Comparing Telitacicept with Azathioprine for ANCA-associated Vasculitis Maintenance

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the efficacy and safety of Telitacicept in combination with azathioprine compared to azathioprine alone for maintaining remission in patients with ANCA-associated vasculitis (AAV). It is a prospective, open-label, randomized, controlled, single-center trial involving patients aged 18 to 65 who are in complete remission after treatment with glucocorticoids and Rituximab. The study will assess relapse rates to determine if the addition of Telitacicept can improve maintenance therapy outcomes for AAV patients. The trial is significant as Telitacicept has not been previously studied in this context, despite its potential benefits in rheumatic diseases.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients age 18 to 65 years, both genders can be included.
2. 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.
3. 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).
4. Patients have to be ANCA-positive at diagnosis or during the course of their disease.

Exclusion Criteria:

1. Patients with TPMT gene mutation.
2. Patients who had been treated with either AZA but relapsed in the past.
3. Patients who had been treated with either AZA but had to stop due to adverse events or intolerance.
4. Patients who have planned for pregnancy in next 1.5 years.
5. 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).
6. Patients with uncontrolled sever hypertension, diabetes, active bacteria or fungal infection;
7. Patients with active hepatitis virus infection as well as patients who have active mycobacteria infection;
8. Patients who had other autoimmune diseases.
9. Patients with malignancy.
10. Patients who are not eligible according to the judge of the principal investigators or site investigators.

Where it's running

• Peking Union Medical College Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: JIng Li, M.D. — Peking Unione Mdecial College Hospital
• Study coordinator: Yunjiao Yang, M.D.
• Email: yangyunjiao81@163.com
• Phone: +86-13671313079

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.