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

NCT05965284 | Recruiting Phase 4

• 1 other identifier: CSTAR-K2374
• 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 compare the remission rate of patients treated with Telitacicept combined with azathioprine and azathioprine alone in remission-maintenance treatment of AAV.

Conditions

ANCA-associated Vasculitis; Maintenance Therapy

Keywords

ANCA-associated Vasculitis; Telitacicept; Azathioprine; Relapse rate

Outcome Measures

Primary Outcomes (1)

• 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

  from inclusion to the end of the study, 12 months in total

Secondary Outcomes (7)

• The percentage of patients with severe relapse at months 12

  from inclusion to the end of the study, 12 months in total

• The percentage of patients with moderate relapse at months 12

  from inclusion to the end of the study, 12 months in total

• The percentage of patients with mild relapse at months 12

  from inclusion to the end of the study, 12 months in total

• The percentage of patients with sustained remission at months 12

  from inclusion to the end of the study, 12 months in total

• The rate of adverse events

  from inclusion to the end of the study, 12 months in total

Study Arms (2)

Azathioprine treatment arm

OTHER

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.

Drug: Azathioprine

Telitacicept treatment arm

EXPERIMENTAL

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.

Drug: Azathioprine; Drug: Telitacicept

Interventions

Azathioprine DRUG

All patients included into this study will be treated with Azathioprine tablets 100mg QD for 12 months.

Azathioprine treatment arm; Telitacicept treatment arm

Telitacicept DRUG

Patient will be treated with Telitacicept (Taiai the commercial name) 160 mg every week subcutaneously for 12 months

Also known as: Taiai for commercial name

Telitacicept treatment 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese SLE Treatment And Research Group: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

Interventions

Azathioprine; 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

Intervention Hierarchy (Ancestors)

Thionucleosides; Sulfur Compounds; Organic Chemicals; Mercaptopurine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• JIng Li, M.D.

  Peking Unione Mdecial College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yunjiao Yang, M.D.

CONTACT

+86-13671313079; yangyunjiao81@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective, randomized, open-label, control, pilot study

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: July 28, 2023
• Study Start: March 9, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 28, 2023

Record last verified: 2023-07

Locations

CN (1)