Efficacy and Safety for Telitacicept in the Remission Maintenance Treatment of ANCA-associated Vasculitis (TTCAZAREM)

Korábbi kezelés

• Patients who had been treated with either AZA but relapsed in the past.
• Patients who had been treated with either AZA but had to stop due to adverse events or intolerance.

Más betegség

• Patients with uncontrolled sever hypertension, diabetes, active bacteria or fungal infection;
• Patients with active hepatitis virus infection as well as patients who have active mycobacteria infection;
• Patients who had other autoimmune diseases.
• Patients with malignancy.

Laborértékek

• Patients with severe liver dysfunction(defined as the 2-folds elevation of normal upper limit or Child grade III), heart failure or ESRD(eGFR<30ml/min).

Egyéb

• Patients with TPMT gene mutation.
• Patients who have planned for pregnancy in next 1.5 years.
• Patients who are not eligible according to the judge of the principal investigators or site investigators.

• Patients age 18 to 65 years, both genders can be included.
• Patients who are newly diagnosed or relapsing granulomatosis with polyangiitis or microscopic polyangiitis must fulfill the 2022 ACR/EULAR classification criteria of GPA or MPA.
• Patients who are in complete remission after combined treatment with glucocorticoids and Rituximab. Remission is defined as a Birmingham Vasculitis Activity Score (BVAS version 3) of 0. And the daily dosage of prednisone are no more than 10mg (or equivalent).
• Patients have to be ANCA-positive at diagnosis or during the course of their disease.