ANCA-associated Vasculitis Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. Patients age 18 to 65 years, both genders can be included. 2. 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. 3. 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). 4. Patients have to be ANCA-positive at diagnosis or during the course of their disease. Exclusion Criteria: 1. Patients with TPMT gene mutation. 2. Patients who had been treated with either AZA but relapsed in the past. 3. Patients who had been treated with either AZA but had to stop due to adverse events or intolerance. 4. Patients who have planned for pregnancy in next 1.5 years. 5. 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). 6. Patients with uncontrolled sever hypertension, diabetes, active bacteria or fungal infection; 7. Patients with active hepatitis virus infection as well as patients who have active mycobacteria infection; 8. Patients who had other autoimmune diseases. 9. Patients with malignancy. 10. Patients who are not eligible according to the judge of the principal investigators or site investigators. |
Country | Name | City | State |
---|---|---|---|
China | Peking Union Medical College Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Chinese SLE Treatment And Research Group |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The time of first relapse during 12 months follow-up of two groups | The time from baseline to first relapse(re-appearance of disease with a BVAS >0) of patients during 12 months follow-up of two groups | from inclusion to the end of the study, 12 months in total | |
Secondary | The percentage of patients with severe relapse at months 12 | The percentage of patients with severe relapse (re-appearance or worsening of disease with a BVAS =6 and involvement of at least one major organ, a life-threatening manifestation, or both) at months 12 | from inclusion to the end of the study, 12 months in total | |
Secondary | The percentage of patients with moderate relapse at months 12 | The percentage of patients with moderate relapse (re-appearance or worsening of disease with a BVAS =3 without involvement of major organ or life-threatening manifestation) at months 12 | from inclusion to the end of the study, 12 months in total | |
Secondary | The percentage of patients with mild relapse at months 12 | The percentage of patients with mild relapse (re-appearance or worsening of disease with a 0 < BVAS < 3 without involvement of major organ or life-threatening manifestation) at months 12 | from inclusion to the end of the study, 12 months in total | |
Secondary | The percentage of patients with sustained remission at months 12 | The percentage of patients with sustained remission (BVAS =0 without dosage increase of glucocorticoid) at months 12 | from inclusion to the end of the study, 12 months in total | |
Secondary | The rate of adverse events | The rate of adverse events and their severity (Severe events were defined as the adverse events of grade 3 or 4, deaths caused by any cause, cancers, side effects that necessitate hospitalization) in both two groups during the study period. | from inclusion to the end of the study, 12 months in total | |
Secondary | The percentage of patients who progress to ESRD | The percentage of patients who progress to ESRD at the end of the study | from inclusion to the end of the study, 12 months in total | |
Secondary | The rate of complication of AAV | The rate of complication of AAV in both treatment groups during 12 months of the study period. | from inclusion to the end of the study, 12 months in total |
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