NCT05962840 Efficacy and Safety for Rituximab Combined With Telitacicept in the Treatment of ANCA-associated Vasculitis (TTCAAVREM)
| NCT ID | NCT05962840 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Chinese SLE Treatment And Research Group |
| Condition | ANCA Associated Vasculitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2023-06-29 |
| Primary Completion | 2026-12-31 |
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 2023-06-29 with a primary completion date of 2026-12-31.
⚠ 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 investigate the remission rate of patients treated with Telitacicept combined with Rituximab in remission-induction and Telitacicept alone in remission-maintain treatment.
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 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.
Contact & Investigator
Jing Li, MD
PRINCIPAL INVESTIGATOR
Peking Unione Mdecial College Hospital
Frequently Asked Questions
Who can join the NCT05962840 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 NCT05962840 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 NCT05962840 currently recruiting?
Yes, NCT05962840 is actively recruiting participants. Contact the research team at yangyunjiao81@163.com for enrollment information.
Where is the NCT05962840 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT05962840 clinical trial?
NCT05962840 is sponsored by Chinese SLE Treatment And Research Group. The principal investigator is Jing Li, MD at Peking Unione Mdecial College Hospital. The trial plans to enroll 40 participants.