What is this study trying to find out about Takayasu arteritis?

This study is evaluating which biological treatment, tocilizumab or adalimumab, may better control severe Takayasu arteritis. Researchers aim to identify the most effective intervention strategy for patients with severe disease. The study is sponsored by Shanghai Zhongshan Hospital and focuses on improving treatment options for this rare condition.

Who may be eligible for this Takayasu arteritis clinical trial?

People aged 14 to 100 with active and severe Takayasu arteritis may be eligible. Participants should have high blood pressure or significant artery narrowing and organ problems related to TAK. Both males and females can join. Please review eligibility criteria for more details.

Is there any cost to participate in this Takayasu arteritis clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. Personal travel and other expenses may vary and are not guaranteed to be covered. Participants should prepare for potential personal costs related to attending visits.

Actively Recruiting

Phase 4

Age: 14Years - 100Years

All Genders

ID04300686

A Pilot Study in the Treatment of Severe Patients With Takayasu Arteritis With Tocilizumab and Adalimumab, Based on ECTA Cohort

Led by Shanghai Zhongshan Hospital · Updated on 2021-08-10

Participants Needed

Research Sites

87 weeks

Total Duration

AI-Summary

What this Trial Is About

Takayasu arteritis TAK is a rare chronic inflammatory disease affecting arteries, and there is no widely accepted effective treatment strategy. Researchers classify TAK patients into three severity levels mild, moderate, and severe. This study focuses on severe TAK patients and compares two biological agents, tocilizumab and adalimumab, to find which treatment may provide better intervention outcomes in this group. The study randomly assigns severe TAK patients to receive either tocilizumab at a dose of 8mgkg intravenously every four weeks or adalimumab at 40mg biweekly by injection for 24 weeks. Patients start with prednisone at 40mg daily, tapered gradually over months, and treatment adjustments are made if disease relapse occurs. After 24 weeks, if remission is not achieved, patients switch to the other biological agent for an additional 24 weeks. Participants are monitored throughout treatment and follow-up for disease remission using clinical and laboratory assessments. Researchers track disease relapse, vascular progression through angiographic exams, prednisone dose reduction, and quality of life changes using questionnaires over a total of 48 weeks. The primary outcome is disease remission at 24 weeks. Safety and disease activity are closely observed during the study.

CONDITIONS

Brief Title

A Pilot Study in Severe Patients With Takayasu Arteritis.

Who Can Participate

Age: 14Years - 100Years

All Genders

Eligibility Criteria

You may qualify if you...

Age 14 years or older
Active disease with Kerr score of 2 or higher
Severe disease defined by any of the following: blood pressure over 180/110 mmHg; involvement of three or more artery branches with stenosis rate over 70%; significant organ insufficiency such as NYHA class III-IV heart failure or eGFR between 15 and 60 ml/min

You will not qualify if you...

Severe organ insufficiency
Acute or chronic active infections including tuberculosis and hepatitis
Other autoimmune diseases such as systemic lupus erythematosus, Behcet disease, or IgG4 related disease
Malignant tumors
History of severe drug allergy
Two consecutive relapses despite intervention adjustment

Research Team

Rongyi Chen, PhD

Lili Ma, PhD

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