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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04086745
Collaborator
Incyte Corporation (Industry)
1,300
Enrollment
108
Locations
3
Arms
71.6
Anticipated Duration (Months)
12
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized, Controlled Pragmatic Phase 3b/4 Study of Baricitinib in Patients With Rheumatoid Arthritis
Actual Study Start Date :
Feb 14, 2020
Anticipated Primary Completion Date :
Dec 27, 2024
Anticipated Study Completion Date :
Feb 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Baricitinib Low Dose

Baricitinib administered orally.

Drug: Baricitinib
Administered orally.
Other Names:
  • LY3009104

    		•
    Experimental: Baricitinib High Dose

    Baricitinib administered orally.

    Drug: Baricitinib
    Administered orally.
    Other Names:
  • LY3009104

    		•
    Active Comparator: TNF Inhibitor

    Adalimumab or etanercept administered subcutaneously (SC) per standard of care.

    Drug: TNF Inhibitor
    Administered SC
    Other Names:
  • Etanercept
  • Adalimumab

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Time from First Dose of Study Treatment to First Event of Venous Thromboembolism (VTE) [Baseline through Study Completion (Approximately 5.5 Years)]

      Time from First Dose of Study Treatment to First Event of VTE

    Secondary Outcome Measures

    1. 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 ATE

    2. 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 MACE

    3. 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 Malignancy (excluding NMSC)

    4. 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 Opportunistic Infection

    5. Time from First Dose of Study Treatment to First Serious Infection [Baseline through Study Completion (Approximately 5.5 Years)]

      Time from First Dose of Study Treatment to First Serious Infection

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Arizona Arthritis & Rheumatology Research, PLLC Flagstaff Arizona United States 86001
    2 Arizona Arthritis & Rheumatology Associates, P. C. Gilbert Arizona United States 85704
    3 Arizona Arthritis & Rheumatology Research Glendale Arizona United States 85306
    4 Arizona Arthritis & Rheumatology Associates, P. C. Mesa Arizona United States 85210
    5 Sun Valley Arthritis Center, LTD Peoria Arizona United States 85381
    6 Arizona Arthritis & Rheumatology Research Phoenix Arizona United States 85032
    7 Arizona Arthritis & Rheumatology Associates, P. C. Phoenix Arizona United States 85037
    8 Arizona Arthritis & Rheumatology Associates, P. C. Sun City Arizona United States 85351
    9 Arizona Arthritis & Rheumatology Associates, P. C. Tucson Arizona United States 85704
    10 Arthritis and Rheumatism Associates Jonesboro Arkansas United States 72401
    11 Medvin Clinical Research - Covina Covina California United States 91722
    12 Providence Medical Foundation Fullerton California United States 92835
    13 Newport Huntington Med Grp Huntington Beach California United States 92648
    14 BioSolutions Clinical Research Center La Mesa California United States 91942
    15 Purushotham & Akther Kotha MD Inc La Mesa California United States 91942
    16 Soha Dolatabadi, MD Los Angeles California United States 90017
    17 Providence St. Joseph's Medical Center Mission Hills California United States 91345
    18 Desert Medical Advances Palm Desert California United States 92260
    19 ACRC Studies Poway California United States 92064
    20 TriWest Research Associates LLC San Diego California United States 92108
    21 East Bay Rheumatology Medical Group, Inc San Leandro California United States 94578
    22 Dan La, MD Inc Tujunga California United States 91042
    23 Office: Dr Robin K Dore Tustin California United States 92780
    24 Inland Rheumatology & Osteoporosis Medical Group Upland California United States 91786
    25 Nazanin Firooz, MD Inc. West Hills California United States 91307
    26 Medvin Clinical Research - Whittier Whittier California United States 90602
    27 Danbury Clinical Research, LLC Danbury Connecticut United States 06810
    28 Delaware Arthritis Lewes Delaware United States 19958
    29 Omega Research Debary, LLC DeBary Florida United States 32713
    30 Cria Center for Rheumatology Fort Lauderdale Florida United States 33334
    31 GNP Research at Mark Jaffe, MD Hollywood Florida United States 33024
    32 Arthritis and Rheumatology Center of South Florida Margate Florida United States 33063
    33 Miami Clinical Reserach Miami Florida United States 33155
    34 Rheumatology Associates of Central Florida Orlando Florida United States 32806
    35 Heuer MD Research Orlando Florida United States 32819
    36 IRIS Research and Development, LLC Plantation Florida United States 33324
    37 Lovelace Scientific Resources Riverview Florida United States 33569
    38 BayCare Health System Inc Saint Petersburg Florida United States 33705
    39 West Broward Rheumatology Associates, Inc Tamarac Florida United States 33321
    40 Avita Clinical Research Tampa Florida United States 33613
    41 Tampa Medical Group, P.A. Tampa Florida United States 33614
    42 Florida Medical Clinic LLC Zephyrhills Florida United States 33542-7505
    43 Arthritis Center of North Georgia Gainesville Georgia United States 30501
    44 St Luke's Clinic - Intermountain Orthopaedics Boise Idaho United States 83702
    45 Hinsdale Orthopaedics, Illinois Bone and Joint Hinsdale Illinois United States 60521
    46 Rockford Orthopedic Associates Rockford Illinois United States 61114
    47 Greater Chicago Specialty Physicians, LLC Schaumburg Illinois United States 60195
    48 Center of Robert Hozman Skokie Illinois United States 60076
    49 Graves-Gilbert Clinic Bowling Green Kentucky United States 42101
    50 Western KY Rheumatology PLLC Hopkinsville Kentucky United States 42240
    51 Ochsner Clinic Foundation Baton Rouge Louisiana United States 70836
    52 Arthritis and Diabetes Clinic, Inc. Monroe Louisiana United States 71203
    53 Klein and Associates MD, PA Cumberland Maryland United States 21502
    54 Klein and Associates MD, PA Hagerstown Maryland United States 21740
    55 NECCR PrimaCare Research Fall River Massachusetts United States 02721
    56 Michigan Rheumatology Group Grand Blanc Michigan United States 48439
    57 Pandit Rheumatology PC Okemos Michigan United States 48864
    58 Jefferson City Medical Group Jefferson City Missouri United States 65109
    59 West County Rheumatology Saint Louis Missouri United States 63131
    60 Clinvest Research LLC Springfield Missouri United States 65810
    61 Dartmouth Hitchcock Medical Center Lebanon New Hampshire United States 03756
    62 Arthritis Care Medical Center Somerset New Jersey United States 08873
    63 Atlantic Coastal Research Toms River New Jersey United States 08755
    64 Sahni Rheumatology & Therapy PC West Long Branch New Jersey United States 07764
    65 NYU Langone New York New York United States 11201
    66 M3-Emerging Medical Research, LLC Durham North Carolina United States 27704
    67 Medication Management Greensboro North Carolina United States 27408
    68 Cape Fear Arthritis Care Leland North Carolina United States 28451
    69 Carolina Arthritis Associates Wilmington North Carolina United States 28401
    70 Cincinnati Arthritis Associates Cincinnati Ohio United States 45242
    71 Craig S Thompson MD LLC Marion Ohio United States 43302
    72 Paramount Medical Research Middleburg Heights Ohio United States 44130
    73 Arthritis & Rheumatology Center of Oklahoma PLLC Oklahoma City Oklahoma United States 73102
    74 Good Samaritan Hospital Corvallis Corvallis Oregon United States 97330
    75 Altoona Center For Clinical Research Duncansville Pennsylvania United States 16635
    76 Advanced Rheumatology and Arthritis Research Center, PC Wexford Pennsylvania United States 15090
    77 Pennsylvania Regional Center for Arthritis and Osteoporosis Research Wyomissing Pennsylvania United States 19610
    78 Articularis Healthcare d/b/a/ Low Country Rheumatology, PA Summerville South Carolina United States 29486
    79 Monument Health Clinical Research, a department of Monument Health Rapid City Hospital, Inc. Rapid City South Dakota United States 57701
    80 Cumberland Rheumatology Crossville Tennessee United States 38555
    81 West Tennessee Research Institute Jackson Tennessee United States 38305
    82 Accent Clinical Research Professionals, LLC Allen Texas United States 75013
    83 Amarillo Center for Clinical Research Amarillo Texas United States 79124
    84 Accurate Clinical Management Baytown Texas United States 77521
    85 Pioneer Research Solutions Cypress Texas United States 77429
    86 Metroplex Clinical Research Center Dallas Texas United States 75231
    87 El Paso Integrated Physicians Group, P.A., an Elligo Health Research, Inc. Healthcare Enabled Research Organization El Paso Texas United States 79912
    88 Biopharma Informatic, LLC Houston Texas United States 77043
    89 DM Clinical Research Houston Texas United States 77065
    90 Accurate Clinical Management - Houston Houston Texas United States 77084
    91 Accurate Clinical Research Houston Texas United States 77089
    92 Biopharma Informatic, LLC Houston Texas United States 77089
    93 Houston Rheumatology & Arthritis Specialists Katy Texas United States 77494
    94 Accurate Clinical Research League City Texas United States 77573
    95 Southwest Rheumatology, P.A. Mesquite Texas United States 75150
    96 Clinrx Research Joseph INC. Plano Texas United States 75007
    97 Accurate Clinical Research, Inc. San Antonio Texas United States 78229
    98 Fort Bend Clinical Research, LLC Sugar Land Texas United States 77479
    99 Mt. Olympus Medical Research Sugar Land Texas United States 77479
    100 North Houston Rheumatology Associates The Woodlands Texas United States 77380
    101 Dynamed Clinical Research, LP d/b/a DM Clinical Research Tomball Texas United States 77375
    102 Center for Arthritis and Rheumatic Diseases, PC Chesapeake Virginia United States 23320
    103 Spectrum Medical Inc. Danville Virginia United States 24541
    104 Arthritis & Osteoporosis Center of Northern Virinia Manassas Virginia United States 20109
    105 TPMG Rheumatology/TPMG Clinical Research Newport News Virginia United States 23606
    106 Arthritis Northwest, PLLC Spokane Washington United States 99204
    107 Rheumatology & Pulmonary Clinic Beckley West Virginia United States 25801
    108 Rheumatic Disease Center Glendale Wisconsin United States 53217

    Sponsors and Collaborators

    • Eli Lilly and Company
    • Incyte Corporation

    Investigators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT04086745
    Other Study ID Numbers:
    • 17363
    • I4V-MC-JAJD
    First Posted:
    Sep 12, 2019
    Last Update Posted:
    Aug 18, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Arthritis
    Arthritis, Rheumatoid
    Adalimumab
    Etanercept
    Tumor Necrosis Factor Inhibitors

    Study Results

    No Results Posted as of Aug 18, 2022