An Adaptive Phase 2a/2b Study of LY3871801 in Adult Participants With Rheumatoid Arthritis
Rheumatoid Arthritis
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
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
Sites / Locations
- Integrity Clinical ResearchRecruiting
- Advanced Clinical Research of Orlando - OcoeeRecruiting
- Conquest ResearchRecruiting
- PMG Research of SalisburyRecruiting
- Medicina ReumatológicaRecruiting
- Instituto de Alta Complejidad San IsidroRecruiting
- Mautalen Salud e InvestigaciónRecruiting
- CENUDIABRecruiting
- Medical PlusRecruiting
- CHU de NiceRecruiting
- CHU Strasbourg-HautepierreRecruiting
- Centre Hospitalier Universitaire de Reims - l'Hôpital Maison BlancheRecruiting
- Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire CarémeauRecruiting
- CHU Montpellier Lapeyronie HospitalRecruiting
- Infirmerie Protestante de LyonRecruiting
- CHD VendeeRecruiting
- Centre Hospitalier Regional D'OrleansRecruiting
- Hopitaux Universitaires Paris Centre-Hopital Cochin
- University Hospital of Cologne
- Rheumazentrum Ratingen StudienambulanzRecruiting
- Institut für Präventive Medizin & Klinische Forschung GbRRecruiting
- HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg GmbHRecruiting
- Avron HospitalsRecruiting
- Sushruta Multispeciality Hospital & Research CentreRecruiting
- Government Medical College And Hospital - NagpurRecruiting
- All India Institute of Medical Sciences (AIIMS) - NagpurRecruiting
- Grant Medical Foundation - Ruby Hall Clinic
- CIMAB SA de CV
- Biológicos Especializados
- Cicmex Centro de Investigación Clínica de México
- Medical Care and Research SA de CV
- Kohler and Milstein Research S.A. de C.V.
- Investigacion y Biomedicina de Chihuahua
- Estudios Clínicos Internacionales (ECI) - Querétaro
- Centro de Atención e Investigación Cardiovascular del Potosí
- The Dudley Group NHS Foundation Trust
- Northumbria Healthcare NHS Foundation Trust
- New Cross Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Placebo Comparator
Experimental
Experimental
Experimental
Placebo Comparator
LY3871801 Phase 2a
Placebo Phase 2a
LY3871801 Dose 1 Phase 2b
LY3871801 Dose 2 Phase 2b
LY3871801 Dose 3 Phase 2b
Placebo Phase 2b
Participants will receive LY3871801 administered orally.
Participants will receive placebo.
Participants will receive LY3871801 administered orally.
Participants will receive LY3871801 administered orally.
Participants will receive LY3871801 administered orally.
Participants will receive placebo.