Overview
The main purpose of this study is to evaluate the efficacy and safety of LY3871801 in adult participants with active moderately-to-severe rheumatoid arthritis (RA).
Eligibility
Inclusion Criteria:
- Have a diagnosis of adult-onset 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 a history of failure (an inadequate response, intolerance, or loss of
response) to at least 1 conventional synthetic disease modifying anti rheumatic drug (csDMARD) and either 1 biologic (bDMARD), or targeted synthetic (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 IIIa or 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
- reactive arthritis
- gout
- scleroderma
- polymyositis
- dermatomyositis
- active fibromyalgia, or
- multiple sclerosis