Phase
Condition
Arthritis And Arthritic Pain
Musculoskeletal Diseases
Dermatomyositis (Connective Tissue Disease)
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 StatesActive - Recruiting
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff
Flagstaff, Arizona 86001
United StatesActive - Recruiting
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa
Mesa, Arizona 85210
United StatesActive - Recruiting
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 StatesActive - Recruiting
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson Southeast
Tucson, Arizona 85748
United StatesActive - Recruiting
Medvin Clinical Research - Covina
Covina, California 91722
United StatesActive - Recruiting
Newport Huntington Medical Group
Huntington Beach, California 92648
United StatesActive - Recruiting
Medvin Clinical Research - Tujunga
Tujunga, California 91042
United StatesActive - Recruiting
Medvin Clinical Research - Whittier
Whittier, California 90602
United StatesActive - Recruiting
Clinical Research of West Florida, Inc. (Clearwater)
Clearwater, Florida 33765
United StatesSite Not Available
Clinical Research of West Florida
Tampa, Florida 33606
United StatesActive - Recruiting
Conquest Research
Winter Park, Florida 32789
United StatesActive - Recruiting
Willow Rheumatology and Wellness PLLC
Willowbrook, Illinois 60527
United StatesActive - Recruiting
Accurate Clinical Research, Inc
Lake Charles, Louisiana 70605
United StatesActive - Recruiting
Saint Paul Rheumatology
Eagan, Minnesota 55121
United StatesActive - Recruiting
University of Rochester Medical Center
Rochester, New York 14642
United StatesSite Not Available
Altoona Center For Clinical Research
Duncansville, Pennsylvania 16635
United StatesActive - Recruiting
Accurate Clinical Management, LLC
Baytown, Texas 77521
United StatesActive - Recruiting
Accurate Clinical Research, Inc
Houston, Texas 77089
United StatesActive - Recruiting
DM Clinical Research - TRA
Tomball, Texas 77375
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.