Phase
Condition
Joint Injuries
Rheumatoid Arthritis
Arthritis And Arthritic Pain
Treatment
LY3541860
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Have a diagnosis of adult-onset Rheumatoid Arthritis (RA) for at least 3 monthsprior to screening, as defined by the 2010 ACR/EULAR classification criteria.
Have moderately to severely active RA, at screening (Visit 1) and baseline (Visit 2), defined by the presence of
≥6 swollen joints based on 66 joint count (and ≥4 swollen joints on 28 jointcount), and
≥6 tender joints based on 68 joint count (and ≥4 tender joints on 28 jointcount).
Have active synovitis in ≥1 joint, in hands or wrists, of the investigator choosingat screening, having an MRI synovitis RAMRIS score of ≥2 as determined from thecentral reading of the images.
Exclusion
Exclusion Criteria:
Have a diagnosis or history of malignant disease within 5 years prior to baseline,with the exceptions of
basal cell or squamous epithelial carcinomas of the skin that have beenresected with no evidence of metastatic disease for 3 years, or
cervical carcinoma in situ, with no evidence of recurrence within the 5 yearsprior to baseline.
Have estimated glomerular filtration rate (eGFR) of <45 milliliter per minute (mL/minute) from serum creatinine using the Chronic Kidney Disease EpidemiologyCollaboration (CKD-EPI) creatinine equation.
Have a current or recent active infection.
Have presence of 1 or more significant concurrent medical conditions perinvestigator judgment, including but not limited to
poorly controlled diabetes or hypertension
chronic kidney disease Stage 3a or b, 4, or 5
symptomatic heart failure according to New York Heart Association Class 2, 3,or 4
myocardial infarction, unstable angina pectoris, stroke, or transient ischemicattack within the past 12 months before baseline
severe chronic pulmonary disease, for example, requiring oxygen therapy majorchronic 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-radiographicaxial spondyloarthritis
reactive arthritis
gout
scleroderma
polymyositis
dermatomyositis
active fibromyalgia, or
multiple sclerosis
Have received any prior B-cell targeted therapy (for example, anti-CD19 antibodiesor anti-CD20 antibodies, such as rituximab).
Received corticosteroids, opioids, conventional disease-modifying antirheumatic drug (cDMARD), with changes in dose or have received Janus kinase (JAK) inhibitors within 28 days prior to the screening MRI or plan on receiving these drugs during thestudy.
Study Design
Connect with a study center
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Avondale
Avondale, Arizona 85392
United StatesSite Not Available
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff
Flagstaff, Arizona 86001
United StatesSite Not Available
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa
Mesa, Arizona 85210
United StatesSite Not Available
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix PV
Phoenix, Arizona 85032
United StatesActive - Recruiting
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix West
Phoenix, Arizona 85037
United StatesSite Not Available
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Sun City
Sun City, Arizona 85351
United StatesSite Not Available
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson Southeast
Tucson, Arizona 85748
United StatesSite Not Available
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Avondale
Avondale 5552301, Arizona 5551752 85392
United StatesSite Not Available
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff
Flagstaff 5294810, Arizona 5551752 86001
United StatesSite Not Available
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa
Mesa 5304391, Arizona 5551752 85210
United StatesSite Not Available
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix PV
Phoenix 5308655, Arizona 5551752 85032
United StatesSite Not Available
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Sun City
Sun City 5316201, Arizona 5551752 85351
United StatesSite Not Available
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson Southeast
Tucson 5318313, Arizona 5551752 85748
United StatesSite Not Available
Medvin Clinical Research - Covina
Covina, California 91722
United StatesSite Not Available
Newport Huntington Medical Group
Huntington Beach, California 92648
United StatesSite Not Available
Stanford University Medical Center
Palo Alto, California 94304
United StatesSite Not Available
Medvin Clinical Research - Tujunga
Tujunga, California 91042
United StatesSite Not Available
Medvin Clinical Research - Whittier
Whittier, California 90602
United StatesSite Not Available
Medvin Clinical Research - Covina
Covina 5340175, California 5332921 91722
United StatesSite Not Available
Newport Huntington Medical Group
Huntington Beach 5358705, California 5332921 92648
United StatesSite Not Available
Stanford University Medical Center
Palo Alto 5380748, California 5332921 94304
United StatesSite Not Available
Medvin Clinical Research - Tujunga
Tujunga 5403767, California 5332921 91042
United StatesSite Not Available
Medvin Clinical Research - Whittier
Whittier 5409059, California 5332921 90602
United StatesSite Not Available
Clinical Research of West Florida, Inc. (Clearwater)
Clearwater, Florida 33765
United StatesSite Not Available
Clinical Research of West Florida
Tampa, Florida 33606
United StatesSite Not Available
Conquest Research
Winter Park, Florida 32789
United StatesSite Not Available
Clinical Research of West Florida, Inc. (Clearwater)
Clearwater 4151316, Florida 4155751 33765
United StatesSite Not Available
Clinical Research of West Florida
Tampa 4174757, Florida 4155751 33606
United StatesSite Not Available
Conquest Research
Winter Park 4178560, Florida 4155751 32789
United StatesSite Not Available
Willow Rheumatology and Wellness PLLC
Willowbrook, Illinois 60527
United StatesSite Not Available
Willow Rheumatology and Wellness PLLC
Willowbrook 4916709, Illinois 4896861 60527
United StatesSite Not Available
Accurate Clinical Research, Inc
Lake Charles, Louisiana 70605
United StatesSite Not Available
Accurate Clinical Research, Inc
Lake Charles 4330236, Louisiana 4331987 70605
United StatesSite Not Available
Saint Paul Rheumatology
Eagan, Minnesota 55121
United StatesSite Not Available
Saint Paul Rheumatology
Eagan 5024825, Minnesota 5037779 55121
United StatesSite Not Available
University of Rochester Medical Center
Rochester, New York 14642
United StatesSite Not Available
Altoona Center For Clinical Research
Duncansville, Pennsylvania 16635
United StatesSite Not Available
Altoona Center For Clinical Research
Duncansville 5187508, Pennsylvania 6254927 16635
United StatesSite Not Available
Accurate Clinical Management, LLC
Baytown, Texas 77521
United StatesSite Not Available
Accurate Clinical Research, Inc
Houston, Texas 77089
United StatesSite Not Available
DM Clinical Research - TRA
Tomball, Texas 77375
United StatesSite Not Available
Accurate Clinical Management, LLC
Baytown 4672731, Texas 4736286 77521
United StatesSite Not Available
Accurate Clinical Research, Inc
Houston 4699066, Texas 4736286 77089
United StatesSite Not Available
DM Clinical Research - TRA
Tomball 4737094, Texas 4736286 77375
United StatesSite Not Available

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