A Phase 4 interventional study of Telitacicept and Placebo of Telitacicept in ANCA Associated Vasculitis, sponsored by Chinese SLE Treatment And Research Group. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-07-27.
Sponsored by Chinese SLE Treatment And Research Group · Phase 4, Interventional, and Treatment
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.
Background: The basic theme of AAV is relapse and remission. The maintenance therapy of AAV aimed to reduce or prevent relapse is very challenge. Although many medications have been used for the maintenance of AAV, Telitacicept (a BAFF/APRIL dual-target-inhibitor, which has been proved to be effect in treatment of SLE) has not been studied yet. One study tested the efficacy of Belimumab in the maintenance therapy for AAV. When taken Rituximab as remission-induction treatment, no relapse was observed. However, the sample size of this study is small, and the Belimumab, as a BAFF inhibitor, was not been proved to have effect on APRIL.
Many experiences have been accumulated about the efficacy and safety of Telitacicept in Chinese patients with rheumatic diseases. But there is no study to show its effectiveness in the reduction of the relapse of AAV in China. In this study, we take Telitacicept as maintain treatment in AAV patients who receive Rituximab as remission-induction treatment, to verify the effectiveness of Telitacicept in maintenance therapy of AAV.
Objectives: To investigate the effectiveness of Telitacicept in reducing relapse rate by using from remission-induction treatment combined with Rituximab to maintenance treatment of AAV.
Study Design: This is a prospective, randomized, open-label, control, pilot study.
230 studies on the registry are indexed under Vasculitis; 68 are open to participants now.
This study's planned enrollment of 40 is below the median of 48 across 119 interventional studies indexed under Vasculitis.
Browse Vasculitis studies →Chinese SLE Treatment And Research Group is the lead sponsor of 24 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients with active AAV will be treated with Rituximab and glucocorticoid to induce remission. And the placebo of Telitacicept would be given 80 mg every week subcutaneously for 12 months. Glucocorticoid would be tapered as recommended by 2022 EULAR AAV recommendation (as protocol of PEXIVAS study)
Other: Placebo of Telitacicept
Patients with active AAV will be treated with Rituximab and glucocorticoid to induce remission. And the Telitacicept would be given 80 mg every week subcutaneously for 12 months. Glucocorticoid would be tapered as recommended by 2022 EULAR AAV recommendation (as protocol of PEXIVAS study)
Drug: Telitacicept
Patient will be treated with Telitacicept (Taiai the commercial name) 80 mg every week subcutaneously for 12 months
Also known as: Taiai for commercial name
Patient will be treated with placebo of Telitacicept (Taiai the commercial name) 80 mg every week subcutaneously for 12 months
The time of first relapse during 24 months follow-up of two groups
The time from baseline to first relapse(re-appearance of disease with a BVAS \>0) of patients during 24 months follow-up of two groups
Time frame: from inclusion to the end of the study, 24 months in total
The time to remission of two groups
The time from baseline to remission (disappearance of disease with a BVAS = 0) of patients of two groups
Time frame: from inclusion to the end of the study, 24 months in total
The time from remission to first relapse of two groups
The time from remission (disappearance of disease with a BVAS = 0) to first relapse (re-appearance of disease with a BVAS \>0) of patients of two groups
Time frame: from inclusion to the end of the study, 24 months in total
The percentage of patients with sustained remission at months 12 and at months 24 of two groups
The percentage of patients with sustained remission (disappearance of disease with a BVAS = 0) at months 12 and at months 24 of two groups
Time frame: from inclusion to the end of the study, 24 months in total
The percentage of patients with relapse at months 12 and at months 24 of two groups
The percentage of patients with relapse (re-appearance of disease with a BVAS \>0), major relapse (re-appearance or worsening of disease with a BVAS \>0 and involvement of at least one major organ, a life-threatening manifestation, or both) and minor relapse (re-appearance of disease with a BVAS \>0 without involvement of major organ or a life-threatening manifestation) at months 12 and at months 24 of two groups
Time frame: from inclusion to the end of the study, 24 months in total
The rate of adverse events and their severity in both treatment groups during 24 months of the study period.
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 treatment groups during the study period.
Time frame: from inclusion to the end of the study, 24 months in total
The percentage of patients who progress to ESRD at the end of the study
The percentage of patients who progress to ESRD at the end of the study
Time frame: from inclusion to the end of the study, 24 months in total
The time of ANCA from positive to negative of two groups
The time of ANCA from positive to negative of two groups
Time frame: from inclusion to the end of the study, 24 months in total
The rate of complication of AAV in both treatment groups during 24 months of the study period.
The rate of complication of AAV in both treatment groups during 24 months of the study period.
Time frame: from inclusion to the end of the study, 24 months in total
Plan to share: No — Only patient clincial information coud be released to public
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Chinese SLE Treatment And Research Group