EUCTR2011-002328-42-DEActive, not recruitingPhase 1
Protocol I1F-MC-RHBE 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
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Eli Lilly and Company
- Enrollment
- 360
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
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