A Study of Ixekizumab in Participants With Active Psoriatic Arthritis
- Conditions
- Arthritic PsoriasisMedDRA version: 17.1Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 100000004859Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2011-002328-42-ES
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 360
? Presents with established diagnosis of active psoriatic arthritis (PSA) for at least 6 months, and currently meets Classification for Psoriatic Arthritis (CASPAR) criteria
? Active psoriatic arthritis 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
? Have been treated with 1 or more conventional disease-modifying antirheumatic drugs (cDMARDs)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 342
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18
? Current use of biologic agents for treatment of Ps or PsA
? Inadequate response to greater than 2 bDMARDs
? Current use of more than one cDMARD
? Diagnosis of active inflammatory arthritic syndromes or spondyloarthropathies other than PsA
? Have received treatment with IL-17 or IL12/23 targeted MAb therapy
? Serious disorder or illness other than psoriatic arthritis
? Serious infection within the last 3 months
? Breastfeeding or nursing (lactating) women
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Efficacy of ixekizumab (LY2439821) compared to placebo in participants with active psoriatic arthritis who are biologic disease-modifying antirheumatic drugs (bDMARD0-experienced, as measured by the percentage of patients achieving ACR20 response at Week 24.;Secondary Objective: ? Efficacy of ixekizumab compared to placebo in participants with active psoriatic arthritis based on ACR20 through 24 Weeks<br>? Efficacy of ixekizumab compared to placebo in participants with active psoriatic arthritis based on Non-Arthritic Disease Assessments through 24 Weeks<br>? Efficacy of ixekizumab compared to placebo in participants with active psoriatic arthritis based on Patient Reported Outcomes (PROs) through 24 Weeks;Primary end point(s): American College of Rheumatology 20 Index (ACR20);Timepoint(s) of evaluation of this end point: At 24 Weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): ? ACR20<br>? Non-Arthritic Disease Assessments<br>? Patient Reported Outcomes (PRO);Timepoint(s) of evaluation of this end point: Baseline through 24 Weeks