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Trial record 27 of 63 for:    Baricitinib

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 3, 2020
Sponsor:
Collaborator:
Incyte Corporation
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE April 12, 2019
First Posted Date  ICMJE April 16, 2019
Last Update Posted Date January 3, 2020
Actual Study Start Date  ICMJE April 25, 2019
Estimated Primary Completion Date February 1, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 12, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03915964 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2019)
  • 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
  • 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
  • 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)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Baricitinib (LY3009104) in Participants With Rheumatoid Arthritis
Official Title  ICMJE A Randomized, Active-Controlled, Parallel-Group, Phase 3b/4 Study of Baricitinib in Patients With Rheumatoid Arthritis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • Drug: Baricitinib
    Administered orally.
    Other Name: LY3009104
  • Drug: TNF Inhibitor
    Administered SC
    Other Names:
    • Etanercept
    • Adalimumab
Study Arms  ICMJE
  • Experimental: Baricitinib Low Dose
    Baricitinib administered orally.
    Intervention: Drug: Baricitinib
  • Experimental: Baricitinib High Dose
    Baricitinib administered orally.
    Intervention: Drug: Baricitinib
  • Active Comparator: TNF Inhibitor
    Adalimumab or etanercept administered subcutaneously (SC) per standard of care.
    Intervention: Drug: TNF Inhibitor
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 12, 2019)
2600
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 1, 2026
Estimated Primary Completion Date February 1, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Czechia,   Denmark,   France,   Germany,   Greece,   Hungary,   Israel,   Italy,   Lithuania,   Netherlands,   Poland,   Puerto Rico,   Romania,   Russian Federation,   Slovakia,   South Africa,   Spain,   Switzerland,   Turkey,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03915964
Other Study ID Numbers  ICMJE 17172
I4V-MC-JAJA ( Other Identifier: Eli Lilly and Company )
2018-003351-37 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: 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/
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Incyte Corporation
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP