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

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ClinicalTrials.gov Identifier: NCT03915964

Recruitment Status : Active, not recruiting

First Posted : April 16, 2019

Last Update Posted : April 14, 2023

View this study on Beta.ClinicalTrials.gov

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

April 14, 2023

Actual Study Start Date ^ICMJE

April 25, 2019

Estimated Primary Completion Date

April 14, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Current Secondary Outcome Measures ^ICMJE

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

Active, not recruiting

Estimated Enrollment ^ICMJE

2600

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date ^ICMJE

February 1, 2026

Estimated Primary Completion Date

April 14, 2025 (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

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

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/

Current Responsible Party

Eli Lilly and Company

Original Responsible Party

Same as current

Current Study Sponsor ^ICMJE

Eli Lilly and Company

Original Study Sponsor ^ICMJE

Same as current

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

April 2023

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

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