A Pilot Study in the Treatment of Severe Patients With Takayasu Arteritis With Tocilizumab and Adalimumab, Based on ECTA Cohort
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Disease remission at 24 weeks.
研究概览
简要总结
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.
详细描述
The Takayasu arteritis (TAK) is a rare chronic inflammatory arteritis, which lacks an effective well-accepted intervention strategy. Previous studies have revealed that methotrexate, tofacitinib, adalimumab, and tocilizumab were effective in controlling disease activity and preventing disease relapse in some TAK patients, especially the latter two biological agents. However, we believed that different patients should be prescribed different drug combinations, i.e. personalized medicine, to obtain the optimal intervention effect.
Here we tried to classify the TAK patients into three levels including mild, moderate, and severe, and prescribe different drug interventions to discover which biological agent is better in severe TAK patients.
- Patients were classified as mild, moderate, and severe groups according to the disease severity of TAK patients.
1.1 Severe
- Severe hypertension
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
盲法说明
None. Open-label.
入排标准
- 年龄范围
- 14 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age≥14 years old;
- •active: Kerr score≥ 2;
- •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;
排除标准
- •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)
结局指标
主要结局
Disease remission at 24 weeks.
时间窗: 24 weeks
comparison of clinical remission rate between adalimumab and tocilizumab groups at the end of 24th week follow-up;
次要结局
- Change of the quality of life with questionnaire SF-36(At the time point of 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 36 weeks, 48 weeks.)
- Prednisone dose reduction at endpoint(24 weeks and 48 weeks.)
- Vascular progression in angiographic examination at 6 months and 12 months.(24 weeks and 48 weeks.)
- Change of the quality of life with questionnaire MOS-sleep scale(At the time point of 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 36 weeks, 48 weeks.)
- disease relapse in the follow-up(At the time point of 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 36 weeks, 48 weeks.)
- Change of the quality of life with the Fatigue severity scale(At the time point of 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 36 weeks, 48 weeks.)
- Disease remission at 48 weeks.(48 weeks)