q2W / Ixe 80 mg Q2W - Extended Treatment Period', 'description': 'Participants who were randomized to ixekizumab 80 mg Q2W at week 0 and continued on ixekizumab 80 mg Q2W during the Extension Period.', 'otherNumAtRisk': 107, 'otherNumAffected': 59, 'seriousNumAtRisk': 107, 'seriousNumAffected': 10}, {'id': 'EG008', 'title': 'Ixe 80 mg Q4W / Ixe 80 mg Q4W - Extended Treatment Period', 'description': 'Participants who were randomized to ixekizumab 80 mg Q4W at week 0 and continued on ixekizumab 80 mg Q4W during the Extension Period.', 'otherNumAtRisk': 111, 'otherNumAffected': 65, 'seriousNumAtRisk': 111, 'seriousNumAffected': 13}, {'id': 'EG009', 'title': 'Placebo/ Ixe 80 mg Q2W - Extended Treatment Period', 'description': 'Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q2W during the Extension Period.\n\nParticipants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24.\n\nParticipants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.', 'otherNumAtRisk': 46, 'otherNumAffected': 20, 'seriousNumAtRisk': 46, 'seriousNumAffected': 6}, {'id': 'EG010', 'title': 'Placebo/ Ixe 80 mg Q4W - Extended Treatment Period', 'description': 'Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q4W during the Extension Period.\n\nParticipants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24.\n\nParticipants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.', 'otherNumAtRisk': 46, 'otherNumAffected': 32, 'seriousNumAtRisk': 46, 'seriousNumAffected': 3}, {'id': 'EG011', 'title': 'Ixe 80 mg Q2W - Post Treatment Follow-Up Period', 'description': 'Participants who received ixekizumab 80 mg Q2W prior to entering the post-treatment follow-up period, who were either completed the study or discontinued the study early entered the post-treatment follow-up period (a 12-24 week period after their last scheduled treatment visit).', 'otherNumAtRisk': 142, 'otherNumAffected': 16, 'seriousNumAtRisk': 142, 'seriousNumAffected': 1}, {'id': 'EG012', 'title': 'Ixe 80 mg Q4W - Post Treatment Follow-Up Period', 'description': 'Participants who received ixekizumab 80 mg Q4W prior to entering the post-treatment follow-up period, who were either completed the study or discontinued the study early entered the post-treatment follow-up period (a 12-24 week period after their last scheduled treatment visit).', 'otherNumAtRisk': 145, 'otherNumAffected': 13, 'seriousNumAtRisk': 145, 'seriousNumAffected': 2}, {'id': 'EG013', 'title': 'PBO - Post Treatment Follow-Up Period', 'description': 'Participants who received PBO prior to entering the post-treatment follow-up period, who were either completed the study or discontinued the study early entered the post-treatment follow-up period (a 12-24 week period after their last scheduled treatment visit).', 'otherNumAtRisk': 17, 'otherNumAffected': 2, 'seriousNumAtRisk': 17, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Goitre', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Entropion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 107, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 111, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 46, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG011', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 46, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG011', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 46, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG011', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 46, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 20, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numEvents': 11, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 1, 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118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving American College of Rheumatology 20 Index (ACR20)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22'}, {'id': 'OG001', 'title': 'Ixekizumab 80 mg Q4W', 'description': 'Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22'}, {'id': 'OG002', 'title': 'Ixekizumab 80 mg Q2W', 'description': 'Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22'}], 'classes': [{'categories': [{'measurements': [{'value': '19.5', 'groupId': 'OG000'}, {'value': '53.3', 'groupId': 'OG001'}, {'value': '48.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.74', 'ciLowerLimit': '2.65', 'ciUpperLimit': '8.48', 'pValueComment': 'model includes: treatment, geographic region, and tumor necrosis factor inhibitor (TNFi) experience (inadequate responder to 1 TNFi, inadequate responder to 2 TNFi, or intolerance to a TNFi).', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER', 'statisticalComment': "1\\) uses a Wald's test , 2) Non-responder imputation (NRI) was used to calculate the response rates."}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.79', 'ciLowerLimit': '2.12', 'ciUpperLimit': '6.78', 'groupDescription': 'model includes: treatment, geographic region, and TNFi experience (inadequate responder to 1 TNFi, inadequate responder to 2 TNFi, or intolerance to a TNFi)', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "1\\) uses a Wald's test , 2) Non-responder imputation (NRI) was used to calculate the response rates."}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': "ACR20 response is defined as a greater than or equal to (≥) 20% improvement from baseline for tender joint count (TJC) and swollen joint count (SJC) and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain visual analog scale (VAS), Participant's Global Assessment of Disease Activity VAS (PatGA), Physician's Global Assessment of the Disease Activity VAS (PGA), Participant's Assessment of Physical Function using the Health Assessment Questionnaire Disability Index (HAQ-DI), or Acute Phase Reactant as measured by high sensitivity C-reactive protein (hs-CRP).", 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants. Non-responder Imputation (NRI) is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22'}, {'id': 'OG001', 'title': 'Ixekizumab 80 mg Q4W', 'description': 'Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22'}, {'id': 'OG002', 'title': 'Ixekizumab 80 mg Q2W', 'description': 'Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '0.07', 'groupId': 'OG001'}, {'value': '-0.4', 'spread': '0.07', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': "HAQ-DI is a participant reported questionnaire that measures disease-associated disability(physical function).It consists of 24 questions with 8 domains: dressing/grooming,arising,eating,walking,hygiene,reach,grip and other daily activities. The disability section scores the participant's self-perception on degree of difficulty (0=without any difficulty,1=with some difficulty,2=with much difficulty,3=unable to do)covering the 8 domains.The HAQ-DI is a composite ranging from 0-3 with lower scores indicating less functional disability.The reported use of special aids/devices and/or the need for assistance of another person to perform these activities is assessed.Least Square (LS) mean calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment,baseline score,geographic region, TNFi experience,visit, treatment-by-visit interaction(itcn), geographic region-by-visit itcn,TNFi experience-by-visit itcn and baseline score-by-visit itcn.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving ACR20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22'}, {'id': 'OG001', 'title': 'Ixekizumab 80 mg Q4W', 'description': 'Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22'}, {'id': 'OG002', 'title': 'Ixekizumab 80 mg Q2W', 'description': 'Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22'}], 'classes': [{'categories': [{'measurements': [{'value': '22.0', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}, {'value': '48.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': "ACR20 response is defined as a ≥20% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.", 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving American College of Rheumatology 50 Index (ACR50)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22'}, {'id': 'OG001', 'title': 'Ixekizumab 80 mg Q4W', 'description': 'Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22'}, {'id': 'OG002', 'title': 'Ixekizumab 80 mg Q2W', 'description': 'Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22'}], 'classes': [{'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000'}, {'value': '35.2', 'groupId': 'OG001'}, {'value': '33.3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': "ACR50 response is defined as a ≥50% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.", 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving American College of Rheumatology 70 Index (ACR70)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22'}, {'id': 'OG001', 'title': 'Ixekizumab 80 mg Q4W', 'description': 'Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22'}, {'id': 'OG002', 'title': 'Ixekizumab 80 mg Q2W', 'description': 'Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '22.1', 'groupId': 'OG001'}, {'value': '12.2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': "ACR70 response is defined as a ≥70% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.", 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Psoriasis Area and Severity Index (PASI) 75', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22'}, {'id': 'OG001', 'title': 'Ixekizumab 80 mg Q4W', 'description': 'Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22'}, {'id': 'OG002', 'title': 'Ixekizumab 80 mg Q2W', 'description': 'Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22'}], 'classes': [{'categories': [{'measurements': [{'value': '10.4', 'groupId': 'OG000'}, {'value': '57.4', 'groupId': 'OG001'}, {'value': '61.8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'The PASI is an index that combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 were defined as having an improvement of at least 75% in the PASI compared to their baseline measures.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with baseline psoriatic lesion(s) involving ≥3% body surface area (BSA). NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Achieving Minimal Disease Activity (MDA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22'}, {'id': 'OG001', 'title': 'Ixekizumab 80 mg Q4W', 'description': 'Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22'}, {'id': 'OG002', 'title': 'Ixekizumab 80 mg Q2W', 'description': 'Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22'}], 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000'}, {'value': '27.9', 'groupId': 'OG001'}, {'value': '23.6', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': "It uses a composite of 7 key outcome measures (includes PASI) used in PsA to encompass all of the domains of the disease to measure the overall state of a patients' disease. The LEI is used to assess tender entheseal points. Patients are classified as achieving MDA if they fulfill 5 of 7 outcome measures: 1. TJC ≤1, 2. SJC ≤1, 3. PASI total score ≤1 or BSA ≤3, 4. patient pain VAS score of ≤15, 5. patient global VAS score of ≤20, 6. HAQ-DI score ≤0.5, 7. tender entheseal points (6 entheseal points) ≤1.", 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Achieving Complete Resolution in Enthesitis as Assessed by the Leeds Enthesitis Index (LEI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22'}, {'id': 'OG001', 'title': 'Ixekizumab 80 mg Q4W', 'description': 'Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22'}, {'id': 'OG002', 'title': 'Ixekizumab 80 mg Q2W', 'description': 'Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22'}], 'classes': [{'categories': [{'measurements': [{'value': '21.7', 'groupId': 'OG000'}, {'value': '35.3', 'groupId': 'OG001'}, {'value': '31.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'The LEI was developed specifically for use in PsA. It measures enthesitis at 6 sites (lateral epicondyle, left and right; medial femoral condyle, left and right; Achilles tendon insertion, left and right). Each site was assigned a score of 0 (absent) or 1 (present); the results from each site were then added to produce a total score (range 0 to 6). So, "0" indicates good score here.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had baseline enthesitis, baseline LEI score and post baseline LEI score data. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Itch Numeric Rating Scale (NRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22'}, {'id': 'OG001', 'title': 'Ixekizumab 80 mg Q4W', 'description': 'Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22'}, {'id': 'OG002', 'title': 'Ixekizumab 80 mg Q2W', 'description': 'Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.40', 'groupId': 'OG000'}, {'value': '-3.4', 'spread': '0.39', 'groupId': 'OG001'}, {'value': '-3.3', 'spread': '0.39', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participants itching from psoriasis was indicated by circling the number that best described the worst level of itching in the past 24 hours. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had baseline psoriatic lesion(s) involving \\>=3% BSA, baseline itch NRS score and post baseline itch NRS score data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Tender Joint Count (TJC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22'}, {'id': 'OG001', 'title': 'Ixekizumab 80 mg Q4W', 'description': 'Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22'}, {'id': 'OG002', 'title': 'Ixekizumab 80 mg Q2W', 'description': 'Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.2', 'spread': '1.96', 'groupId': 'OG000'}, {'value': '-12.7', 'spread': '1.87', 'groupId': 'OG001'}, {'value': '-12.5', 'spread': '1.77', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'TJC is the number of tender and painful joints determined for each participant by examination of 68 joints. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.', 'unitOfMeasure': 'Tender Joint Count', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with baseline and post baseline TJC data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Swollen Joint Count (SJC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22'}, {'id': 'OG001', 'title': 'Ixekizumab 80 mg Q4W', 'description': 'Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22'}, {'id': 'OG002', 'title': 'Ixekizumab 80 mg Q2W', 'description': 'Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.0', 'spread': '1.05', 'groupId': 'OG000'}, {'value': '-8.5', 'spread': '0.99', 'groupId': 'OG001'}, {'value': '-7.4', 'spread': '0.94', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'SJC is the number of swollen joints determined for each participant by examination of 66 joints. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.', 'unitOfMeasure': 'Swollen Joint Count', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with baseline and post baseline SJC data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Participants Assessment of Pain Visual Analog Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22'}, {'id': 'OG001', 'title': 'Ixekizumab 80 mg Q4W', 'description': 'Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22'}, {'id': 'OG002', 'title': 'Ixekizumab 80 mg Q2W', 'description': 'Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22'}], 'classes': [{'categories': [{'measurements': [{'value': '-21.4', 'spread': '3.97', 'groupId': 'OG000'}, {'value': '-36.9', 'spread': '3.74', 'groupId': 'OG001'}, {'value': '-33.5', 'spread': '3.58', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': "The pain VAS is a participant-administered single-item scale designed to measure current joint pain from Psoriatic arthritis (PsA) using a 100-millimeter(mm) horizontal VAS. Overall severity of participant's joint pain from PsA is indicated by marking a vertical tick on the horizontal 100-mm scale, where the left end from 0 mm (no pain) to right end 100 mm (worst possible joint pain). LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.", 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with baseline and post baseline TJC and SJC data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Patients Global Assessment of Disease Activity VAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22'}, {'id': 'OG001', 'title': 'Ixekizumab 80 mg Q4W', 'description': 'Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22'}, {'id': 'OG002', 'title': 'Ixekizumab 80 mg Q2W', 'description': 'Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22'}], 'classes': [{'categories': [{'measurements': [{'value': '-19.0', 'spread': '3.91', 'groupId': 'OG000'}, {'value': '-40.7', 'spread': '3.68', 'groupId': 'OG001'}, {'value': '-37.3', 'spread': '3.53', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': "The patient's overall assessment of his or her PsA activity will be recorded using a 100-mm horizontal VAS, where 0 represents no disease activity and 100 represents extremely active disease. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.", 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with baseline and post baseline Patients Global Assessment of Disease Activity VAS score.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Physicians Global Assessment of Disease Activity VAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22'}, {'id': 'OG001', 'title': 'Ixekizumab 80 mg Q4W', 'description': 'Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22'}, {'id': 'OG002', 'title': 'Ixekizumab 80 mg Q2W', 'description': 'Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22'}], 'classes': [{'categories': [{'measurements': [{'value': '-18.3', 'spread': '3.98', 'groupId': 'OG000'}, {'value': '-40.0', 'spread': '3.85', 'groupId': 'OG001'}, {'value': '-37.9', 'spread': '3.75', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': "The investigator will be asked to give an overall assessment of the severity of the participant's current PsA activity using a 100-mm horizontal VAS, where 0 represents no disease activity and 100 represents extremely active disease. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.", 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with baseline and post baseline Physicians Global Assessment of Disease Activity VAS score.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in C-Reactive Protein (CRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22'}, {'id': 'OG001', 'title': 'Ixekizumab 80 mg Q4W', 'description': 'Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22'}, {'id': 'OG002', 'title': 'Ixekizumab 80 mg Q2W', 'description': 'Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.6', 'spread': '1.87', 'groupId': 'OG000'}, {'value': '-11.8', 'spread': '1.76', 'groupId': 'OG001'}, {'value': '-9.8', 'spread': '1.68', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'C-reactive protein (CRP) is a disease related biomarker and measured in milligrams per liter. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.', 'unitOfMeasure': 'milligram per liter (mg/L)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with baseline and post baseline CRP data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Disease Activity Score-CRP (DAS28-CRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22'}, {'id': 'OG001', 'title': 'Ixekizumab 80 mg Q4W', 'description': 'Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22'}, {'id': 'OG002', 'title': 'Ixekizumab 80 mg Q2W', 'description': 'Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '-2.1', 'spread': '0.19', 'groupId': 'OG001'}, {'value': '-1.8', 'spread': '0.18', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': "The DAS28-CRP is a measure of disease activity in 28 joints that consists of a composite numerical score with the following variables: TJC28, SJC28, hs-CRP (measured in mg/L), and Participant's Global Assessment of Disease Activity recorded by participants on a 0 to 100 millimeter (mm) VAS. For DAS28-CRP, the Tender Joint Count 28 (TJC28) and Swollen Joint Count (SJC28) are a subset of TJC and SJC, and include 14 joints on each side of the body: 2 shoulders, 2 elbows, 2 wrists, 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. DAS28 values range from 0 to 9.4. Higher values indicate more severe symptoms and greater functional impairment. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.", 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had baseline and post baseline DAS28-CRP data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22'}, {'id': 'OG001', 'title': 'Ixekizumab 80 mg Q4W', 'description': 'Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22'}, {'id': 'OG002', 'title': 'Ixekizumab 80 mg Q2W', 'description': 'Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.1', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '-3.7', 'spread': '0.36', 'groupId': 'OG001'}, {'value': '-3.6', 'spread': '0.35', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'The BASDAI is a self-administered measure used to answer 6 questions with a 0 to 10 centimeter (cm) VAS pertaining to the 5 major symptoms of axial activity. To give each symptom equal weighting, the mean of the 2 scores relating to morning stiffness was taken. The resulting 0 to 50 score was divided by 5 to give a final 0 to 10 BASDAI Score. BASDAI ranges from 0-10. Higher scores represent greater disease activity. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had baseline axial involvement defined as baseline BASDAI score \\>4, baseline BASDAI score and post baseline BASDAI score data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fatigue Severity Numeric Rating Scale (NRS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22'}, {'id': 'OG001', 'title': 'Ixekizumab 80 mg Q4W', 'description': 'Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22'}, {'id': 'OG002', 'title': 'Ixekizumab 80 mg Q2W', 'description': 'Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.37', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '0.35', 'groupId': 'OG001'}, {'value': '-2.1', 'spread': '0.34', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'The Fatigue Severity NRS is a participant-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing "no fatigue" and 10 representing "as bad as you can imagine." Participants rated their fatigue (feeling tired or worn out) by circling the 1 number that described their worst level of fatigue during the past 24 hours. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had baseline and post baseline fatigue NRS data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Scores: Physical Component Summary (PCS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22'}, {'id': 'OG001', 'title': 'Ixekizumab 80 mg Q4W', 'description': 'Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22'}, {'id': 'OG002', 'title': 'Ixekizumab 80 mg Q2W', 'description': 'Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22'}], 'classes': [{'categories': [{'measurements': [{'value': '3.3', 'spread': '1.36', 'groupId': 'OG000'}, {'value': '8.9', 'spread': '1.29', 'groupId': 'OG001'}, {'value': '8.2', 'spread': '1.23', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': "The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into the PCS and MCS scores. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. In this study, the SF-36 acute version was used, which has a 1 week recall period. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.", 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had baseline and post baseline PCS data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Scores: Mental Component Summary (MCS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22'}, {'id': 'OG001', 'title': 'Ixekizumab 80 mg Q4W', 'description': 'Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22'}, {'id': 'OG002', 'title': 'Ixekizumab 80 mg Q2W', 'description': 'Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'spread': '1.32', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '1.24', 'groupId': 'OG001'}, {'value': '4.0', 'spread': '1.18', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': "The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into the PCS and MCS scores. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. In this study, the SF-36 acute version was used, which has a 1 week recall period. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.", 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had baseline and post baseline MCS data.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22'}, {'id': 'OG001', 'title': 'Ixekizumab 80 mg Q4W', 'description': 'Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22'}, {'id': 'OG002', 'title': 'Ixekizumab 80 mg Q2W', 'description': 'Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'Number of participants with positive treatment emergent anti-ixekizumab antibodies was summarized by treatment group.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of ixekizumab and had evaluable anti-ixekizumab antibody measurement.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (PK):Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Ixekizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixekizumab 80 mg Q4W', 'description': 'Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22'}, {'id': 'OG001', 'title': 'Ixekizumab 80 mg Q2W', 'description': 'Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22'}], 'classes': [{'categories': [{'measurements': [{'value': '2.46', 'spread': '79.1', 'groupId': 'OG000'}, {'value': '7.96', 'spread': '71.1', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'All immunogenicity samples post the first Ixekizumab dose (Week 4, 12, 24, 36, and 52) and PK samples collected per dedicated sparse sampling plan (4-5 samples per patient) across Weeks 1 through 24 and Early termination visit (ETV)', 'description': 'The Ctrough is the minimum observed serum concentration at steady state of Ixekizumab. The Ctrough at Week 24 was reported.', 'unitOfMeasure': 'micograms per milliliter (mcg/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK Population included all enrolled participants who received at least one dose of the study drug and had evaluable ixekizumab PK data.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics: Area Under the Concentration-Time Curve for Dosing Interval (Tau) at Steady State [AUC(Tau,Steady State)] of Ixekizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixekizumab 80 mg Q4W', 'description': 'Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22'}, {'id': 'OG001', 'title': 'Ixekizumab 80 mg Q2W', 'description': 'Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22'}], 'classes': [{'categories': [{'measurements': [{'value': '141', 'spread': '59.3', 'groupId': 'OG000'}, {'value': '143', 'spread': '57.5', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'All immunogenicity samples post the first Ixekizumab dose (Week 4, 12, 24, 36, and 52) and PK samples collected per dedicated sparse sampling plan (4-5 samples per patient) across Weeks 1 through 24 and Early termination visit (ETV)', 'description': 'The AUC(Tau,Steady State) is the area under the concentration-time curve for dosing interval (Tau) at steady state of ixekizumab (Tau is 28 days for 80 mg Q4W cohort, and is 14 days for 80mg Q2W cohort, respectively).', 'unitOfMeasure': 'mcg*day/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK Population included all enrolled participants who received at least one dose of the study drug and had evaluable ixekizumab PK data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving ACR 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixe 80 mg Q2W / Ixe 80 mg Q2W - Extended Treatment Period', 'description': 'Participants who were randomized to ixekizumab 80 mg Q2W at week 0 and continued on ixekizumab 80 mg Q2W during the Extension Period.'}, {'id': 'OG001', 'title': 'Ixe 80 mg Q4W / Ixe 80 mg Q4W - Extended Treatment Period', 'description': 'Participants who were randomized to ixekizumab 80 mg Q4W at week 0 and continued on ixekizumab 80 mg Q4W during the Extension Period.'}, {'id': 'OG002', 'title': 'Placebo/ Ixe 80 mg Q2W - Extended Treatment Period', 'description': 'Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q2W during the Extension Period.\n\nParticipants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24.\n\nParticipants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.'}, {'id': 'OG003', 'title': 'Placebo/ Ixe 80 mg Q4W - Extended Treatment Period', 'description': 'Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q4W during the Extension Period.\n\nParticipants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24.\n\nParticipants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.'}], 'classes': [{'title': 'Week 52', 'categories': [{'measurements': [{'value': '58.9', 'groupId': 'OG000'}, {'value': '67.6', 'groupId': 'OG001'}, {'value': '50.0', 'groupId': 'OG002'}, {'value': '60.9', 'groupId': 'OG003'}]}]}, {'title': 'Week 156', 'categories': [{'measurements': [{'value': '42.1', 'groupId': 'OG000'}, {'value': '50.5', 'groupId': 'OG001'}, {'value': '39.1', 'groupId': 'OG002'}, {'value': '45.7', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52 and Week 156', 'description': "ACR20 response is defined as a ≥20% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants. Non-responder Imputation (NRI) is applied for inadequate responders at week 16 and participants who discontinued on or prior to week 24.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving ACR 50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixe 80 mg Q2W / Ixe 80 mg Q2W - Extended Treatment Period', 'description': 'Participants who were randomized to ixekizumab 80 mg Q2W at week 0 and continued on ixekizumab 80 mg Q2W during the Extension Period.'}, {'id': 'OG001', 'title': 'Ixe 80 mg Q4W / Ixe 80 mg Q4W - Extended Treatment Period', 'description': 'Participants who were randomized to ixekizumab 80 mg Q4W at week 0 and continued on ixekizumab 80 mg Q4W during the Extension Period.'}, {'id': 'OG002', 'title': 'Placebo/ Ixe 80 mg Q2W - Extended Treatment Period', 'description': 'Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q2W during the Extension Period.\n\nParticipants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24.\n\nParticipants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.'}, {'id': 'OG003', 'title': 'Placebo/ Ixe 80 mg Q4W - Extended Treatment Period', 'description': 'Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q4W during the Extension Period.\n\nParticipants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24.\n\nParticipants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.'}], 'classes': [{'title': 'Week 52', 'categories': [{'measurements': [{'value': '38.3', 'groupId': 'OG000'}, {'value': '45.9', 'groupId': 'OG001'}, {'value': '34.8', 'groupId': 'OG002'}, {'value': '43.5', 'groupId': 'OG003'}]}]}, {'title': 'Week 156', 'categories': [{'measurements': [{'value': '29.0', 'groupId': 'OG000'}, {'value': '35.1', 'groupId': 'OG001'}, {'value': '26.1', 'groupId': 'OG002'}, {'value': '34.8', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52 and Week 156', 'description': "ACR50 response is defined as a ≥50% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants. Non-responder Imputation (NRI) is applied for inadequate responders at week 16 and participants who discontinued on or prior to week 24.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving ACR 70', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixe 80 mg Q2W / Ixe 80 mg Q2W - Extended Treatment Period', 'description': 'Participants who were randomized to ixekizumab 80 mg Q2W at week 0 and continued on ixekizumab 80 mg Q2W during the Extension Period.'}, {'id': 'OG001', 'title': 'Ixe 80 mg Q4W / Ixe 80 mg Q4W - Extended Treatment Period', 'description': 'Participants who were randomized to ixekizumab 80 mg Q4W at week 0 and continued on ixekizumab 80 mg Q4W during the Extension Period.'}, {'id': 'OG002', 'title': 'Placebo/ Ixe 80 mg Q2W - Extended Treatment Period', 'description': 'Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q2W during the Extension Period.\n\nParticipants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24.\n\nParticipants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.'}, {'id': 'OG003', 'title': 'Placebo/ Ixe 80 mg Q4W - Extended Treatment Period', 'description': 'Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q4W during the Extension Period.\n\nParticipants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24.\n\nParticipants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.'}], 'classes': [{'title': 'Week 52', 'categories': [{'measurements': [{'value': '20.6', 'groupId': 'OG000'}, {'value': '28.8', 'groupId': 'OG001'}, {'value': '15.2', 'groupId': 'OG002'}, {'value': '23.9', 'groupId': 'OG003'}]}]}, {'title': 'Week 156', 'categories': [{'measurements': [{'value': '22.4', 'groupId': 'OG000'}, {'value': '21.6', 'groupId': 'OG001'}, {'value': '10.9', 'groupId': 'OG002'}, {'value': '19.6', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52 and Week 156', 'description': "ACR70 response is defined as a ≥70% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants. Non-responder Imputation (NRI) is applied for inadequate responders at week 16 and participants who discontinued on or prior to week 24.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ixekizumab 80 mg Q2W (Ixe 80 mg Q2W)- Blinded Treatment Period', 'description': 'Participants received a starting dose of 160 mg of ixekizumab given as 2 subcutaneous (SC) injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab every 2 Weeks (Q2W) given on Weeks 2, 4, 6, 8, 10, 12,14, 16, 18, 20, 22, and 24.'}, {'id': 'FG001', 'title': 'Ixekizumab 80 mg Q4W (Ixe 80 mg Q4W)- Blinded Treatment Period', 'description': 'Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14, 18, and 22.'}, {'id': 'FG002', 'title': 'Placebo (PBO) - Blinded Treatment Period', 'description': 'Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24.'}, {'id': 'FG003', 'title': 'Ixe 80 mg Q2W - Blinded Treatment Period IR', 'description': 'Week 16 inadequate responders from the placebo treatment group who were re-randomized (1:1) to ixekizumab 80 mg Q2W and IR from ixekizumab 80 mg Q2W who continued on ixekizumab 80 mg Q2W. Participants received rescue therapy while receiving ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20, 22, and 24.'}, {'id': 'FG004', 'title': 'Ixe 80 mg Q4W - Blinded Treatment Period IR', 'description': 'Week 16 inadequate responders from the placebo treatment group who were re-randomized (1:1) to ixekizumab 80 mg Q4W and IR from ixekizumab 80 mg Q4W who continued on ixekizumab 80 mg Q4W. Participants received rescue therapy while receiving ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22.'}, {'id': 'FG005', 'title': 'PBO IR / Ixe 80 mg Q2W - Blinded Treatment Period IR', 'description': 'Participants initially randomized to placebo treatment group in the double blind treatment period who were flagged as inadequate responders at week 16 were re-randomized to ixekizumab 80 mg Q2W for the remainder of the current period and following period.'}, {'id': 'FG006', 'title': 'PBO IR / Ixe 80 mg Q4W - Blinded Treatment Period IR', 'description': 'Participants initially randomized to placebo treatment group in the double blind treatment period who were flagged as inadequate responders at week 16 were re-randomized to ixekizumab 80 mg Q4W for the remainder of the current period and following period.'}, {'id': 'FG007', 'title': 'Ixe 80 mg Q2W / Ixe 80 mg Q2W - Extended Treatment Period', 'description': 'Participants who were randomized to ixekizumab 80 mg Q2W at week 0 and continued on ixekizumab 80 mg Q2W during the Extension Period.'}, {'id': 'FG008', 'title': 'Ixe 80 mg Q4W / Ixe 80 mg Q4W - Extended Treatment Period', 'description': 'Participants who were randomized to ixekizumab 80 mg Q4W at week 0 and continued on ixekizumab 80 mg Q4W during the Extension Period.'}, {'id': 'FG009', 'title': 'Placebo/ Ixe 80 mg Q2W - Extended Treatment Period', 'description': 'Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q2W during the Extension Period.\n\nParticipants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24.\n\nParticipants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.'}, {'id': 'FG010', 'title': 'Placebo/ Ixe 80 mg Q4W - Extended Treatment Period', 'description': 'Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q4W during the Extension Period.\n\nParticipants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24.\n\nParticipants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.'}, {'id': 'FG011', 'title': 'Ixe 80 mg Q2W - Post Treatment Follow-Up Period', 'description': 'Participants who received ixekizumab 80 mg Q2W prior to entering the post-treatment follow-up period, who were either completed the study or discontinued the study early entered the post-treatment follow-up period (a 12-24 week period after their last scheduled treatment visit).'}, {'id': 'FG012', 'title': 'Ixe 80 mg Q4W - Post Treatment Follow-Up Period', 'description': 'Participants who received ixekizumab 80 mg Q4W prior to entering the post-treatment follow-up period, who were either completed the study or discontinued the study early entered the post-treatment follow-up period (a 12-24 week period after their last scheduled treatment visit).'}, {'id': 'FG013', 'title': 'PBO - Post Treatment Follow-Up Period', 'description': 'Participants who received PBO prior to entering the post-treatment follow-up period, who were either completed the study or discontinued the study early entered the post-treatment follow-up period (a 12-24 week period after their last scheduled treatment visit).'}], 'periods': [{'title': 'Double Blind Treatment (Week 0-24)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '123'}, {'groupId': 'FG001', 'numSubjects': '122'}, {'groupId': 'FG002', 'numSubjects': '118'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}]}, {'type': 'Received Atleast One Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '123'}, {'groupId': 'FG001', 'numSubjects': '122'}, {'groupId': 'FG002', 'numSubjects': '118'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '109'}, {'groupId': 'FG001', 'numSubjects': '111'}, {'groupId': 'FG002', 'numSubjects': '94'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '24'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}]}, {'type': 'Failure To Meet Randomization', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}]}]}, {'title': 'IR (Week 16-24)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Only IR participants were included.', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Only IR participants were included.', 'groupId': 'FG001', 'numSubjects': '0'}, {'comment': 'Only IR participants were included.', 'groupId': 'FG002', 'numSubjects': '0'}, {'comment': 'IR from ixekizumab 80 mg Q2W only.', 'groupId': 'FG003', 'numSubjects': '17'}, {'comment': 'IR from ixekizumab 80 mg Q4W only.', 'groupId': 'FG004', 'numSubjects': '15'}, {'comment': 'IR from placebo who re-randomized (1:1) to ixekizumab 80 mg Q2W.', 'groupId': 'FG005', 'numSubjects': '16'}, {'comment': 'IR from placebo who re-randomized (1:1) to ixekizumab 80 mg Q4W.', 'groupId': 'FG006', 'numSubjects': '16'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '16'}, {'groupId': 'FG004', 'numSubjects': '15'}, {'groupId': 'FG005', 'numSubjects': '16'}, {'groupId': 'FG006', 'numSubjects': '16'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}]}]}, {'title': 'Long-Term Extension Period (Week 24-156)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'comment': 'Only included combined extension participants.', 'groupId': 'FG003', 'numSubjects': '0'}, {'comment': 'Only included combined extension participants.', 'groupId': 'FG004', 'numSubjects': '0'}, {'comment': 'Only included combined extension participants.', 'groupId': 'FG005', 'numSubjects': '0'}, {'comment': 'Only included combined extension participants.', 'groupId': 'FG006', 'numSubjects': '0'}, {'comment': 'IxeQ2W participants who entered the long-term extension period.', 'groupId': 'FG007', 'numSubjects': '107'}, {'comment': 'IxeQ4W participants who entered the long-term extension period.', 'groupId': 'FG008', 'numSubjects': '111'}, {'comment': 'Placebo/IxeQ2W participants who entered the long-term extension period.', 'groupId': 'FG009', 'numSubjects': '46'}, {'comment': 'Placebo/IxeQ4W participants who entered the long-term extension period.', 'groupId': 'FG010', 'numSubjects': '46'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '55'}, {'groupId': 'FG008', 'numSubjects': '70'}, {'groupId': 'FG009', 'numSubjects': '20'}, {'groupId': 'FG010', 'numSubjects': '23'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '52'}, {'groupId': 'FG008', 'numSubjects': '41'}, {'groupId': 'FG009', 'numSubjects': '26'}, {'groupId': 'FG010', 'numSubjects': '23'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '32'}, {'groupId': 'FG008', 'numSubjects': '25'}, {'groupId': 'FG009', 'numSubjects': '19'}, {'groupId': 'FG010', 'numSubjects': '18'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '9'}, {'groupId': 'FG008', 'numSubjects': '9'}, {'groupId': 'FG009', 'numSubjects': '2'}, {'groupId': 'FG010', 'numSubjects': '2'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}]}, {'type': 'Unknown/Missing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '3'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '4'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '3'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}]}]}, {'title': 'Follow-Up Period (Up to 12-24 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'comment': 'Only included post-treatment follow-up participants.', 'groupId': 'FG007', 'numSubjects': '0'}, {'comment': 'Only included post-treatment follow-up participants.', 'groupId': 'FG008', 'numSubjects': '0'}, {'comment': 'Only included post-treatment follow-up participants.', 'groupId': 'FG009', 'numSubjects': '0'}, {'comment': 'Only included post-treatment follow-up participants.', 'groupId': 'FG010', 'numSubjects': '0'}, {'comment': 'IxeQ2W participants who entered post-treatment follow-up.', 'groupId': 'FG011', 'numSubjects': '142'}, {'comment': 'IxeQ4W participants who entered post-treatment follow-up.', 'groupId': 'FG012', 'numSubjects': '145'}, {'comment': 'PBO participants who entered post-treatment follow-up.', 'groupId': 'FG013', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '133'}, {'groupId': 'FG012', 'numSubjects': '137'}, {'groupId': 'FG013', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '9'}, {'groupId': 'FG012', 'numSubjects': '8'}, {'groupId': 'FG013', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '1'}, {'groupId': 'FG012', 'numSubjects': '5'}, {'groupId': 'FG013', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '1'}, {'groupId': 'FG012', 'numSubjects': '2'}, {'groupId': 'FG013', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '1'}, {'groupId': 'FG012', 'numSubjects': '1'}, {'groupId': 'FG013', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '2'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}]}, {'type': 'Unknown/Missing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '4'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}, {'value': '363', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22'}, {'id': 'BG001', 'title': 'Ixekizumab 80 mg Q4W', 'description': 'Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22'}, {'id': 'BG002', 'title': 'Ixekizumab 80 mg Q2W', 'description': 'Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.5', 'spread': '10.39', 'groupId': 'BG000'}, {'value': '52.6', 'spread': '13.57', 'groupId': 'BG001'}, {'value': '51.7', 'spread': '11.85', 'groupId': 'BG002'}, {'value': '51.9', 'spread': '12.00', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}, {'value': '194', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '169', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '324', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}, {'value': '332', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Czechia', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '188', 'groupId': 'BG003'}]}]}, {'title': 'Taiwan', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All randomized participants.'}}, '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': 363}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09-01', 'completionDateStruct': {'date': '2019-06-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-19', 'studyFirstSubmitDate': '2014-10-10', 'resultsFirstSubmitDate': '2017-09-06', 'studyFirstSubmitQcDate': '2015-01-23', 'lastUpdatePostDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-11-17', 'studyFirstPostDateStruct': {'date': '2015-01-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving American College of Rheumatology 20 Index (ACR20)', 'timeFrame': 'Week 24', 'description': "ACR20 response is defined as a greater than or equal to (≥) 20% improvement from baseline for tender joint count (TJC) and swollen joint count (SJC) and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain visual analog scale (VAS), Participant's Global Assessment of Disease Activity VAS (PatGA), Physician's Global Assessment of the Disease Activity VAS (PGA), Participant's Assessment of Physical Function using the Health Assessment Questionnaire Disability Index (HAQ-DI), or Acute Phase Reactant as measured by high sensitivity C-reactive protein (hs-CRP)."}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score', 'timeFrame': 'Baseline, Week 24', 'description': "HAQ-DI is a participant reported questionnaire that measures disease-associated disability(physical function).It consists of 24 questions with 8 domains: dressing/grooming,arising,eating,walking,hygiene,reach,grip and other daily activities. The disability section scores the participant's self-perception on degree of difficulty (0=without any difficulty,1=with some difficulty,2=with much difficulty,3=unable to do)covering the 8 domains.The HAQ-DI is a composite ranging from 0-3 with lower scores indicating less functional disability.The reported use of special aids/devices and/or the need for assistance of another person to perform these activities is assessed.Least Square (LS) mean calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment,baseline score,geographic region, TNFi experience,visit, treatment-by-visit interaction(itcn), geographic region-by-visit itcn,TNFi experience-by-visit itcn and baseline score-by-visit itcn."}, {'measure': 'Percentage of Participants Achieving ACR20', 'timeFrame': 'Week 12', 'description': "ACR20 response is defined as a ≥20% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP."}, {'measure': 'Percentage of Participants Achieving American College of Rheumatology 50 Index (ACR50)', 'timeFrame': 'Week 24', 'description': "ACR50 response is defined as a ≥50% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP."}, {'measure': 'Percentage of Participants Achieving American College of Rheumatology 70 Index (ACR70)', 'timeFrame': 'Week 24', 'description': "ACR70 response is defined as a ≥70% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP."}, {'measure': 'Percentage of Participants With Psoriasis Area and Severity Index (PASI) 75', 'timeFrame': 'Week 12', 'description': 'The PASI is an index that combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 were defined as having an improvement of at least 75% in the PASI compared to their baseline measures.'}, {'measure': 'Percentage of Patients Achieving Minimal Disease Activity (MDA)', 'timeFrame': 'Week 24', 'description': "It uses a composite of 7 key outcome measures (includes PASI) used in PsA to encompass all of the domains of the disease to measure the overall state of a patients' disease. The LEI is used to assess tender entheseal points. Patients are classified as achieving MDA if they fulfill 5 of 7 outcome measures: 1. TJC ≤1, 2. SJC ≤1, 3. PASI total score ≤1 or BSA ≤3, 4. patient pain VAS score of ≤15, 5. patient global VAS score of ≤20, 6. HAQ-DI score ≤0.5, 7. tender entheseal points (6 entheseal points) ≤1."}, {'measure': 'Percentage of Patients Achieving Complete Resolution in Enthesitis as Assessed by the Leeds Enthesitis Index (LEI)', 'timeFrame': 'Week 24', 'description': 'The LEI was developed specifically for use in PsA. It measures enthesitis at 6 sites (lateral epicondyle, left and right; medial femoral condyle, left and right; Achilles tendon insertion, left and right). Each site was assigned a score of 0 (absent) or 1 (present); the results from each site were then added to produce a total score (range 0 to 6). So, "0" indicates good score here.'}, {'measure': 'Change From Baseline in Itch Numeric Rating Scale (NRS)', 'timeFrame': 'Baseline, Week 12', 'description': 'The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participants itching from psoriasis was indicated by circling the number that best described the worst level of itching in the past 24 hours. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.'}, {'measure': 'Change From Baseline in Tender Joint Count (TJC)', 'timeFrame': 'Baseline, Week 24', 'description': 'TJC is the number of tender and painful joints determined for each participant by examination of 68 joints. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.'}, {'measure': 'Change From Baseline in Swollen Joint Count (SJC)', 'timeFrame': 'Baseline, Week 24', 'description': 'SJC is the number of swollen joints determined for each participant by examination of 66 joints. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.'}, {'measure': 'Change From Baseline in Participants Assessment of Pain Visual Analog Scale (VAS)', 'timeFrame': 'Baseline, Week 24', 'description': "The pain VAS is a participant-administered single-item scale designed to measure current joint pain from Psoriatic arthritis (PsA) using a 100-millimeter(mm) horizontal VAS. Overall severity of participant's joint pain from PsA is indicated by marking a vertical tick on the horizontal 100-mm scale, where the left end from 0 mm (no pain) to right end 100 mm (worst possible joint pain). LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction."}, {'measure': 'Change From Baseline in Patients Global Assessment of Disease Activity VAS', 'timeFrame': 'Baseline, Week 24', 'description': "The patient's overall assessment of his or her PsA activity will be recorded using a 100-mm horizontal VAS, where 0 represents no disease activity and 100 represents extremely active disease. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction."}, {'measure': 'Change From Baseline in Physicians Global Assessment of Disease Activity VAS', 'timeFrame': 'Baseline, Week 24', 'description': "The investigator will be asked to give an overall assessment of the severity of the participant's current PsA activity using a 100-mm horizontal VAS, where 0 represents no disease activity and 100 represents extremely active disease. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction."}, {'measure': 'Change From Baseline in C-Reactive Protein (CRP)', 'timeFrame': 'Baseline, Week 24', 'description': 'C-reactive protein (CRP) is a disease related biomarker and measured in milligrams per liter. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.'}, {'measure': 'Change From Baseline in Disease Activity Score-CRP (DAS28-CRP)', 'timeFrame': 'Baseline, Week 24', 'description': "The DAS28-CRP is a measure of disease activity in 28 joints that consists of a composite numerical score with the following variables: TJC28, SJC28, hs-CRP (measured in mg/L), and Participant's Global Assessment of Disease Activity recorded by participants on a 0 to 100 millimeter (mm) VAS. For DAS28-CRP, the Tender Joint Count 28 (TJC28) and Swollen Joint Count (SJC28) are a subset of TJC and SJC, and include 14 joints on each side of the body: 2 shoulders, 2 elbows, 2 wrists, 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. DAS28 values range from 0 to 9.4. Higher values indicate more severe symptoms and greater functional impairment. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction."}, {'measure': 'Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score', 'timeFrame': 'Baseline, Week 24', 'description': 'The BASDAI is a self-administered measure used to answer 6 questions with a 0 to 10 centimeter (cm) VAS pertaining to the 5 major symptoms of axial activity. To give each symptom equal weighting, the mean of the 2 scores relating to morning stiffness was taken. The resulting 0 to 50 score was divided by 5 to give a final 0 to 10 BASDAI Score. BASDAI ranges from 0-10. Higher scores represent greater disease activity. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.'}, {'measure': 'Change From Baseline in Fatigue Severity Numeric Rating Scale (NRS) Score', 'timeFrame': 'Baseline, Week 24', 'description': 'The Fatigue Severity NRS is a participant-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing "no fatigue" and 10 representing "as bad as you can imagine." Participants rated their fatigue (feeling tired or worn out) by circling the 1 number that described their worst level of fatigue during the past 24 hours. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.'}, {'measure': 'Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Scores: Physical Component Summary (PCS)', 'timeFrame': 'Baseline, Week 24', 'description': "The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into the PCS and MCS scores. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. In this study, the SF-36 acute version was used, which has a 1 week recall period. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction."}, {'measure': 'Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Scores: Mental Component Summary (MCS)', 'timeFrame': 'Baseline, Week 24', 'description': "The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into the PCS and MCS scores. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. In this study, the SF-36 acute version was used, which has a 1 week recall period. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction."}, {'measure': 'Number of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA)', 'timeFrame': 'Week 24', 'description': 'Number of participants with positive treatment emergent anti-ixekizumab antibodies was summarized by treatment group.'}, {'measure': 'Pharmacokinetics (PK):Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Ixekizumab', 'timeFrame': 'All immunogenicity samples post the first Ixekizumab dose (Week 4, 12, 24, 36, and 52) and PK samples collected per dedicated sparse sampling plan (4-5 samples per patient) across Weeks 1 through 24 and Early termination visit (ETV)', 'description': 'The Ctrough is the minimum observed serum concentration at steady state of Ixekizumab. The Ctrough at Week 24 was reported.'}, {'measure': 'Pharmacokinetics: Area Under the Concentration-Time Curve for Dosing Interval (Tau) at Steady State [AUC(Tau,Steady State)] of Ixekizumab', 'timeFrame': 'All immunogenicity samples post the first Ixekizumab dose (Week 4, 12, 24, 36, and 52) and PK samples collected per dedicated sparse sampling plan (4-5 samples per patient) across Weeks 1 through 24 and Early termination visit (ETV)', 'description': 'The AUC(Tau,Steady State) is the area under the concentration-time curve for dosing interval (Tau) at steady state of ixekizumab (Tau is 28 days for 80 mg Q4W cohort, and is 14 days for 80mg Q2W cohort, respectively).'}, {'measure': 'Percentage of Participants Achieving ACR 20', 'timeFrame': 'Week 52 and Week 156', 'description': "ACR20 response is defined as a ≥20% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP."}, {'measure': 'Percentage of Participants Achieving ACR 50', 'timeFrame': 'Week 52 and Week 156', 'description': "ACR50 response is defined as a ≥50% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP."}, {'measure': 'Percentage of Participants Achieving ACR 70', 'timeFrame': 'Week 52 and Week 156', 'description': "ACR70 response is defined as a ≥70% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Psoriatic Arthritis']}, 'referencesModule': {'references': [{'pmid': '40014255', 'type': 'DERIVED', 'citation': 'Kristensen LE, McGonagle D, Rudwaleit M, Kameda H, Wurtzen PA, Ngantcha M, Holzkamper T, Smolen J. 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Safety of ixekizumab in patients with psoriatic arthritis: data from four clinical trials with over 2000 patient-years of exposure. Ann Rheum Dis. 2022 Jul;81(7):944-950. doi: 10.1136/annrheumdis-2021-222027. Epub 2022 Apr 7.'}, {'pmid': '33499913', 'type': 'DERIVED', 'citation': 'Combe B, Tsai TF, Huffstutter JE, Sprabery AT, Lin CY, Park SY, Kronbergs A, Hufford MM, Nash P. Ixekizumab, with or without concomitant methotrexate, improves signs and symptoms of PsA: week 52 results from Spirit-P1 and Spirit-P2 studies. Arthritis Res Ther. 2021 Jan 27;23(1):41. doi: 10.1186/s13075-020-02388-5.'}, {'pmid': '33278016', 'type': 'DERIVED', 'citation': 'Orbai AM, Gratacos J, Turkiewicz A, Hall S, Dokoupilova E, Combe B, Nash P, Gallo G, Bertram CC, Gellett AM, Sprabery AT, Birt J, Macpherson L, Geneus VJ, Constantin A. Efficacy and Safety of Ixekizumab in Patients with Psoriatic Arthritis and Inadequate Response to TNF Inhibitors: 3-Year Follow-Up (SPIRIT-P2). Rheumatol Ther. 2021 Mar;8(1):199-217. doi: 10.1007/s40744-020-00261-0. Epub 2020 Dec 5.'}, {'pmid': '32792421', 'type': 'DERIVED', 'citation': 'Schweikert B, Malmberg C, Nunez M, Dilla T, Sapin C, Hartz S. Cost-effectiveness analysis of ixekizumab versus secukinumab in patients with psoriatic arthritis and concomitant moderate-to-severe psoriasis in Spain. BMJ Open. 2020 Aug 13;10(8):e032552. doi: 10.1136/bmjopen-2019-032552.'}, {'pmid': '31964419', 'type': 'DERIVED', 'citation': 'Combe B, Rahman P, Kameda H, Canete JD, Gallo G, Agada N, Xu W, Genovese MC. Safety results of ixekizumab with 1822.2 patient-years of exposure: an integrated analysis of 3 clinical trials in adult patients with psoriatic arthritis. Arthritis Res Ther. 2020 Jan 21;22(1):14. doi: 10.1186/s13075-020-2099-0.'}, {'pmid': '31154634', 'type': 'DERIVED', 'citation': 'Tillett W, Lin CY, Zbrozek A, Sprabery AT, Birt J. A Threshold of Meaning for Work Disability Improvement in Psoriatic Arthritis Measured by the Work Productivity and Activity Impairment Questionnaire. Rheumatol Ther. 2019 Sep;6(3):379-391. doi: 10.1007/s40744-019-0155-5. Epub 2019 Jun 1.'}, {'pmid': '30886974', 'type': 'DERIVED', 'citation': "Coates LC, Orbai AM, Morita A, Benichou O, Kerr L, Adams DH, Shuler CL, Birt J, Helliwell PS. Achieving minimal disease activity in psoriatic arthritis predicts meaningful improvements in patients' health-related quality of life and productivity. BMC Rheumatol. 2018 Aug 13;2:24. doi: 10.1186/s41927-018-0030-y. eCollection 2018."}, {'pmid': '30696483', 'type': 'DERIVED', 'citation': 'Gladman DD, Orbai AM, Klitz U, Wei JC, Gallo G, Birt J, Rathmann S, Shrom D, Marzo-Ortega H. Ixekizumab and complete resolution of enthesitis and dactylitis: integrated analysis of two phase 3 randomized trials in psoriatic arthritis. Arthritis Res Ther. 2019 Jan 29;21(1):38. doi: 10.1186/s13075-019-1831-0.'}, {'pmid': '30053162', 'type': 'DERIVED', 'citation': 'Genovese MC, Combe B, Kremer JM, Tsai TF, Behrens F, Adams DH, Lee C, Kerr L, Nash P. Safety and efficacy of ixekizumab in patients with PsA and previous inadequate response to TNF inhibitors: week 52 results from SPIRIT-P2. Rheumatology (Oxford). 2018 Nov 1;57(11):2001-2011. doi: 10.1093/rheumatology/key182.'}, {'pmid': '28551073', 'type': 'DERIVED', 'citation': 'Nash P, Kirkham B, Okada M, Rahman P, Combe B, Burmester GR, Adams DH, Kerr L, Lee C, Shuler CL, Genovese M; SPIRIT-P2 Study Group. Ixekizumab for the treatment of patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors: results from the 24-week randomised, double-blind, placebo-controlled period of the SPIRIT-P2 phase 3 trial. Lancet. 2017 Jun 10;389(10086):2317-2327. doi: 10.1016/S0140-6736(17)31429-0. Epub 2017 May 24.'}], 'seeAlsoLinks': [{'url': 'http://www.lillytrialguide.com/EN-us/studies/arthritis/rhbe', 'label': 'Click here for more information about this study: A Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to evaluate how effective and safe the study drug known as ixekizumab is in participants with active psoriatic arthritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presents with established diagnosis of active psoriatic arthritis (PsA) for at least 6 months, and currently meets Classification for Psoriatic Arthritis (CASPAR) criteria\n* Active PsA defined as the presence of at least 3 tender and at least 3 swollen joints\n* Presence of active psoriatic skin lesion or a history of plaque psoriasis (Ps)\n* Men must agree to use a reliable method of birth control or remain abstinent during the study\n* Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment\n* Have been treated with 1 or more conventional disease-modifying antirheumatic drugs (cDMARDs)\n* Have had prior treatment with at least 1 and not more than 2 tumor necrosis factor (TNF) inhibitors. The participant must have discontinued at least 1 TNF inhibitor due to either an inadequate response (based on a minimum of 12 weeks on therapy) or documented intolerance.\n\nExclusion Criteria:\n\n* Current use of biologic agents for treatment of Ps or PsA\n* Inadequate response to greater than 2 biologic DMARDs\n* Current use of more than one cDMARDs\n* Diagnosis of active inflammatory arthritic syndromes or spondyloarthropathies other than PsA\n* Have received treatment with interleukin (IL) -17 or IL12/23 targeted monoclonal antibody (MAb) therapy\n* Serious disorder or illness other than psoriatic arthritis\n* Serious infection within the last 3 months\n* Breastfeeding or nursing (lactating) women'}, 'identificationModule': {'nctId': 'NCT02349295', 'acronym': 'SPIRIT-P2', 'briefTitle': 'A Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Placebo Controlled 24-Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Biologic Disease-Modifying Antirheumatic Drug-Experienced Patients With Active Psoriatic Arthritis', 'orgStudyIdInfo': {'id': '14310'}, 'secondaryIdInfos': [{'id': 'I1F-MC-RHBE', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': '2011-002328-42', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ixekizumab 80 milligram (mg) every 2 Weeks (Q2W)', 'description': 'Blinded Treatment Period (Week(wk) 0-24): Participants (pts) received a starting dose of 160 mg of ixekizumab (ixe) given as 2 subcutaneous (SC) injections at Wk 0 followed by 1 SC injection of 80 mg of ixe Q2W given on Wks 2,4,6,8,10,12,14,16,18,20,22, and 24.Week 16 inadequate responders (IR) from the placebo treatment group who were re-randomized (1:1) to ixe 80 mg Q2W and IR from ixekizumab 80 mg Q2W who continued on ixekizumab 80 mg Q2W. Pts receive rescue therapy while receiving ixekizumab given as 1 injection of 80 mg Q2W given on Wks 16,18,20,22,24. Extension Period (Wk24-156):Pts who were randomized to ixe 80 mg Q2W at week 0 and continued on ixe 80 mg Q2W during the Extension Period. Pts who received ixekizumab 80 mg Q2W,who were either completed the study or discontinued the study early entered the post-treatment follow-up period (12-24 weeks).', 'interventionNames': ['Drug: Placebo', 'Drug: Ixekizumab 80 mg Q2W']}, {'type': 'EXPERIMENTAL', 'label': 'Ixekizumab 80 mg Q4W', 'description': 'Blinded Treatment Period (Week 0-24): Participants (pts) received a starting dose of 160 mg of ixekizumab (ixe) given as 2 subcutaneous (SC) injections at Wk 0 followed by 1 SC injection of 80 mg of ixe Q4W given on Wks 4, 8 and 12 alternating with placebo for ixe injections Q4W given on Wks 2,6,10,14,18, and 22.Week 16 inadequate responders (IR) from the placebo treatment group who were re-randomized (1:1) to ixe 80 mg Q4W and IR from ixekizumab 80 mg Q4W who continued on ixekizumab 80 mg Q4W. Pts receive rescue therapy while receiving ixekizumab given as 1 injection of 80 mg Q4W given on Wks 16 and 20 alternating with placebo for ixe injections Q4W given on Wks 18 and 22.Extension Period (Wk24-156):Pts who were randomized to ixe 80 mg Q4W at week 0 and continued on ixe 80 mg Q4W during the Extension Period.Pts who received ixekizumab 80 mg Q4W,who were either completed the study or discontinued the study early entered the post-treatment follow-up period (12-24 weeks).', 'interventionNames': ['Drug: Placebo', 'Drug: Ixekizumab 80 mg Q4W']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Blinded Treatment Period (Wk 0-24): Pts received placebo for Ixe as 2 SC injections followed by 1 SC injection Q2W given on Wks 2,4,6,8,10,12,14,16,18,20,22 and 24. Pts initially randomized to placebo treatment group in the double blind treatment period,flagged as IR at Wk 16,re-randomized to ixe 80 mg Q2W/Q4W for the remainder of the current period and following period. Extended Treatment Period (Wk 24-156): Pts who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q2W/Q4W during the Extension Period.Pts who remained on placebo at the completion of the double blind treatment period received the first dose of ixe (160 mg starting dose) at Wk 24.Pts who were IRs at Wk 16 and were re-randomized to ixe at Wk 16 received the first dose of ixe (160 mg starting dose) at Wk 16. Pts who received placebo,who were either completed the study or discontinued the study early entered the post-treatment follow-up period (12-24 weeks).', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['Ixekizumab 80 mg Q4W', 'Ixekizumab 80 milligram (mg) every 2 Weeks (Q2W)', 'Placebo']}, {'name': 'Ixekizumab 80 mg Q4W', 'type': 'DRUG', 'otherNames': ['LY2439821'], 'description': 'Administered SC', 'armGroupLabels': ['Ixekizumab 80 mg Q4W']}, {'name': 'Ixekizumab 80 mg Q2W', 'type': 'DRUG', 'otherNames': ['LY2439821'], 'description': 'Administered SC', 'armGroupLabels': ['Ixekizumab 80 milligram (mg) every 2 Weeks (Q2W)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Rheumatology Associates PC', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85304', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Arthritis & Rheumatology Research', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'zip': '85210', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Arthritis & Rheumatology Research, PLLC', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Arthritis & Rheumatology Research', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Little Rock Diagnostic Clinic', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California - San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '91942', 'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Purushotham & Akther Kotha MD Inc', 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University Hospital', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '94578', 'city': 'San Leandro', 'state': 'California', 'country': 'United States', 'facility': 'East Bay Rheumatology Medical Group', 'geoPoint': {'lat': 37.72493, 'lon': -122.15608}}, {'zip': '92780', 'city': 'Tustin', 'state': 'California', 'country': 'United States', 'facility': 'Office: Dr Robin K Dore', 'geoPoint': {'lat': 33.74585, 'lon': -117.82617}}, {'zip': '33486', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Rheumatology Associates of South Florida', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '34102', 'city': 'Naples', 'state': 'Florida', 'country': 'United States', 'facility': 'Jeffrey Alper MD Research', 'geoPoint': {'lat': 26.14234, 'lon': -81.79596}}, {'zip': '32073', 'city': 'Orange Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Arthritis & Osteoporosis Treatment Center, PA', 'geoPoint': {'lat': 30.16607, 'lon': -81.70648}}, {'zip': '33542-7505', 'city': 'Zephyrhills', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Medical Clinic PA', 'geoPoint': {'lat': 28.23362, 'lon': -82.18119}}, {'zip': '46227', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Diagnostic Rheumatology and Research', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '52403', 'city': 'Cedar Rapids', 'state': 'Iowa', 'country': 'United States', 'facility': 'Physicians Clinic of Iowa', 'geoPoint': {'lat': 42.00833, 'lon': -91.64407}}, {'zip': '67207', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Heartland Research Associates', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '40504', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Bluegrass Community Research. 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