A Study of Ixekizumab (LY2439821) Versus Adalimumab in Participants With Psoriatic Arthritis

• Status: Completed
• Trial end date: 2019-09-04
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to evaluate the effectiveness and safety of ixekizumab versus adalimumab in participants with psoriatic arthritis (PsA) who are biologic disease-modifying anti-rheumatic drugs (DMARD) naive.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Adalimumab; Antirheumatic Agents; Ixekizumab

Criteria

Inclusion Criteria:

• Presence of 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 randomization

• Women who are breastfeeding