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

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05468879` - Bioequivalence Study of 3 mg Glimepiride Tablet in Indonesia Healthy Subjects	N/A
Completed	`NCT02293057` - Gender-Responsive Drug Use Treatment for Juvenile Justice Girls	N/A
Completed	`NCT01941108` - Technology-Enhanced Peer Navigation to Improve IDUs' Engagement in HIV Care	N/A
Completed	`NCT01380613` - Neighborhoods, Networks, Depression, and HIV Risk	Phase 2
Withdrawn	`NCT00914719` - Alcohol Use and Sexual Risk: An Intervention	N/A
Recruiting	`NCT03671629` - Pharmacist Intervention to Reduce Drug-related Readmissions Among the Elderly	N/A
Completed	`NCT03290391` - Linking Infectious and Narcology Care-Part II	Phase 4
Completed	`NCT04008927` - A Community-based Intervention Among Active Drug Users in Montpellier	N/A
Completed	`NCT03627546` - HCV Seek, Test and Rapid Treatment for Young PWID	N/A
Recruiting	`NCT05380765` - Developing a Positive Approach to Substance Use Prevention in North American Indian Adolescents	N/A
Not yet recruiting	`NCT03967262` - Secondary Prevention and Recidivism Reduction in Trauma Patients	N/A
Completed	`NCT03079856` - Drug Use and Sexual Risk Behaviors Among Emerging Adults in the ER	N/A
Completed	`NCT03855410` - Preventing Cigarette Use Among Urban Youth Via an M-Health Primary Care Preventive Intervention	N/A
Terminated	`NCT02457949` - The Impact of Alternative Social Assistance Disbursement on Drug-related Harm	N/A
Completed	`NCT06238154` - Flurbiprofen Tablet vs Spray In Oral Soft Tissue Wounds	Phase 4
Terminated	`NCT04436055` - Intergenerational Effects of Paternal Periconceptional Cannabis and Other Drug Use (EPIC)
Recruiting	`NCT04717856` - Evaluation of the Use of the GenXpert to Detect Hepatitis C RNA	N/A
Completed	`NCT00249496` - Employment-based Reinforcement to Motivate Drug Abstinence in the Treatment of Drug Addiction. - 1	N/A
Recruiting	`NCT05597865` - Assessing the Feasibility of Economic Approaches to Prevent Substance Abuse Among Adolescents	N/A
Completed	`NCT05553054` - Drug Wastage : Observational Study in Intensive Care Units in France