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Study Condition(s): Psoriasis, Psoriatic Arthritis
A Long-Term Efficacy and Safety Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis (SPIRIT P3)
Study Alias: RHBF
Study Identifier(s):
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Active, not recruiting
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Study Purpose
The main purpose of this study is to evaluate the safety and long-term efficacy of ixekizumab compared to placebo in participants with active psoriatic arthritis.
Key Participation Requirements
All clinical trials have rules about who can participate. This section outlines some of those rules. Please contact a study center to discuss the full set of criteria
Gender
Age
18+
years
Time Commitment
Your participation could last up to 2.5 years and include 32 visits to the study center.
Participant must have a diagnosis of active psoriatic arthritis (PsA) for at least 6 months. Active PsA is defined as the presence of at least 3 tender and at least 3 swollen joints
Participant must have the presence of active psoriatic skin lesions or a history of plaque psoriasis (Ps)
Male participants must agree to use a reliable method of birth control or remain abstinent during the study
Female participants must agree to use reliable method of birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment
Participant must have been previously treated with 1 or more conventional disease-modifying antirheumatic drugs (cDMARDs)
Participant must not be currently using more than one cDMARD
Participant must not have current or prior use of biologic agents for treatment of Ps or PsA
Participant must not have a diagnosis of active inflammatory arthritic syndromes or spondyloarthropathies other than PsA
Participant must not have received treatment with interleukin (IL) -17 or IL12/23 targeted monoclonal antibody (MAb) therapy
Female participant must not be pregnant or breastfeeding