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

April 5, 2024 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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1300

Phase

  • 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

  • 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: ClinicalTrials.gov@lilly.com

Study Locations

  • United States
    • Arizona
      • Flagstaff, Arizona, United States, 86001
        • Recruiting
        • Arizona Arthritis & Rheumatology Associates
        • Principal Investigator:
          • Alexander Hu
        • Contact:
          • Phone Number: 480-626-6653
      • Gilbert, Arizona, United States, 85704
        • Recruiting
        • Arizona Arthritis & Rheumatology Associates, P. C.
        • Principal Investigator:
          • Daniel Kreutz
        • Contact:
          • Phone Number: 480-443-8400
      • Glendale, Arizona, United States, 85306
        • Recruiting
        • Arizona Arthritis & Rheumatology Research
        • Contact:
          • Phone Number: 480-626-6653
        • Principal Investigator:
          • Mona Amin
      • Mesa, Arizona, United States, 85210
        • Recruiting
        • Arizona Arthritis & Rheumatology Associates, P. C.
        • Contact:
          • Phone Number: 480-626-6653
        • Principal Investigator:
          • Swati Bharadwaj
      • Peoria, Arizona, United States, 85381
        • Recruiting
        • Sun Valley Arthritis Center, LTD
        • Contact:
          • Phone Number: 623-825-5591
        • Principal Investigator:
          • Joy Schechtman
      • Phoenix, Arizona, United States, 85032
        • Recruiting
        • Arizona Arthritis & Rheumatology Research
        • Principal Investigator:
          • Areena Swarup
        • Contact:
          • Phone Number: 480-443-8400
      • Phoenix, Arizona, United States, 85037
        • Recruiting
        • Arizona Arthritis & Rheumatology Associates, P. C.
        • Contact:
          • Phone Number: 480-443-8400
        • Principal Investigator:
          • John Tesser
      • Sun City, Arizona, United States, 85351
        • Recruiting
        • Arizona Arthritis & Rheumatology Associates, P. C.
        • Contact:
          • Phone Number: 480-443-8400
        • Principal Investigator:
          • Nehad Soloman
      • Tucson, Arizona, United States, 85704
        • Recruiting
        • Arizona Arthritis & Rheumatology Associates, P. C.
        • Principal Investigator:
          • Jeffrey Loomer
        • Contact:
          • Phone Number: 480-626-6653
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Recruiting
        • Arthritis and Rheumatism Associates
        • Contact:
          • Phone Number: 870-333-2721
        • Principal Investigator:
          • Beata Filip-Majewski
    • California
      • Covina, California, United States, 91722
        • Recruiting
        • Medvin Clinical Research - Covina
        • Contact:
          • Phone Number: 626-869-5730
        • Principal Investigator:
          • Samy Kamal Metyas
      • Huntington Beach, California, United States, 92648
        • Recruiting
        • Newport Huntington Med Grp
        • Contact:
          • Phone Number: 714-378-2440
        • Principal Investigator:
          • Christine Thai
      • Los Angeles, California, United States, 90017
        • Recruiting
        • Soha Dolatabadi, MD
        • Principal Investigator:
          • Soha Dolatabadi
      • Mission Hills, California, United States, 91345
        • Recruiting
        • Providence St. Joseph's Medical Center
        • Contact:
          • Phone Number: 818-869-7059
        • Principal Investigator:
          • Sue Chung
      • Palm Desert, California, United States, 92260
        • Recruiting
        • Desert Medical Advances
        • Contact:
          • Phone Number: 760-341-9638
        • Principal Investigator:
          • Maria Greenwald
      • San Diego, California, United States, 92108
        • Recruiting
        • TriWest Research Associates LLC
        • Contact:
          • Phone Number: 619-334-4735
        • Principal Investigator:
          • Arthur Mabaquiao
      • San Leandro, California, United States, 94578
        • Recruiting
        • East Bay Rheumatology Medical Group, Inc
        • Contact:
          • Phone Number: 510-357-1303
        • Principal Investigator:
          • Suneet Grewal
      • Tujunga, California, United States, 91042
        • Recruiting
        • Dan La, MD Inc
        • Contact:
          • Phone Number: 213-281-5146
        • Principal Investigator:
          • DAN T LA
      • Tustin, California, United States, 92780
        • Recruiting
        • Office: Dr Robin K Dore
        • Contact:
          • Phone Number: 714-505-5500
        • Principal Investigator:
          • Roger Kornu
      • Upland, California, United States, 91786
        • Recruiting
        • Inland Rheumatology & Osteoporosis Medical Group
        • Principal Investigator:
          • Eric Lee
        • Contact:
          • Phone Number: 909-296-8700
      • Whittier, California, United States, 90602
        • Recruiting
        • Medvin Clinical Research - Whittier
        • Contact:
          • Phone Number: 562-758-6600
        • Principal Investigator:
          • Tien-I Su
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Recruiting
        • Danbury Clinical Research, LLC
        • Contact:
          • Phone Number: 203-616-2710
        • Principal Investigator:
          • Richard Roseff
    • Delaware
      • Lewes, Delaware, United States, 19958
        • Recruiting
        • Delaware Arthritis
        • Contact:
          • Phone Number: 302-703-5050
        • Principal Investigator:
          • Jose Pando
    • Florida
      • DeBary, Florida, United States, 32713
        • Recruiting
        • Omega Research Debary, LLC
        • Contact:
          • Phone Number: 386-668-4202
        • Principal Investigator:
          • Luis Ramos
      • Fort Lauderdale, Florida, United States, 33334
        • Recruiting
        • Cria Center for Rheumatology
        • Contact:
          • Phone Number: 954-229-0425
        • Principal Investigator:
          • Yvonne Sherrer
      • Hollywood, Florida, United States, 33024
        • Recruiting
        • GNP Research at Mark Jaffe, MD
        • Contact:
          • Phone Number: 754-248-3589
        • Principal Investigator:
          • Mark Jaffe
      • Margate, Florida, United States, 33063
        • Recruiting
        • Arthritis and Rheumatology Center of South Florida
        • Contact:
          • Phone Number: 954-669-1052
        • Principal Investigator:
          • Jigar Shah
      • Miami, Florida, United States, 33155
        • Recruiting
        • Miami Clinical Reserach
        • Contact:
          • Phone Number: 305-433-6496
        • Principal Investigator:
          • Keila Hoover
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Rheumatology Associates of Central Florida
        • Contact:
          • Phone Number: 4075894540 EXT 124
        • Principal Investigator:
          • Pamela Freeman
      • Orlando, Florida, United States, 32819
        • Recruiting
        • Heuer MD Research
        • Contact:
          • Phone Number: 407-612-6300
        • Principal Investigator:
          • Marvin Heuer
      • Plantation, Florida, United States, 33324
        • Recruiting
        • IRIS Research and Development, LLC
        • Principal Investigator:
          • Guillermo Valenzuela
      • Riverview, Florida, United States, 33569
        • Completed
        • Lovelace Scientific Resources
      • Tamarac, Florida, United States, 33321
        • Recruiting
        • West Broward Rheumatology Associates
        • Contact:
          • Phone Number: 954-545-8400
        • Principal Investigator:
          • Alan Alberts
      • Zephyrhills, Florida, United States, 33542-7505
        • Recruiting
        • Florida Medical Clinic LLC
        • Contact:
          • Phone Number: 813-782-1234
        • Principal Investigator:
          • Natalie A. Faith
    • Georgia
      • Gainesville, Georgia, United States, 30501
        • Recruiting
        • Arthritis Center of North Georgia
        • Contact:
          • Phone Number: 678-677-8824
        • Principal Investigator:
          • Marta Bognar
    • Idaho
      • Boise, Idaho, United States, 83702
        • Not yet recruiting
        • St Luke's Clinic - Intermountain Orthopaedics
        • Principal Investigator:
          • James Loveless
    • Illinois
      • Hinsdale, Illinois, United States, 60521
        • Recruiting
        • Hinsdale Orthopaedics, Illinois Bone and Joint
        • Contact:
          • Phone Number: 630-794-8676
        • Principal Investigator:
          • Angela Crowley
      • Rockford, Illinois, United States, 61114
        • Recruiting
        • Rockford Orthopedic Associates
        • Contact:
          • Phone Number: 815-381-6986
        • Principal Investigator:
          • Andrzej Jasek
      • Schaumburg, Illinois, United States, 60195
        • Recruiting
        • Greater Chicago Specialty Physicians, LLC
        • Contact:
          • Phone Number: 630-339-5300
        • Principal Investigator:
          • Kamran Chaudhary
      • Skokie, Illinois, United States, 60076
        • Recruiting
        • Center of Robert Hozman
        • Principal Investigator:
          • Robert Hozman
        • Contact:
          • Phone Number: 847-673-8473
    • Kentucky
      • Bowling Green, Kentucky, United States, 42101
        • Recruiting
        • Graves-Gilbert Clinic
        • Principal Investigator:
          • Asad Fraser
        • Contact:
          • Phone Number: 270-781-5111
      • Hopkinsville, Kentucky, United States, 42240
        • Recruiting
        • Western KY Rheumatology PLLC
        • Contact:
          • Phone Number: 931-542-9124
        • Principal Investigator:
          • Kishorkumar Desai
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70836
        • Recruiting
        • Ochsner Clinic Foundation
        • Principal Investigator:
          • Saravanan Thiagarajan
        • Contact:
          • Phone Number: 225-761-5607
      • Monroe, Louisiana, United States, 71203
        • Recruiting
        • Arthritis and Diabetes Clinic, Inc.
        • Principal Investigator:
          • Jyothi Mallepalli
        • Contact:
          • Phone Number: 318-812-1250
    • Maryland
      • Cumberland, Maryland, United States, 21502
        • Recruiting
        • Klein and Associates MD, PA
        • Contact:
          • Phone Number: 301-724-4337
        • Principal Investigator:
          • Steven Klein
      • Hagerstown, Maryland, United States, 21740
        • Recruiting
        • Klein and Associates MD, PA
        • Contact:
          • Phone Number: 301-791-6680
        • Principal Investigator:
          • Mary Howell
    • Massachusetts
      • Fall River, Massachusetts, United States, 02721
        • Recruiting
        • NECCR PrimaCare Research
        • Contact:
          • Phone Number: 508-679-6611
        • Principal Investigator:
          • Mark Fisher
    • Michigan
      • Okemos, Michigan, United States, 48864
        • Recruiting
        • Pandit Rheumatology PC
        • Contact:
          • Phone Number: 517-993-6366
        • Principal Investigator:
          • Srijana Pradhan Bakshi
    • Missouri
      • Jefferson City, Missouri, United States, 65109
        • Recruiting
        • Jefferson City Medical Group
        • Contact:
          • Phone Number: 573-556-7785
        • Principal Investigator:
          • Stephen Sides
      • Saint Louis, Missouri, United States, 63131
        • Recruiting
        • West County Rheumatology
        • Contact:
          • Phone Number: 314-492-2323
        • Principal Investigator:
          • Sona Kamat
      • Springfield, Missouri, United States, 65810
        • Recruiting
        • Clinvest Research LLC
        • Contact:
          • Phone Number: 4178837889
        • Principal Investigator:
          • David Gregory True
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Recruiting
        • Dartmouth-Hitchcock Medical Center
        • Principal Investigator:
          • William Rigby
        • Contact:
          • Phone Number: 603-650-8622
    • New Jersey
      • Toms River, New Jersey, United States, 08755
        • Recruiting
        • Atlantic Coastal Research
        • Contact:
          • Phone Number: 732-505-3510
        • Principal Investigator:
          • Rajat Dhar
      • West Long Branch, New Jersey, United States, 07764
        • Recruiting
        • Sahni Rheumatology & Therapy PC
        • Contact:
          • Phone Number: 732-272-1456
        • Principal Investigator:
          • Kiren Sahni
    • New York
      • New York, New York, United States, 11201
        • Recruiting
        • NYU Langone
        • Contact:
          • Phone Number: 929-455-2399
        • Principal Investigator:
          • David Goddard
    • North Carolina
      • Greensboro, North Carolina, United States, 27408
        • Recruiting
        • Medication Management
        • Contact:
          • Phone Number: 3367636968
        • Principal Investigator:
          • James Donald Franklin
      • Leland, North Carolina, United States, 28451
        • Recruiting
        • Cape Fear Arthritis Care
        • Contact:
          • Phone Number: 608-848-8900
        • Principal Investigator:
          • David Snow
      • Wilmington, North Carolina, United States, 28401
        • Recruiting
        • Carolina Arthritis Associates
        • Contact:
          • Phone Number: 910-762-1182
        • Principal Investigator:
          • Mark Harris
    • Ohio
      • Marion, Ohio, United States, 43302
        • Recruiting
        • Craig S Thompson MD LLC
        • Contact:
          • Phone Number: 740-383-7039
        • Principal Investigator:
          • Madhu Mehta
      • Middleburg Heights, Ohio, United States, 44130
        • Recruiting
        • Paramount Medical Research
        • Contact:
          • Phone Number: 440-891-9395
        • Principal Investigator:
          • Isam Diab
    • Oregon
      • Corvallis, Oregon, United States, 97330
        • Recruiting
        • Good Samaritan Hospital Corvallis
        • Contact:
          • Phone Number: 541-768-5800
        • Principal Investigator:
          • Jonathan Jones
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Recruiting
        • Altoona Center For Clinical Research
        • Contact:
          • Phone Number: 814-693-0300 Ext. 154
        • Principal Investigator:
          • Alan Kivitz
      • Wyomissing, Pennsylvania, United States, 19610
        • Recruiting
        • Pennsylvania Regional Center for Arthritis and Osteoporosis Research
        • Contact:
          • Phone Number: 610-374-8133
        • Principal Investigator:
          • Gregory Emkey
    • South Carolina
      • Summerville, South Carolina, United States, 29486
        • Recruiting
        • Articularis Healthcare d/b/a/ Low Country Rheumatology, PA
        • Contact:
          • Phone Number: 843-572-1818
        • Principal Investigator:
          • Nicholas Holdgate
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Recruiting
        • Monument Health Rapid City Hospital
        • Principal Investigator:
          • Cynthia Weaver
    • Tennessee
      • Crossville, Tennessee, United States, 38555
        • Recruiting
        • Cumberland Rheumatology
        • Contact:
          • Phone Number: 931-787-1477
        • Principal Investigator:
          • Sivalingam Kanagasegar
      • Jackson, Tennessee, United States, 38305
        • Recruiting
        • West Tennessee Research Institute
        • Contact:
          • Phone Number: 731-633-0145
        • Principal Investigator:
          • Jacob Aelion
    • Texas
      • Amarillo, Texas, United States, 79124
        • Recruiting
        • Amarillo Center for Clinical Research
        • Contact:
          • Phone Number: 806-352-2453
        • Principal Investigator:
          • Constantine Saadeh
      • Dallas, Texas, United States, 75231
        • Recruiting
        • Metroplex Clinical Research Center
        • Principal Investigator:
          • STANLEY COHEN
        • Contact:
          • Phone Number: 214-879-6737
      • El Paso, Texas, United States, 79912
        • Recruiting
        • El Paso Integrated Physicians Group, P.A., an Elligo Health Research, Inc. Healthcare Enabled Research Organization
        • Contact:
          • Phone Number: 512-301-8613
        • Principal Investigator:
          • Franchesca Cruz-Perez
      • Houston, Texas, United States, 77043
        • Recruiting
        • Biopharma Informatic, LLC
        • Principal Investigator:
          • Abigail Neiman, MD
        • Contact:
          • Phone Number: 281-944-3610
      • Houston, Texas, United States, 77089
        • Recruiting
        • Accurate Clinical Research
        • Contact:
          • Phone Number: 281-481-2676
        • Principal Investigator:
          • Philip Waller
      • Houston, Texas, United States, 77065
        • Recruiting
        • Dynamed Clinical Research, LP d/b/a DM Clinical Research
        • Principal Investigator:
          • Qaiser Rehman
      • Katy, Texas, United States, 77494
        • Recruiting
        • Houston Rheumatology & Arthritis Specialists
        • Principal Investigator:
          • Tara Jabeen Rizvi
        • Contact:
          • Phone Number: 281-944-3610
      • League City, Texas, United States, 77573
        • Recruiting
        • Accurate Clinical Research
        • Contact:
          • Phone Number: 281-957-9127
        • Principal Investigator:
          • Prashanth Sunkureddi
      • Mesquite, Texas, United States, 75150
        • Recruiting
        • Southwest Rheumatology, P.A.
        • Contact:
          • Phone Number: 972-288-2600
        • Principal Investigator:
          • Atul Singhal
      • Plano, Texas, United States, 75007
        • Recruiting
        • Clinrx Research Joseph INC.
        • Contact:
          • Phone Number: 214-680-9321
        • Principal Investigator:
          • John Joseph
      • San Antonio, Texas, United States, 78229
        • Completed
        • Accurate Clinical Research, Inc.
      • Sugar Land, Texas, United States, 77479
        • Completed
        • Mt. Olympus Medical Research
      • Sugar Land, Texas, United States, 77479
        • Recruiting
        • Accurate Clinical Management
        • Contact:
          • Phone Number: 281-422-7179
        • Principal Investigator:
          • Sabeen Najam
      • The Woodlands, Texas, United States, 77380
        • Recruiting
        • North Houston Rheumatology Associates
        • Contact:
          • Phone Number: 832-885-7723
        • Principal Investigator:
          • Rama Palwai
      • Tomball, Texas, United States, 77375
        • Recruiting
        • Dynamed Clinical Research, LP d/b/a DM Clinical Research
        • Contact:
          • Phone Number: 281-517-0550
        • Principal Investigator:
          • Shaikh Ali
    • Virginia
      • Chesapeake, Virginia, United States, 23320
        • Recruiting
        • Center for Arthritis and Rheumatic Diseases, PC
        • Contact:
          • Phone Number: 757-461-3400
        • Principal Investigator:
          • Roger Lidman
      • Danville, Virginia, United States, 24541
        • Recruiting
        • Spectrum Medical Inc.
        • Contact:
          • Phone Number: 434-793-4711
        • Principal Investigator:
          • Sharukh Shroff
      • Manassas, Virginia, United States, 20109
        • Recruiting
        • Arthritis & Osteoporosis Center of Northern Virinia
        • Contact:
          • Phone Number: 703-361-3255
        • Principal Investigator:
          • Mohsen Ghafouri
      • Newport News, Virginia, United States, 23606
        • Recruiting
        • TPMG Rheumatology/TPMG Clinical Research
        • Contact:
          • Phone Number: 757-369-8138
        • Principal Investigator:
          • Kristi Mizelle
    • Washington
      • Spokane, Washington, United States, 99204
        • Recruiting
        • Arthritis Northwest, PLLC
        • Contact:
          • Phone Number: 509-838-6500
        • Principal Investigator:
          • Eric Mueller
    • West Virginia
      • Beckley, West Virginia, United States, 25801
        • Recruiting
        • Rheumatology & Pulmonary Clinic
        • Contact:
          • Phone Number: 304-256-0242
        • Principal Investigator:
          • Wassim Saikali
    • Wisconsin
      • Glendale, Wisconsin, United States, 53217
        • Recruiting
        • Rheumatic Disease Center
        • Principal Investigator:
          • Kurt Oelke
        • Contact:
          • Phone Number: 414351400918

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

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 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

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
Intervention / Treatment
Experimental: Baricitinib High Dose
Baricitinib administered orally.
Drug: Baricitinib
Administered orally.
Other Names:
  • LY3009104
Experimental: Baricitinib Low 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time from First Dose of Study Treatment to First Event of Venous Thromboembolism (VTE)
Time Frame: Baseline through Study Completion (Approximately 5.5 Years)
Time from First Dose of Study Treatment to First Event of VTE
Baseline through Study Completion (Approximately 5.5 Years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time from First Dose of Study Treatment to First Arterial Thromboembolic Event (ATE)
Time Frame: Baseline through Study Completion (Approximately 5.5 Years)
Time from First Dose of Study Treatment to First ATE
Baseline through Study Completion (Approximately 5.5 Years)
Time from First Dose of Study Treatment to First Major Adverse Cerebro-Cardiovascular Event (MACE)
Time Frame: Baseline through Study Completion (Approximately 5.5 Years)
Time from First Dose of Study Treatment to First MACE
Baseline through Study Completion (Approximately 5.5 Years)
Time from First Dose of Study Treatment to First Malignancy (excluding nonmelanoma skin cancer [NMSC])
Time Frame: Baseline through Study Completion (Approximately 5.5 Years)
Time from First Dose of Study Treatment to First Malignancy (excluding NMSC)
Baseline through Study Completion (Approximately 5.5 Years)
Time from First Dose of Study Treatment to First Opportunistic Infection
Time Frame: 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
Time Frame: 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)

Collaborators and Investigators

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

Sponsor

Eli Lilly and Company

Collaborators

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

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)

February 14, 2020

Primary Completion (Estimated)

December 27, 2024

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

September 10, 2019

First Submitted That Met QC Criteria

September 10, 2019

First Posted (Actual)

September 12, 2019

Study Record Updates

Last Update Posted (Actual)

April 8, 2024

Last Update Submitted That Met QC Criteria

April 5, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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

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