An Adaptive Phase 2a/2b Study of LY3871801 in Adult Participants With Rheumatoid Arthritis
Phase 2 – studying effectiveness and dosage
Conditions:
Rheumatoid Arthritis
Sponsor: Eli Lilly and Company
trial.available_in:
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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).
Who can participate
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
Interventions
LY3871801
DRUG
Placebo
DRUG
Locations
54
Argentina (5)
CIPREC
Buenos Aires
Mautalen Salud e Investigación
Buenos Aires
CENUDIAB
Buenos Aires
Medicina Reumatológica
San Fernando
Instituto de Alta Complejidad San Isidro
San Isidro
Czech Republic (1)
Medical Plus
Uherské Hradiště
France (7)
CHD Vendee
La Roche-sur-Yon
CHU Montpellier Lapeyronie Hospital
Montpellier
CHU de Nice
Nice
Centre Hospitalier Regional D'Orleans
Orléans
Hopitaux Universitaires Paris Centre-Hopital Cochin
Paris
Centre Hospitalier Universitaire de Reims - l'Hôpital Maison Blanche
Reims
CHU Strasbourg-Hautepierre
Strasbourg
Germany (2)
Universitaetsklinikum Koeln
Cologne
HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg GmbH / -T
Hamburg
Hungary (7)
Revita Clinic
Budapest
Óbudai Egészségügyi Centrum
Budapest
CRU Hungary Kft.
Encs
Vásárhelyi Sárkányfű KFT
Hódmezővásárhely
Kistarcsai Flor Ferenc Korhaz
Kistarcsa
Regia Med Kft
Székesfehérvár
Vital Medical Center
Veszprém
India (5)
Avron Hospitals
Ahmedabad
Sushruta Multispeciality Hospital & Research Centre
Hubli
All India Institute of Medical Sciences (AIIMS) - Nagpur
Nagpur
Grant Medical Foundation - Ruby Hall Clinic
Pune
Medipoint Hospitals Pvt. Ltd.
Pune
Mexico (9)
Investigacion y Biomedicina de Chihuahua
Chihuahua City
Hospital Aranda de La Parra
León
Kohler and Milstein Research S.A. de C.V.
Mérida
Medical Care and Research SA de CV
Mérida
Biológicos Especializados
Mexico City
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey
Cicmex Centro de Investigación Clínica de México
Morelia
Centro de Atención e Investigación Cardiovascular del Potosí
San Luis Potosí City
CIMAB SA de CV
Torreón
Poland (4)
Nova Reuma Domyslawska i Rusilowicz Spolka Partnerska Lekarza Reumatologa i Fizjoterapeuty
Bialystok
Nzoz Bif-Med
Bytom
MICS Centrum Medyczne Warszawa
Warsaw
Centrum Medyczne Reuma Park
Warsaw
United Kingdom (2)
Hull Royal Infirmary
Hull
New Cross Hospital
Wolverhampton
United States (12)
Overlake Arthritis and Osteoporosis Center
Bellevue , Washington
Joseph S. and Diane H. Steinberg Ambulatory Care Center