NCT06662721

Baricitinib for Refractory Takayasu Arteritis

Baricitinib for Takayasu Arteritis Refractory to TNF-α Inhibitors: a Prospective Pilot Open-label Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Liu Tian · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Takayasu arteritis (TKA) is an autoimmune vasculitis characterized with involvement of aorta and its primary branches. For TKA refractory to TNF-α, Baricitinib, a reversible inhibitor of Janus kinases (JAK) family members JKA1 and JAK2, represents a potential treatment option. This study aims to assess the efficacy and safety of Baricitinib in TKA refractory to TNF-α inhibitors.

Detailed description

This is a multi-center, single-arm trial conducted to evaluate the safety and efficacy of baricitinib in Takayasu arteritis (TKA) refractory to TNF-α inhibitors. Patients in active TKA and unresponsive to at least 6 months of TNF-α inhibitors therapy were enrolled. Patients discontinued TNF-α inhibitors and received baricitinib at 4 mg/day for up to 48 weeks, which was added to the glucocorticoid and immunosuppressants. The clinical manifestations, inflammatory indicators, imaging and treatment of patients were recorded by investigators during the follow up.

Conditions

• Takayasu Arteritis

Interventions

Type	Name	Description
DRUG	Baricitinib 4 MG	The patients received Baricitinib for 48 weeks. The method is to take Baricitinib 4mg every day for a period of 48 weeks. All the patients will be followed up prospectively for 48 weeks.

Timeline

• Start date: 2023-04-03
• Primary completion: 2023-12-23
• Completion: 2024-06-08
• First posted: 2024-10-29
• Last updated: 2024-10-29

Locations

1 site across 1 country: China