A Study of LY3462817 in Participants With Rheumatoid Arthritis
Study Details
Study Description
Brief Summary
The reason for this study is to see if the study drug LY3462817 is safe and effective in participants with moderately to severely active rheumatoid arthritis (RA).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: LY3462817 Low Dose LY3462817 given intravenously (IV). |
Drug: LY3462817
Given IV
|
Experimental: LY3462817 High Dose LY3462817 given IV. |
Drug: LY3462817
Given IV
|
Placebo Comparator: Placebo Placebo given IV. |
Drug: Placebo
Given IV
|
Outcome Measures
Primary Outcome Measures
- Change from Baseline on the Disease Activity Score Modified to Include the 28 Diarthrodial Joint Count-High-Sensitivity C-Reactive Protein (DAS28-hsCRP) [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.
Secondary Outcome Measures
- Percentage of Participants Achieving 20% Improvement in American College of Rheumatology Criteria (ACR20), (ACR50) and (ACR70) [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) [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) [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) [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 [Week 12]
PK: Observed Concentration of LY3462817
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Have a diagnosis of adult onset RA as defined by the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for at least 3 months prior to screening
-
Have moderately to severely active RA defined by the presence of ≥6 swollen joints (based on 66 joint count) and ≥6 tender joints (based on 68 joint count) at screening and baseline. The distal interphalangeal joint should be evaluated but not included in the total count to determine eligibility
-
Have at least 1 of the following:
-
positive test results for rheumatoid factor or anti-citrullinated peptide antibodies at screening, OR
-
previous radiographs documenting bony erosions in hands or feet consistent with RA
-
Have C-reactive protein (CRP) >1.2 times upper limit of normal (ULN) per the central laboratory at screening
-
Demonstrated an inadequate response to, or loss of response or intolerance to:
-
at least 1 conventional synthetic disease-modifying antirheumatic drug (csDMARD) treatment OR
-
at least 1 biologic DMARD/tsDMARD treatment
Exclusion Criteria:
-
Class IV RA according to ACR revised response 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 been resected with no evidence of metastatic disease for 3 years, or
-
cervical carcinoma in situ, with no evidence of recurrence within the 5 years prior to baseline
-
Have presence of confirmed cervical dysplasia
-
Have had various types of infection within 3 months of screening or develops any of these infections before the randomization visit.
-
Have any of the following:
-
Human immunodeficiency virus (HIV) infection
-
Current infection with hepatitis B virus (HBV) (i.e., positive for hepatitis B surface antigen and/or polymerase chain reaction (PCR) positive for HBV DNA
-
Current infection with hepatitis C virus (HCV) (i.e., positive for HCV RNA)
-
Active tuberculosis (TB)
-
Have failed more than 2 biologic DMARDs (bDMARDs) or tsDMARDs (e.g. excluded if have received 2 bDMARDs and 1 tsDMARD)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Arizona Arthritis & Rheumatology Associates, P. C. | Mesa | Arizona | United States | 85210 |
2 | Arizona Arthritis & Rheumatology Associates, P. C. | Phoenix | Arizona | United States | 85037 |
3 | Desert Medical Advances | Palm Desert | California | United States | 92260 |
4 | Inland Rheumatology & Osteoporosis Medical Group | Upland | California | United States | 91786 |
5 | Physician Research Collaboration, LLC | Lincoln | Nebraska | United States | 68516 |
6 | Health Research of Oklahoma | Oklahoma City | Oklahoma | United States | 73103 |
7 | Altoona Center For Clinical Research | Duncansville | Pennsylvania | United States | 16635 |
8 | Medical Plus | Uherske Hradiste | Zlínský Kraj | Czechia | 686 01 |
9 | PV Medical Services s.r.o. | Zlin | Czechia | 760 01 | |
10 | CRU Hungary Kft. | Miskolc | Borsod-Abaúj-Zemplén | Hungary | 3529 |
11 | Revita Clinic | Budapest | Pest | Hungary | 1027 |
12 | Vital Medical Center | Veszprem | Veszprém City | Hungary | 8200 |
13 | Budai Irgalmasrendi Korhaz | Budapest | Hungary | 1027 | |
14 | Clinexpert Egeszsegugyi Szolgaltato es Kereskedelmi Kft. | Budapest | Hungary | 1033 | |
15 | Centro Medico del Angel | Mexicali | Baja California | Mexico | 21100 |
16 | RM Pharma Specialists S.A. de C.V. | Mexico City | Distrito Federal | Mexico | 03100 |
17 | Centro de Estudios de Investigacion Basica y Clinica, S.C. | Guadalajara | Jalisco | Mexico | 44690 |
18 | Köhler & Milstein Research | Mérida | Yucatan | Mexico | 97070 |
19 | Investigacion y Biomedicina de Chihuahua | Chihuahua | Mexico | 31000 | |
20 | Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej | Bydgoszcz | Kujawsko-pomorskie | Poland | 85-168 |
21 | Twoja Przychodnia Centrum Medyczne Nowa Sol | Nowa Sol | Lubuskie | Poland | 67-100 |
22 | Reumatika - Centrum Reumatologii | Warszawa | Mazowieckie | Poland | 02-691 |
23 | Nzoz Bif-Med | Bytom | Śląskie | Poland | 41-902 |
24 | Centro Reumatologico Caguas | Caguas | Puerto Rico | 00725 | |
25 | Latin Clinical Trial Center | San Juan | Puerto Rico | 909 | |
26 | Royal Free Hospital | Barnet | United Kingdom | EN53DJ |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- 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
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 17424
- J1A-MC-KDAD
- 2020-002673-10