CTRI/2017/09/009850.

Methods	RCT, active/placebo‐controlled, open‐label Date of study: August 2017 (Starting date) ‐ May 2018 Location: worldwide
Participants	Number of patients : 566 Inclusion criteria: Presents with established diagnosis of active psoriatic arthritis for at least 6 months, and currently meets Classification for Psoriatic Arthritis (CASPAR) criteria (Active PsA defined as the presence of at least 3 (out of 68) tender and at least 3 (out of 66) swollen joints Presence of active plaque psoriasis with a BSA ≥ 3% Men must agree to use a reliable method of birth control or remain abstinent during the study Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment Have had an inadequate response when treated with 1 or more conventional synthetic disease‐modifying antirheumatic drugs (csDMARDs) Exclusion criteria: Current or prior use of biologic agents for treatment of Ps or PsA Evidence of active inflammatory arthritic syndromes or spondyloarthropathies other than PsA Have participated in any study with interleukin 17 (IL‐17) antagonists, including ixekizumab Serious disorder or illness other than psoriatic arthritis Serious infection within the last 3 months Active Crohn's disease or active ulcerative colitis Active vasculitis or uveitis Diagnosis of or history of malignant disease < 5 years prior to randomisation Women who are breastfeeding
Interventions	Intervention 1: Ixekizumab 160 milligrams (mg) ixekizumab given subcutaneously (SC) at baseline for all participants 80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate‐to‐severe plaque Ps 80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate‐to‐severe plaque Ps Adalimumab Intervention 2: adalimumab 80 mg given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate‐to‐severe plaque Ps 40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate‐to‐severe plaque Ps
Outcomes	Primary outcome :Percentage of participants simultaneously achieving American College of Rheumatology 50 (ACR50) and Psoriasis Area and Severity Index 100 (PASI100) at Week 24 Secondary outcome: ACR50at week 24 PASI 100 at week 24 Change From Baseline in TJC Week 52 Change From Baseline in SJC Week 52 Change From Baseline in Participant's Assessment of Pain VAS Week 52 Change From Baseline in Participant's Global Assessment of Disease Activity Week 52 Change From Baseline in Physician's Global Assessment of Disease Activity Week 52 Change From Baseline in C‐Reactive Protein Week 52 Change From Baseline in HAQ‐DI Week 52 Percentage of participants simultaneously achieving ACR50 and PASI100 Week 52 Change From Baseline in Disease Activity Score‐CRP (DAS28‐CRP) Week 52 Percentage of participants achieving Minimal Disease Activity (MDA) Week 52 Percentage of participants achieving Psoriatic Arthritis Response Criteria (PsARC) Week 52 ] Change From Baseline in Modified Composite Psoriatic Disease Activity Index (CPDAI) Score (Modified) Week 52 Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index in Participants With Enthesitis Week 52 Change From Baseline in the Leeds Enthesitis Index (LEI) in Participants With Enthesitis at Baseline Week 52 Change From Baseline in the Leeds Dactylitis Index‐Basic (LDI‐B) in Participants With Dactylitis at Baseline Week 52 Change From Baseline in Psoriasis Body Surface Area (BSA) Week 52 Change From Baseline in the Nail Psoriasis Severity Index (NAPSI) Fingernails Score in the Subgroup of Participants With Fingernail Involvement at Baseline Week 52 Change From Baseline in the Itch NRS Week 52 Change From Baseline in Fatigue Severity NRS (Fatigue NRS) Score Week 52 Change From Baseline in Medical Outcomes Study 36‐item Short Form Health Survey (SF‐36): Physical Component Summary (PCS) Week 52 SF‐36 is a standardised participant‐administered measure designed to evaluate 8 domains of functional health and well‐being. Change From Baseline in Measures of Health Utility (EuroQol‐5 Dimensions 5 Level [EQ‐5D 5L]) Week 52 Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Week 52 Change From Baseline on the Treatment Satisfaction Questionnaire Week 52 Change From Baseline in Columbia Suicide Severity Rating Scale (C‐SSRS) Week 52
Notes	NCT03151551 Lilly