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

NCT05962840 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-07-27

No results posted yet for this study

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.

Conditions

  • ANCA Associated Vasculitis

Interventions

DRUG

Telitacicept

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

OTHER

Placebo of Telitacicept

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

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    collaborator OTHER
  • Chinese SLE Treatment And Research Group

    lead OTHER

Principal Investigators

  • Jing Li, MD · Peking Unione Mdecial College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-29
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05962840 on ClinicalTrials.gov