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

Primary Purpose

ANCA-associated Vasculitis, Maintenance Therapy

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Azathioprine
Telitacicept
Sponsored by
Chinese SLE Treatment And Research Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ANCA-associated Vasculitis focused on measuring ANCA-associated Vasculitis, Telitacicept, Azathioprine, Relapse rate

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Azathioprine treatment arm

Telitacicept treatment arm

Arm Description

Patients will be treated with Azathioprine 100mg per day for 12 months combined with prednisone no more than 10mg daily. The dosage of prednisone is tapered in the study period while sustained remission achieved. All included patients will be treated with TMPco 2 tablets per day during the study period if not contraindicated or intolerant.

Patients will be treated with Telitacicept 160mg per week combined with Azathioprine 100mg per day for 12 months combined with prednisone no more than 10mg daily. The dosage of prednisone is tapered in the study period while sustained remission achieved. All included patients will be treated with TMPco 2 tablets per day during the study period if not contraindicated or intolerant.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
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
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.
The percentage of patients who progress to ESRD
The percentage of patients who progress to ESRD at the end of the study
The rate of complication of AAV
The rate of complication of AAV in both treatment groups during 12 months of the study period.

Full Information

First Posted
July 20, 2023
Last Updated
July 20, 2023
Sponsor
Chinese SLE Treatment And Research Group
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1. Study Identification

Unique Protocol Identification Number
NCT05965284
Brief Title
Efficacy and Safety for Telitacicept in the Remission Maintenance Treatment of ANCA-associated Vasculitis (TTCAZAREM)
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 9, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chinese SLE Treatment And Research Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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 add Telitacicept to azathioprine in maintain treatment in AAV patients who receive Rituximab as remission-induction treatment, to compare the relapse rates of Telitacicept combining azathioprine and azathioprine alone in maintenance therapy of AAV. Objectives: To compare the relapse rates of Telitacicept combining azathioprine and azathioprine alone in maintenance treatment of AAV. Study Design: This is a prospective, randomized, open-label, control, pilot study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ANCA-associated Vasculitis, Maintenance Therapy
Keywords
ANCA-associated Vasculitis, Telitacicept, Azathioprine, Relapse rate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
prospective, randomized, open-label, control, pilot study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Azathioprine treatment arm
Arm Type
Other
Arm Description
Patients will be treated with Azathioprine 100mg per day for 12 months combined with prednisone no more than 10mg daily. The dosage of prednisone is tapered in the study period while sustained remission achieved. All included patients will be treated with TMPco 2 tablets per day during the study period if not contraindicated or intolerant.
Arm Title
Telitacicept treatment arm
Arm Type
Experimental
Arm Description
Patients will be treated with Telitacicept 160mg per week combined with Azathioprine 100mg per day for 12 months combined with prednisone no more than 10mg daily. The dosage of prednisone is tapered in the study period while sustained remission achieved. All included patients will be treated with TMPco 2 tablets per day during the study period if not contraindicated or intolerant.
Intervention Type
Drug
Intervention Name(s)
Azathioprine
Intervention Description
All patients included into this study will be treated with Azathioprine tablets 100mg QD for 12 months.
Intervention Type
Drug
Intervention Name(s)
Telitacicept
Other Intervention Name(s)
Taiai for commercial name
Intervention Description
Patient will be treated with Telitacicept (Taiai the commercial name) 160 mg every week subcutaneously for 12 months
Primary Outcome Measure Information:
Title
The time of first relapse during 12 months follow-up of two groups
Description
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
Time Frame
from inclusion to the end of the study, 12 months in total
Secondary Outcome Measure Information:
Title
The percentage of patients with severe relapse at months 12
Description
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
Time Frame
from inclusion to the end of the study, 12 months in total
Title
The percentage of patients with moderate relapse at months 12
Description
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
Time Frame
from inclusion to the end of the study, 12 months in total
Title
The percentage of patients with mild relapse at months 12
Description
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
Time Frame
from inclusion to the end of the study, 12 months in total
Title
The percentage of patients with sustained remission at months 12
Description
The percentage of patients with sustained remission (BVAS =0 without dosage increase of glucocorticoid) at months 12
Time Frame
from inclusion to the end of the study, 12 months in total
Title
The rate of adverse events
Description
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.
Time Frame
from inclusion to the end of the study, 12 months in total
Title
The percentage of patients who progress to ESRD
Description
The percentage of patients who progress to ESRD at the end of the study
Time Frame
from inclusion to the end of the study, 12 months in total
Title
The rate of complication of AAV
Description
The rate of complication of AAV in both treatment groups during 12 months of the study period.
Time Frame
from inclusion to the end of the study, 12 months in total

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: Patients with TPMT gene mutation. 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 who have planned for pregnancy in next 1.5 years. 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 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 who are not eligible according to the judge of the principal investigators or site investigators.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yunjiao Yang, M.D.
Phone
+86-13671313079
Email
yangyunjiao81@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JIng Li, M.D.
Organizational Affiliation
Peking Unione Mdecial College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yunjiao Yang, M.D.
Phone
86-13671313079
Email
yangyunjiao81@163.com
First Name & Middle Initial & Last Name & Degree
Hanqi Wang, RN
Phone
86-15810927696
Email
lijing6515@pumch.cn

12. IPD Sharing Statement

Learn more about this trial

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

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