A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 24-Week Study Followed by Long-Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Biologic Disease-Modifying Antirheumatic Drug-Naive Patients with Active Psoriatic Arthritis

Phase 3

Completed

Conditions: Active Psoriatic Arthritis
10003816

Registration Number: NL-OMON39972

Lead Sponsor: Eli Lilly

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 14

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 psoriatic arthritis (PsA) defined as the presence of at least 3 tender and at least 3 swollen joints
• Presence of active psoriatic skin lesion or a history of plaque psoriasis (Ps)
• 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 ;Please refer to page 42 of the protocol for a full list of inclusion criteria.

Exclusion Criteria

• Current or prior use of biologic agents for treatment of Ps or PsA
• Inadequate response to greater than or equal to 4 conventional disease-modifying antirheumatic drugs (DMARDs)
• Current use of more than one conventional DMARD
• 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 3 months prior to randomization
• Breastfeeding or nursing (lactating) women;Please refer to page 43 of the protocol for the full list of exclusion criteria.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>American College of Rheumatology 20 Index (ACR20) at 24 weeks. The individual<br /><br>components that make up the ACR Core Set of measures for PsA are described in<br /><br>section 10.1.1 of the protocol.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>· modified Total Sharp Score (mTSS)<br /><br>· ACR20<br /><br>· Non-Arthritic Disease Assessments<br /><br>· Patient Reported Outcomes (PRO)<br /><br>Measured from baseline through 24 weeks.<br /><br><br /><br>For more information regarding the secundary study parameters, you are referred<br /><br>to section 10.1.2 of the protocol.</p><br>