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

Conditions

• Rheumatoid Arthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Baricitinib — DRUG
  Administered orally.
• TNF Inhibitor — DRUG
  Administered subcutaneously.

Study Details

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.

Key Dates

First listed

Apr 16, 2019

Start date

Apr 25, 2019

Status verified

May 2026

Primary completion

May 28, 2025

Completion

May 28, 2025

Study Design

Enrollment

2,659 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Baricitinib 2mg
  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 2mg could receive rescue treatment with baricitinib 4mg.
• Experimental: Baricitinib 4mg
  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.
• Active Comparator: Tumor Necrosis Factor (TNF) Inhibitor
  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.

Primary Outcome Measure

Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Event of Venous Thromboembolism (VTE) [Combined Baricitinib Dose Versus TNF Inhibitor] [ Time Frame: From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants) ]

Locations (81)

Find similar trials in Flagstaff, AZ

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