Tests telitacicept with azathioprine to maintain remission in ANCA-associated vasculitis
Compares telitacicept plus azathioprine with azathioprine alone in adults with vasculitis.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety for Telitacicept in the Remission Maintenance Treatment of ANCA-associated Vasculitis (TTCAZAREM)
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT05965284, who can take part
Where in China
- Peking Union Medical College HospitalBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Chinese SLE Treatment And Research Group
- Trial code
- NCT05965284
- Record updated
- 28 July 2023
- Original description
This study is a prospective, open-labelled, randomized, controlled, single-center clinical trial. The aim of this study is to compare the remission rate of patients treated with Telitacicept combined with azathioprine and azathioprine alone in remission-maintenance treatment of AAV.Read full original descriptionShow less
A Prospective, Open-label, Controlled, Single Center Clinical Study of the Efficacy and Safety for Telitacicept in the Remission Maintenance Treatment of ANCA-associated Vasculitis
This study is a prospective, open-labelled, randomized, controlled, single-center clinical trial. The aim of this study is to compare the remission rate of patients treated with Telitacicept combined with azathioprine and azathioprine alone in remission-maintenance treatment of AAV.
Inclusion: 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.
Exclusion: 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; 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; 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 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.