A Study of Baricitinib in Participants With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

— RA-BRANCH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04086745
• Other study ID #: 17363
• Secondary ID: I4V-MC-JAJD
• Status: Recruiting
• Phase: Phase 4
• Start date: February 14, 2020
• Est. completion date: February 1, 2026

Study information

• Verified date: May 1, 2024
• Source: Eli Lilly and Company
• Contact: There may be multiple sites in this clinical trial. 1-877-CTLILL
• Phone: 1-317-615-4559
• Email: Clinicaltrials.gov[@]lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1300
• Est. completion date: February 1, 2026
• Est. primary completion date: December 27, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Baricitinib
Administered orally.
• TNF Inhibitor
Administered SC

Locations

Country	Name	City	State
United States	Amarillo Center for Clinical Research	Amarillo	Texas
United States	Ochsner Clinic Foundation	Baton Rouge	Louisiana
United States	Accurate Clinical Management	Baytown	Texas
United States	Rheumatology & Pulmonary Clinic	Beckley	West Virginia
United States	St Luke's Clinic - Intermountain Orthopaedics	Boise	Idaho
United States	Graves-Gilbert Clinic	Bowling Green	Kentucky
United States	NYU Langone	Brooklyn	New York
United States	Center for Arthritis and Rheumatic Diseases, PC	Chesapeake	Virginia
United States	Good Samaritan Hospital Corvallis	Corvallis	Oregon
United States	Medvin Clinical Research - Covina	Covina	California
United States	Cumberland Rheumatology	Crossville	Tennessee
United States	Klein and Associates MD, PA	Cumberland	Maryland
United States	Spectrum Medical Inc.	Danville	Virginia
United States	Omega Research Debary, LLC	DeBary	Florida
United States	Altoona Center For Clinical Research	Duncansville	Pennsylvania
United States	El Paso Integrated Physicians Group, P.A., an Elligo Health Research, Inc. Healthcare Enabled Research Organization	El Paso	Texas
United States	NECCR PrimaCare Research	Fall River	Massachusetts
United States	Arizona Arthritis & Rheumatology Associates	Flagstaff	Arizona
United States	Cria Center for Rheumatology	Fort Lauderdale	Florida
United States	Arthritis Center of North Georgia	Gainesville	Georgia
United States	Arizona Arthritis & Rheumatology Associates, P. C.	Gilbert	Arizona
United States	Arizona Arthritis & Rheumatology Research	Glendale	Arizona
United States	Rheumatic Disease Center	Glendale	Wisconsin
United States	Medication Management	Greensboro	North Carolina
United States	Klein and Associates MD, PA	Hagerstown	Maryland
United States	Hinsdale Orthopaedics, Illinois Bone and Joint	Hinsdale	Illinois
United States	GNP Research at Mark Jaffe, MD	Hollywood	Florida
United States	Western KY Rheumatology PLLC	Hopkinsville	Kentucky
United States	Accurate Clinical Research	Houston	Texas
United States	Biopharma Informatic, LLC	Houston	Texas
United States	Dynamed Clinical Research, LP d/b/a DM Clinical Research	Houston	Texas
United States	Newport Huntington Med Grp	Huntington Beach	California
United States	West Tennessee Research Institute	Jackson	Tennessee
United States	Jefferson City Medical Group	Jefferson City	Missouri
United States	Arthritis and Rheumatism Associates	Jonesboro	Arkansas
United States	Houston Rheumatology & Arthritis Specialists	Katy	Texas
United States	Accurate Clinical Research	League City	Texas
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Cape Fear Arthritis Care	Leland	North Carolina
United States	Delaware Arthritis	Lewes	Delaware
United States	Soha Dolatabadi, MD	Los Angeles	California
United States	Arthritis & Osteoporosis Center of Northern Virinia	Manassas	Virginia
United States	Arthritis and Rheumatology Center of South Florida	Margate	Florida
United States	Craig S Thompson MD LLC	Marion	Ohio
United States	Arizona Arthritis & Rheumatology Associates, P. C.	Mesa	Arizona
United States	Southwest Rheumatology, P.A.	Mesquite	Texas
United States	Paramount Medical Research	Middleburg Heights	Ohio
United States	Providence St. Joseph's Medical Center	Mission Hills	California
United States	Arthritis and Diabetes Clinic, Inc.	Monroe	Louisiana
United States	TPMG Rheumatology/TPMG Clinical Research	Newport News	Virginia
United States	Pandit Rheumatology PC	Okemos	Michigan
United States	Rheumatology Associates of Central Florida	Orlando	Florida
United States	Desert Medical Advances	Palm Desert	California
United States	Sun Valley Arthritis Center, LTD	Peoria	Arizona
United States	Arizona Arthritis & Rheumatology Associates, P. C.	Phoenix	Arizona
United States	Arizona Arthritis & Rheumatology Research	Phoenix	Arizona
United States	Clinrx Research Joseph INC.	Plano	Texas
United States	IRIS Research and Development, LLC	Plantation	Florida
United States	Monument Health Rapid City Hospital	Rapid City	South Dakota
United States	Lovelace Scientific Resources	Riverview	Florida
United States	Rockford Orthopedic Associates	Rockford	Illinois
United States	Accurate Clinical Research, Inc.	San Antonio	Texas
United States	TriWest Research Associates LLC	San Diego	California
United States	East Bay Rheumatology Medical Group, Inc	San Leandro	California
United States	Greater Chicago Specialty Physicians, LLC	Schaumburg	Illinois
United States	Center of Robert Hozman	Skokie	Illinois
United States	Arthritis Northwest, PLLC	Spokane	Washington
United States	Clinvest Research LLC	Springfield	Missouri
United States	Mt. Olympus Medical Research	Sugar Land	Texas
United States	Articularis Healthcare d/b/a/ Low Country Rheumatology, PA	Summerville	South Carolina
United States	Arizona Arthritis & Rheumatology Associates, P. C.	Sun City	Arizona
United States	West Broward Rheumatology Associates	Tamarac	Florida
United States	North Houston Rheumatology Associates	The Woodlands	Texas
United States	Dynamed Clinical Research, LP d/b/a DM Clinical Research	Tomball	Texas
United States	Atlantic Coastal Research	Toms River	New Jersey
United States	Arizona Arthritis & Rheumatology Associates, P. C.	Tucson	Arizona
United States	Dan La, MD Inc	Tujunga	California
United States	Office: Dr Robin K Dore	Tustin	California
United States	Inland Rheumatology & Osteoporosis Medical Group	Upland	California
United States	Sahni Rheumatology & Therapy PC	West Long Branch	New Jersey
United States	Medvin Clinical Research - Whittier	Whittier	California
United States	Carolina Arthritis Associates	Wilmington	North Carolina
United States	Florida Medical Clinic LLC	Zephyrhills	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	Incyte Corporation

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   A Study of Baricitinib in Participants With Rheumatoid Arthritis