RECRUITINGPhase 2INTERVENTIONAL
An Adaptive Phase 2a/2b Study of LY3871801 in Adult Participants With Rheumatoid Arthritis
An Adaptive Phase 2a/2b, Randomized, Double-Blind, Placebo-Controlled Study of LY3871801 in Adult Participants With Moderately-to-Severely Active Rheumatoid Arthritis
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
- 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.
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DRUG
LY3871801
Administered orally
DRUG
Placebo
Administered orally
Locations (20)
Newport Huntington Medical Group
Huntington Beach, California, United States
Integrity Clinical Research
Doral, Florida, United States
Advanced Clinical Research of Orlando - Ocoee
Ocoee, Florida, United States
Encore Medical Research - Weston
Weston, Florida, United States
Conquest Research
Winter Park, Florida, United States
Willow Rheumatology and Wellness PLLC
Willowbrook, Illinois, United States
Accurate Clinical Research, Inc
Lake Charles, Louisiana, United States
Joseph S. and Diane H. Steinberg Ambulatory Care Center
Brooklyn, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Accellacare - Salisbury
Salisbury, North Carolina, United States
Accurate Clinical Research, Inc
Houston, Texas, United States
Overlake Arthritis and Osteoporosis Center
Bellevue, Washington, United States
CIPREC
Buenos Aires, Argentina
Mautalen Salud e Investigación
Buenos Aires, Argentina
CENUDIAB
Buenos Aires, Argentina
Medicina Reumatológica
San Fernando, Argentina
Instituto de Alta Complejidad San Isidro
San Isidro, Argentina
Medical Plus
Uherské Hradiště, Czechia
CHD Vendee
La Roche-sur-Yon, France
CHU Montpellier Lapeyronie Hospital
Montpellier, France