ANCA-associated VasculitisPhase 4NCT05965284
Efficacy and Safety for Telitacicept in the Remission Maintenance Treatment of ANCA-associated Vasculitis (TTCAZAREM)
A Phase 4 study testing Azathioprine and Telitacicept in people with ANCA-associated Vasculitis and Maintenance Therapy, run by Chinese SLE Treatment And Research Group at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- ANCA-associated Vasculitis, Maintenance Therapy
- What is being tested?
- Azathioprine and Telitacicept
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 9 Mar 2023to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with TPMT gene mutation.
- 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.
- Patients who have planned for pregnancy in next 1.5 years.
- 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).
- Patients with uncontrolled sever hypertension, diabetes, active bacteria or fungal infection;
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- Patients with active hepatitis virus infection as well as patients who have active mycobacteria infection;
- Patients who had other autoimmune diseases.
- Patients with malignancy.
- Patients who are not eligible according to the judge of the principal investigators or site investigators.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Yunjiao Yang, M.D., 86-13671313079, yangyunjiao81@163.com
Hanqi Wang, RN, 86-15810927696, lijing6515@pumch.cn
About this study
Official title: 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
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.
Read the detailed description
Background: The basic theme of AAV is relapse and remission. The maintenance therapy of AAV aimed to reduce or prevent relapse is very challenge. Although many medications have been used for the maintenance of AAV, Telitacicept (a BAFF/APRIL dual-target-inhibitor, which has been proved to be effect in treatment of SLE) has not been studied yet. One study tested the efficacy of Belimumab in the maintenance therapy for AAV. When taken Rituximab as remission-induction treatment, no relapse was observed. However, the sample size of this study is small, and the Belimumab, as a BAFF inhibitor, was not been proved to have effect on APRIL.
Many experiences have been accumulated about the efficacy and safety of Telitacicept in Chinese patients with rheumatic diseases. But there is no study to show its effectiveness in the reduction of the relapse of AAV in China. In this study, we add Telitacicept to azathioprine in maintain treatment in AAV patients who receive Rituximab as remission-induction treatment, to compare the relapse rates of Telitacicept combining azathioprine and azathioprine alone in maintenance therapy of AAV.
Objectives: To compare the relapse rates of Telitacicept combining azathioprine and azathioprine alone in maintenance treatment of AAV.
Study Design: This is a prospective, randomized, open-label, control, pilot study.
- Conditions
- ANCA-associated Vasculitis, Maintenance Therapy
- Being tested
- Azathioprine, Telitacicept
- Keywords
- ANCA-associated Vasculitis, Telitacicept, Azathioprine, Relapse rate
- Medical subject headings
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzathioprineDrug
All patients included into this study will be treated with Azathioprine tablets 100mg QD for 12 months.
TelitaciceptDrug
Also called Taiai for commercial name
Patient will be treated with Telitacicept (Taiai the commercial name) 160 mg every week subcutaneously for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Azathioprine treatment arm | Other | Patients will be treated with Azathioprine 100mg per day for 12 months combined with prednisone no more than 10mg daily. The dosage of prednisone is tapered in the study period while sustained remission achieved. All included patients will be treated with TMPco 2 tablets per day during the study period if not contraindicated or intolerant. Receives: Drug: Azathioprine |
| Telitacicept treatment arm | Experimental | Patients will be treated with Telitacicept 160mg per week combined with Azathioprine 100mg per day for 12 months combined with prednisone no more than 10mg daily. The dosage of prednisone is tapered in the study period while sustained remission achieved. All included patients will be treated with TMPco 2 tablets per day during the study period if not contraindicated or intolerant. Receives: Drug: Azathioprine; Drug: Telitacicept |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time of first relapse during 12 months follow-up of two groups
The time from baseline to first relapse(re-appearance of disease with a BVAS >0) of patients during 12 months follow-up of two groups
Measured: from inclusion to the end of the study, 12 months in total
Secondary outcomes (7)
The percentage of patients with severe relapse at months 12
The percentage of patients with severe relapse (re-appearance or worsening of disease with a BVAS ≥6 and involvement of at least one major organ, a life-threatening manifestation, or both) at months 12
Measured: from inclusion to the end of the study, 12 months in total
The percentage of patients with moderate relapse at months 12
The percentage of patients with moderate relapse (re-appearance or worsening of disease with a BVAS ≥3 without involvement of major organ or life-threatening manifestation) at months 12
Measured: from inclusion to the end of the study, 12 months in total
The percentage of patients with mild relapse at months 12
The percentage of patients with mild relapse (re-appearance or worsening of disease with a 0 < BVAS < 3 without involvement of major organ or life-threatening manifestation) at months 12
Measured: from inclusion to the end of the study, 12 months in total
The percentage of patients with sustained remission at months 12
The percentage of patients with sustained remission (BVAS =0 without dosage increase of glucocorticoid) at months 12
Measured: from inclusion to the end of the study, 12 months in total
The rate of adverse events
The rate of adverse events and their severity (Severe events were defined as the adverse events of grade 3 or 4, deaths caused by any cause, cancers, side effects that necessitate hospitalization) in both two groups during the study period.
Measured: from inclusion to the end of the study, 12 months in total
The percentage of patients who progress to ESRD
The percentage of patients who progress to ESRD at the end of the study
Measured: from inclusion to the end of the study, 12 months in total
The rate of complication of AAV
The rate of complication of AAV in both treatment groups during 12 months of the study period.
Measured: from inclusion to the end of the study, 12 months in total
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start9 Mar 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ANCA-associated VasculitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, randomized, open-label, control, pilot study
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese SLE Treatment And Research Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- JIng Li, M.D., Principal investigator, Peking Unione Mdecial College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05965284
- Sponsor's protocol ID
- CSTAR-K2374
- Status last verified
- Jul 2023
- First submitted
- 20 Jul 2023
- Last updated
- 28 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05965284
- Acronym / sponsor ID
- CSTAR-K2374
- Conditions
- ANCA-associated Vasculitis, Maintenance Therapy
- Keywords
- ANCA-associated Vasculitis, Telitacicept, Azathioprine, Relapse rate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chinese SLE Treatment And Research GroupUniversity, hospital or other
- Study start
- 9 Mar 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background: The basic theme of AAV is relapse and remission. The maintenance therapy of AAV aimed to reduce or prevent relapse is very challenge. Although many medications have been used for the maintenance of AAV, Telitacicept (a BAFF/APRIL dual-target-inhibitor, which has been proved to be effect in treatment of SLE) has not been studied yet. One study tested the efficacy of Belimumab in the maintenance therapy for AAV. When taken Rituximab as remission-induction treatment, no relapse was observed. However, the sample size of this study is small, and the Belimumab, as a BAFF inhibitor, was not been proved to have effect on APRIL.
Many experiences have been accumulated about the efficacy and safety of Telitacicept in Chinese patients with rheumatic diseases. But there is no study to show its effectiveness in the reduction of the relapse of AAV in China. In this study, we add Telitacicept to azathioprine in maintain treatment in AAV patients who receive Rituximab as remission-induction treatment, to compare the relapse rates of Telitacicept combining azathioprine and azathioprine alone in maintenance therapy of AAV.
Objectives: To compare the relapse rates of Telitacicept combining azathioprine and azathioprine alone in maintenance treatment of AAV.
Study Design: This is a prospective, randomized, open-label, control, pilot study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective, randomized, open-label, control, pilot study
| Arm | Type | Receives |
|---|---|---|
| Azathioprine treatment arm | Other | Drug: AzathioprinePatients will be treated with Azathioprine 100mg per day for 12 months combined with prednisone no more than 10mg daily. The dosage of prednisone is tapered in the study period while sustained remission achieved. All included patients will be treated with TMPco 2 tablets per day during the study period if not contraindicated or intolerant. |
| Telitacicept treatment arm | Experimental | Drug: Azathioprine, Drug: TelitaciceptPatients will be treated with Telitacicept 160mg per week combined with Azathioprine 100mg per day for 12 months combined with prednisone no more than 10mg daily. The dosage of prednisone is tapered in the study period while sustained remission achieved. All included patients will be treated with TMPco 2 tablets per day during the study period if not contraindicated or intolerant. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- Patients with TPMT gene mutation.
- 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.
- Patients who have planned for pregnancy in next 1.5 years.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AzathioprineAll patients included into this study will be treated with Azathioprine tablets 100mg QD for 12 months. | Drug | Azathioprine treatment arm, Telitacicept treatment arm |
| TelitaciceptAlso: Taiai for commercial namePatient will be treated with Telitacicept (Taiai the commercial name) 160 mg every week subcutaneously for 12 months | Drug | Telitacicept treatment arm |
Primary outcome
The time of first relapse during 12 months follow-up of two groups
Time frame: from inclusion to the end of the study, 12 months in total
The time from baseline to first relapse(re-appearance of disease with a BVAS >0) of patients during 12 months follow-up of two groups
7 secondary outcomes
The percentage of patients with severe relapse at months 12
Time frame: from inclusion to the end of the study, 12 months in total
The percentage of patients with moderate relapse at months 12
Time frame: from inclusion to the end of the study, 12 months in total
The percentage of patients with mild relapse at months 12
Time frame: from inclusion to the end of the study, 12 months in total
The percentage of patients with sustained remission at months 12
Time frame: from inclusion to the end of the study, 12 months in total
The rate of adverse events
Time frame: from inclusion to the end of the study, 12 months in total
The percentage of patients who progress to ESRD
Time frame: from inclusion to the end of the study, 12 months in total
The rate of complication of AAV
Time frame: from inclusion to the end of the study, 12 months in total
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
JIng Li, M.D. principal investigator
Peking Unione Mdecial College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Azathioprine and Telitacicept in people with ANCA-associated Vasculitis and Maintenance Therapy, run by Chinese SLE Treatment And Research Group at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yunjiao Yang, M.D. (+86-13671313079, yangyunjiao81@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time of first relapse during 12 months follow-up of two groups (time frame: from inclusion to the end of the study, 12 months in total). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2023.