NCT05965284RecruitingPhase 4
Efficacy and Safety for Telitacicept in the Remission Maintenance Treatment of ANCA-associated Vasculitis (TTCAZAREM)
A Prospective, Open-label, Controlled, Single Center Clinical Study of the Efficacy and Safety for Telitacicept in the Remission Maintenance Treatment of ANCA-associated Vasculitis
Source: ClinicalTrials.gov · Last updated 28 Jul 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 20 Jul 2023
- Start date
- 9 Mar 2023
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Chinese SLE Treatment And Research Group
- Diseases
- ANCA-associated vasculitis
- NCT number
- NCT05965284
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 40
- From 9 Mar 2023 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Lab values
- 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).
Other
- Patients with TPMT gene mutation.
- Patients who have planned for pregnancy in next 1.5 years.
- Patients who are not eligible according to the judge of the principal investigators or site investigators.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.