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Rheumatoid ArthritisPhase 4RA-BRANCHNCT04086745

A Study of Baricitinib in Participants With Rheumatoid Arthritis

A Phase 4 study testing Baricitinib and TNF Inhibitor in people with Rheumatoid Arthritis, run by Eli Lilly and Company at 119 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Baricitinib and TNF Inhibitor
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,050 participants
Where
119 sitesUnited States
Study dates
14 Feb 2020to 19 May 2025
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 drug (DMARD) (synthetic or biologic)

Who cannot join

  • 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 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
Show all 10Show fewer
  • 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

Trial locations and contacts

119 sites in 1 country.

119 sites in 1 country

United States119 sites

  • Accent Clinical Research Professionals, LLC

    Allen, Texas, 75013

  • Amarillo Center for Clinical Research

    Amarillo, Texas, 79124

  • Arthritis & Rheumatology of Georgia

    Atlanta, Georgia, 30342

  • Rheumatology & Pulmonary Clinic

    Beckley, West Virginia, 25801

  • St Luke's Clinic - Intermountain Orthopaedics

    Boise, Idaho, 83702

  • Graves-Gilbert Clinic

    Bowling Green, Kentucky, 42101

  • Providence St. Joseph's Medical Center

    Burbank, California, 91505

  • Hope Clinical Research, Inc.

    Canoga Park, California, 91303

  • Arizona Research Clinic PLLC

    Chandler, Arizona, 85225

  • Center for Arthritis and Rheumatic Diseases, PC

    Chesapeake, Virginia, 23320

  • Cincinnati Arthritis Associates

    Cincinnati, Ohio, 45242

  • Arthritis & Osteoporosis Clinic of Brazos Valley

    College Station, Texas, 77845

  • Good Samaritan Hospital Corvallis

    Corvallis, Oregon, 97330

  • Medvin Clinical Research - Covina

    Covina, California, 91722

  • Advanced Rheumatology and Arthritis Research Center, PC

    Cranberry Township, Pennsylvania, 15090

  • Cumberland Rheumatology

    Crossville, Tennessee, 38555

  • Klein and Associates MD, PA

    Cumberland, Maryland, 21502

  • Metroplex Clinical Research Center

    Dallas, Texas, 75235

  • Danbury Clinical Research, LLC

    Danbury, Connecticut, 06810

  • Spectrum Medical Inc.

    Danville, Virginia, 24541

  • Omega Research Debary, LLC

    DeBary, Florida, 32713

  • Altoona Center For Clinical Research

    Duncansville, Pennsylvania, 16635

  • TriWest Research Associates LLC

    El Cajon, California, 92020

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

    El Paso, Texas, 79912

  • NECCR PrimaCare Research

    Fall River, Massachusetts, 02721

  • Cria Center for Rheumatology

    Fort Lauderdale, Florida, 33334

  • SIMED Health

    Gainesville, Florida, 32607

  • Arthritis Center of North Georgia

    Gainesville, Georgia, 30501

  • Michigan Rheumatology Group

    Grand Blanc, Michigan, 48439

  • Medication Management

    Greensboro, North Carolina, 27408

  • Lovelace Scientific Resources

    Henderson, Nevada, 89104

  • PMG Research of Hickory, LLC

    Hickory, North Carolina, 28601

  • Hinsdale Orthopaedics, Illinois Bone and Joint

    Hinsdale, Illinois, 60521

  • GNP Research at Mark Jaffe, MD

    Hollywood, Florida, 33024

  • Western KY Rheumatology PLLC

    Hopkinsville, Kentucky, 42240

  • UDL Clinical Research, LLC

    Houston, Texas, 77002

  • Pioneer Research Solutions

    Houston, Texas, 77008

  • Biopharma Informatic, LLC

    Houston, Texas, 77043

  • Accurate Clinical Management - Houston

    Houston, Texas, 77084

  • Newport Huntington Med Grp

    Huntington Beach, California, 92648

  • West Tennessee Research Institute

    Jackson, Tennessee, 38305

  • Jefferson City Medical Group

    Jefferson City, Missouri, 65109

  • Arthritis and Rheumatism Associates

    Jonesboro, Arkansas, 72401

  • Synergy Group US

    Katy, Texas, 77450

  • Houston Rheumatology & Arthritis Specialists

    Katy, Texas, 77494

  • R and H Clinical Research

    Katy, Texas, 77494

  • BioSolutions Clinical Research Center

    La Mesa, California, 91942

  • Accurate Clinical Research

    Lake Charles, Louisiana, 70605

  • Rheumatology Center Of Palm Beach, Pllc

    Lake Worth, Florida, 33467 2991

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Cape Fear Arthritis Care

    Leland, North Carolina, 28451

  • Delaware Arthritis

    Lewes, Delaware, 19958

  • Valerius Medical Group and Research Center of Greater Long Beach

    Los Alamitos, California, 90720

  • Arthritis & Osteoporosis Center of Northern Virinia

    Manassas, Virginia, 20109

  • Prime Clinical Research

    Mansfield, Texas, 76063

  • Arthritis and Rheumatology Center of South Florida

    Margate, Florida, 33063

  • Craig S Thompson MD LLC

    Marion, Ohio, 43302

  • Arizona Arthritis & Rheumatology Associates, P. C.

    Mesa, Arizona, 85202

  • Southwest Rheumatology, P.A.

    Mesquite, Texas, 75150

  • Miami Clinical Reserach

    Miami, Florida, 33155

  • Felicidad Medical Research

    Miami, Florida, 33185

  • Paramount Medical Research

    Middleburg Heights, Ohio, 44130

  • Rheumatic Disease Center

    Milwaukee, Wisconsin, 53211

  • Arthritis and Diabetes Clinic, Inc.

    Monroe, Louisiana, 71203

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

    Monterey Park, California, 91754

  • Nashville Arthritis and Rheumatology

    Nashville, Tennessee, 37203

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • NYU Langone

    New York, New York, 10016

  • TPMG Rheumatology/TPMG Clinical Research

    Newport News, Virginia, 23606

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

    North Charleston, South Carolina, 29406

  • Pandit Rheumatology PC

    Okemos, Michigan, 48864

  • Arthritis & Rheumatology Center of Oklahoma PLLC

    Oklahoma City, Oklahoma, 73103

  • Rheumatology Associates of Central Florida

    Orlando, Florida, 32806

  • Heuer MD Research

    Orlando, Florida, 32819

  • UCF Health Lake Nona Orlando

    Orlando, Florida, 32827

  • Arizona Arthritis & Rheumatology Research

    Paradise Valley, Arizona, 85253

  • Advanced Clinical Research Center of Houston

    Pearland, Texas, 77584

  • Sun Valley Arthritis Center, LTD

    Peoria, Arizona, 85381

  • Arizona Arthritis & Rheumatology Associates

    Phoenix, Arizona, 85037

  • Clinrx Research Joseph INC.

    Plano, Texas, 75007

  • IRIS Research and Development, LLC

    Plantation, Florida, 33324

  • Violeta T. Baddour, MD

    Pleasanton, Texas, 78064

  • ACRC Studies

    Poway, California, 92064

  • Desert Medical Advances

    Rancho Mirage, California, 92270

  • Monument Health Rapid City Hospital

    Rapid City, South Dakota, 57701

  • Allied Clinical Research

    Reno, Nevada, 89519

  • Rockford Orthopedic Associates

    Rockford, Illinois, 61107

  • Orthoillinois

    Rockford, Illinois, 61114

  • Accurate Clinical Research, Inc.

    San Antonio, Texas, 78229

  • Purushotham & Akther Kotha MD Inc

    San Diego, California, 92120

  • East Bay Rheumatology Medical Group, Inc

    San Leandro, California, 94578

  • Providence Medical Foundation

    Santa Rosa, California, 95403

  • Greater Chicago Specialty Physicians, LLC

    Schaumburg, Illinois, 60195

  • Center of Robert Hozman

    Skokie, Illinois, 60076

  • Arthritis Care Medical Center

    Somerset, New Jersey, 08873

  • Beacon Medical Group Clinical Research

    South Bend, Indiana, 46617

  • Arthritis Northwest, PLLC

    Spokane, Washington, 99204

  • Clinvest Research LLC

    Springfield, Missouri, 65807

  • West County Rheumatology

    St Louis, Missouri, 63131

  • BayCare Health System Inc

    St. Petersburg, Florida, 33705

  • Accurate Clinical Management

    Sugar Land, Texas, 77479

  • Fort Bend Clinical Research, LLC

    Sugar Land, Texas, 77479

  • Mt. Olympus Medical Research

    Sugar Land, Texas, 77479

  • West Broward Rheumatology Associates

    Tamarac, Florida, 33321

  • Avita Clinical Research

    Tampa, Florida, 33613

  • Tampa Medical Group, P.A.

    Tampa, Florida, 33614

  • Baylor Scott & White Health

    Temple, Texas, 76508

  • North Houston Rheumatology Associates

    The Woodlands, Texas, 77380

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

    Tomball, Texas, 77375

  • Atlantic Coastal Research

    Toms River, New Jersey, 08757

  • Dan La, MD Inc

    Tujunga, California, 91042

  • Office: Dr Robin K Dore

    Tustin, California, 92780

  • Inland Rheumatology & Osteoporosis Medical Group

    Upland, California, 91786

  • Nazanin Firooz, MD Inc.

    West Hills, California, 91307

  • Sahni Rheumatology & Therapy PC

    West Long Branch, New Jersey, 07764

  • Medvin Clinical Research - Whittier

    Whittier, California, 90602

  • Carolina Arthritis Associates

    Wilmington, North Carolina, 28401

  • Pennsylvania Regional Center for Arthritis and Osteoporosis Research

    Wyomissing, Pennsylvania, 19610

  • Florida Medical Clinic LLC

    Zephyrhills, Florida, 33542-7505

Other trials in United States

About this study

Official title: 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).

Being tested
Baricitinib, TNF Inhibitor
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BaricitinibDrug

    Also called LY3009104

    Administered orally.

  • TNF InhibitorDrug

    Also called Etanercept, Adalimumab

    Administered subcutaneously.

Study groups in NCT04086745
Study groupRoleWhat they receive
Baricitinib 2mgExperimentalParticipants received 2 milligrams (mg) of baricitinib once daily until the planned number of adjudicated primary endpoint events occurred or until the data monitoring committee (DMC) recommended early termination. Those with inadequate response at 1-year after start of treatment with baricitinib 2 mg could receive rescue treatment with baricitinib 4 mg.
Receives: Drug: Baricitinib
Baricitinib 4mgExperimentalParticipants received 4 mg of baricitinib once daily until the planned number of adjudicated primary endpoint events occurred or until the DMC recommended early termination.
Receives: Drug: Baricitinib
Tumor Necrosis Factor (TNF) InhibitorActive comparatorParticipants received a TNF inhibitor (adalimumab or etanercept) administered according to approved local labeling until the planned number of adjudicated primary endpoint events occurred or until the DMC recommended early termination.
Receives: Drug: TNF Inhibitor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Event of Venous Thromboembolism (VTE) [Combined Baricitinib Dose Versus TNF Inhibitor]

    Time from first dose of study treatment to first event of VTE was evaluated using hazard ratio as the measure of treatment effect, estimated from Cox proportional hazards regression model. The analysis was based on pooled data from studies JAJA (NCT03915964) and JAJD (NCT04086745) and was stratified by study, with treatment group and randomization stratification factors (VTE history, age/Body Mass Index (BMI) combination, prior inadequate response or intolerance to a TNF inhibitor, and geographic region) as explanatory variables.

    Measured: From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)

Secondary outcomes (6)

  1. Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Event of Venous Thromboembolism (VTE) [Individual Baricitinib Dose Versus TNF Inhibitor]

    Time from first dose of study treatment to first event of VTE was evaluated using hazard ratio as the measure of treatment effect, estimated from Cox proportional hazards regression model. The analysis was based on pooled data from studies JAJA (NCT03915964) and JAJD (NCT04086745) and was stratified by study, with treatment group and randomization stratification factors (VTE history, age/BMI combination, prior inadequate response or intolerance to a TNF inhibitor, and geographic region) as explanatory variables.

    Measured: From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)

  2. Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Arterial Thromboembolic Event (ATE) [Combined and Individual Baricitinib Dose Versus TNF Inhibitor]

    Time from first dose of study treatment to first ATE was evaluated using hazard ratio as the measure of treatment effect, estimated from Cox proportional hazards regression model. The analysis was based on pooled data from studies JAJA (NCT03915964) and JAJD (NCT04086745) and was stratified by study, with treatment group and randomization stratification factors (VTE history, age/BMI combination, prior inadequate response or intolerance to a TNF inhibitor, and geographic region) as explanatory variables.

    Measured: From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)

  3. Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Major Adverse Cerebro-Cardiovascular Event (MACE) [Combined and Individual Baricitinib Dose Versus TNF Inhibitor]

    Time from first dose of study treatment to first MACE was evaluated using hazard ratio as the measure of treatment effect, estimated from Cox proportional hazards regression model. The analysis was based on pooled data from studies JAJA (NCT03915964) and JAJD (NCT04086745) and was stratified by study, with treatment group and randomization stratification factors (VTE history, age/BMI combination, prior inadequate response or intolerance to a TNF inhibitor, and geographic region) as explanatory variables.

    Measured: From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)

  4. Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Malignancy (Excluding Nonmelanoma Skin Cancer [NMSC]) [Combined and Individual Baricitinib Dose Versus TNF Inhibitor]

    Time from first dose of study treatment to first malignancy (excluding NMSC) was evaluated using hazard ratio as the measure of treatment effect, estimated from Cox proportional hazards regression model. The analysis was based on pooled data from studies JAJA (NCT03915964) and JAJD (NCT04086745) and was stratified by study, with treatment group and randomization stratification factors (VTE history, age/BMI combination, prior inadequate response or intolerance to a TNF inhibitor, and geographic region) as explanatory variables.

    Measured: From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)

  5. Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Opportunistic Infection [Combined and Individual Baricitinib Dose Versus TNF Inhibitor]

    Time from first dose of study treatment to first opportunistic infection was evaluated using hazard ratio as the measure of treatment effect, estimated from Cox proportional hazards regression model. The analysis was based on pooled data from studies JAJA (NCT03915964) and JAJD (NCT04086745) and was stratified by study, with treatment group and randomization stratification factors (VTE history, age/BMI combination, prior inadequate response or intolerance to a TNF inhibitor, and geographic region) as explanatory variables.

    Measured: From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)

  6. Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Serious Infection [Combined and Individual Baricitinib Dose Versus TNF Inhibitor]

    Time from first dose of study treatment to first serious infection was evaluated using hazard ratio as the measure of treatment effect, estimated from Cox proportional hazards regression model. The analysis was based on pooled data from studies JAJA (NCT03915964) and JAJD (NCT04086745) and was stratified by study, with treatment group and randomization stratification factors (VTE history, age/BMI combination, prior inadequate response or intolerance to a TNF inhibitor, and geographic region) as explanatory variables.

    Measured: From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2019
  2. Study start14 Feb 2020
  3. Primary completion19 May 2025
  4. Study completion19 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,050 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04086745
Sponsor's protocol ID
17363
Other IDs
I4V-MC-JAJD
Acronym
RA-BRANCH
Status last verified
Jun 2026
First submitted
10 Sep 2019
Last updated
10 Jul 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Baricitinib and TNF Inhibitor in people with Rheumatoid Arthritis, run by Eli Lilly and Company at 119 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 119 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Event of Venous Thromboembolism (VTE) [Combined Baricitinib Dose Versus TNF Inhibitor] (time frame: From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04086745.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.

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