A Study of Baricitinib in Participants With Rheumatoid Arthritis

Last updated: February 27, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

4

Condition

Rheumatoid Arthritis

Arthritis And Arthritic Pain

Dermatomyositis (Connective Tissue Disease)

Treatment

TNF Inhibitor

Baricitinib

Clinical Study ID

NCT04086745
17363
I4V-MC-JAJD
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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 1disease-modifying antirheumatic drugs (DMARD) (synthetic or biologic)

Exclusion

Exclusion Criteria:

  • Participant must not have prior use of a Janus kinase (JAK) inhibitor or havereceived 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, activetuberculosis, 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 fourweeks of study start

  • Participants must not have a history of IV drug use, other illicit drug abuse, orchronic alcohol abuse in the past year

Study Design

Total Participants: 1300
Treatment Group(s): 2
Primary Treatment: TNF Inhibitor
Phase: 4
Study Start date:
February 14, 2020
Estimated Completion Date:
April 30, 2026

Connect with a study center

  • Arizona Research Clinic

    Chandler, Arizona 85225
    United States

    Site Not Available

  • Arizona Research Clinic PLLC

    Chandler, Arizona 85225
    United States

    Active - Recruiting

  • Arizona Arthritis & Rheumatology Associates

    Flagstaff, Arizona 86001
    United States

    Site Not Available

  • Arizona Arthritis & Rheumatology Research, PLLC

    Flagstaff, Arizona 86001
    United States

    Active - Recruiting

  • Arizona Arthritis & Rheumatology Associates, P. C.

    Gilbert, Arizona 85704
    United States

    Site Not Available

  • Arizona Arthritis & Rheumatology Research

    Glendale, Arizona 85306
    United States

    Site Not Available

  • Arizona Arthritis & Rheumatology Associates, P. C.

    Mesa, Arizona 85202
    United States

    Active - Recruiting

  • Arizona Arthritis & Rheumatology Research

    Paradise Valley, Arizona 85253
    United States

    Active - Recruiting

  • Sun Valley Arthritis Center, LTD

    Peoria, Arizona 85381
    United States

    Active - Recruiting

  • Arizona Arthritis & Rheumatology Associates

    Phoenix, Arizona 85037
    United States

    Active - Recruiting

  • Arizona Arthritis & Rheumatology Associates, P. C.

    Phoenix, Arizona 85037
    United States

    Active - Recruiting

  • Arizona Arthritis & Rheumatology Research

    Phoenix, Arizona 85032
    United States

    Active - Recruiting

  • Prescott Rheumatology

    Prescott, Arizona 86305
    United States

    Site Not Available

  • Imaging Endpoints

    Scottsdale, Arizona 85258
    United States

    Site Not Available

  • Arizona Arthritis & Rheumatology Associates, P. C.

    Sun City, Arizona 85351
    United States

    Site Not Available

  • Arizona Arthritis & Rheumatology Associates, P. C.

    Tucson, Arizona 85704
    United States

    Site Not Available

  • Arthritis and Rheumatism Associates

    Jonesboro, Arkansas 72401
    United States

    Active - Recruiting

  • Smart Cures Clinical Research

    Anaheim, California 92806
    United States

    Site Not Available

  • Wallace Rheumatic Studies Center

    Beverly Hills, California 90211
    United States

    Site Not Available

  • Wallace Rheumatic Study Center

    Beverly Hills, California 90211
    United States

    Site Not Available

  • Providence St. Joseph's Medical Center

    Burbank, California 91505
    United States

    Active - Recruiting

  • Hope Clinical Research

    Canoga Park, California 91303
    United States

    Site Not Available

  • Medvin Clinical Research - Covina

    Covina, California 91722
    United States

    Active - Recruiting

  • TriWest Research Associates LLC

    El Cajon, California 92020
    United States

    Active - Recruiting

  • Providence Medical Foundation

    Fullerton, California 92835
    United States

    Site Not Available

  • MD Medical Corporation

    Hemet, California 92543
    United States

    Site Not Available

  • Newport Huntington Med Grp

    Huntington Beach, California 92648
    United States

    Active - Recruiting

  • ADVA Clinical Research

    Inglewood, California 90301
    United States

    Site Not Available

  • BioSolutions Clinical Research Center

    La Mesa, California 91942
    United States

    Active - Recruiting

  • Purushotham & Akther Kotha MD Inc

    La Mesa, California 91942
    United States

    Site Not Available

  • Valerius Medical Group and Research Center of Greater Long Beach

    Los Alamitos, California 90720
    United States

    Site Not Available

  • Soha Dolatabadi, MD

    Los Angeles, California 90017
    United States

    Active - Recruiting

  • Providence St. Joseph's Medical Center

    Mission Hills, California 91345
    United States

    Site Not Available

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

    Monterey Park, California 91754
    United States

    Site Not Available

  • Desert Medical Advances

    Palm Desert, California 92260
    United States

    Site Not Available

  • ACRC Studies

    Poway, California 92064
    United States

    Active - Recruiting

  • Desert Medical Advances

    Rancho Mirage, California 92270
    United States

    Active - Recruiting

  • CV Mehta MD, MED Corp. - Riverside

    Riverside, California 92508
    United States

    Site Not Available

  • Sierra Rheumatology

    Roseville, California 95661
    United States

    Site Not Available

  • Purushotham & Akther Kotha MD Inc

    San Diego, California 92120
    United States

    Active - Recruiting

  • TriWest Research Associates LLC

    San Diego, California 92108
    United States

    Active - Recruiting

  • East Bay Rheumatology Medical Group, Inc

    San Leandro, California 94578
    United States

    Active - Recruiting

  • Providence Medical Foundation

    Santa Rosa, California 95403
    United States

    Active - Recruiting

  • Dan La, MD Inc

    Tujunga, California 91042
    United States

    Active - Recruiting

  • Iraj Sabahi Research Inc.

    Turlock, California 93582
    United States

    Site Not Available

  • Office: Dr Robin K Dore

    Tustin, California 92780
    United States

    Active - Recruiting

  • Inland Rheumatology & Osteoporosis Medical Group

    Upland, California 91786
    United States

    Active - Recruiting

  • Nazanin Firooz, MD Inc.

    West Hills, California 91307
    United States

    Active - Recruiting

  • Medvin Clinical Research - Whittier

    Whittier, California 90602
    United States

    Active - Recruiting

  • Danbury Clinical Research, LLC

    Danbury, Connecticut 06810
    United States

    Active - Recruiting

  • Delaware Arthritis

    Lewes, Delaware 19958
    United States

    Active - Recruiting

  • Bay Area Arthritis and Osteoporosis

    Brandon, Florida 33511
    United States

    Site Not Available

  • International Medical Research

    Daytona Beach, Florida 32117
    United States

    Site Not Available

  • Omega Research Debary, LLC

    DeBary, Florida 32713
    United States

    Active - Recruiting

  • Unique Clinical Trials

    Doral, Florida 33172
    United States

    Site Not Available

  • Cria Center for Rheumatology

    Fort Lauderdale, Florida 33334
    United States

    Active - Recruiting

  • GNP Research at Mark Jaffe, MD

    Hollywood, Florida 33024
    United States

    Active - Recruiting

  • Rheumatology Center Of Palm Beach, Pllc

    Lake Worth, Florida 33467 2991
    United States

    Site Not Available

  • Arthritis and Rheumatology Center of South Florida

    Margate, Florida 33063
    United States

    Active - Recruiting

  • Felicidad Medical Research

    Miami, Florida 33185
    United States

    Site Not Available

  • Miami Clinical Reserach

    Miami, Florida 33155
    United States

    Active - Recruiting

  • Oceane7 Clinical Research, LLC

    Miami, Florida 33144
    United States

    Site Not Available

  • Heuer MD Research

    Orlando, Florida 32819
    United States

    Active - Recruiting

  • Rheumatology Associates of Central Florida

    Orlando, Florida 32806
    United States

    Active - Recruiting

  • UCF Health Lake Nona Orlando

    Orlando, Florida 32827
    United States

    Site Not Available

  • Arthritis Center, Inc

    Palm Harbor, Florida 34684
    United States

    Site Not Available

  • IRIS Research and Development, LLC

    Plantation, Florida 33324
    United States

    Active - Recruiting

  • Lovelace Scientific Resources

    Riverview, Florida 33569
    United States

    Site Not Available

  • BayCare Health System Inc

    Saint Petersburg, Florida 33705
    United States

    Active - Recruiting

  • West Broward Rheumatology Associates

    Tamarac, Florida 33321
    United States

    Active - Recruiting

  • Avita Clinical Research

    Tampa, Florida 33613
    United States

    Active - Recruiting

  • Tampa Medical Group, P.A.

    Tampa, Florida 33614
    United States

    Active - Recruiting

  • Florida Medical Clinic LLC

    Zephyrhills, Florida 33542-7505
    United States

    Active - Recruiting

  • Arthritis & Rheumatology of Georgia

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Arthritis and Rheumatology of Georgia

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Piedmont Healthcare

    Atlanta, Georgia 30309
    United States

    Site Not Available

  • Arthritis Center of North Georgia

    Gainesville, Georgia 30501
    United States

    Active - Recruiting

  • St Luke's Clinic - Intermountain Orthopaedics

    Boise, Idaho 83702
    United States

    Active - Recruiting

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Hinsdale Orthopaedics, Illinois Bone and Joint

    Hinsdale, Illinois 60521
    United States

    Active - Recruiting

  • Orthoillinois

    Rockford, Illinois 61114
    United States

    Site Not Available

  • Rockford Orthopedic Associates

    Rockford, Illinois 61107
    United States

    Active - Recruiting

  • Greater Chicago Specialty Physicians, LLC

    Schaumburg, Illinois 60195
    United States

    Active - Recruiting

  • Center of Robert Hozman

    Skokie, Illinois 60076
    United States

    Active - Recruiting

  • Reddy Rheumatology of Northwest Indiana

    Merrillville, Indiana 46410
    United States

    Site Not Available

  • Beacon Medical Group Clinical Research

    South Bend, Indiana 46617
    United States

    Site Not Available

  • Graves-Gilbert Clinic

    Bowling Green, Kentucky 42101
    United States

    Active - Recruiting

  • Western KY Rheumatology PLLC

    Hopkinsville, Kentucky 42240
    United States

    Active - Recruiting

  • Ochsner Clinic Foundation

    Baton Rouge, Louisiana 70836
    United States

    Site Not Available

  • Accurate Clinical Research

    Lake Charles, Louisiana 70605
    United States

    Active - Recruiting

  • Arthritis and Diabetes Clinic, Inc.

    Monroe, Louisiana 71203
    United States

    Active - Recruiting

  • Ochsner Clinic Foundation

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • Arthritis Care Specialists of Maryland

    Columbia, Maryland 21046
    United States

    Site Not Available

  • Klein and Associates MD, PA

    Cumberland, Maryland 21502
    United States

    Active - Recruiting

  • Klein and Associates MD, PA

    Hagerstown, Maryland 21740
    United States

    Site Not Available

  • NECCR PrimaCare Research

    Fall River, Massachusetts 02721
    United States

    Active - Recruiting

  • University of Michigan

    Brighton, Michigan 48116
    United States

    Site Not Available

  • Michigan Rheumatology Group

    Grand Blanc, Michigan 48439
    United States

    Active - Recruiting

  • Pandit Rheumatology PC

    Okemos, Michigan 48864
    United States

    Active - Recruiting

  • Jefferson City Medical Group

    Jefferson City, Missouri 65109
    United States

    Active - Recruiting

  • West County Rheumatology

    Saint Louis, Missouri 63131
    United States

    Site Not Available

  • Clinvest Headlands Llc

    Springfield, Missouri 65810
    United States

    Active - Recruiting

  • Clinvest Research LLC

    Springfield, Missouri 65807
    United States

    Active - Recruiting

  • Lovelace Scientific Resources

    Henderson, Nevada 89104
    United States

    Completed

  • Allied Clinical Research

    Reno, Nevada 89519
    United States

    Site Not Available

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire 03756
    United States

    Active - Recruiting

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire 03756
    United States

    Active - Recruiting

  • Arthritis Care Medical Center

    Somerset, New Jersey 08873
    United States

    Site Not Available

  • Atlantic Coastal Research

    Toms River, New Jersey 08757
    United States

    Active - Recruiting

  • Sahni Rheumatology & Therapy PC

    West Long Branch, New Jersey 07764
    United States

    Active - Recruiting

  • Santa Fe Rheumatology

    Santa Fe, New Mexico 87505
    United States

    Site Not Available

  • NYU Langone

    Brooklyn, New York 11201
    United States

    Site Not Available

  • NYU Langone

    New York, New York 10016
    United States

    Active - Recruiting

  • M3-Emerging Medical Research, LLC

    Durham, North Carolina 27704
    United States

    Site Not Available

  • Medication Management

    Greensboro, North Carolina 27408
    United States

    Active - Recruiting

  • PMG Research of Hickory, LLC

    Hickory, North Carolina 28602
    United States

    Site Not Available

  • Cape Fear Arthritis Care

    Leland, North Carolina 28451
    United States

    Active - Recruiting

  • PMG Research of Salisbury

    Salisbury, North Carolina 28144
    United States

    Site Not Available

  • Carolina Arthritis Associates

    Wilmington, North Carolina 28401
    United States

    Active - Recruiting

  • Trinity Medical Group

    Minot, North Dakota 58701
    United States

    Site Not Available

  • Cincinnati Arthritis Associates

    Cincinnati, Ohio 45242
    United States

    Active - Recruiting

  • Craig S Thompson MD LLC

    Marion, Ohio 43302
    United States

    Active - Recruiting

  • Paramount Medical Research

    Middleburg Heights, Ohio 44130
    United States

    Active - Recruiting

  • Arthritis & Rheumatology Center of Oklahoma PLLC

    Oklahoma City, Oklahoma 73103
    United States

    Site Not Available

  • The Oklahoma Center For Arthritis Therapy

    Tulsa, Oklahoma 74104
    United States

    Site Not Available

  • Good Samaritan Hospital Corvallis

    Corvallis, Oregon 97330
    United States

    Active - Recruiting

  • Advanced Rheumatology and Arthritis Research Center, PC

    Cranberry Township, Pennsylvania 15090
    United States

    Site Not Available

  • Altoona Center For Clinical Research

    Duncansville, Pennsylvania 16635
    United States

    Active - Recruiting

  • Arthritis Group

    Philadelphia, Pennsylvania 19152
    United States

    Site Not Available

  • Clinical Research of Philadelphia

    Philadelphia, Pennsylvania 19114
    United States

    Site Not Available

  • Clinical Research of Philadelphia, LLC

    Philadelphia, Pennsylvania 19114
    United States

    Site Not Available

  • Advanced Rheumatology and Arthritis Research Center, PC

    Wexford, Pennsylvania 15090
    United States

    Site Not Available

  • Pennsylvania Regional Center for Arthritis and Osteoporosis Research

    Wyomissing, Pennsylvania 19610
    United States

    Active - Recruiting

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

    North Charleston, South Carolina 29406
    United States

    Active - Recruiting

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

    Summerville, South Carolina 29486
    United States

    Site Not Available

  • Monument Health Clinical Research, a department of Monument Health Rapid City Hospital, Inc.

    Rapid City, South Dakota 57701
    United States

    Active - Recruiting

  • Monument Health Rapid City Hospital

    Rapid City, South Dakota 57701
    United States

    Active - Recruiting

  • Cumberland Rheumatology

    Crossville, Tennessee 38555
    United States

    Active - Recruiting

  • West Tennessee Research Institute

    Jackson, Tennessee 38305
    United States

    Active - Recruiting

  • Nashville Arthritis and Rheumatology

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Accent Clinical Research Professionals, LLC

    Allen, Texas 75013
    United States

    Site Not Available

  • Amarillo Center for Clinical Research

    Amarillo, Texas 79124
    United States

    Active - Recruiting

  • Accurate Clinical Management

    Baytown, Texas 77521
    United States

    Site Not Available

  • Clinrx Research Joseph INC.

    Carrollton, Texas 75007
    United States

    Site Not Available

  • Arthritis & Osteoporosis Clinic of Brazos Valley

    College Station, Texas 77845
    United States

    Site Not Available

  • Adriana Pop Moody Clinic PA

    Corpus Christi, Texas 78404
    United States

    Site Not Available

  • Pioneer Research Solutions

    Cypress, Texas 77429
    United States

    Site Not Available

  • Metroplex Clinical Research Center

    Dallas, Texas 75235
    United States

    Site Not Available

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

    El Paso, Texas 79912
    United States

    Active - Recruiting

  • Accurate Clinical Management - Houston

    Houston, Texas 77084
    United States

    Site Not Available

  • Accurate Clinical Research

    Houston, Texas 77089
    United States

    Active - Recruiting

  • Biopharma Informatic, LLC

    Houston, Texas 77043
    United States

    Active - Recruiting

  • DM Clinical Research

    Houston, Texas 77065
    United States

    Active - Recruiting

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

    Houston, Texas 77065
    United States

    Active - Recruiting

  • Pioneer Research Solutions

    Houston, Texas 77008
    United States

    Site Not Available

  • UDL Clinical Research, LLC

    Houston, Texas 77002
    United States

    Active - Recruiting

  • Houston Rheumatology & Arthritis Specialists

    Katy, Texas 77494
    United States

    Active - Recruiting

  • R and H Clinical Research

    Katy, Texas 77494
    United States

    Site Not Available

  • Accurate Clinical Research

    League City, Texas 77573
    United States

    Site Not Available

  • Prime Clinical Research

    Mansfield, Texas 76063
    United States

    Active - Recruiting

  • Southwest Rheumatology, P.A.

    Mesquite, Texas 75150
    United States

    Active - Recruiting

  • Synergy Group US

    Missouri City, Texas 77459
    United States

    Site Not Available

  • Advanced Clinical Research Center of Houston

    Pearland, Texas 77584
    United States

    Active - Recruiting

  • Clinrx Research Joseph INC.

    Plano, Texas 75007
    United States

    Active - Recruiting

  • Violeta T. Baddour, MD

    Pleasanton, Texas 78064
    United States

    Site Not Available

  • Epic Medical Research

    Red Oak, Texas 75154
    United States

    Site Not Available

  • Accurate Clinical Research, Inc.

    San Antonio, Texas 78229
    United States

    Completed

  • Arthritis Clinic Of Central Texas

    San Marcos, Texas 78666
    United States

    Site Not Available

  • Accurate Clinical Management

    Sugar Land, Texas 77479
    United States

    Active - Recruiting

  • Mt. Olympus Medical Research

    Sugar Land, Texas 77479
    United States

    Completed

  • Baylor Scott & White Health

    Temple, Texas 76508
    United States

    Site Not Available

  • Baylor Scott & White Medical Center - Temple

    Temple, Texas 76508
    United States

    Site Not Available

  • North Houston Rheumatology Associates

    The Woodlands, Texas 77380
    United States

    Active - Recruiting

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

    Tomball, Texas 77375
    United States

    Active - Recruiting

  • Epic Medical Research

    Murray, Utah 84123
    United States

    Site Not Available

  • Center for Arthritis and Rheumatic Diseases, PC

    Chesapeake, Virginia 23320
    United States

    Active - Recruiting

  • Spectrum Medical Inc.

    Danville, Virginia 24541
    United States

    Active - Recruiting

  • Arthritis & Osteoporosis Center of Northern Virinia

    Manassas, Virginia 20109
    United States

    Active - Recruiting

  • TPMG Rheumatology/TPMG Clinical Research

    Newport News, Virginia 23606
    United States

    Active - Recruiting

  • Arthritis Northwest, PLLC

    Spokane, Washington 99204
    United States

    Active - Recruiting

  • Rheumatology & Pulmonary Clinic

    Beckley, West Virginia 25801
    United States

    Active - Recruiting

  • Rheumatology and Pulmonary Clinic

    Beckley, West Virginia 25801
    United States

    Active - Recruiting

  • Rheumatic Disease Center

    Glendale, Wisconsin 53217
    United States

    Active - Recruiting

  • Rheumatic Disease Center

    Milwaukee, Wisconsin 53211
    United States

    Active - Recruiting

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