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

NCT05962840 | Recruiting Phase 4

• 1 other identifier: CSTAR-K2956
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

ANCA Associated Vasculitis

Keywords

Telitacicept; relapse rate; remission maintain treatment

Outcome Measures

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

  from inclusion to the end of the study, 24 months in total

Secondary Outcomes (8)

• The time to remission of two groups

  from inclusion to the end of the study, 24 months in total

• The time from remission to first relapse of two groups

  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

  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

  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.

  from inclusion to the end of the study, 24 months in total

Study Arms (2)

Placebo arm

PLACEBO COMPARATOR

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

Telitacicept treatment arm

EXPERIMENTAL

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

Interventions

Telitacicept DRUG

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

Telitacicept treatment arm

Placebo of Telitacicept OTHER

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

Placebo arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese SLE Treatment And Research Group: lead
• Peking Union Medical College Hospital: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, 100730, China

RECRUITING

MeSH Terms

Conditions

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

Interventions

telitacicept

Condition Hierarchy (Ancestors)

Systemic Vasculitis; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jing Li, MD

  Peking Unione Mdecial College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yunjiao Yang, MD

CONTACT

86-13671313079; yangyunjiao81@163.com

Hanqi Wang, RN

CONTACT

86-15810927696; lijing6515@pumch.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective, randomized, single-blinded, placebo-controlled, pilot study

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: July 27, 2023
• Study Start: June 29, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)