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Baricitinib vs TNF Inhibitors in Rheumatoid Arthritis
NCT04086745Phase 4
Key facts
- Status
- Completed
- Start
- Feb 2020
- Primary completion
- May 2025
- Countries
- 1
- Sponsor
- Eli Lilly and Company
- Modality
- Recombinant Proteins and Enzymes, Small Molecules, Antibody-Based Therapeutics
- Drugs
- baricitinib
- Conditions
- rheumatoid arthritis (RA)
01
Overview
Phase 4, randomised trial of baricitinib in rheumatoid arthritis (RA) (3 arms), sponsored by Eli Lilly and Company. Primary endpoint: Time to First Event of Venous Thromboembolism up to 6.1 years. Started Feb 2020; status: completed.
02
Design
3 arms- Study design
- Randomized
Baricitinib 2mg
Participants received 2 mg of baricitinib once daily.
Baricitinib 4mg
Participants received 4 mg of baricitinib once daily.
Tumor Necrosis Factor (TNF) Inhibitor
Participants received a TNF inhibitor (adalimumab or etanercept).
03
Who it enrols
Patients with rheumatoid arthritis who have an inadequate response or intolerance to at least 1 DMARD, and have specific risk factors for VTE (prior VTE, age >=60, BMI >=30, or age 50-<60 with BMI 25-<30). Excludes patients with prior JAK inhibitor use, >1 prior TNF inhibitor discontinued for lack of efficacy/intolerance, >1 VTE, cancer, or active serious infections.
04
Endpoints
Primary
Time to First Event of Venous Thromboembolism
Secondary
Time to First Event of Venous Thromboembolism
Time to First Arterial Thromboembolic Event
Time to First Major Adverse Cerebro-Cardiovascular Event
Time to First Malignancy (Excluding NMSC)
Time to First Opportunistic Infection
Time to First Serious Infection
05
Results
Primary endpoints met
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