NCT05102448

Comparison of Tofacitinib and Methotrexate in Takayasu's Arteritis

Comparison of the Efficacy and Safety of Tofacitinib and Methotrexate Based on Prednisone Therapy in Patients with Active Phase of Takayasu's Arteritis: a Randomized Controlled Trial

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate and compare the efficacy and safety of tofacitinib and methotrexate based on prednisone therapy in patients with Takayasu arteritis

Detailed description

Takayasu's arteritis (TAK), a chronic large vessel vasculitis, involves the aorta and its main branches. Glucocorticoids and immunosuppressants such as methotrexate, cyclophosphamide are common agents for TAK treatment. However, their effects for remission induction and relapse prevention are not satisfied. More effective agents for TAK treatment remain to be investigated. Tofacitinib (TOF) is a Jak inhibitor, which has been proved to be effective in multiple autoimmune diseases such as rheumatoid arthritis. Our preliminary real-world study also demonstrated a promising treatment effect of TOF in patients with TAK. But its efficacy and safety needs further verification. The present randomized controlled trial aimes to compare efficacy between methotrexate and tofacitinib in TAK treatment.

Conditions

• Takayasu Arteritis

Interventions

Type	Name	Description
DRUG	Tofacitinib	1. Tofacitinib 5mg twice a day for 12 months; 2. Basic treatment with prednisone: (1) the initial dose of prednisone (or equivalent): 0.8mg/kg/day (maximum 60mg/day). (2) Glucocorticoids tapering: glucocorticoids is tapered after two weeks treatment and is tapered 5mg each 2 weeks to 10mg qd in the first 6 months if patients were in inactive status based on the NIH disease activity criteria. During the 6th to 12th month, glucocorticoids is tapered 2.5mg each 4 weeks until 7.5mg qd if patients were in inactive status based on the NIH disease activity criteria.
DRUG	Methotrexate	1. Methotrexate (15mg each week) for 12 months 2. Basic treatment with prednisone: (1) the initial dose of prednisone (or equivalent): 0.8mg/kg/day (maximum 60mg/day). (2) Glucocorticoids tapering: glucocorticoids is tapered after two weeks treatment and is tapered 5mg each 2 weeks to 10mg qd in the first 6 months if patients were in inactive status based on the NIH disease activity criteria. During the 6th to 12th month, glucocorticoids is tapered 2.5mg each 4 weeks until 7.5mg qd if patients were in inactive status based on the NIH disease activity criteria.

Timeline

• Start date: 2021-11-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2021-11-01
• Last updated: 2024-10-15

Locations

1 site across 1 country: China