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NCT05151848 | RECRUITING | Takayasu Arteritis

Comparison of Adalimumab and Tofacitinib in the Treatment of Active Takayasu Arteritis
Sponsor:

Chinese SLE Treatment And Research Group

Information provided by (Responsible Party):

ξ十号 TI press

Brief Summary:

This is a prospective,open-labelled,multi-center,randomized clinical trial.It compares the clinical efficacy and safety of there 2 drugs in the treatment of relapse active Takayasu's arteritis patients.

Condition or disease

Takayasu Ar Terriji S

Intervention/treatment

Adalimumab Injection

Tofacitinib 5 MG

Phase

PHASE4

Detailed Description:

In this study, 100 relapse Takayasu's arteritis patients will be enrolled. Patients are randomized into the adalimumab treatment group and tofacitinib treatment.Patients will also be treated with reduced dose of glucocorticoid at the same time. The primary end point is the percentage of patients who are in complete response at week 12 and maintain in complete response at week 78. 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 100 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : An Open-label，Randomized, Controlled, Multicenter Study of Adalimumab and Tofacitinib in the Treatment of Active Takayasu Arteritis
Actual Study Start Date : 2022-01-05
Estimated Primary Completion Date : 2026-01-15
Estimated Study Completion Date : 2026-01-15

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Patients aged between 18-65 years old;
  • 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
  • 1. Patients who failed or intolerant to either adalimumab or tofacitinib;
  • 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.
Comparison of Adalimumab and Tofacitinib in the Treatment of Active Takayasu Arteritis

Location Details

NCT05151848

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How to Participate

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Locations

RECRUITING

China,

Beijing an authentic hospital

Beijing, China, 100000

NOT YET RECRUITING

China,

The General Hospital of the People's Liberation Army

Beijing, China, 100000

NOT YET RECRUITING

China,

Beijing shi altar hospital

Beijing, China, 100053

NOT YET RECRUITING

China,

Beijing X UA N hospital

Beijing, China, 100053