A Phase 2a, Single-Arm Study to Investigate the Efficacy and Safety of LY3541860 in Adult Participants With Moderately to Severely Active Rheumatoid Arthritis
Status: Recruiting
Location: See all (21) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The main purpose of this study is to evaluate the effects of LY3541860 in adult participants with moderately to severely active Rheumatoid Arthritis with inadequate response to a least one biologic disease-modifying antirheumatic drug (bDMARD)or targeted synthetic disease-modifying antirheumatic drug (tsDMARD). Study participation is approximately 50 weeks, including a 6-week screening period, 24-week treatment period, and a 20-week safety follow up period.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Have a diagnosis of adult-onset Rheumatoid Arthritis (RA) for at least 3 months prior 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 joint count), and
⁃ ≥6 tender joints based on 68 joint count (and ≥4 tender joints on 28 joint count).
• Have active synovitis in ≥1 joint, in hands or wrists, of the investigator choosing at screening, having an MRI synovitis RAMRIS score of ≥2 as determined from the central reading of the images.