A Study of Baricitinib in Participants With Rheumatoid Arthritis
RA-BRANCH
A Randomized, Controlled Pragmatic Phase 3b/4 Study of Baricitinib in Patients With Rheumatoid Arthritis
2 other identifiers
interventional
1,317
1 country
119
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 rheumatoid-arthritis
Started Feb 2020
Longer than P75 for phase_4 rheumatoid-arthritis
119 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 10, 2019
CompletedFirst Posted
Study publicly available on registry
September 12, 2019
CompletedStudy Start
First participant enrolled
February 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 19, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 19, 2025
CompletedJuly 17, 2025
July 1, 2025
5.3 years
September 10, 2019
July 16, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Time from First Dose of Study Treatment to First Event of Venous Thromboembolism (VTE)
Time from First Dose of Study Treatment to First Event of VTE
Baseline through Study Completion (Approximately 5.5 Years)
Secondary Outcomes (5)
Time from First Dose of Study Treatment to First Arterial Thromboembolic Event (ATE)
Baseline through Study Completion (Approximately 5.5 Years)
Time from First Dose of Study Treatment to First Major Adverse Cerebro-Cardiovascular Event (MACE)
Baseline through Study Completion (Approximately 5.5 Years)
Time from First Dose of Study Treatment to First Malignancy (excluding nonmelanoma skin cancer [NMSC])
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
Baseline through Study Completion (Approximately 5.5 Years)
Study Arms (3)
Baricitinib Low Dose
EXPERIMENTALBaricitinib administered orally.
Baricitinib High Dose
EXPERIMENTALBaricitinib administered orally.
TNF Inhibitor
ACTIVE COMPARATORAdalimumab or etanercept administered subcutaneously (SC) per standard of care.
Interventions
Administered orally.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eli Lilly and Companylead
- Incyte Corporationcollaborator
Study Sites (119)
Arizona Research Clinic PLLC
Chandler, Arizona, 85225, United States
Arizona Arthritis & Rheumatology Associates, P. C.
Mesa, Arizona, 85202, United States
Arizona Arthritis & Rheumatology Research
Paradise Valley, Arizona, 85253, United States
Sun Valley Arthritis Center, LTD
Peoria, Arizona, 85381, United States
Arizona Arthritis & Rheumatology Associates
Phoenix, Arizona, 85037, United States
Arthritis and Rheumatism Associates
Jonesboro, Arkansas, 72401, United States
Providence St. Joseph's Medical Center
Burbank, California, 91505, United States
Hope Clinical Research, Inc.
Canoga Park, California, 91303, United States
Medvin Clinical Research - Covina
Covina, California, 91722, United States
TriWest Research Associates LLC
El Cajon, California, 92020, United States
Newport Huntington Med Grp
Huntington Beach, California, 92648, United States
BioSolutions Clinical Research Center
La Mesa, California, 91942, United States
Valerius Medical Group and Research Center of Greater Long Beach
Los Alamitos, California, 90720, United States
R. Srinivasan, M.D., Inc. dba Monterey Park Medical Center
Monterey Park, California, 91754, United States
ACRC Studies
Poway, California, 92064, United States
Desert Medical Advances
Rancho Mirage, California, 92270, United States
Purushotham & Akther Kotha MD Inc
San Diego, California, 92120, United States
East Bay Rheumatology Medical Group, Inc
San Leandro, California, 94578, United States
Providence Medical Foundation
Santa Rosa, California, 95403, United States
Dan La, MD Inc
Tujunga, California, 91042, United States
Office: Dr Robin K Dore
Tustin, California, 92780, United States
Inland Rheumatology & Osteoporosis Medical Group
Upland, California, 91786, United States
Nazanin Firooz, MD Inc.
West Hills, California, 91307, United States
Medvin Clinical Research - Whittier
Whittier, California, 90602, United States
Danbury Clinical Research, LLC
Danbury, Connecticut, 06810, United States
Delaware Arthritis
Lewes, Delaware, 19958, United States
Omega Research Debary, LLC
DeBary, Florida, 32713, United States
Cria Center for Rheumatology
Fort Lauderdale, Florida, 33334, United States
SIMED Health
Gainesville, Florida, 32607, United States
GNP Research at Mark Jaffe, MD
Hollywood, Florida, 33024, United States
Rheumatology Center Of Palm Beach, Pllc
Lake Worth, Florida, 33467 2991, United States
Arthritis and Rheumatology Center of South Florida
Margate, Florida, 33063, United States
Miami Clinical Reserach
Miami, Florida, 33155, United States
Felicidad Medical Research
Miami, Florida, 33185, United States
Rheumatology Associates of Central Florida
Orlando, Florida, 32806, United States
Heuer MD Research
Orlando, Florida, 32819, United States
UCF Health Lake Nona Orlando
Orlando, Florida, 32827, United States
IRIS Research and Development, LLC
Plantation, Florida, 33324, United States
BayCare Health System Inc
St. Petersburg, Florida, 33705, United States
West Broward Rheumatology Associates
Tamarac, Florida, 33321, United States
Avita Clinical Research
Tampa, Florida, 33613, United States
Tampa Medical Group, P.A.
Tampa, Florida, 33614, United States
Florida Medical Clinic LLC
Zephyrhills, Florida, 33542-7505, United States
Arthritis & Rheumatology of Georgia
Atlanta, Georgia, 30342, United States
Arthritis Center of North Georgia
Gainesville, Georgia, 30501, United States
St Luke's Clinic - Intermountain Orthopaedics
Boise, Idaho, 83702, United States
Hinsdale Orthopaedics, Illinois Bone and Joint
Hinsdale, Illinois, 60521, United States
Rockford Orthopedic Associates
Rockford, Illinois, 61107, United States
Orthoillinois
Rockford, Illinois, 61114, United States
Greater Chicago Specialty Physicians, LLC
Schaumburg, Illinois, 60195, United States
Center of Robert Hozman
Skokie, Illinois, 60076, United States
Beacon Medical Group Clinical Research
South Bend, Indiana, 46617, United States
Graves-Gilbert Clinic
Bowling Green, Kentucky, 42101, United States
Western KY Rheumatology PLLC
Hopkinsville, Kentucky, 42240, United States
Accurate Clinical Research
Lake Charles, Louisiana, 70605, United States
Arthritis and Diabetes Clinic, Inc.
Monroe, Louisiana, 71203, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Klein and Associates MD, PA
Cumberland, Maryland, 21502, United States
NECCR PrimaCare Research
Fall River, Massachusetts, 02721, United States
Michigan Rheumatology Group
Grand Blanc, Michigan, 48439, United States
Pandit Rheumatology PC
Okemos, Michigan, 48864, United States
Jefferson City Medical Group
Jefferson City, Missouri, 65109, United States
Clinvest Research LLC
Springfield, Missouri, 65807, United States
West County Rheumatology
St Louis, Missouri, 63131, United States
Lovelace Scientific Resources
Henderson, Nevada, 89104, United States
Allied Clinical Research
Reno, Nevada, 89519, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Arthritis Care Medical Center
Somerset, New Jersey, 08873, United States
Atlantic Coastal Research
Toms River, New Jersey, 08757, United States
Sahni Rheumatology & Therapy PC
West Long Branch, New Jersey, 07764, United States
NYU Langone
New York, New York, 10016, United States
Medication Management
Greensboro, North Carolina, 27408, United States
PMG Research of Hickory, LLC
Hickory, North Carolina, 28601, United States
Cape Fear Arthritis Care
Leland, North Carolina, 28451, United States
Carolina Arthritis Associates
Wilmington, North Carolina, 28401, United States
Cincinnati Arthritis Associates
Cincinnati, Ohio, 45242, United States
Craig S Thompson MD LLC
Marion, Ohio, 43302, United States
Paramount Medical Research
Middleburg Heights, Ohio, 44130, United States
Arthritis & Rheumatology Center of Oklahoma PLLC
Oklahoma City, Oklahoma, 73103, United States
Good Samaritan Hospital Corvallis
Corvallis, Oregon, 97330, United States
Advanced Rheumatology and Arthritis Research Center, PC
Cranberry Township, Pennsylvania, 15090, United States
Altoona Center For Clinical Research
Duncansville, Pennsylvania, 16635, United States
Pennsylvania Regional Center for Arthritis and Osteoporosis Research
Wyomissing, Pennsylvania, 19610, United States
Articularis Healthcare d/b/a/ Low Country Rheumatology, PA
North Charleston, South Carolina, 29406, United States
Monument Health Rapid City Hospital
Rapid City, South Dakota, 57701, United States
Cumberland Rheumatology
Crossville, Tennessee, 38555, United States
West Tennessee Research Institute
Jackson, Tennessee, 38305, United States
Nashville Arthritis and Rheumatology
Nashville, Tennessee, 37203, United States
Accent Clinical Research Professionals, LLC
Allen, Texas, 75013, United States
Amarillo Center for Clinical Research
Amarillo, Texas, 79124, United States
Arthritis & Osteoporosis Clinic of Brazos Valley
College Station, Texas, 77845, United States
Metroplex Clinical Research Center
Dallas, Texas, 75235, United States
El Paso Integrated Physicians Group, P.A., an Elligo Health Research, Inc. Healthcare Enabled Research Organization
El Paso, Texas, 79912, United States
UDL Clinical Research, LLC
Houston, Texas, 77002, United States
Pioneer Research Solutions
Houston, Texas, 77008, United States
Biopharma Informatic, LLC
Houston, Texas, 77043, United States
Accurate Clinical Management - Houston
Houston, Texas, 77084, United States
Synergy Group US
Katy, Texas, 77450, United States
Houston Rheumatology & Arthritis Specialists
Katy, Texas, 77494, United States
R and H Clinical Research
Katy, Texas, 77494, United States
Prime Clinical Research
Mansfield, Texas, 76063, United States
Southwest Rheumatology, P.A.
Mesquite, Texas, 75150, United States
Advanced Clinical Research Center of Houston
Pearland, Texas, 77584, United States
Clinrx Research Joseph INC.
Plano, Texas, 75007, United States
Violeta T. Baddour, MD
Pleasanton, Texas, 78064, United States
Accurate Clinical Research, Inc.
San Antonio, Texas, 78229, United States
Accurate Clinical Management
Sugar Land, Texas, 77479, United States
Fort Bend Clinical Research, LLC
Sugar Land, Texas, 77479, United States
Mt. Olympus Medical Research
Sugar Land, Texas, 77479, United States
Baylor Scott & White Health
Temple, Texas, 76508, United States
North Houston Rheumatology Associates
The Woodlands, Texas, 77380, United States
Dynamed Clinical Research, LP d/b/a DM Clinical Research
Tomball, Texas, 77375, United States
Center for Arthritis and Rheumatic Diseases, PC
Chesapeake, Virginia, 23320, United States
Spectrum Medical Inc.
Danville, Virginia, 24541, United States
Arthritis & Osteoporosis Center of Northern Virinia
Manassas, Virginia, 20109, United States
TPMG Rheumatology/TPMG Clinical Research
Newport News, Virginia, 23606, United States
Arthritis Northwest, PLLC
Spokane, Washington, 99204, United States
Rheumatology & Pulmonary Clinic
Beckley, West Virginia, 25801, United States
Rheumatic Disease Center
Milwaukee, Wisconsin, 53211, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2019
First Posted
September 12, 2019
Study Start
February 14, 2020
Primary Completion
May 19, 2025
Study Completion
May 19, 2025
Last Updated
July 17, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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.