Baricitinib Versus TNF Inhibitors for Venous Thromboembolism Risk in Rheumatoid Arthritis: Phase 3b/4 Active-Controlled Study

The primary objective of this study is to compare the risk of venous thromboembolism between combined doses of baricitinib and TNF inhibitors in patients diagnosed with rheumatoid arthritis. This evaluation is clinically relevant for assessing the safety profile of the investigational agent relative to established biological therapies. The trial is designed to evaluate efficacy and safety.

This clinical trial involves a total of 748 patients diagnosed with rheumatoid arthritis. The study population includes both male and female participants. The inclusion criteria require an inadequate response or intolerance to at least one disease-modifying antirheumatic drug. Eligible subjects must possess at least one of the following characteristics: documented history of venous thromboembolism, an age of 60 years or older, a body mass index of 30 kg/m² or greater, or an age between 50 and 60 years with a body mass index between 25 and 30 kg/m².

This Phase 3b/4, randomized, active-controlled, parallel-group study evaluates the safety profile of baricitinib compared to TNF inhibitors in patients diagnosed with rheumatoid arthritis. The primary objective is to compare the risk of venous thromboembolism (VTE) between the test product and the comparators, which include adalimumab and etanercept. Eligible participants must demonstrate an inadequate response or intolerance to at least one disease-modifying antirheumatic drug (DMARD) and meet specific criteria regarding age, body mass index (BMI), or prior history of VTE. The study measures the time from the first dose of study treatment to the first occurrence of a VTE event. Total participant involvement is estimated to last approximately 5.5 years from baseline through study completion.

The experimental treatment consists of baricitinib administered via oral use at a dosage of 4 mg. This substance is evaluated as the test medication in patients with rheumatoid arthritis.

The comparator treatments include adalimumab, provided as a solution for injection at a dose of 80 mg, and etanercept, administered as a solution for injection at a dose of 50 mg. These TNF inhibitors serve as the active controls in the study design.

The primary efficacy assessment in this study of rheumatoid arthritis focuses on the time from the first dose of study treatment to the first occurrence of venous thromboembolism. This parameter is monitored from baseline through study completion, which is estimated to be approximately 5.5 years.