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

• Register: ClinicalTrials.gov
• Last refreshed on: 25 March 2024
• Main ID: NCT03915964
• Date of registration: 12/04/2019
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company
• Public title: A Study of Baricitinib (LY3009104) in Participants With Rheumatoid Arthritis RA-BRIDGE
• Scientific title: A Randomized, Active-Controlled, Parallel-Group, Phase 3b/4 Study of Baricitinib in Patients With Rheumatoid Arthritis
• Date of first enrolment: April 25, 2019
• Target sample size: 2600
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03915964
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

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

Contacts

• Name: 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)
• Affiliation: Eli Lilly and Company

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Baricitinib

Drug: TNF Inhibitor

Primary Outcome(s)

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

Secondary Outcome(s)

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 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 Serious Infection [Time Frame: Baseline through Study Completion (Approximately 5.5 Years)]

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 Major Adverse Cerebro-Cardiovascular Event (MACE) [Time Frame: Baseline through Study Completion (Approximately 5.5 Years)]

Secondary ID(s)

17172

I4V-MC-JAJA

2018-003351-37

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Incyte Corporation