About this trial
This study is a prospective, open-labelled, randomized, controlled, single-center clinical trial. The aim of this study is to investigate the remission rate of patients treated with Telitacicept combined with Rituximab in remission-induction and Telitacicept alone in remission-maintain treatment.
Eligibility criteria
Qualifiers
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 have severe active AAV according to the 2021 ACR/vasculitis foundation definition.
Patients have to be PR3-ANCA-positive at diagnosis or during the course of their disease.
Disqualifiers
Patients who had been treated with Rituximab but had to stop due to adverse events or intolerance.
Patients who had other autoimmune diseases.
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).
Patients who are pregnant or have planned for pregnancy in next 2 years.
Trial design
Treatments tested in this trial
- Telitacicept
- Placebo of Telitacicept
Treatment groups
Sponsors and collaborators
Chinese SLE Treatment And Research Group
Lead sponsor
Peking Union Medical College Hospital
Collaborator