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

June 15, 2026 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1050

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: clinical_inquiry_hub@lilly.com

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
      • St. 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
      • Springfield, Missouri, United States, 65807
        • Clinvest Research LLC
      • St Louis, Missouri, United States, 63131
        • West County Rheumatology
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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 drug (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 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Baricitinib 4mg
Participants received 4 mg of baricitinib once daily until the planned number of adjudicated primary endpoint events occurred or until the DMC recommended early termination.
Drug: Baricitinib
Administered orally.
Other Names:
  • LY3009104
Active Comparator: Tumor Necrosis Factor (TNF) Inhibitor
Participants 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.
Drug: TNF Inhibitor
Administered subcutaneously.
Other Names:
  • Etanercept
  • Adalimumab
Experimental: Baricitinib 2mg
Participants 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.
Drug: Baricitinib
Administered orally.
Other Names:
  • LY3009104

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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 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)
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.
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)
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 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)
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.
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)
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 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)
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.
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)
Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Opportunistic Infection [Combined and Individual 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)
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.
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)
Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Serious Infection [Combined and Individual 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)
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.
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)
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 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)
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.
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)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total Duration of Treatment Exposure for Combined Baricitinib Dose, Individual Baricitinib Dose and TNF Inhibitor
Time Frame: From the date of first dose of study drug up to the last dose (approximately up to 5.3 years)

Duration of exposure was calculated as:

  • Baricitinib 2mg exposure = date of last baricitinib 2mg treatment - date of first baricitinib 2mg dose + 1. For participants who were rescued from baricitinib 2 mg to 4 mg, their drug exposure after rescue was censored and not counted as exposure to baricitinib 2mg.
  • Baricitinib 4mg exposure = date of last baricitinib 4mg treatment - date of first baricitinib 4mg dose + 1.

TNF inhibitor exposure = date of last TNFi (adalimumab or etanercept) - date of first TNFi dose (adalimumab or etanercept) + 1, regardless of treatment cycling from adalimumab to etanercept or vice versa.

- Total baricitinib exposure (2/4 mg) = date of last baricitinib (2mg or 4mg) treatment - date of first baricitinib (2mg or 4mg) dose + 1, regardless of rescue from baricitinib 2mg to baricitinib 4mg.

Patient-years is calculated as sum of duration of exposure in days for all patients in dosing regimen divided by 365.25.
From the date of first dose of study drug up to the last dose (approximately up to 5.3 years)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Incyte Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 14, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 19, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 19, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 10, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 12, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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