2024-516965-35-00招募中3 期
TAWIS - Evaluation of TNF-alpha antagonists (Infliximab) withdrawal in sarcoidosis : a prospective, randomized, controlled trial.
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 10
- 主要终点
- The primary endpoint is the percentage of patients with major relapses in the 2 groups
研究概览
简要总结
To compare 2 strategies of remission maintenance in patients who are in remission after infliximab administration
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age superior or equal to 18 years
- •Affiliated to the National French social security system
- •Clinical and radiological presentation consistent with sarcoidosis
- •Presence of non-caseating granulomas in at least one organ
- •Exclusion or other causes of granulomas
- •Infliximab treatment for at least 6 months
- •Steroid dosage < or equal to 10 mg/day for at least 6 months
- •No activity of the disease (ePOST score 0) for at least 6 months
- •Normal ACE and serum calcemia level
- •Signed informed consent
排除标准
- •Pregnancy or breast-feeding
- •Concurrent vaccination with live vaccines during therapy
- •Inability to understand information about protocol
- •Adult subject under legal protection or unable ton consent
- •Absence of effective contraceptive method for men and women for duration of the study and 6 months after the end of participation
- •Concomitant participation to another biomedical research (only Category 1 trial according to the Jardé law)
- •Positive IGRA test without previous antituberculous antibiotherapy
- •Active infection
- •Patients with moderate to severe heart failure (NYHA class III/ IV)
- •Severe liver function disorders (factor V<5%)
- •Alcoholism (>10 drinks/week)
- •Severe kidney function disorders (clearance <20 mL/min)
- •Pre-existing blood dyscrasias
- •History of cancer in the 5 years before enrolment (except for cutaneous non melanoma cancers)
结局指标
主要结局
The primary endpoint is the percentage of patients with major relapses in the 2 groups
The primary endpoint is the percentage of patients with major relapses in the 2 groups
次要结局
未报告次要终点
研究者
Professor
Scientific
Assistance Publique Hopitaux De Paris
研究点 (10)
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