Comparison of Adalimumab and Tofacitinib in the Treatment of Active Takayasu Arteritis
NCT ID: NCT05151848
Last Updated: 2023-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
100 participants
INTERVENTIONAL
2022-01-05
2026-01-15
Brief Summary
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Detailed Description
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The efficacy will be evaluated at week 12, 24, 36, 52 and 78. If the patient does not respond to one drug at week 24, then the investigator will shift the treatment to another intervention. Safety is also monitored during the study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Adalimumab group
Adalimumab 40mg injected subcutaneously every 2 weeks for 78 weeks.
Adalimumab Injection
Adalimumab Injection injected subcutaneously every other week for 78 weeks
Tofacitinib 5MG group
Tofacitinib 5mg BID taken orally for 78 weeks.
Tofacitinib 5 MG
Tofacitinib 5 MG BID taken orally for 78 weeks
Interventions
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Adalimumab Injection
Adalimumab Injection injected subcutaneously every other week for 78 weeks
Tofacitinib 5 MG
Tofacitinib 5 MG BID taken orally for 78 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Fulfilled the classification criteria of Takayasu's arteritis by ACR 1990;
3. relapse active TAK: defined by the definition of active disease in the recommendations released by EULAR in 2018;
4. Patients who signed the informed consent form.
Exclusion Criteria
2. patients with severe liver disease defined by the serum ALT or AST elevated more than 2 times the upper limits;
3. not well controlled diabetes;
4. uncontrolled heart failure od renal dysfunction(eGFR\<30ml/min);
5. Patients with active infection,including tuberculosis, hepatitis B and C,HIV infection, bacteria or fungal infection;
6. upper GI bleeding 3 months before enrolement;
7. refractory hypertension;
8. Pregnant or intended to be pregnant 3 months after the trial;
9. Severe coronary artery involvement demonstrated by CTA;
10. severe cranial or cervical or renal artery diseases that need surgery;
11. Patients that should not be included by the investigator.
18 Years
65 Years
ALL
No
Sponsors
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Chinese SLE Treatment And Research Group
OTHER
Responsible Party
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Xinping Tian
Professor of Medicine
Principal Investigators
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Xiaofeng Zeng, MD
Role: PRINCIPAL_INVESTIGATOR
Peking Union Medical College Hospital
Locations
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Beijing Anzhen Hospital
Beijing, , China
The General Hospital of the People's Liberation Army
Beijing, , China
Beijing Shijitan Hospital
Beijing, , China
Beijing Xuanwu Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CSTAR-007
Identifier Type: -
Identifier Source: org_study_id
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