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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Administered IV
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Avondale
Avondale, Arizona, United States
Change from Baseline in Disease Activity Score - High-Sensitivity C-Reactive Protein (DAS28 - hsCRP)
DAS28-hsCRP measures disease activity in 28 joints using a composite numeric score. Total scores range from 1.0 to 9.4, where a lower score indicates less disease activity.
Time frame: Baseline, Week 12
Change from Baseline in Rheumatoid Arthritis Magnetic Resonance Imaging Score (RAMRIS) Synovitis Score
RAMRIS synovitis score ranges from 0-24, where a lower score indicates a lower level of inflammation.
Time frame: Baseline, Week 12
Percentage of Participants Achieving American College of Rheumatology (ACR) 20
ACR20 Responder is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity using VAS, Patient's Global Assessment of Disease Activity using VAS, HAQ-DI, pain due to arthritis, and hsCRP.
Time frame: Week 12
Percentage of Participants Achieving American College of Rheumatology (ACR) 50
ACR50 Responder is a participant who has at least 50% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, HAQ-DI, pain due to arthritis, and hsCRP.
Time frame: Week 12
Percentage of Participants Achieving American College of Rheumatology (ACR) 70
ACR70 Responder is a participant who has at least 70% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, HAQ-DI, pain due to arthritis, and hsCRP.
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AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff
Flagstaff, Arizona, United States
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa
Mesa, Arizona, United States
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix PV
Phoenix, Arizona, United States
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Sun City
Sun City, Arizona, United States
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson Southeast
Tucson, Arizona, United States
Medvin Clinical Research - Covina
Covina, California, United States
Newport Huntington Medical Group
Huntington Beach, California, United States
Medvin Clinical Research - Tujunga
Tujunga, California, United States
Medvin Clinical Research - Whittier
Whittier, California, United States
...and 10 more locations
Time frame: Week 12
Change from Baseline in Disease Activity Score - Erythrocyte Sedimentation Rate (DAS28 - ESR)
DAS28-ESR measures disease activity in 28 joints using a composite numeric score. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.
Time frame: Baseline, Week 12
Percentage of Participants Achieving Low disease activity (LDA) or Remission in Disease Activity Score - high-sensitivity C-reactive protein (DAS28-hsCRP)
DAS28-hsCRP measures disease activity in 28 joints using a composite numeric score. Total scores range from 1.0 to 9.4, where a lower score indicates less disease activity. The DAS28-hsCRP LDA is defined as DAS28-hsCRP ≤3.2.
Time frame: Week 12
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Good Response Criteria
EULAR Responder index based on 28 joint counts categorizes clinical response based on improvement since baseline in DAS28-hsCRP. DAS28-CRP scores range from 1.0-9.4, where lower scores indicated less disease activity. EULAR DAS28-hsCRP responder index defines good response criteria as change in DAS28-hSCRP \> 1.2 from baseline with a new DAS28 score \<=3.2.
Time frame: Week 12
Change from Baseline in ACR Core Set Values Patient's Assessment of Arthritis Pain Using Visual Analog Scale (VAS)
Participants were asked to assess their current level of arthritis pain by marking a vertical tick on a 100-mm horizontal VAS with the left end (0 mm) marked as "no pain" and the right end (100 mm) marked "worst possible pain."
Time frame: Baseline, Week 12
Change from Baseline in ACR Core Set Values Patient's Assessment of Physical Function Using Health Assessment Questionnaire - Disability Index (HAQ-DI)
Participants assess their degree of difficulty of physical function over the past week on a 4-item ordinal scale ranging from 0, "without any difficulty," to 3, "unable to do."
Time frame: Baseline, Week 12