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Efficacy and Safety for Rituximab Combined With Telitacicept in the Treatment of ANCA-associated Vasculitis (TTCAAVREM)

Primary Purpose

ANCA Associated Vasculitis

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Telitacicept
Placebo of 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 Telitacicept, relapse rate, remission maintain treatment

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 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. Exclusion Criteria: 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. 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 with malignancy. Patients who are not eligible according to the judge of the principal investigators.

Sites / Locations

  • Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo arm

Telitacicept treatment arm

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
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
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.
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
The time of ANCA from positive to negative of two groups
The time of ANCA from positive to negative of two groups
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.

Full Information

First Posted
July 18, 2023
Last Updated
July 19, 2023
Sponsor
Chinese SLE Treatment And Research Group
Collaborators
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05962840
Brief Title
Efficacy and Safety for Rituximab Combined With Telitacicept in the Treatment of ANCA-associated Vasculitis (TTCAAVREM)
Official Title
A Prospective, Randomized, Single-blinded Placebo-controlled, Single Center Clinical Study of the Efficacy and Safety for Rituximab Combined With Telitacicept in the Treatment of ANCA-associated Vasculitis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 29, 2023 (Actual)
Primary Completion Date
December 31, 2026 (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
Collaborators
Peking Union Medical College Hospital

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 investigate the remission rate of patients treated with Telitacicept combined with Rituximab in remission-induction and Telitacicept alone in remission-maintain treatment.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ANCA Associated Vasculitis
Keywords
Telitacicept, relapse rate, remission maintain treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
prospective, randomized, single-blinded, placebo-controlled, pilot study
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo arm
Arm Type
Placebo Comparator
Arm Description
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)
Arm Title
Telitacicept treatment arm
Arm Type
Experimental
Arm Description
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)
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) 80 mg every week subcutaneously for 12 months
Intervention Type
Other
Intervention Name(s)
Placebo of Telitacicept
Intervention Description
Patient will be treated with placebo of Telitacicept (Taiai the commercial name) 80 mg every week subcutaneously for 12 months
Primary Outcome Measure Information:
Title
The time of first relapse during 24 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 24 months follow-up of two groups
Time Frame
from inclusion to the end of the study, 24 months in total
Secondary Outcome Measure Information:
Title
The time to remission of two groups
Description
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
Title
The time from remission to first relapse of two groups
Description
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
Title
The percentage of patients with sustained remission at months 12 and at months 24 of two groups
Description
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
Title
The percentage of patients with relapse at months 12 and at months 24 of two groups
Description
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
Title
The rate of adverse events and their severity in both treatment groups during 24 months of the study period.
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 treatment groups during the study period.
Time Frame
from inclusion to the end of the study, 24 months in total
Title
The percentage of patients who progress to ESRD at the end of the study
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, 24 months in total
Title
The time of ANCA from positive to negative of two groups
Description
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
Title
The rate of complication of AAV in both treatment groups during 24 months of the study period.
Description
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

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 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. Exclusion Criteria: 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. 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 with malignancy. Patients who are not eligible according to the judge of the principal investigators.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yunjiao Yang, MD
Phone
86-13671313079
Email
yangyunjiao81@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hanqi Wang, RN
Phone
86-15810927696
Email
lijing6515@pumch.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing Li, MD
Organizational Affiliation
Peking Unione Mdecial College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yunjiao Yang, MD
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

Plan to Share IPD
No
IPD Sharing Plan Description
Only patient clincial information coud be released to public

Learn more about this trial

Efficacy and Safety for Rituximab Combined With Telitacicept in the Treatment of ANCA-associated Vasculitis (TTCAAVREM)

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