An interventional study of Tofacitinib in ANCA Associated Vasculitis, Drug Use and JAK-STAT Pathway Deregulation, sponsored by Shanghai Zhongshan Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-07-22.
Sponsored by Shanghai Zhongshan Hospital · Not applicable, Interventional, and Treatment
The goal of this study is to evaluate the efficacy and safety of tofacitinib 5 mg twice daily in AAV patients.
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.
230 studies on the registry are indexed under Vasculitis; 68 are open to participants now.
This study's enrollment of 10 is below the median of 48 across 119 interventional studies indexed under Vasculitis.
Browse Vasculitis studies →Shanghai Zhongshan Hospital is the lead sponsor of 638 studies on the registry; 285 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Tofacitinib 5mg twice a day
Drug: Tofacitinib
patients enrolled were prescribed tofacitinib 5mg twice a day orally.
Also known as: Tofacitinib 5mg.bid.po.
The response rate (CR, PR and TR)
The percent of patients who achieved disease response. The disease response includes:(1) complete remission (CR), defined as the absence of disease activity (BVAS = 0); (2) partial remission (PR) defined as at least 50% reduction of BVAS and no new manifestations; (3) treatment resistance (TR) was defined as less than a 50% reduction or increased disease activity after 4 \~ 6 weeks of treatment.
Time frame: From the enrollment to the end of follow-up [0 to 13 months.]
The rate of adverse event
The percent of different kinds of adverse events occurred during follow-up. The adverse event was evaluated according to the CTC-AE 4.0 standard.
Time frame: From the enrollment to the end of follow-up [0 to 13 months].
Changes in erythrocyte sedimentation rate (ESR)
The change of ESR in different follow-up point compared with the baseline.
Time frame: From the enrollment to the end of follow-up [0 to 13 months].
Changes in CRP
The change of CRP in different follow-up point compared with the baseline.
Time frame: From the enrollment to the end of follow-up [0 to 13 months].
Changes in glucocorticoids steroids (GCs) dosage
The change of the prednisone or its equivalent drug in different follow-up point compared with the baseline.
Time frame: From the enrollment to the end of follow-up [0 to 13 months].
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Shanghai Zhongshan Hospital