NCT05749666

Comparison of Tofacitinib and Prednisolone in the Treatment of Active Takayasu's Arteritis

A Prospective Randomized Double-blinded Controlled Single Center Clinical Study of the Efficacy and Safety for Tofacitinib Compared With Glucocorticoid in the Remission-reduction Treatment of Active Takayasu's Arteritis

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Chinese SLE Treatment And Research Group · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, double-blinded, single center, randomized clinical trial. It compares the clinical efficacy and safety of thees 2 drugs in the treatment of active Takayasu's arteritis patients.

Detailed description

In this study, 40 Takayasu's arteritis patients with active disease will be enrolled. Patients are randomized into the tofacitinib treatment group and prednisolone treatment group. Patients will follow the same reduction steps for prednisolone and its placebo. The primary end point is the percentage of patients who are in complete response at week 24. The efficacy will be evaluated at week 4, 12 and 24. Safety is also monitored during the study.

Conditions

• Takayasu Arteritis

Interventions

Type	Name	Description
DRUG	Tofacitinib 5 MG	Tofacitinib 5 MG BID taken orally for 24 weeks
DRUG	Prednisolone	Prednisolone taken daily according to preset tapering protocol
OTHER	Placebo of tofacitinib 5mg	Placebo of tofacitinib 5mg BID taken orally for 24 weeks
OTHER	Placebo of prednisolone	Placebo of prednisolone taken daily according to preset tapering protocol for 24 weeks

Timeline

• Start date: 2023-01-20
• Primary completion: 2025-07-20
• Completion: 2025-07-20
• First posted: 2023-03-01
• Last updated: 2023-03-01

Locations

1 site across 1 country: China