A Pilot Study in Severe Patients With Takayasu Arteritis.

Recruiting now · Phase 4

Conditions studied: Takayasu Arteritis, Tocilizumab, Adalimumab, Treatment

In brief

Takayasu arteritis (TAK) is a rare chronic inflammatory arteritis, which lacks an effective well-accepted intervention strategy. We classify TAK patients into 3 levels, including mild, moderate, and severe. And the biological agents tocilizumab and adalimumab are randomly prescribed in severe patients, to find out the relatively better treatment strategy, facilitating better intervention strategy in severe TAK patients.

Key facts

Study ID

NCT04300686

Run by

Shanghai Zhongshan Hospital

People needed

40

Starts

2020-03-01

Expected to finish

2023-12-31

Last updated by the study team

2021-08-10

Who can join

Age: 14 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• age≥14 years old;
• active: Kerr score≥ 2;
• severe:
• Blood pressure > 180/110mmHg;
• ≥ 3 branches with the stenotic rate > 70% involved;
• high degree of organ insufficiency: NYHF III\~IV; eGFR (MRDR) 15\~ 60ml/min;

You may not qualify if…

• 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)

Where it is running

• Department of Rheumatology in Zhongshan hospital, Fudan University — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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