NCT05151848

Comparison of Adalimumab and Tofacitinib in the Treatment of Active Takayasu Arteritis

An Open-label，Randomized, Controlled, Multicenter Study of Adalimumab and Tofacitinib in the Treatment of Active Takayasu Arteritis

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (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,open-labelled,multi-center,randomized clinical trial.It compares the clinical efficacy and safety of there 2 drugs in the treatment of relapse active Takayasu's arteritis patients.

Detailed description

In this study, 100 relapse Takayasu's arteritis patients will be enrolled. Patients are randomized into the adalimumab treatment group and tofacitinib treatment.Patients will also be treated with reduced dose of glucocorticoid at the same time. The primary end point is the percentage of patients who are in complete response at week 12 and maintain in complete response at week 78. The efficacy will be evaluated at week 12, 24, 36, 52 and 78. If the patient does not respond to one drug at week 24, then the investigator will shift the treatment to another intervention. Safety is also monitored during the study.

Conditions

• Takayasu Arteritis

Interventions

Type	Name	Description
DRUG	Adalimumab Injection	Adalimumab Injection injected subcutaneously every other week for 78 weeks
DRUG	Tofacitinib 5 MG	Tofacitinib 5 MG BID taken orally for 78 weeks

Timeline

• Start date: 2022-01-05
• Primary completion: 2026-01-15
• Completion: 2026-01-15
• First posted: 2021-12-09
• Last updated: 2023-07-24

Locations

4 sites across 1 country: China