CER San Juan | San Juan, Argentina
Status and phase
Conditions
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Study type
Funder types
Identifiers
About
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.
Enrollment
Sex
Ages
Volunteers
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
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,
Primary purpose
Allocation
Interventional model
Masking
491 participants in 4 patient groups
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Central trial contact
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Data sourced from clinicaltrials.gov
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