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

ConditionANCA Associated Vasculitis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorChinese SLE Treatment And Research Group

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Telitacicept

    Drug

    Patient will be treated with Telitacicept (Taiai the commercial name) 80 mg every week subcutaneously for 12 months

  • Placebo of Telitacicept

    Other intervention

    Patient will be treated with placebo of Telitacicept (Taiai the commercial name) 80 mg every week subcutaneously for 12 months

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Placebo armPlacebo comparator 1 intervention
Group B: Telitacicept treatment armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chinese SLE Treatment And Research Group

Lead sponsor

Peking Union Medical College Hospital

Collaborator

Source ClinicalTrials.gov
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