disease causing swollen and painful joints Psoriatic arthritis
Conditions
Interventions
At Week 0 (randomization, Visit 2), routine safety assessments, laboratory
tests, and clinical efficacy assessments (including height, weight, and
temperature, as well as review of habits) will be p
Ixekizumab
Psoriatic Arthritis
Sponsors
Eli Lilly
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
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 plaque psoriasis -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
Exclusion criteria
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 -Women who are breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Proportion of patients simultaneously achieving ACR50 and PASI 100 at Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| -Proportion of patients achieving ACR50 in each treatment group at Week 24 -Proportion of patients achieving PASI 100 in each treatment group at Week 24 PsA Endpoints Time course of response to treatment over 52 weeks as measured by: -Proportion of patients achieving ACR20, ACR50, and ACR70 responses -Change from baseline in individual components of the American College of Rheumatology (ACR) Core Set - tender joint count, swollen joint count, patient*s pain assessment, Patient*s Global Assessment of Disease Activity, Physician*s Global Assessment of Disease Activity, C-reactive protein (CRP), and Health Assessment Questionnaire*Disability Index (HAQ-DI) score -Proportion of patients simultaneously achieving ACR50 and PASI 100 response -Change from baseline in the Disease Activity Score (28 diarthrodial joint count) based on C-reactive protein (DAS28-CRP) -Proportion of patients achieving Minimal Disease Activity (MDA) -Proportion of patients achieving Psoriatic Arthritis Response Criteria (PsARC) -Change from baseline in Modified Composite Psoriatic Disease Activity Index (CPDAI) score -Proportion of patients achieving low disease activity or remission according to the Modified Composite Psoriatic Disease Activity Index definition -Proportion of patients with HAQ-DI improvement *0.35 -Change from baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index score in patients with enthesitis at baseline (ie, baseline SPARCC Enthesitis Index score >0) -Change from baseline in the Leeds Enthesitis Index (LEI) score in patients with enthesitis at baseline (ie, baseline LEI score >0) -Proportion of patients with resolution in enthesitis in the subgroup of patients with enthesitis at baseline as measured by the SPARCC Enthesitis Index (ie, baseline SPARCC Enthesitis Index score >0) -Proportion of patients with resolution in enthesitis in the subgroup of patients with enthesitis at baseline as measured by the LEI (ie | — |
Countries
Argentina, Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Hungary, India, Israel, Italy, Mexico, Netherlands, South Africa, Spain, Sweden, Switzerland, Ukraine, United Kingdom
Outcome results
None listed