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A Study of Baricitinib (LY3009104) in Participants With Rheumatoid Arthritis (RA-BRIDGE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03915964
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : January 18, 2020
Sponsor:
Collaborator:
Incyte Corporation
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Baricitinib Drug: TNF Inhibitor Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Active-Controlled, Parallel-Group, Phase 3b/4 Study of Baricitinib in Patients With Rheumatoid Arthritis
Actual Study Start Date : April 25, 2019
Estimated Primary Completion Date : February 1, 2026
Estimated Study Completion Date : February 1, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Baricitinib Low Dose
Baricitinib administered orally.
 Drug: Baricitinib
Administered orally.
Other Name: LY3009104
Experimental: Baricitinib High Dose
Baricitinib administered orally.
 Drug: Baricitinib
Administered orally.
Other Name: 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
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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)

  4. 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

  5. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 should have no reason to not take a TNF inhibitor.
  • 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03915964


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Clinicaltrials.gov@lilly.com

Locations
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Sponsors and Collaborators
Eli Lilly and Company
Incyte Corporation
Investigators
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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
More Information
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Additional Information:
A Study of Baricitinib (LY3009104) in Participants With Rheumatoid Arthritis  This link exits the ClinicalTrials.gov site

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03915964    
Other Study ID Numbers: 17172
I4V-MC-JAJA ( Other Identifier: Eli Lilly and Company )
2018-003351-37 ( EudraCT Number )
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (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.
URL: https://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Adalimumab
Etanercept
Anti-Inflammatory Agents
 Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors