A Study of Baricitinib in Participants With Rheumatoid Arthritis

NCT ID: NCT04086745

Last Updated: 2025-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1317 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-14

Study Completion Date

2025-05-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This post-marketing study is designed to compare the safety of baricitinib versus tumor necrosis factor (TNF) inhibitors with respect to venous thromboembolic events (VTEs) when given to participants with rheumatoid arthritis (RA).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rheumatoid Arthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Baricitinib Low Dose

Baricitinib administered orally.

Group Type EXPERIMENTAL

Baricitinib

Intervention Type DRUG

Administered orally.

Baricitinib High Dose

Baricitinib administered orally.

Group Type EXPERIMENTAL

Baricitinib

Intervention Type DRUG

Administered orally.

TNF Inhibitor

Adalimumab or etanercept administered subcutaneously (SC) per standard of care.

Group Type ACTIVE_COMPARATOR

TNF Inhibitor

Intervention Type DRUG

Administered SC

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Baricitinib

Administered orally.

Intervention Type DRUG

TNF Inhibitor

Administered SC

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

LY3009104 Etanercept Adalimumab

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Participants must have at least one of the following characteristics:

* Documented evidence of a VTE prior to this study
* At least 60 years of age
* A body mass index (BMI) greater than or equal to 30 kilograms per meter squared (kg/m²), or
* Age 50 to less than 60 years and BMI 25 to less than 30 kg/m²
* Participants must have an inadequate response or intolerance to at least 1 disease-modifying antirheumatic drugs (DMARD) (synthetic or biologic)

Exclusion Criteria

* Participant must not have prior use of a Janus kinase (JAK) inhibitor or have received more than 1 prior TNF inhibitor that was:

* discontinued for IR (lack or loss of efficacy) for RA, or
* discontinued for intolerance (AE) when used for any indication
* Participants must not be pregnant or breastfeeding
* Participants must not have had more than one VTE
* Participants must not have cancer
* Participants must not have active herpes zoster, serious infection, active tuberculosis, or any other serious illness
* Participants must not have had a live vaccine within four weeks of study start
* Participants must not have participated in any other clinical trial within four weeks of study start
* Participants must not have a history of IV drug use, other illicit drug abuse, or chronic alcohol abuse in the past year
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Incyte Corporation

INDUSTRY

Sponsor Role collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Arizona Research Clinic PLLC

Chandler, Arizona, United States

Site Status

Arizona Arthritis & Rheumatology Associates, P. C.

Mesa, Arizona, United States

Site Status

Arizona Arthritis & Rheumatology Research

Paradise Valley, Arizona, United States

Site Status

Sun Valley Arthritis Center, LTD

Peoria, Arizona, United States

Site Status

Arizona Arthritis & Rheumatology Associates

Phoenix, Arizona, United States

Site Status

Arthritis and Rheumatism Associates

Jonesboro, Arkansas, United States

Site Status

Providence St. Joseph's Medical Center

Burbank, California, United States

Site Status

Hope Clinical Research, Inc.

Canoga Park, California, United States

Site Status

Medvin Clinical Research - Covina

Covina, California, United States

Site Status

TriWest Research Associates LLC

El Cajon, California, United States

Site Status

Newport Huntington Med Grp

Huntington Beach, California, United States

Site Status

BioSolutions Clinical Research Center

La Mesa, California, United States

Site Status

Valerius Medical Group and Research Center of Greater Long Beach

Los Alamitos, California, United States

Site Status

R. Srinivasan, M.D., Inc. dba Monterey Park Medical Center

Monterey Park, California, United States

Site Status

ACRC Studies

Poway, California, United States

Site Status

Desert Medical Advances

Rancho Mirage, California, United States

Site Status

Purushotham & Akther Kotha MD Inc

San Diego, California, United States

Site Status

East Bay Rheumatology Medical Group, Inc

San Leandro, California, United States

Site Status

Providence Medical Foundation

Santa Rosa, California, United States

Site Status

Dan La, MD Inc

Tujunga, California, United States

Site Status

Office: Dr Robin K Dore

Tustin, California, United States

Site Status

Inland Rheumatology & Osteoporosis Medical Group

Upland, California, United States

Site Status

Nazanin Firooz, MD Inc.

West Hills, California, United States

Site Status

Medvin Clinical Research - Whittier

Whittier, California, United States

Site Status

Danbury Clinical Research, LLC

Danbury, Connecticut, United States

Site Status

Delaware Arthritis

Lewes, Delaware, United States

Site Status

Omega Research Debary, LLC

DeBary, Florida, United States

Site Status

Cria Center for Rheumatology

Fort Lauderdale, Florida, United States

Site Status

SIMED Health

Gainesville, Florida, United States

Site Status

GNP Research at Mark Jaffe, MD

Hollywood, Florida, United States

Site Status

Rheumatology Center Of Palm Beach, Pllc

Lake Worth, Florida, United States

Site Status

Arthritis and Rheumatology Center of South Florida

Margate, Florida, United States

Site Status

Miami Clinical Reserach

Miami, Florida, United States

Site Status

Felicidad Medical Research

Miami, Florida, United States

Site Status

Rheumatology Associates of Central Florida

Orlando, Florida, United States

Site Status

Heuer MD Research

Orlando, Florida, United States

Site Status

UCF Health Lake Nona Orlando

Orlando, Florida, United States

Site Status

IRIS Research and Development, LLC

Plantation, Florida, United States

Site Status

BayCare Health System Inc

St. Petersburg, Florida, United States

Site Status

West Broward Rheumatology Associates

Tamarac, Florida, United States

Site Status

Avita Clinical Research

Tampa, Florida, United States

Site Status

Tampa Medical Group, P.A.

Tampa, Florida, United States

Site Status

Florida Medical Clinic LLC

Zephyrhills, Florida, United States

Site Status

Arthritis & Rheumatology of Georgia

Atlanta, Georgia, United States

Site Status

Arthritis Center of North Georgia

Gainesville, Georgia, United States

Site Status

St Luke's Clinic - Intermountain Orthopaedics

Boise, Idaho, United States

Site Status

Hinsdale Orthopaedics, Illinois Bone and Joint

Hinsdale, Illinois, United States

Site Status

Rockford Orthopedic Associates

Rockford, Illinois, United States

Site Status

Orthoillinois

Rockford, Illinois, United States

Site Status

Greater Chicago Specialty Physicians, LLC

Schaumburg, Illinois, United States

Site Status

Center of Robert Hozman

Skokie, Illinois, United States

Site Status

Beacon Medical Group Clinical Research

South Bend, Indiana, United States

Site Status

Graves-Gilbert Clinic

Bowling Green, Kentucky, United States

Site Status

Western KY Rheumatology PLLC

Hopkinsville, Kentucky, United States

Site Status

Accurate Clinical Research

Lake Charles, Louisiana, United States

Site Status

Arthritis and Diabetes Clinic, Inc.

Monroe, Louisiana, United States

Site Status

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Site Status

Klein and Associates MD, PA

Cumberland, Maryland, United States

Site Status

NECCR PrimaCare Research

Fall River, Massachusetts, United States

Site Status

Michigan Rheumatology Group

Grand Blanc, Michigan, United States

Site Status

Pandit Rheumatology PC

Okemos, Michigan, United States

Site Status

Jefferson City Medical Group

Jefferson City, Missouri, United States

Site Status

Clinvest Research LLC

Springfield, Missouri, United States

Site Status

West County Rheumatology

St Louis, Missouri, United States

Site Status

Lovelace Scientific Resources

Henderson, Nevada, United States

Site Status

Allied Clinical Research

Reno, Nevada, United States

Site Status

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Arthritis Care Medical Center

Somerset, New Jersey, United States

Site Status

Atlantic Coastal Research

Toms River, New Jersey, United States

Site Status

Sahni Rheumatology & Therapy PC

West Long Branch, New Jersey, United States

Site Status

NYU Langone

New York, New York, United States

Site Status

Medication Management

Greensboro, North Carolina, United States

Site Status

PMG Research of Hickory, LLC

Hickory, North Carolina, United States

Site Status

Cape Fear Arthritis Care

Leland, North Carolina, United States

Site Status

Carolina Arthritis Associates

Wilmington, North Carolina, United States

Site Status

Cincinnati Arthritis Associates

Cincinnati, Ohio, United States

Site Status

Craig S Thompson MD LLC

Marion, Ohio, United States

Site Status

Paramount Medical Research

Middleburg Heights, Ohio, United States

Site Status

Arthritis & Rheumatology Center of Oklahoma PLLC

Oklahoma City, Oklahoma, United States

Site Status

Good Samaritan Hospital Corvallis

Corvallis, Oregon, United States

Site Status

Advanced Rheumatology and Arthritis Research Center, PC

Cranberry Township, Pennsylvania, United States

Site Status

Altoona Center For Clinical Research

Duncansville, Pennsylvania, United States

Site Status

Pennsylvania Regional Center for Arthritis and Osteoporosis Research

Wyomissing, Pennsylvania, United States

Site Status

Articularis Healthcare d/b/a/ Low Country Rheumatology, PA

North Charleston, South Carolina, United States

Site Status

Monument Health Rapid City Hospital

Rapid City, South Dakota, United States

Site Status

Cumberland Rheumatology

Crossville, Tennessee, United States

Site Status

West Tennessee Research Institute

Jackson, Tennessee, United States

Site Status

Nashville Arthritis and Rheumatology

Nashville, Tennessee, United States

Site Status

Accent Clinical Research Professionals, LLC

Allen, Texas, United States

Site Status

Amarillo Center for Clinical Research

Amarillo, Texas, United States

Site Status

Arthritis & Osteoporosis Clinic of Brazos Valley

College Station, Texas, United States

Site Status

Metroplex Clinical Research Center

Dallas, Texas, United States

Site Status

El Paso Integrated Physicians Group, P.A., an Elligo Health Research, Inc. Healthcare Enabled Research Organization

El Paso, Texas, United States

Site Status

UDL Clinical Research, LLC

Houston, Texas, United States

Site Status

Pioneer Research Solutions

Houston, Texas, United States

Site Status

Biopharma Informatic, LLC

Houston, Texas, United States

Site Status

Accurate Clinical Management - Houston

Houston, Texas, United States

Site Status

Synergy Group US

Katy, Texas, United States

Site Status

Houston Rheumatology & Arthritis Specialists

Katy, Texas, United States

Site Status

R and H Clinical Research

Katy, Texas, United States

Site Status

Prime Clinical Research

Mansfield, Texas, United States

Site Status

Southwest Rheumatology, P.A.

Mesquite, Texas, United States

Site Status

Advanced Clinical Research Center of Houston

Pearland, Texas, United States

Site Status

Clinrx Research Joseph INC.

Plano, Texas, United States

Site Status

Violeta T. Baddour, MD

Pleasanton, Texas, United States

Site Status

Accurate Clinical Research, Inc.

San Antonio, Texas, United States

Site Status

Accurate Clinical Management

Sugar Land, Texas, United States

Site Status

Fort Bend Clinical Research, LLC

Sugar Land, Texas, United States

Site Status

Mt. Olympus Medical Research

Sugar Land, Texas, United States

Site Status

Baylor Scott & White Health

Temple, Texas, United States

Site Status

North Houston Rheumatology Associates

The Woodlands, Texas, United States

Site Status

Dynamed Clinical Research, LP d/b/a DM Clinical Research

Tomball, Texas, United States

Site Status

Center for Arthritis and Rheumatic Diseases, PC

Chesapeake, Virginia, United States

Site Status

Spectrum Medical Inc.

Danville, Virginia, United States

Site Status

Arthritis & Osteoporosis Center of Northern Virinia

Manassas, Virginia, United States

Site Status

TPMG Rheumatology/TPMG Clinical Research

Newport News, Virginia, United States

Site Status

Arthritis Northwest, PLLC

Spokane, Washington, United States

Site Status

Rheumatology & Pulmonary Clinic

Beckley, West Virginia, United States

Site Status

Rheumatic Disease Center

Milwaukee, Wisconsin, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

https://trials.lillytrialguide.com/en-US/trial/6bOD3ngGslJ7hrvp0NfPrN

A Study of Baricitinib in Participants With Rheumatoid Arthritis

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

I4V-MC-JAJD

Identifier Type: OTHER

Identifier Source: secondary_id

17363

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Safety and Efficacy of Baricitinib for COVID-19
NCT04340232 WITHDRAWN PHASE2/PHASE3