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

Lilly

Status and phase: Completed; Phase 4

Conditions: Rheumatoid Arthritis

Treatments: Drug: TNF Inhibitor; Drug: Baricitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT04086745

I4V-MC-JAJD (Other Identifier)

17363

Details and patient eligibility

About

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 (RA).

Enrollment: 1,050 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 drug (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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,050 participants in 3 patient groups

Baricitinib 2mg

Experimental group

Description:

Participants received 2 milligrams (mg) of baricitinib once daily until the planned number of adjudicated primary endpoint events occurred or until the data monitoring committee (DMC) recommended early termination. Those with inadequate response at 1-year after start of treatment with baricitinib 2 mg could receive rescue treatment with baricitinib 4 mg.

Treatment:

Drug: Baricitinib

Baricitinib 4mg

Experimental group

Description:

Participants received 4 mg of baricitinib once daily until the planned number of adjudicated primary endpoint events occurred or until the DMC recommended early termination.

Treatment:

Drug: Baricitinib

Tumor Necrosis Factor (TNF) Inhibitor

Active Comparator group

Description:

Participants received a TNF inhibitor (adalimumab or etanercept) administered according to approved local labeling until the planned number of adjudicated primary endpoint events occurred or until the DMC recommended early termination.

Treatment:

Drug: TNF Inhibitor