A Study of LY3462817 in Participants With Rheumatoid Arthritis
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|ClinicalTrials.gov Identifier: NCT04634253|
Recruitment Status : Active, not recruiting
First Posted : November 18, 2020
Last Update Posted : February 7, 2022
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Drug: Placebo Drug: LY3462817||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase 2 Study to Evaluate the Efficacy and Safety of LY3462817 in Participants With Moderately to Severely Active Rheumatoid Arthritis|
|Actual Study Start Date :||January 4, 2021|
|Actual Primary Completion Date :||January 10, 2022|
|Estimated Study Completion Date :||June 30, 2022|
Experimental: LY3462817 Low Dose
LY3462817 given intravenously (IV).
Experimental: LY3462817 High Dose
LY3462817 given IV.
Placebo Comparator: Placebo
Placebo given IV.
- Change from Baseline on the Disease Activity Score Modified to Include the 28 Diarthrodial Joint Count-High-Sensitivity C-Reactive Protein (DAS28-hsCRP) [ Time Frame: Baseline, Week 12 ]DAS28 consists of a composite score of the following variables: tender joint count out of 28 (TJC28), swollen joint count out of 28 (SJC28), hsCRP [milligrams per liter (mg/L)], and Patient's Global Assessment of Disease Activity (PaGADA_VAS) on a 0 to 100 millimeter (mm) VAS (0=very well to 100=very poor). A decrease in DAS28-CRP indicates an improvement in participant's condition.
- Percentage of Participants Achieving 20% Improvement in American College of Rheumatology Criteria (ACR20), (ACR50) and (ACR70) [ Time Frame: Week 12 ]ACR responders are participants with at least 20%, 50% and 70% improvement from baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: Health Assessment Questionnaire-Disability Index (HAQ-DI) which measures participants perceived degree of difficulty performing daily activities, acute phase reactant as measured by hsCRP, Patient's Assessment of Pain-Visual Analog Scale (Pain-VAS), Patient's Global Assessment of Disease Activity (PaGADA_VAS), and Physician's Global Assessment of Disease Activity (PhGADA_VAS).
- Change from Baseline for Mean Simplified Disease Activity Index (SDAI) [ Time Frame: Baseline, Week 12 ]The SDAI is the numerical sum of 5 outcome parameters: TJC28, SJC28, patient and physician global assessment of disease activity and CRP. Lower SDAI values indicate lower disease activity.
- Change from Baseline for Mean Clinical Disease Activity Index (CDAI) [ Time Frame: Baseline, Week 12 ]The CDAI measures disease activity in RA. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-100 mm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-100 mm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. Lower CDAI scores indicate lower disease activity. A negative change from baseline indicates improvement in condition.
- Change from Baseline on the 36 Item Short Form Health Survey (SF-36) [ Time Frame: Baseline, Week 12 ]The SF-36 is a health-related survey that assesses participant's health status and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health, mental health, social functioning, and vitality. The 8 domains are combined to form 2 component scores mental (MCS) and physical (PCS). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status.
- Pharmacokinetics (PK): Observed Concentration of LY3462817 [ Time Frame: Week 12 ]PK: Observed Concentration of LY3462817
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04634253
|Study Director:||Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)||Eli Lilly and Company|