A Study of Baricitinib in Participants With Rheumatoid Arthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 15 April 2024
• Main ID: NCT04086745
• Date of registration: 10/09/2019
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company
• Public title: A Study of Baricitinib in Participants With Rheumatoid Arthritis RA-BRANCH
• Scientific title: A Randomized, Controlled Pragmatic Phase 3b/4 Study of Baricitinib in Patients With Rheumatoid Arthritis
• Date of first enrolment: February 14, 2020
• Target sample size: 1300
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT04086745
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

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

• Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

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 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



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 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)]

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

Secondary ID(s)

17363

I4V-MC-JAJD

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Incyte Corporation