Combining Rituximab and Telitacicept for treating ANCA-associated Vasculitis

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 investigates the effectiveness of Telitacicept in reducing relapse rates in patients with ANCA-associated vasculitis (AAV) who are undergoing remission-induction treatment with Rituximab. It is a prospective, open-label, randomized, controlled, single-center trial that aims to evaluate the efficacy of Telitacicept as a maintenance therapy following Rituximab treatment. The study will enroll patients aged 18 to 65 who meet specific diagnostic criteria for AAV and are PR3-ANCA-positive. The trial will compare the outcomes of patients receiving Telitacicept against those receiving a placebo.

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 have severe active AAV according to the 2021 ACR/vasculitis foundation definition.
4. Patients have to be PR3-ANCA-positive at diagnosis or during the course of their disease.

Exclusion Criteria:

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

Where it's running

• Peking Union Medical College Hospital
  Beijing, China Recruiting

Study contacts

• Principal investigator: Jing Li, MD — Peking Unione Mdecial College Hospital
• Study coordinator: Yunjiao Yang, MD
• 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.