Takayasu ArteritisPhase 4NCT04299971
Efficiency of Methotrexate and Tofacitinib in Mild and Moderate Patients
A Phase 4 study testing Methotrexate Tablets and Tofacitinib tablet in people with Takayasu Arteritis and Methotrexate, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
Takayasu arteritis (TAK) is a rare chronic inflammatory arteritis, which lacks an effective well-accepted intervention strategy. Here we tried to classify TAK patients in 3 levels, including mild, moderate, and severe, and prescribe methotrexate and tofacitinib randomly in mild and moderate patients, to observe the… Read more about this study
- Who is it for?
- Ages 14 to 100 years
- Conditions the study is for
- Takayasu Arteritis, Methotrexate, Inhibition
- What is being tested?
- Methotrexate Tablets and Tofacitinib tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2020to 31 Dec 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 14 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- age≥14 years;
- active status: Kerr score≥ 2;
- mild and moderate:
- Blood pressure (maximum) < 180/110mmHg;
- 1-2 branches with the stenotic rate < 70% involved;
- mildly ischemic manifestation relative to activity but relieve after rest;
- no or low degree of organ insufficiency: NYHF I~II; eGFR (MRDR) ≥ 60ml/min;
Who cannot join
- Severe organ insufficiency;
- Acute or chronic active infections including tuberculosis, hepatitis virus, etc.;
- Other autoimmune diseases including systemic lupus erythematosus, Behcet disease, IgG4 relative disease;
- malignant tumors;
- history of severe drug allergy;
- successive twice relapse occurs even after the intervention adjustment ( for the benefits of patients)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Lindi Jiang
Shanghai, 200032
Lindi Jiang, PhD, +86-021-64041990, zsh-rheum@hotmail.com
Rongyi Chen, PhD, +86-15221160538, chenry825@hotmail.com
About this study
Official title: Randomized Open-label Study in Mild and Moderate Patients With Takayasu Arteritis Between Methotrexate and Tofacitinib Based on the ECTA Cohort.
Takayasu arteritis (TAK) is a rare chronic inflammatory arteritis, which lacks an effective well-accepted intervention strategy. Here we tried to classify TAK patients in 3 levels, including mild, moderate, and severe, and prescribe methotrexate and tofacitinib randomly in mild and moderate patients, to observe the relatively better treatment strategy, facilitating better intervention strategy in TAK patients.
Read the detailed description
The Takayasu arteritis (TAK) is a rare chronic inflammatory arteritis, which lacks effective well-accepted intervention strategy. Previous studies have revealed that methoxamine, tofacitinib, adalimumab, and tocilizumab were effective in controlling disease activity and preventing disease relapse in some TAK patients. However, we believed that different patients should be prescribed different drug combinations, i.e. personalized medicine, to obtain the optimal intervention effect.
So, here we tried to classify the TAK patients into three levels, and prescribe different drug interventions to discover the relatively better treatment strategy.
- Patients were classified as mild, moderate and severe group according to the disease severity of TAK patients.
1.1 Severe
- Severe hypertension
- Continuously upper limb systolic blood pressure ≥180mmHg or diastolic blood pressure ≥110mmHg;
- OR upper limb blood pressure cannot be measured if lower limb systolic blood pressure ≥200mmHg or diastolic blood pressure ≥120mmHg;
- With target organ damage due to hypertension;
- Aortic arch and its branches involved
- Multiple branches involved (two or more) and severe stenosis (stenosis rate ≥70%); b. stenosis rate ≥50%, accompanied by nervous system ischemic symptoms and / or signs; c. stenosis rate ≥50%, accompanied by recent history of cerebrovascular events;
- Carotid artery and its branches involved
- Multiple branches (two or more) involved and severe stenosis (stenosis rate ≥70%);
- stenosis rate ≥50%, accompanied by nervous system ischemic symptoms and / or signs;
- stenosis rate ≥50%, accompanied by recent history of cerebrovascular events;
- Pulmonary artery involvement
- Chest tightness, hemoptysis, dyspnea, radionuclide pulmonary ventilation / blood perfusion imaging or CTA suggesting pulmonary artery thrombosis with respiratory failure (type I); b. Chest tightness, shortness of breath, and cardiac ultrasound suggesting severe pulmonary artery hypertension with cardiac function abnormality (NYHA class III and above);
- Coronary artery involved
- Onset of unstable angina pectoris or myocardial infarction;
- Cardiac ultrasound indicating ischemic cardiomyopathy, NYHA class III and above;
- Aortic valve and aortic root involved
- Severe reflux of the aortic valve;
- OR aortic valve leakage, annulus tearing;
- OR aneurysm in aortic root and / or ascending aortic (≥2 times in diameter);
- OR dilation of the aortic root and / or ascending aorta (≥5cm in diameter);
- OR dissection of the aortic root and / or ascending aorta; Any item of the above a - e is accompanied by abnormal cardiac function (NYHA III and above);
- Renal artery involved a. Severe stenosis of renal artery secondary to malignant hypertension (blood pressure is still 180 / 120mmHg after treatment with three or more antihypertensive drugs) b. Severe renal artery stenosis accompanied by a progressive increase in serum creatinine or a reduction in glomerular filtration rate (GFR) of ≥25%;
- Glucocorticoids, and the traditional synthetic chemical immunosuppressants were of no use. And the disease is not well controlled with severe injury of the organs.
1.2 Moderate
- Hypertension
- Upper limb systolic blood pressure ≥160-180mmHg or / and diastolic blood pressure ≥100-110mmHg; b. OR upper limb blood pressure is unmeasurable or lower limb systolic blood pressure is ≥180mmHg or diastolic blood pressure is ≥100-110mmHg;
- Aortic arch and its branches involved
- 1-2 vessels are involved with moderate stenosis (stenosis rate ≥50%-<70%); b. Dizziness occurs during physical activity, and symptoms disappear in the resting state;
- Carotid artery and its branches involved
- Unilateral or bilateral vascular stenosis rate ≥50% -70%, with dizziness during light physical activity;
- Pulmonary artery involved
- Radionuclide pulmonary ventilation / blood perfusion imaging or CTA indicates pulmonary vascular disease; chest tightness after activity; Cardiac ultrasound indicates moderate pulmonary artery hypertension (pressure> 40-60mmHg), with abnormal cardiac function (NYHA class Ⅱ);
- Coronary artery involvement a. Chest tightness and chest pain after moderate activities, CTA showed 50% or more in coronary artery stenosis, abnormal cardiac function (NYHA class Ⅱ);
- Aortic valve and aortic root involved
- Moderate aortic regurgitation;
- Aortic root and / or ascending aortic aneurysm (diameter <2 times);
- Dilation of the aortic root and / or ascending aorta (diameter <5cm); Each item of a - c is accompanied by abnormal cardiac function (NYHA Class II);
- Renal artery involvement a. Renal artery stenosis rate ≥50%, and blood pressure 160-180 / 110-120 (excluding 120) mmHg after treatment, or with left ventricular myocardial hypertrophy, hypertension and heart disease, CKD-II;
1.3 Mild
- Hypertension
- Upper limb systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg;
- OR upper limb blood pressure is unmeasurable or lower limb systolic blood pressure is ≥140mmHg or diastolic blood pressure is ≥90mmHg;
- Aortic arch and its branches involved
- Single or multiple lesions with mild stenosis (stenosis rate <50%), and without neurological ischemic symptoms and / or signs in daily activities;
- Carotid artery and its branches involved
- Single or multiple lesions with mild stenosis (stenosis rate <50%) and no neurological ischemic symptoms and / or signs during daily activities;
- Pulmonary artery involved
- Cardiac ultrasound indicates mild or normal pulmonary artery pressure (pressure 30-40mmHg); b. Imaging shows pulmonary arteritis or pulmonary artery stenosis, occlusion a and b, with chest tightness, shortness of breath, and hemoptysis without activity; cardiac function (NYHA I), normal blood gas analysis;
- Coronary artery involved
- Chest tightness, shortness of breath, chest pain after inactivity; cardiac function (NYHA I);
- Aortic valve and aortic root involved
- Mild aortic regurgitation;
- Aortic root and / or ascending aortic aneurysm-like expansion (diameter <1.5 times); a and b, each with cardiac function (NYHA I);
- Renal artery involved a. Renal artery stenosis rate <50%, without/with mild hypertension (see 1), or normal serum creatinine, normal or slightly impaired glomerular filtration rate (GFR);
- Based on the TAK patients in the ECTA cohort (Clinical trials. No: NCT03893136), we tried to compare the treatment efficacy between Tofacitinib (TOF) and methotrexate (MTX) in mild and moderate patients, with a randomized open-label study.
Other important detailed description of the study are listed as follows:
- Basic treatment of prednisone: The initial prednisone dose is 40mg.qd.po, and maintained for 1 month. After 1 month's treatment, the dose is gradually tapered to 15mg by 5mg per 2 weeks. Subsequently, the dose is decreased to 5mg by 2.5mg per 3 months. The 5mg is the final target maintained dose. In the treatment, if the relapse occurs, the dose of prednisone returned to the last dosage. For example, if the patient gets a relapse at the dose of 15mg of prednisone, then the dose of prednisone returned to 20mg. The relapse of TAK is defined according to the "2018 Update of the EULAR recommendations for the management of large vessel vasculitis". Relapse includes major relapse or minor relapse. Major relapse: Recurrence of active disease with either of the following: a. Clinical features of ischemia* (including jaw claudication, visual symptoms, the visual loss attributable to TAK, scalp necrosis, stroke, limb claudication). b. Evidence of active aortic inflammation resulting in progressive aortic or large vessel dilatation, stenosis or dissection. Minor relapse Recurrence of active disease, not fulfilling the criteria for a major relapse.
- TOF: 5mg bid p.o.
- MTX: 15mg qw p.o.
- Treatment shift: if the TAK patients in the TOF group failed to reach clinical remission at the end of the 24th week, they would be shifted to MTX group starting a new round of induction and complete the rest 24-week follow-up; and vice versa.
In the follow-up, the disease remission and related markers are monitored.
- Conditions
- Takayasu Arteritis, Methotrexate, Inhibition, Treatment
- Being tested
- Methotrexate Tablets, Tofacitinib tablet
- Keywords
- Takayasu arteritis, methotrexate, tofacitinib, treatment
- Medical subject headings
- Takayasu Arteritis, Inhibition, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methotrexate TabletsDrug
Also called methotrexate pills
The methotrexate group is prescribed with methotrexate Tablets for 24 weeks, and the disease activity is monitored in the follow-up (primary endpoint).
After 24 weeks of treatment, if the disease is alleviated, then the usage of methotrexate is maintained for another 24 weeks, otherwise (resistant), patients would be given tofacitinib (5.0mg.bid.p.o.) for 24 weeks instead.
Tofacitinib tabletDrug
Also called Xeljanz
The tofacitinib group is prescribed with tofacitinib tablets for 24 weeks, and the disease activity is monitored in the follow-up (primary endpoint).
After 24 weeks of treatment, if the disease is alleviated, then the usage of tofacitinib is maintained for another 24 weeks, otherwise (resistant), patients would be given methotrexate (15.0mg.qw.p.o.) for 24 weeks instead.
| Study group | Role | What they receive |
|---|---|---|
| methotrexate | Active comparator | This group of 38 TAK cases are prescribed with methotrexate tablets (Dose: 15.0 mg. qw. p.o.) for 24 weeks. Receives: Drug: Methotrexate Tablets |
| Tofacitinib | Experimental | This group of 38 TAK cases are prescribed with tofacitinib tablets (Dose: 5.0 mg. bid. p.o.) for 24 weeks. Receives: Drug: Tofacitinib tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease remission at 24 weeks.
comparison of clinical remission rate between tofacitinib and methotrexate groups at the end of 24th week follow-up;
Measured: 24 weeks
Secondary outcomes (7)
Disease remission at 48 weeks.
comparison of clinical remission rate between tofacitinib and methotrexate groups at the end of 48th week follow-up;
Measured: 48 weeks
Prednisone dose reduction at endpoint
comparison of targeted prednisone usage between tofacitinib and methotrexate groups at the end of 24th and 48th week follow-up;
Measured: 24 weeks and 48 weeks.
disease relapse in the follow-up
comparison of relapse between tofacitinib and methotrexate groups; (Relapse is defined as: (1) Major relapse: Major relapse Recurrence of active disease with either of the following: a. Clinical features of ischaemia* (including jaw claudication,visual symptoms, visual loss attributable to TAK, scalp necrosis, stroke, limb claudication). b. Evidence of active aortic inflammation resulting in progressive aortic or large vessel dilatation, stenosis or dissection. (2) Minor relapse: Recurrence of active disease, not fulfilling the criteria for a major relapse. )
Measured: At the time point of 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 36 weeks, 48 weeks.
Vascular progression in angiographic examination at 6 months and 12 months.
comparison of vascular change with MRA, CTA, or doppler ultrasound angiographic examinations between tofacitinib and methotrexate groups;
Measured: 24 weeks and 48 weeks.
Change of the quality of life with questionnaire SF-36
comparison of quality of life between tofacitinib and methotrexate groups with the 36-Item Short Form Health Survey questionnaire (SF-36) (Scores:0~100, lower score means more disability)
Measured: At the time point of 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 36 weeks, 48 weeks.
Change of the quality of life with MOS-sleep scale
comparison of quality of life between tofacitinib and methotrexate groups with the questionnaire of sleep scale from medical outcomes study (MOS-sleep scale) (Scores: 11-65, lower scores indicates more difficulty in sleep)
Measured: At the time point of 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 36 weeks, 48 weeks.
Change of the quality of life with the Fatigue severity scale
comparison of quality of life between tofacitinib and methotrexate groups with the Fatigue severity scale (Scores: 9-63, higher score means severe fatigue)
Measured: At the time point of 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 36 weeks, 48 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start1 Mar 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (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.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- 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
- Crossover
- Model description
- Mild and moderate TAK patients were divided into two groups, with 38 cases for each group at the randomized ratio 1:1, prescribed with methotrexate (15mg.qw.po) and tofacitinib (5mg.bid.po) respectively, in the presence of prednisone. After the 24 weeks of treatment, the disease remission is evaluated (primary endpoint). If the disease activity is alleviated, the strategy would be maintained for another 24weeks, otherwise, the treatment strategy would be shifted to the opposite for 24weeks. After 48 weeks, the disease remission would be evaluated once again (secondary endpoint)
- Masking
- None (open label)
- Enrolment
- 130 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
- NCT04299971
- Sponsor's protocol ID
- TACTIC-MM
- Status last verified
- Mar 2020
- First submitted
- 5 Mar 2020
- Last updated
- 12 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Open-label Study in Mild and Moderate Patients With Takayasu Arteritis Between Methotrexate and Tofacitinib Based on the ECTA Cohort.
- ClinicalTrials.gov ID
- NCT04299971
- Acronym / sponsor ID
- TACTIC-MM
- Conditions
- Takayasu Arteritis, Methotrexate, Inhibition, Treatment
- Keywords
- Takayasu arteritis, methotrexate, tofacitinib, treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 9 Mar 2020 (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.
Takayasu arteritis (TAK) is a rare chronic inflammatory arteritis, which lacks an effective well-accepted intervention strategy. Here we tried to classify TAK patients in 3 levels, including mild, moderate, and severe, and prescribe methotrexate and tofacitinib randomly in mild and moderate patients, to observe the relatively better treatment strategy, facilitating better intervention strategy in TAK patients.
Detailed description
The Takayasu arteritis (TAK) is a rare chronic inflammatory arteritis, which lacks effective well-accepted intervention strategy. Previous studies have revealed that methoxamine, tofacitinib, adalimumab, and tocilizumab were effective in controlling disease activity and preventing disease relapse in some TAK patients. However, we believed that different patients should be prescribed different drug combinations, i.e. personalized medicine, to obtain the optimal intervention effect.
So, here we tried to classify the TAK patients into three levels, and prescribe different drug interventions to discover the relatively better treatment strategy.
- Patients were classified as mild, moderate and severe group according to the disease severity of TAK patients.
1.1 Severe
- Severe hypertension
- Continuously upper limb systolic blood pressure ≥180mmHg or diastolic blood pressure ≥110mmHg;
- OR upper limb blood pressure cannot be measured if lower limb systolic blood pressure ≥200mmHg or diastolic blood pressure ≥120mmHg;
- With target organ damage due to hypertension;
- Aortic arch and its branches involved
- Multiple branches involved (two or more) and severe stenosis (stenosis rate ≥70%); b. stenosis rate ≥50%, accompanied by nervous system ischemic symptoms and / or signs; c. stenosis rate ≥50%, accompanied by recent history of cerebrovascular events;
- Carotid artery and its branches involved
- Multiple branches (two or more) involved and severe stenosis (stenosis rate ≥70%);
- stenosis rate ≥50%, accompanied by nervous system ischemic symptoms and / or signs;
- stenosis rate ≥50%, accompanied by recent history of cerebrovascular events;
- Pulmonary artery involvement
- Chest tightness, hemoptysis, dyspnea, radionuclide pulmonary ventilation / blood perfusion imaging or CTA suggesting pulmonary artery thrombosis with respiratory failure (type I); b. Chest tightness, shortness of breath, and cardiac ultrasound suggesting severe pulmonary artery hypertension with cardiac function abnormality (NYHA class III and above);
- Coronary artery involved
- Onset of unstable angina pectoris or myocardial infarction;
- Cardiac ultrasound indicating ischemic cardiomyopathy, NYHA class III and above;
- Aortic valve and aortic root involved
- Severe reflux of the aortic valve;
- OR aortic valve leakage, annulus tearing;
- OR aneurysm in aortic root and / or ascending aortic (≥2 times in diameter);
- OR dilation of the aortic root and / or ascending aorta (≥5cm in diameter);
- OR dissection of the aortic root and / or ascending aorta; Any item of the above a - e is accompanied by abnormal cardiac function (NYHA III and above);
- Renal artery involved a. Severe stenosis of renal artery secondary to malignant hypertension (blood pressure is still 180 / 120mmHg after treatment with three or more antihypertensive drugs) b. Severe renal artery stenosis accompanied by a progressive increase in serum creatinine or a reduction in glomerular filtration rate (GFR) of ≥25%;
- Glucocorticoids, and the traditional synthetic chemical immunosuppressants were of no use. And the disease is not well controlled with severe injury of the organs.
1.2 Moderate
- Hypertension
- Upper limb systolic blood pressure ≥160-180mmHg or / and diastolic blood pressure ≥100-110mmHg; b. OR upper limb blood pressure is unmeasurable or lower limb systolic blood pressure is ≥180mmHg or diastolic blood pressure is ≥100-110mmHg;
- Aortic arch and its branches involved
- 1-2 vessels are involved with moderate stenosis (stenosis rate ≥50%-<70%); b. Dizziness occurs during physical activity, and symptoms disappear in the resting state;
- Carotid artery and its branches involved
- Unilateral or bilateral vascular stenosis rate ≥50% -70%, with dizziness during light physical activity;
- Pulmonary artery involved
- Radionuclide pulmonary ventilation / blood perfusion imaging or CTA indicates pulmonary vascular disease; chest tightness after activity; Cardiac ultrasound indicates moderate pulmonary artery hypertension (pressure> 40-60mmHg), with abnormal cardiac function (NYHA class Ⅱ);
- Coronary artery involvement a. Chest tightness and chest pain after moderate activities, CTA showed 50% or more in coronary artery stenosis, abnormal cardiac function (NYHA class Ⅱ);
- Aortic valve and aortic root involved
- Moderate aortic regurgitation;
- Aortic root and / or ascending aortic aneurysm (diameter <2 times);
- Dilation of the aortic root and / or ascending aorta (diameter <5cm); Each item of a - c is accompanied by abnormal cardiac function (NYHA Class II);
- Renal artery involvement a. Renal artery stenosis rate ≥50%, and blood pressure 160-180 / 110-120 (excluding 120) mmHg after treatment, or with left ventricular myocardial hypertrophy, hypertension and heart disease, CKD-II;
1.3 Mild
- Hypertension
- Upper limb systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg;
- OR upper limb blood pressure is unmeasurable or lower limb systolic blood pressure is ≥140mmHg or diastolic blood pressure is ≥90mmHg;
- Aortic arch and its branches involved
- Single or multiple lesions with mild stenosis (stenosis rate <50%), and without neurological ischemic symptoms and / or signs in daily activities;
- Carotid artery and its branches involved
- Single or multiple lesions with mild stenosis (stenosis rate <50%) and no neurological ischemic symptoms and / or signs during daily activities;
- Pulmonary artery involved
- Cardiac ultrasound indicates mild or normal pulmonary artery pressure (pressure 30-40mmHg); b. Imaging shows pulmonary arteritis or pulmonary artery stenosis, occlusion a and b, with chest tightness, shortness of breath, and hemoptysis without activity; cardiac function (NYHA I), normal blood gas analysis;
- Coronary artery involved
- Chest tightness, shortness of breath, chest pain after inactivity; cardiac function (NYHA I);
- Aortic valve and aortic root involved
- Mild aortic regurgitation;
- Aortic root and / or ascending aortic aneurysm-like expansion (diameter <1.5 times); a and b, each with cardiac function (NYHA I);
- Renal artery involved a. Renal artery stenosis rate <50%, without/with mild hypertension (see 1), or normal serum creatinine, normal or slightly impaired glomerular filtration rate (GFR);
- Based on the TAK patients in the ECTA cohort (Clinical trials. No: NCT03893136), we tried to compare the treatment efficacy between Tofacitinib (TOF) and methotrexate (MTX) in mild and moderate patients, with a randomized open-label study.
Other important detailed description of the study are listed as follows:
- Basic treatment of prednisone: The initial prednisone dose is 40mg.qd.po, and maintained for 1 month. After 1 month's treatment, the dose is gradually tapered to 15mg by 5mg per 2 weeks. Subsequently, the dose is decreased to 5mg by 2.5mg per 3 months. The 5mg is the final target maintained dose. In the treatment, if the relapse occurs, the dose of prednisone returned to the last dosage. For example, if the patient gets a relapse at the dose of 15mg of prednisone, then the dose of prednisone returned to 20mg. The relapse of TAK is defined according to the "2018 Update of the EULAR recommendations for the management of large vessel vasculitis". Relapse includes major relapse or minor relapse. Major relapse: Recurrence of active disease with either of the following: a. Clinical features of ischemia* (including jaw claudication, visual symptoms, the visual loss attributable to TAK, scalp necrosis, stroke, limb claudication). b. Evidence of active aortic inflammation resulting in progressive aortic or large vessel dilatation, stenosis or dissection. Minor relapse Recurrence of active disease, not fulfilling the criteria for a major relapse.
- TOF: 5mg bid p.o.
- MTX: 15mg qw p.o.
- Treatment shift: if the TAK patients in the TOF group failed to reach clinical remission at the end of the 24th week, they would be shifted to MTX group starting a new round of induction and complete the rest 24-week follow-up; and vice versa.
In the follow-up, the disease remission and related markers are monitored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Mild and moderate TAK patients were divided into two groups, with 38 cases for each group at the randomized ratio 1:1, prescribed with methotrexate (15mg.qw.po) and tofacitinib (5mg.bid.po) respectively, in the presence of prednisone. After the 24 weeks of treatment, the disease remission is evaluated (primary endpoint). If the disease activity is alleviated, the strategy would be maintained for another 24weeks, otherwise, the treatment strategy would be shifted to the opposite for 24weeks. After 48 weeks, the disease remission would be evaluated once again (secondary endpoint)
| Arm | Type | Receives |
|---|---|---|
| methotrexate | Active comparator | Drug: Methotrexate TabletsThis group of 38 TAK cases are prescribed with methotrexate tablets (Dose: 15.0 mg. qw. p.o.) for 24 weeks. |
| Tofacitinib | Experimental | Drug: Tofacitinib tabletThis group of 38 TAK cases are prescribed with tofacitinib tablets (Dose: 5.0 mg. bid. p.o.) for 24 weeks. |
Who may qualify
- Ages
- 14 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- age≥14 years;
- active status: Kerr score≥ 2;
- mild and moderate:
Key exclusion criteria (6 listed)
- Severe organ insufficiency;
- Acute or chronic active infections including tuberculosis, hepatitis virus, etc.;
- Other autoimmune diseases including systemic lupus erythematosus, Behcet disease, IgG4 relative disease;
- malignant tumors;
- history of severe drug allergy;
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 |
|---|---|---|
| Methotrexate TabletsAlso: methotrexate pillsThe methotrexate group is prescribed with methotrexate Tablets for 24 weeks, and the disease activity is monitored in the follow-up (primary endpoint). After 24 weeks of treatment, if the disease is alleviated, then the usage of methotrexate is maintained for another 24 weeks, otherwise (resistant), patients would be given tofacitinib (5.0mg.bid.p.o.) for 24 weeks instead. | Drug | methotrexate |
| Tofacitinib tabletAlso: XeljanzThe tofacitinib group is prescribed with tofacitinib tablets for 24 weeks, and the disease activity is monitored in the follow-up (primary endpoint). After 24 weeks of treatment, if the disease is alleviated, then the usage of tofacitinib is maintained for another 24 weeks, otherwise (resistant), patients would be given methotrexate (15.0mg.qw.p.o.) for 24 weeks instead. | Drug | Tofacitinib |
Primary outcome
Disease remission at 24 weeks.
Time frame: 24 weeks
comparison of clinical remission rate between tofacitinib and methotrexate groups at the end of 24th week follow-up;
7 secondary outcomes
Disease remission at 48 weeks.
Time frame: 48 weeks
Prednisone dose reduction at endpoint
Time frame: 24 weeks and 48 weeks.
disease relapse in the follow-up
Time frame: At the time point of 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 36 weeks, 48 weeks.
Vascular progression in angiographic examination at 6 months and 12 months.
Time frame: 24 weeks and 48 weeks.
Change of the quality of life with questionnaire SF-36
Time frame: At the time point of 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 36 weeks, 48 weeks.
Change of the quality of life with MOS-sleep scale
Time frame: At the time point of 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 36 weeks, 48 weeks.
Change of the quality of life with the Fatigue severity scale
Time frame: At the time point of 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 36 weeks, 48 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2020.
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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. This study is not recruiting at the moment.
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 Methotrexate Tablets and Tofacitinib tablet in people with Takayasu Arteritis and Methotrexate, 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 7 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 12 Jun 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rongyi Chen, PhD (+86-15221160538, chenry825@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease remission at 24 weeks. (time frame: 24 weeks). 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 12 Jun 2020.