A Study of Peresolimab (LY3462817) in Participants With Moderately-to-Severely Active Rheumatoid … (NCT05516758) | Clinical Trial Compass
TerminatedPhase 2
A Study of Peresolimab (LY3462817) in Participants With Moderately-to-Severely Active Rheumatoid Arthritis
Stopped: Study terminated due to an unfavourable benefit-risk profile observed in interim data analysis.
United States491 participantsStarted 2022-08-31
Plain-language summary
The main purpose of this study is to assess the safety and efficacy of peresolimab in adult participants with moderately-to-severely active rheumatoid arthritis.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Have a diagnosis of adult onset rheumatoid arthritis (RA) for at least 3 months prior to screening, as defined by the 2010 ACR/European League Against Rheumatism (EULAR) classification criteria
* Have moderately-to-severely active RA, at screening and baseline, defined by the presence of
* ≥6 swollen joints based on 66 joint count, and
* ≥6 tender joints based on 68 joint count.
* Have had an inadequate response to, or loss of response or intolerance to at least 1 conventional synthetic DMARD (csDMARD), biologic DMARD ( bDMARD), or targeted synthetic DMARD (tsDMARD) treatment.
Exclusion Criteria:
* Have Class IV RA according to ACR revised criteria.
* Have presence of 1 or more significant concurrent medical conditions per investigator judgment, including but not limited to
* poorly controlled diabetes or hypertension
* chronic kidney disease stage IIIb, IV, or V
* symptomatic heart failure according to New York Heart Association Class II, III, or IV
* myocardial infarction, unstable angina pectoris, stroke or transient ischemic attack, within the past 12 months before randomization
* severe chronic pulmonary disease, for example, requiring oxygen therapy
* major chronic inflammatory disease or connective tissue disease other than RA, including but not limited to,
* systemic lupus erythematosus
* psoriatic arthritis
* axial spondyloarthritis including ankylosing spondylitis and non-radiographic axial spondyloarthritis
…
What they're measuring
1
Percentage of Participants Achieving 20% Improvement in American College of Rheumatology Criteria (ACR20) Response at Week 12