Arthritic Psoriasis MedDRA version: 18.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859
Conditions
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients are eligible to be included in the study only if they meet all of the following criteria: [1] are male or female patients 18 years or older who agree to use reliable method of birth control or remain abstinent during the study [2] have had diagnosis of active PsA for at least 6 months and meet Classification for Psoriatic Arthritis (CASPAR) criteria [3] active PsA defined as the presence of at least 3 tender and at least 3 swollen joints [4] have been treated with 1 or more conventional disease-modifying antirheumatic drugs (DMARDs) [5] have active psoriatic skin lesions (plaque) or a documented history of plaque psoriasis 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 380 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: Patients will be excluded from study enrollment if they meet any of the following criteria: [7] have received any previous treatment or are currently receiving treatment with any biologic or small-molecule therapy for PsA or psoriasis [10] have had, in the opinion of the investigator, inadequate response to treatment with =4 cDMARDs or immune modifiers [12] are receiving treatment with more than 1 cDMARD [20] have a known allergy or hypersensitivity to any biologic therapy that would pose an unacceptable risk to the patient if participating in this study [24] have a diagnosis of other inflammatory arthritic syndromes such as RA, ankylosing spondylitis, reactive arthritis, or enteropathic arthritis [33] have serious disorder other than psoriatic arthritis [36] had a serious infection within 12 weeks [43] are positive for human immunodeficiency virus serology [44] have evidence of or test positive for hepatitis B or hepatitis C virus [50] are women who are lactating or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to compare ixekizumab 80 mg Q2W with placebo in maintenance of treatment response, as measured by the time to relapse during the randomized double-blind withdrawal period in cDMARD-IR and bDMARD-naive patients with active PsA who meet randomization criteria (Coates criteria for MDA for 3 consecutive months over 4 consecutive visits).;Secondary Objective: compare ixekizumab 80mg Q2W with placebo in maintenance of treatment response,measured by the proportion of patients who meet relapse criteria during the randomized double-blind withdrawal period in cDMARD-IR and bDMARD-naive patients with active PsA who meet randomization criteria (Coates criteria for MDA for 3 consecutive mths over 4 consecutive visits) evaluate the time to loss of response for each individual component of MDA in the randomized double-blind withdrawal period evaluate time to first meeting Coates criteria for MDA during the initial open-label treatment period evaluate time to achieving Coates criteria for MDA during the initial open-label treatment period (Coates criteria for MDA for 3 consecutive mths over 4 consecutive visits) assess the efficacy of ixekizumab 80mg Q2W after disease relapse after randomization in the randomized double-blind treatment period assess effect of treatment response as measured by the HAQ-DI of ixekizumab 80mg Q2W throughout study;Primary end point(s): Relapse as defined by loss of Coates Criteria for MDA;Timepoint(s) of evaluation of this end point: up to 104 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Tender and swollen joint count, enthesitis, PASI, patient reported outcomes (PRO). ;Timepoint(s) of evaluation of this end point: 36-64 weeks; 104 weeks | — |
Countries
Argentina, Bulgaria, Czech Republic, Estonia, Mexico, Poland, Russian Federation, Slovakia, South Africa, Spain, Ukraine, United Kingdom, United States
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly
Outcome results
None listed