NCT05965284 Efficacy and Safety for Telitacicept in the Remission Maintenance Treatment of ANCA-associated Vasculitis (TTCAZAREM)
| NCT ID | NCT05965284 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Chinese SLE Treatment And Research Group |
| Condition | ANCA-associated Vasculitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2023-03-09 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 40 participants in total. It began in 2023-03-09 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
JIng Li, M.D.
PRINCIPAL INVESTIGATOR
Peking Unione Mdecial College Hospital
Frequently Asked Questions
Who can join the NCT05965284 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying ANCA-associated Vasculitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05965284 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05965284 currently recruiting?
Yes, NCT05965284 is actively recruiting participants. Contact the research team at yangyunjiao81@163.com for enrollment information.
Where is the NCT05965284 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT05965284 clinical trial?
NCT05965284 is sponsored by Chinese SLE Treatment And Research Group. The principal investigator is JIng Li, M.D. at Peking Unione Mdecial College Hospital. The trial plans to enroll 40 participants.