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| ID | Type | Description | Link |
|---|---|---|---|
| J3P-MC-FTAF | Other Identifier | Eli Lilly and Company | |
| 2022-502994-40-00 | Other Identifier | EU Trial Number |
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| Name | Class |
|---|---|
| Rigel Pharmaceuticals | INDUSTRY |
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The main purpose of this study is to evaluate the efficacy and safety of LY3871801 in adult participants with active moderately-to-severe rheumatoid arthritis (RA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3871801 Phase 2a | Experimental | Participants will receive LY3871801 administered orally. |
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| Placebo Phase 2a | Placebo Comparator | Participants will receive placebo. |
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| LY3871801 Dose 1 Phase 2b | Experimental | Participants will receive LY3871801 administered orally. |
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| LY3871801 Dose 2 Phase 2b | Experimental | Participants will receive LY3871801 administered orally. |
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| LY3871801 Dose 3 Phase 2b | Experimental | Participants will receive LY3871801 administered orally. |
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| Placebo Phase 2b | Placebo Comparator | Participants will receive placebo. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3871801 | Drug | Administered orally |
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| Measure | Description | Time Frame |
|---|---|---|
| Phase 2a: Change from Baseline in Disease Activity Score - high-sensitivity C-reactive protein (DAS28-hsCRP) | Baseline, Week 12 | |
| Phase 2b: Percentage of Participants Achieving American College of Rheumatology (ACR)50 | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 2a: Percentage of Participants Achieving ACR20/50/70 | Baseline to Week 12 | |
| Phase 2b: Change from Baseline in DAS28-hsCRP | Baseline, Week 12 | |
| Phase 2b: Percentage of Participants Achieving ACR20/70 |
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Inclusion Criteria:
Have a diagnosis of adult-onset RA for at least 3 months prior to screening as defined by the 2010 ACR/European League Against Rheumatism (EULAR) classification criteria.
Have moderately-to-severely active RA at screening and baseline, defined by the presence of
Have had a history of failure (an inadequate response, intolerance, or loss of response) to at least 1 conventional synthetic disease modifying anti rheumatic drug (csDMARD) and either 1 biologic (bDMARD), or targeted synthetic (tsDMARD) treatment.
Exclusion Criteria:
Have Class IV RA according to ACR revised criteria
Have presence of 1 or more significant concurrent medical conditions per investigator judgment, including but not limited to
poorly controlled diabetes or hypertension
chronic kidney disease stage IIIa or IIIb, IV, or V
symptomatic heart failure according to New York Heart Association class II, III, or IV
myocardial infarction,unstable angina pectoris, stroke, or transient ischemic attack within the past 12 months before randomization
severe chronic pulmonary disease, for example, requiring oxygen therapy
major chronic inflammatory disease or connective tissue disease other than RA, including but not limited to
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Newport Huntington Medical Group | Huntington Beach | California | 92648 | United States | ||
| Integrity Clinical Research |
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| Label | URL |
|---|---|
| An Adaptive Phase 2a/2b Study of LY3871801 in Adult Participants With Rheumatoid Arthritis | View source |
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Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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| Placebo | Drug | Administered orally |
|
| Week 12 |
| Change from Baseline in Simplified Disease Activity Index (SDAI) | Baseline, Week 12 |
| Change from Baseline in Clinical Disease Activity Index (CDAI) | Baseline, Week 12 |
| Change from Baseline in ACR Core Set Values 68 Tender Joint Counts | Baseline, Week 12 |
| Change from Baseline in ACR Core Set Values 66 Swollen Joint Counts | Baseline, Week 12 |
| Change from Baseline in ACR Core Set Values Physician's Global Assessment of Disease Activity (PhGADA) Visual Analog Scale (VAS) | Baseline, Week 12 |
| Change from Baseline in ACR Core Set Values Patient's Global Assessment of Disease Activity (PaGADA) VAS | Baseline, Week 12 |
| Change from Baseline for Participant's Assessment of Arthritis Pain (VAS) | Baseline, Week 12 |
| Change from Baseline for Participant's Assessment of Physical Function Using Health Assessment Questionnaire-Disability Index (HAQ-DI) | Baseline, Week 12 |
| Change from Baseline the Duration and Severity of Morning Joint Stiffness | Baseline, Week 12 |
| Change from Baseline for Short Form-36 (SF-36) Physical Component Summary Score | Baseline, Week 12 |
| Change from Baseline for SF-36 Mental Component Summary Score | Baseline, Week 12 |
| Pharmacokinetics (PK) Trough Plasma Concentrations of LY3871801 | Baseline through Week 20 |
| Doral |
| Florida |
| 33122 |
| United States |
| Advanced Clinical Research of Orlando - Ocoee | Ocoee | Florida | 34761 | United States |
| Encore Medical Research - Weston | Weston | Florida | 33331 | United States |
| Conquest Research | Winter Park | Florida | 32789 | United States |
| Willow Rheumatology and Wellness PLLC | Willowbrook | Illinois | 60527 | United States |
| Accurate Clinical Research, Inc | Lake Charles | Louisiana | 70605 | United States |
| Joseph S. and Diane H. Steinberg Ambulatory Care Center | Brooklyn | New York | 11201 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Accellacare - Salisbury | Salisbury | North Carolina | 28144 | United States |
| Accurate Clinical Research, Inc | Houston | Texas | 77089 | United States |
| Overlake Arthritis and Osteoporosis Center | Bellevue | Washington | 98004 | United States |
| CIPREC | Buenos Aires | C1061AAS | Argentina |
| Mautalen Salud e Investigación | Buenos Aires | C1128AAF | Argentina |
| CENUDIAB | Buenos Aires | C1440AAD | Argentina |
| Medicina Reumatológica | San Fernando | 1646 | Argentina |
| Instituto de Alta Complejidad San Isidro | San Isidro | 1642 | Argentina |
| Medical Plus | Uherské Hradiště | 686 01 | Czechia |
| CHD Vendee | La Roche-sur-Yon | 85000 | France |
| CHU Montpellier Lapeyronie Hospital | Montpellier | 34295 | France |
| CHU de Nice | Nice | 06000 | France |
| Centre Hospitalier Regional D'Orleans | Orléans | 45067 | France |
| Hopitaux Universitaires Paris Centre-Hopital Cochin | Paris | 75679 | France |
| Centre Hospitalier Universitaire de Reims - l'Hôpital Maison Blanche | Reims | 51092 | France |
| CHU Strasbourg-Hautepierre | Strasbourg | 67098 | France |
| Universitaetsklinikum Koeln | Cologne | 50937 | Germany |
| HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg GmbH / -T | Hamburg | 20095 | Germany |
| Revita Clinic | Budapest | 1027 | Hungary |
| Óbudai Egészségügyi Centrum | Budapest | 1036 | Hungary |
| CRU Hungary Kft. | Encs | 3860 | Hungary |
| Vásárhelyi Sárkányfű KFT | Hódmezővásárhely | 6800 | Hungary |
| Kistarcsai Flor Ferenc Korhaz | Kistarcsa | 2143 | Hungary |
| Regia Med Kft | Székesfehérvár | 8000 | Hungary |
| Vital Medical Center | Veszprém | 8200 | Hungary |
| Avron Hospitals | Ahmedabad | 380013 | India |
| Sushruta Multispeciality Hospital & Research Centre | Hubli | 580021 | India |
| All India Institute of Medical Sciences (AIIMS) - Nagpur | Nagpur | 441108 | India |
| Grant Medical Foundation - Ruby Hall Clinic | Pune | 411001 | India |
| Medipoint Hospitals Pvt. Ltd. | Pune | 411007 | India |
| Investigacion y Biomedicina de Chihuahua | Chihuahua City | 31000 | Mexico |
| Hospital Aranda de La Parra | León | 37000 | Mexico |
| Biológicos Especializados | Mexico City | 06700 | Mexico |
| Kohler and Milstein Research S.A. de C.V. | Mérida | 97070 | Mexico |
| Medical Care and Research SA de CV | Mérida | 97070 | Mexico |
| Hospital Universitario "Dr. Jose Eleuterio Gonzalez" | Monterrey | 66460 | Mexico |
| Cicmex Centro de Investigación Clínica de México | Morelia | 58020 | Mexico |
| Centro de Atención e Investigación Cardiovascular del Potosí | San Luis Potosí City | 78200 | Mexico |
| CIMAB SA de CV | Torreón | 27000 | Mexico |
| Nova Reuma Domyslawska i Rusilowicz Spolka Partnerska Lekarza Reumatologa i Fizjoterapeuty | Bialystok | 15-707 | Poland |
| Nzoz Bif-Med | Bytom | 41-902 | Poland |
| MICS Centrum Medyczne Warszawa | Warsaw | 00-874 | Poland |
| Centrum Medyczne Reuma Park | Warsaw | 02-665 | Poland |
| Hull Royal Infirmary | Hull | HU3 2JZ | United Kingdom |
| New Cross Hospital | Wolverhampton | WV10 0QP | United Kingdom |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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