Effect of Tofacitinib in Treating ANCA-associated Vasculitis

• Status: Completed
• Trial end date: 2021-01-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Zhongshan Hospital
• Treatments: Tofacitinib

Criteria

Inclusion Criteria:

• Patients with active AAV met the criteria of 1990 ACR and 2012 Chapel Hill criteria

• Age 18 to 75 years

• Written informed consent obtained before taking part in the study

Exclusion Criteria:

• Severe AAV defined as potentially organ- or life-threatening disease (i.e. alveolar haemorrhage, heart failure caused by myocarditis or pericarditis, progressive neurological symptoms, deaf, blindness, et al.)

• Serum creatinine>120umol/L or proteinuria>1.0g/d

• Receipt of a JAKi therapy previously

• Co-existence of another systemic autoimmune disease

• Secondary vasculitis (following neoplastic disease, an infection or antithyroid drugs)

• Malignancy or history of malignancy

• Infection by HIV, HCV, HBV or tuberculosis-

• Severe uncontrolled cardiovascular, pulmonary, liver, gastrointestinal, endocrine, hematological, neurological, or psychiatric diseases that are not related to systemic vasculitis

• Allergic to JAKi

• Blood dyscrasias including confirmed: Hemoglobin <9 g/dL or Hematocrit <30%; White blood cell count <3.0 x 109/L; Absolute neutrophil count <1.5 x 109/L; Platelet count <100 x 109/L; Alanine transaminase or aspartate aminotransferase or total bilirubin>1.5 upper normal limit; Estimated glomerular filtration rate<60ml/min/1.73m2

• Incapacity or refusal to understand or sign the informed consent form.

• Pregnancy, breastfeeding.