Takayasu ArteritisPhase 4NCT06498089
A Randomized, Controlled, Open-label, Multicenter Clinical Trial Comparing the Efficacy and Safety of a Precision Treatment Regimen Based on Clinical-molecular Phenotypes with a Conventional Treatment Regimen in the Treatment of Patients with Active Takayasu's Arteritis
A Phase 4 study testing Prednisone, Methotrexate and Tocilizumab in people with Takayasu Arteritis, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
This study aimed to compare the efficacy and safety of a precision treatment regimen based on clinical-molecular phenotypes with a conventional treatment regimen in the treatment of patients with active Takayasu's arteritis based on a randomized, controlled, open-label, multicenter study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Takayasu Arteritis
- What is being tested?
- Prednisone, Methotrexate and Tocilizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteChina
- Study dates
- 28 Jun 2024to 30 Jun 2027
- 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
- 1) Meet the 2022 ACR/EULAR classification criteria for aortitis; 2) Women or men aged 18-65 years; 4) Be in active disease: a National Institutes of Health (NIH) score of ≥2; 5) Females with negative serum or urine pregnancy test results and no plans to have children during the clinical trial; (6) If the patient is taking prednisone or its equivalent, the pre-enrolment dose does not exceed 0.6 mg/kg/day and the dose has been stable for at least 4 weeks; 7) If the patient is receiving other medications for aortitis that are inconsistent with the assigned regimen, discontinuation is required for ≥4 weeks for methotrexate, azathioprine, mycophenolate mofetil, cyclosporine, and tacrolimus; for leflunomide, discontinuation is required for 11 days if elimination methods are used (kolexanil or activated charcoal), or ≥8 weeks if elimination is not used; for cyclophosphamide, discontinuation is required for ≥6 months; for biologics, stopping for ≥ 3 weeks is required for etanercept, ≥ 4 weeks for IL-6 receptor antagonists and tumour necrosis factor inhibitors, and ≥ 6 months for rituximab.
- 8)For patients with no obvious active tuberculosis lesions but elevated T-spot, it is recommended that infectious specialists evaluate them, and preventive anti-tuberculosis therapy should be performed first if necessary. After T-spot declines, researchers will assess the relevant risks before deciding whether they are suitable to participate in this study, and continue preventive anti-tuberculosis therapy for a total of 9 months.
- 9)For patients with HBV, if the viral replication was detected, it is recommended to take anti-viral treatment for 2-4 weeks, and researchers will evaluate whether they are suitable to participate in this study when no DNA replication is detected.
Who cannot join
- Presence of organ failure;
- undergoing haemodialysis or major surgery (grade III and above) within 3 months;
- the presence of other autoimmune diseases;
- severe, progressive organ damage;
- Subjects with other comorbidities that may result in the need for additional moderate to high doses of glucocorticoids (prednisone ≥ 10 mg/day or equivalent doses of prednisone equivalents) during the study period;
- Have a history of malignancy;
- Have any serious acute or chronic infection, including hepatitis B surface antigen positive, active tuberculosis.
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
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Xiufang Kong, PhD., +8618317070593, kongxiufang2007@163.com
About this study
This study aimed to compare the efficacy and safety of a precision treatment regimen based on clinical-molecular phenotypes with a conventional treatment regimen in the treatment of patients with active Takayasu's arteritis based on a randomized, controlled, open-label, multicenter study.
Read the detailed description
- This study is a randomised, controlled, open-label, evaluator-blinded, multicentre clinical trial with a 14-month (56-week) study period: a 6-month (0-24 weeks) induction remission period and an 8-month (24-56 weeks) maintenance remission period;
- Subjects with aortitis who meet the entry criteria will be randomised and divided 1:1 into the precision therapy group and the conventional therapy group. The precision therapy group will be stratified according to the clinical-molecular phenotypes, and at the end of 6 months, if subjects achieve clinical remission and the amount of GCs is reduced to 7.5 mg/day for 4 weeks, they will enter into the maintenance period and continue with the original regimen; if they do not meet this, they will be withdrawn from the study;
- The study adopts a superiority design, the primary study objective is to assess the efficacy of the two groups at the end of six months, and the secondary study objectives are to assess the efficiency of the two groups at the end of 12 months, relapse rate, safety, cumulative hormone dose, vascular imaging changes, changes in cytokine profiles, etc.
- According to their new-onset symptoms at baseline or within past three months, the patients were divided into two clinical phenotypes: ①constitutional type: patients with constitutional symptoms, such as fever, fatigue, weakness, and weight loss, without any symptoms of organ ischemia, and at least 4 of the following indicators were above normal upper limits: ESR, CRP, C3, PLT, IL-6, C4, IgG; ②vascular inflammation type: patients with vascular-associated symptoms, such as carotidynia, angina, dizziness, and limb claudication, regardless of the constitutional symptoms or ischemic symptoms.
- Conditions
- Takayasu Arteritis
- Being tested
- Prednisone, Methotrexate, Tocilizumab, Tofacitinib, Adalimumab
- Keywords
- Precise treatment, Clinical-molecular phenotype
- Medical subject headings
- Takayasu Arteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoneDrug
Also called Glucocorticoids
This drug will be used in both arms. Patients' initial daily prednisone dose will be calculated according to their weights (0.6mg * weight(kg), maximum 50mg/day), and then tapered gradually during the study course.
MethotrexateDrug
Also called MTX
This drug will be used in the traditional arm. A dose of 15mg per week will be used.
TocilizumabDrug
Also called TCZ
This drug will be used in the precise treatment arm. For patients in constitutional type a dose (8mg/kg weight) will be used every 2 weeks (iv drip) for 12 weeks, then a dose (8mg/kg weight) will be used every 4 weeks (iv drip). For patients in vascular inflammation type, a dose (8mg/kg weight) will be used every 4 weeks (iv drip).
TofacitinibDrug
Also called TOF
This drug will be used in the precise treatment arm. A sustained release tablet will be used (11mg per day).
AdalimumabDrug
Also called ADA
This drug will be used in the precise treatment arm. A dose of 40mg (ih) will used every 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| The precise therapy arm | Experimental | Patients will be given treatment based on their clinical-molecular phenotype according to a predesigned scheme:
1. Patients in constitutional type will be given treatments with GCs combined with TCZ and MTX.
2. Patients in vascular inflammation type without IL-6 and TNF-α elevation will be given treatments with GCs combined with TOF.
3. Patients in vascular inflammation type with IL-6 elevation will be given treatments with GCs combined with TCZ and MTX.
4. Patients in vascular inflammation type with TNF-α elevation will be given treatments with GCs combined with ADA and MTX. Receives: Drug: Prednisone; Drug: Methotrexate; Drug: Tocilizumab; Drug: Tofacitinib; Drug: Adalimumab |
| The traditional therapy arm | Active comparator | Patients will be given traditional treatment based on their clinical-molecular phenotype according to a predesigned scheme. Receives: Drug: Prednisone; Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness rate
Effectiveness is defined if patients meet the following three in criteria ①-④ and criteria ⑤.
- No systemic symptoms such as fever, malaise, or wasting;
- No new onset of vascular symptoms and signs;
- Normal blood sedimentation (in case of abnormality, it is necessary to exclude non-disease active factors and to review and evaluate with the review value); ④ Imaging: no progression of primary vascular lesions or new vascular lesions; ⑤ Glucocorticoids are reduced to 7.5mg/day and maintained for at least 4 weeks.
Measured: 6 months
Secondary outcomes (9)
Effectiveness rate
- No systemic symptoms such as fever, malaise, or wasting;
- No new onset of vascular symptoms and signs;
- Normal blood sedimentation (in case of abnormality, it is necessary to exclude non-disease active factors and to review and evaluate with the review value); ④ Imaging: no progression of primary vascular lesions or new vascular lesions; ⑤ Glucocorticoids are reduced to 5mg/day and maintained for at least 4 weeks.
Measured: 12 months
Relapse rate
The relapse is defined as disease re-activation after remission. Disease activity is assessed according to NIH criteria. NIH≥2 is considered active status.
NIH criteria includes:
- Systemic symptoms, such as fever, skeletal and muscular symptoms;
- Blood sedimentation (erythrocyte sedimentation rate, ESR) >20mm/H; ③ Characteristics of vascular ischaemia or inflammation: e.g. intermittent claudication, diminished or absent pulse, vascular murmur, vascular pain blood pressure asymmetry; ④Abnormalities of angiography.
Measured: 12 months
Time to the first relapse
The first time to develop relapse during 12 months' treatment.
Measured: 12 months
Adverse events
The occurrence of adverse events and the corresponding rate.
Measured: 12 months
Vascular imaging changes
New vascular lesions, vascular thickness changes, vascular stenosis changes and vascular dilation changes upon MRA or CTA.
Measured: 12 months
Cytokine changes
Changes of different cytokine profiles, including interleukin levels, chemotactic protein levels, fibrotic marker levels. The spepcific parameters include PTX3, IL6, IFN-g,TNFa, IL8, IL10, IL17, YKL40, CCL22, IL16, CCL2, CCL5, VEGF-A, PDGF-AB, FGF2, MMP1,MMP2, MMP3, MMP9,Leptin, PCSK5, FABP3, GPNMB.
Measured: 12 months
Improvement of Visual Analog Score for pain
Visual Analog Score for pain score ranges from 0 to 10, higher scores indicate a worse outcome.
Measured: 12 months
Improvement of 36-Item Short Form Survey
The 36-Item Short Form Survey score ranges from 0 to 800, higher scores indicate a better outcome.
Measured: 12 months
Improvement of Functional Assessment of Chronic Illness Therapy - Fatigue
The Functional Assessment of Chronic Illness Therapy - Fatigue score ranges from 0 to 52, higher socres indicate a worse outcome.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start28 Jun 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Takayasu ArteritisStudies 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
- This study was a randomized, controlled study, including two arms.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lindi Jiang, PhD, Study chair, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06498089
- Sponsor's protocol ID
- B2024-200R
- Status last verified
- Oct 2024
- First submitted
- 29 Jun 2024
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No appliable
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Open-label, Multicenter Clinical Trial Comparing the Efficacy and Safety of a Precision Treatment Regimen Based on Clinical-molecular Phenotypes with a Conventional Treatment Regimen in the Treatment of Patients with Active Takayasu's Arteritis
- ClinicalTrials.gov ID
- NCT06498089
- Acronym / sponsor ID
- B2024-200R
- Conditions
- Takayasu Arteritis
- Keywords
- Precise treatment, Clinical-molecular phenotype
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 28 Jun 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 12 Jul 2024 (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 aimed to compare the efficacy and safety of a precision treatment regimen based on clinical-molecular phenotypes with a conventional treatment regimen in the treatment of patients with active Takayasu's arteritis based on a randomized, controlled, open-label, multicenter study.
Detailed description
- This study is a randomised, controlled, open-label, evaluator-blinded, multicentre clinical trial with a 14-month (56-week) study period: a 6-month (0-24 weeks) induction remission period and an 8-month (24-56 weeks) maintenance remission period;
- Subjects with aortitis who meet the entry criteria will be randomised and divided 1:1 into the precision therapy group and the conventional therapy group. The precision therapy group will be stratified according to the clinical-molecular phenotypes, and at the end of 6 months, if subjects achieve clinical remission and the amount of GCs is reduced to 7.5 mg/day for 4 weeks, they will enter into the maintenance period and continue with the original regimen; if they do not meet this, they will be withdrawn from the study;
- The study adopts a superiority design, the primary study objective is to assess the efficacy of the two groups at the end of six months, and the secondary study objectives are to assess the efficiency of the two groups at the end of 12 months, relapse rate, safety, cumulative hormone dose, vascular imaging changes, changes in cytokine profiles, etc.
- According to their new-onset symptoms at baseline or within past three months, the patients were divided into two clinical phenotypes: ①constitutional type: patients with constitutional symptoms, such as fever, fatigue, weakness, and weight loss, without any symptoms of organ ischemia, and at least 4 of the following indicators were above normal upper limits: ESR, CRP, C3, PLT, IL-6, C4, IgG; ②vascular inflammation type: patients with vascular-associated symptoms, such as carotidynia, angina, dizziness, and limb claudication, regardless of the constitutional symptoms or ischemic symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study was a randomized, controlled study, including two arms.
| Arm | Type | Receives |
|---|---|---|
| The precise therapy arm | Experimental | Drug: Prednisone, Drug: Methotrexate, Drug: Tocilizumab, Drug: Tofacitinib, Drug: AdalimumabPatients will be given treatment based on their clinical-molecular phenotype according to a predesigned scheme: 1. Patients in constitutional type will be given treatments with GCs combined with TCZ and MTX. 2. Patients in vascular inflammation type without IL-6 and TNF-α elevation will be given treatments with GCs combined with TOF. 3. Patients in vascular inflammation type with IL-6 elevation will be given treatments with GCs combined with TCZ and MTX. 4. Patients in vascular inflammation type with TNF-α elevation will be given treatments with GCs combined with ADA and MTX. |
| The traditional therapy arm | Active comparator | Drug: Prednisone, Drug: MethotrexatePatients will be given traditional treatment based on their clinical-molecular phenotype according to a predesigned scheme. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1) Meet the 2022 ACR/EULAR classification criteria for aortitis; 2) Women or men aged 18-65 years; 4) Be in active disease: a National Institutes of Health (NIH) score of ≥2; 5) Females with negative serum or urine pregnancy test results and no plans to have children during the clinical trial; (6) If the patient is taking prednisone or its equivalent, the pre-enrolment dose does not exceed 0.6 mg/kg/day and the dose has been stable for at least 4 weeks; 7) If the patient is receiving other medications for aortitis that are inconsistent with the assigned regimen, discontinuation is required for ≥4 weeks for methotrexate, azathioprine, mycophenolate mofetil, cyclosporine, and tacrolimus; for leflunomide, discontinuation is required for 11 days if elimination methods are used (kolexanil or activated charcoal), or ≥8 weeks if elimination is not used; for cyclophosphamide, discontinuation is required for ≥6 months; for biologics, stopping for ≥ 3 weeks is required for etanercept, ≥ 4 weeks for IL-6 receptor antagonists and tumour necrosis factor inhibitors, and ≥ 6 months for rituximab.
- 8)For patients with no obvious active tuberculosis lesions but elevated T-spot, it is recommended that infectious specialists evaluate them, and preventive anti-tuberculosis therapy should be performed first if necessary. After T-spot declines, researchers will assess the relevant risks before deciding whether they are suitable to participate in this study, and continue preventive anti-tuberculosis therapy for a total of 9 months.
- 9)For patients with HBV, if the viral replication was detected, it is recommended to take anti-viral treatment for 2-4 weeks, and researchers will evaluate whether they are suitable to participate in this study when no DNA replication is detected.
Key exclusion criteria (7 listed)
- Presence of organ failure;
- undergoing haemodialysis or major surgery (grade III and above) within 3 months;
- the presence of other autoimmune diseases;
- severe, progressive organ damage;
- Subjects with other comorbidities that may result in the need for additional moderate to high doses of glucocorticoids (prednisone ≥ 10 mg/day or equivalent doses of prednisone equivalents) during the study period;
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 |
|---|---|---|
| PrednisoneAlso: GlucocorticoidsThis drug will be used in both arms. Patients' initial daily prednisone dose will be calculated according to their weights (0.6mg * weight(kg), maximum 50mg/day), and then tapered gradually during the study course. | Drug | The precise therapy arm, The traditional therapy arm |
| MethotrexateAlso: MTXThis drug will be used in the traditional arm. A dose of 15mg per week will be used. | Drug | The precise therapy arm, The traditional therapy arm |
| TocilizumabAlso: TCZThis drug will be used in the precise treatment arm. For patients in constitutional type a dose (8mg/kg weight) will be used every 2 weeks (iv drip) for 12 weeks, then a dose (8mg/kg weight) will be used every 4 weeks (iv drip). For patients in vascular inflammation type, a dose (8mg/kg weight) will be used every 4 weeks (iv drip). | Drug | The precise therapy arm |
| TofacitinibAlso: TOFThis drug will be used in the precise treatment arm. A sustained release tablet will be used (11mg per day). | Drug | The precise therapy arm |
| AdalimumabAlso: ADAThis drug will be used in the precise treatment arm. A dose of 40mg (ih) will used every 2 weeks. | Drug | The precise therapy arm |
Primary outcome
Effectiveness rate
Time frame: 6 months
Effectiveness is defined if patients meet the following three in criteria ①-④ and criteria ⑤. * No systemic symptoms such as fever, malaise, or wasting; * No new onset of vascular symptoms and signs; * Normal blood sedimentation (in case of abnormality, it is necessary to exclude non-disease active factors and to review and evaluate with the review value); ④ Imaging: no progression of primary vascular lesions or new vascular lesions; ⑤ Glucocorticoids are reduced to 7.5mg/day and maintained for at least 4 weeks.
9 secondary outcomes
Effectiveness rate
Time frame: 12 months
Relapse rate
Time frame: 12 months
Time to the first relapse
Time frame: 12 months
Adverse events
Time frame: 12 months
Vascular imaging changes
Time frame: 12 months
Cytokine changes
Time frame: 12 months
Improvement of Visual Analog Score for pain
Time frame: 12 months
Improvement of 36-Item Short Form Survey
Time frame: 12 months
Improvement of Functional Assessment of Chronic Illness Therapy - Fatigue
Time frame: 12 months
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 17 Oct 2024.
- Individual participant dataSharing planned: No. No appliable
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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.
Lindi Jiang, PhD study chair
Fudan University
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 Prednisone, Methotrexate and Tocilizumab in people with Takayasu Arteritis, run by Shanghai Zhongshan Hospital 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 3 inclusion and 7 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 17 Oct 2024. 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 Xiufang Kong, PhD (+8618317070593, kongxiufang2007@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness rate (time frame: 6 months). 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 17 Oct 2024.