drugset / Trial / NCT04300686

A Pilot Study in Severe Patients With Takayasu Arteritis.

NCT04300686 ↗

Phase 4 Recruiting 40 enrolled Shanghai Zhongshan Hospital
RandomizedCrossoverOpen-labelTreatment

Summary

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.

Timeline

Start
2020-03-01
Primary completion
2022-05-01
Completion
2023-12-31

Outcome

Met primary endpoint

paper In the intention-to-treat (ITT) population, the ER at 6 months was higher in the ADA group (85.71% vs 52.63%, P = 0.02). PMID 37540159 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Adalimumab Monoclonal antibody 40 mg —
Comparator Tocilizumab Monoclonal antibody 8 mg/kg Intravenous

Indications