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Comparison of Tofacitinib and Methotrexate in the Maintained Treatment of GPA

Granulomatosis With Polyangiitis Clinical Trial

Official title:
Randomized Trial of Tofacitinib Versus Methotrexate for Maintenance Therapy in Granulomatosis With Polyangiitis

Clinical Trial Summary

The aim of this study is to identify the optimal maintenance therapy for granulomatosis with polyangiitis (GPA) by comparing the MTX (standard regimen) with Tofacitinib in terms of efficacy, i.e. in preventing relapses.

Clinical Trial Description

Granulomatosis with polyangiitis (GPA), a systemic small-vessel vasculitis, could involve multiple tissues and organs. Remission of GPA can be obtained in approximately 80% of the patients with a combination of corticosteroids and cyclophosphamide. However, relapses are frequent and remain a challenge. The optimal drug for maintenance treatment is not determined. Tofacitinib is a Jak inhibitor which has been proved to be effective in multiple inflammatory diseases such as rheumatoid arthritis. But the efficiency and safety of tofacitinib in treating GPA remains unclear yet. In the present randomized trial, the comparison of MTX (standard regimen) with Tofacitinib in terms of efficacy, i.e. in preventing relapses will be conducted. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04944524
Study type Interventional
Source Shanghai Zhongshan Hospital
Contact Lindi Jiang, PhD
Phone +8602164041990
Email zsh-rheum@hotmail.com
Status Recruiting
Phase Phase 4
Start date July 1, 2021
Completion date July 1, 2024
View Details
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