EUCTR2016-001987-12-IT进行中（未招募）1 期
Open-label, randomized controlled trial comparing tocilizumab to anti-TNF treatment and discovery of biomarkers for treatment selection in rheumatoid arthritis patients with inadequate response to a first anti-TNF - RAFTING
SOCIETA' ITALIANA DI REUMATOLOGIA - SIR0 个研究点目标入组 208 人开始时间: 2021年1月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 208
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Age =18 years at the time of signing the informed consent form and either male or female
- •-Diagnosis of RA according to the 1987 ACR classification criteria OR 2010 ACR/EULAR classification criteria at least 6 months prior to screening
- •-Patients with persistent RA disease activity whilst being treated with an initial TNFi agent on a background MTX up to 20-25 mg/week for at least 12 weeks defined according to SIR and EULAR guidelines as:
- •A)Primary non-response: failing to improve DAS28 by = 1.2 or failing to achieve DAS28 = 3.2 within the first three to six months of starting the initial TNFi;
- •B)Secondary non-response: determined by physician decision with evidence of flare and deterioration in DAS28 of = 1.2
- •C)Drug withdrawal for adverse events (not contraindicating a second course of TNFi (not class-adverse events))
- •-Methotrexate (MTX) dose stable for 28 days prior to screening
- •-Patients on NSAIDs and / or corticosteroids must remain on an unchanged regimen for at least 28 days prior to study drug administration
- •-The patient must be able to comply with the study visit schedule and other protocol requirements
- •-The patient understands the purpose of the study and is able and willing to sign the informed consent form, according to ICH/GCP
- •-Signed written informed consent for biological analysis
- •-Female patients with reproductive potential must have a negative pregnancy test within 7 days prior to start of trial. Women of childbearing potential and male patients must be willing to adopt practice acceptable methods of highly effective contraception measures during treatment and for 6 months (female patients) and 3 months (male patients) after discontinuation of treatment.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •-Patients who have previously received more than 1 TNFi drug OR any other biological therapy
- •-Patients with inflammatory joint disease of different origin or any arthritis with onset prior to 16 years of age
- •-Patients taking any disease-modifying antirheumatic drug (DMARDs) (e.g. all except methotrexate). Discontinuation must occur at least 28 days prior to study treatment start
- •-History or presence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug
- •-Known hypersensitivity to any active substance or excipients of study drug
- •-Pregnancy or breast feeding.
研究者
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