Effect of Tofacitinib in Treating ANCA-associated Vasculitis

Status Completed

Clinical Trial Summary

The goal of this study is to evaluate the efficacy and safety of tofacitinib 5 mg twice daily in AAV patients.

Clinical Trial Description

Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) represents a group of small vessel vasculitides characterized by granulomatous and neutrophilic tissue inflammation, often associated with the production of antibodies that target neutrophil antigens. The predominantly used treatment for induction of remission in AAV consisted of cyclophosphamide (CYC) plus corticosteroids (GCs) which leads to remission in about 90% of patients. 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. Considering that T cells and associated cytokine production play an important role in the pathogenesis of AAV via activation of the JAK/ STAT pathway, we hypothesized that tofacitinib-mediated inhibition of JAK signaling may represent an effective therapy for active AAV. In this prospective, open label, single arm study, tofacitinib 5mg twice a day will be added to the background treatment of GCs and immunosuppressants in AAV, the safety and efficacy of tofacitinib will be assessed. ;

Study Design

Related Conditions & MeSH terms

ANCA Associated Vasculitis
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Drug Use
JAK-STAT Pathway Deregulation
Vasculitis

Clinical Trial Details

NCT number	NCT04973033
Study type	Interventional
Source	Shanghai Zhongshan Hospital
Contact
Status	Completed
Phase	N/A
Start date	December 1, 2019
Completion date	January 31, 2021

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