A Study of Baricitinib in Participants With Rheumatoid Arthritis (RA-BRANCH)

July 16, 2025 updated by: Eli Lilly and Company

A Randomized, Controlled Pragmatic Phase 3b/4 Study of Baricitinib in Patients With Rheumatoid Arthritis

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1317

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Chandler, Arizona, United States, 85225
        • Arizona Research Clinic PLLC
      • Mesa, Arizona, United States, 85202
        • Arizona Arthritis & Rheumatology Associates, P. C.
      • Paradise Valley, Arizona, United States, 85253
        • Arizona Arthritis & Rheumatology Research
      • Peoria, Arizona, United States, 85381
        • Sun Valley Arthritis Center, LTD
      • Phoenix, Arizona, United States, 85037
        • Arizona Arthritis & Rheumatology Associates
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Arthritis and Rheumatism Associates
    • California
      • Burbank, California, United States, 91505
        • Providence St. Joseph's Medical Center
      • Canoga Park, California, United States, 91303
        • Hope Clinical Research, Inc.
      • Covina, California, United States, 91722
        • Medvin Clinical Research - Covina
      • El Cajon, California, United States, 92020
        • Triwest Research Associates Llc
      • Huntington Beach, California, United States, 92648
        • Newport Huntington Med Grp
      • La Mesa, California, United States, 91942
        • BioSolutions Clinical Research Center
      • Los Alamitos, California, United States, 90720
        • Valerius Medical Group and Research Center of Greater Long Beach
      • Monterey Park, California, United States, 91754
        • R. Srinivasan, M.D., Inc. dba Monterey Park Medical Center
      • Poway, California, United States, 92064
        • ACRC Studies
      • Rancho Mirage, California, United States, 92270
        • Desert Medical Advances
      • San Diego, California, United States, 92120
        • Purushotham & Akther Kotha MD Inc
      • San Leandro, California, United States, 94578
        • East Bay Rheumatology Medical Group, Inc
      • Santa Rosa, California, United States, 95403
        • Providence Medical Foundation
      • Tujunga, California, United States, 91042
        • Dan La, MD Inc
      • Tustin, California, United States, 92780
        • Office: Dr Robin K Dore
      • Upland, California, United States, 91786
        • Inland Rheumatology & Osteoporosis Medical Group
      • West Hills, California, United States, 91307
        • Nazanin Firooz, MD Inc.
      • Whittier, California, United States, 90602
        • Medvin Clinical Research - Whittier
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Danbury Clinical Research, LLC
    • Delaware
      • Lewes, Delaware, United States, 19958
        • Delaware Arthritis
    • Florida
      • DeBary, Florida, United States, 32713
        • Omega Research Debary, LLC
      • Fort Lauderdale, Florida, United States, 33334
        • Cria Center for Rheumatology
      • Gainesville, Florida, United States, 32607
        • SIMED Health
      • Hollywood, Florida, United States, 33024
        • GNP Research at Mark Jaffe, MD
      • Lake Worth, Florida, United States, 33467 2991
        • Rheumatology Center Of Palm Beach, Pllc
      • Margate, Florida, United States, 33063
        • Arthritis and Rheumatology Center of South Florida
      • Miami, Florida, United States, 33185
        • Felicidad Medical Research
      • Miami, Florida, United States, 33155
        • Miami Clinical Reserach
      • Orlando, Florida, United States, 32806
        • Rheumatology Associates of Central Florida
      • Orlando, Florida, United States, 32819
        • Heuer MD Research
      • Orlando, Florida, United States, 32827
        • UCF Health Lake Nona Orlando
      • Plantation, Florida, United States, 33324
        • IRIS Research and Development, LLC
      • Saint Petersburg, Florida, United States, 33705
        • BayCare Health System Inc
      • Tamarac, Florida, United States, 33321
        • West Broward Rheumatology Associates
      • Tampa, Florida, United States, 33613
        • Avita Clinical Research
      • Tampa, Florida, United States, 33614
        • Tampa Medical Group, P.A.
      • Zephyrhills, Florida, United States, 33542-7505
        • Florida Medical Clinic LLC
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Arthritis & Rheumatology of Georgia
      • Gainesville, Georgia, United States, 30501
        • Arthritis Center of North Georgia
    • Idaho
      • Boise, Idaho, United States, 83702
        • St Luke's Clinic - Intermountain Orthopaedics
    • Illinois
      • Hinsdale, Illinois, United States, 60521
        • Hinsdale Orthopaedics, Illinois Bone and Joint
      • Rockford, Illinois, United States, 61114
        • OrthoIllinois
      • Rockford, Illinois, United States, 61107
        • Rockford Orthopedic Associates
      • Schaumburg, Illinois, United States, 60195
        • Greater Chicago Specialty Physicians, LLC
      • Skokie, Illinois, United States, 60076
        • Center of Robert Hozman
    • Indiana
      • South Bend, Indiana, United States, 46617
        • Beacon Medical Group Clinical Research
    • Kentucky
      • Bowling Green, Kentucky, United States, 42101
        • Graves-Gilbert Clinic
      • Hopkinsville, Kentucky, United States, 42240
        • Western KY Rheumatology PLLC
    • Louisiana
      • Lake Charles, Louisiana, United States, 70605
        • Accurate Clinical Research
      • Monroe, Louisiana, United States, 71203
        • Arthritis And Diabetes Clinic, Inc.
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
    • Maryland
      • Cumberland, Maryland, United States, 21502
        • Klein and Associates MD, PA
    • Massachusetts
      • Fall River, Massachusetts, United States, 02721
        • NECCR PrimaCare Research
    • Michigan
      • Grand Blanc, Michigan, United States, 48439
        • Michigan Rheumatology Group
      • Okemos, Michigan, United States, 48864
        • Pandit Rheumatology PC
    • Missouri
      • Jefferson City, Missouri, United States, 65109
        • Jefferson City Medical Group
      • Saint Louis, Missouri, United States, 63131
        • West County Rheumatology
      • Springfield, Missouri, United States, 65807
        • Clinvest Research LLC
    • Nevada
      • Henderson, Nevada, United States, 89104
        • Lovelace Scientific Resources
      • Reno, Nevada, United States, 89519
        • Allied Clinical Research
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center
    • New Jersey
      • Somerset, New Jersey, United States, 08873
        • Arthritis Care Medical Center
      • Toms River, New Jersey, United States, 08757
        • Atlantic Coastal Research
      • West Long Branch, New Jersey, United States, 07764
        • Sahni Rheumatology & Therapy PC
    • New York
      • New York, New York, United States, 10016
        • NYU Langone
    • North Carolina
      • Greensboro, North Carolina, United States, 27408
        • Medication Management
      • Hickory, North Carolina, United States, 28601
        • PMG Research of Hickory, LLC
      • Leland, North Carolina, United States, 28451
        • Cape Fear Arthritis Care
      • Wilmington, North Carolina, United States, 28401
        • Carolina Arthritis Associates
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Cincinnati Arthritis Associates
      • Marion, Ohio, United States, 43302
        • Craig S Thompson MD LLC
      • Middleburg Heights, Ohio, United States, 44130
        • Paramount Medical Research
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • Arthritis & Rheumatology Center of Oklahoma PLLC
    • Oregon
      • Corvallis, Oregon, United States, 97330
        • Good Samaritan Hospital Corvallis
    • Pennsylvania
      • Cranberry Township, Pennsylvania, United States, 15090
        • Advanced Rheumatology and Arthritis Research Center, PC
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Center for Clinical Research
      • Wyomissing, Pennsylvania, United States, 19610
        • Pennsylvania Regional Center for Arthritis and Osteoporosis Research
    • South Carolina
      • North Charleston, South Carolina, United States, 29406
        • Articularis Healthcare d/b/a/ Low Country Rheumatology, PA
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Monument Health Rapid City Hospital
    • Tennessee
      • Crossville, Tennessee, United States, 38555
        • Cumberland Rheumatology
      • Jackson, Tennessee, United States, 38305
        • West Tennessee Research Institute
      • Nashville, Tennessee, United States, 37203
        • Nashville Arthritis and Rheumatology
    • Texas
      • Allen, Texas, United States, 75013
        • Accent Clinical Research Professionals, LLC
      • Amarillo, Texas, United States, 79124
        • Amarillo Center for Clinical Research
      • College Station, Texas, United States, 77845
        • Arthritis & Osteoporosis Clinic of Brazos Valley
      • Dallas, Texas, United States, 75235
        • Metroplex Clinical Research Center
      • El Paso, Texas, United States, 79912
        • El Paso Integrated Physicians Group, P.A., an Elligo Health Research, Inc. Healthcare Enabled Research Organization
      • Houston, Texas, United States, 77008
        • Pioneer Research Solutions
      • Houston, Texas, United States, 77043
        • Biopharma Informatic, LLC
      • Houston, Texas, United States, 77084
        • Accurate Clinical Management - Houston
      • Houston, Texas, United States, 77002
        • UDL Clinical Research, LLC
      • Katy, Texas, United States, 77494
        • Houston Rheumatology & Arthritis Specialists
      • Katy, Texas, United States, 77494
        • R and H Clinical Research
      • Katy, Texas, United States, 77450
        • Synergy Group US
      • Mansfield, Texas, United States, 76063
        • Prime Clinical Research
      • Mesquite, Texas, United States, 75150
        • Southwest Rheumatology, P.A.
      • Pearland, Texas, United States, 77584
        • Advanced Clinical Research Center of Houston
      • Plano, Texas, United States, 75007
        • Clinrx Research Joseph INC.
      • Pleasanton, Texas, United States, 78064
        • Violeta T. Baddour, MD
      • San Antonio, Texas, United States, 78229
        • Accurate Clinical Research, Inc.
      • Sugar Land, Texas, United States, 77479
        • Mt. Olympus Medical Research
      • Sugar Land, Texas, United States, 77479
        • Fort Bend Clinical Research, LLC
      • Sugar Land, Texas, United States, 77479
        • Accurate Clinical Management
      • Temple, Texas, United States, 76508
        • Baylor Scott & White Health
      • The Woodlands, Texas, United States, 77380
        • North Houston Rheumatology Associates
      • Tomball, Texas, United States, 77375
        • Dynamed Clinical Research, LP d/b/a DM Clinical Research
    • Virginia
      • Chesapeake, Virginia, United States, 23320
        • Center for Arthritis and Rheumatic Diseases, PC
      • Danville, Virginia, United States, 24541
        • Spectrum Medical Inc.
      • Manassas, Virginia, United States, 20109
        • Arthritis & Osteoporosis Center of Northern Virinia
      • Newport News, Virginia, United States, 23606
        • TPMG Rheumatology/TPMG Clinical Research
    • Washington
      • Spokane, Washington, United States, 99204
        • Arthritis Northwest, PLLC
    • West Virginia
      • Beckley, West Virginia, United States, 25801
        • Rheumatology & Pulmonary Clinic
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53211
        • Rheumatic Disease Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Baricitinib High Dose
Baricitinib administered orally.
Drug: Baricitinib
Administered orally.
Other Names:
  • LY3009104
Experimental: Baricitinib Low Dose
Baricitinib administered orally.
Drug: Baricitinib
Administered orally.
Other Names:
  • LY3009104
Active Comparator: TNF Inhibitor
Adalimumab or etanercept administered subcutaneously (SC) per standard of care.
Drug: TNF Inhibitor
Administered SC
Other Names:
  • Etanercept
  • Adalimumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time from First Dose of Study Treatment to First Event of Venous Thromboembolism (VTE)
Time Frame: Baseline through Study Completion (Approximately 5.5 Years)
Time from First Dose of Study Treatment to First Event of VTE
Baseline through Study Completion (Approximately 5.5 Years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time from First Dose of Study Treatment to First Arterial Thromboembolic Event (ATE)
Time Frame: Baseline through Study Completion (Approximately 5.5 Years)
Time from First Dose of Study Treatment to First ATE
Baseline through Study Completion (Approximately 5.5 Years)
Time from First Dose of Study Treatment to First Major Adverse Cerebro-Cardiovascular Event (MACE)
Time Frame: Baseline through Study Completion (Approximately 5.5 Years)
Time from First Dose of Study Treatment to First MACE
Baseline through Study Completion (Approximately 5.5 Years)
Time from First Dose of Study Treatment to First Malignancy (excluding nonmelanoma skin cancer [NMSC])
Time Frame: Baseline through Study Completion (Approximately 5.5 Years)
Time from First Dose of Study Treatment to First Malignancy (excluding NMSC)
Baseline through Study Completion (Approximately 5.5 Years)
Time from First Dose of Study Treatment to First Opportunistic Infection
Time Frame: Baseline through Study Completion (Approximately 5.5 Years)
Time from First Dose of Study Treatment to First Opportunistic Infection
Baseline through Study Completion (Approximately 5.5 Years)
Time from First Dose of Study Treatment to First Serious Infection
Time Frame: Baseline through Study Completion (Approximately 5.5 Years)
Time from First Dose of Study Treatment to First Serious Infection
Baseline through Study Completion (Approximately 5.5 Years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Collaborators

Incyte Corporation

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2020

Primary Completion (Actual)

May 19, 2025

Study Completion (Actual)

May 19, 2025

Study Registration Dates

First Submitted

September 10, 2019

First Submitted That Met QC Criteria

September 10, 2019

First Posted (Actual)

September 12, 2019

Study Record Updates

Last Update Posted (Actual)

July 17, 2025

Last Update Submitted That Met QC Criteria

July 16, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17363
  • I4V-MC-JAJD (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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