NCT03100253终止4 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
Mario Negri Institute for Pharmacological Research22 个研究点 分布在 1 个国家目标入组 208 人开始时间: 2018年3月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 208
- 试验地点
- 22
- 主要终点
- Proportion of patients with good EULAR
研究概览
简要总结
To compare the efficacy of switching to a different molecular target (from TNF to IL6) versus cycling to a second TNF inhibitor in patients with active RA, who have not adequately responded to a previous treatment with a first anti-TNF.
详细描述
New drugs for the treatment of rheumatoid arthritis (RA) with action on specific molecular target (e.g. anti-TNF) have improved the prognosis of patients with an inadequate response to conventional therapy such as methotrexate (MTX).
However, approximately 50% of patients treated with first-line anti-TNF discontinue treatment after two years due to ineffectiveness or adverse events. The second line treatment involves the use of another anti-TNF drug or switching to a different molecular target (anti-IL6, -CD20 or CTLA-4-Ig) in combination with MTX.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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: 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; secondary non-response: determined by physician decision with evidence of flare and deterioration in DAS28 of ≥ 1.
- •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 serum pregnancy test within 7 days prior to start of trial. Women of childbearing potential and male patients must be willing to practice acceptable methods of contraception during treatment and for 6 months (female patients) and 3 months (male patients) after discontinuation of treatment.
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.
研究组 & 干预措施
"Cycling" strategy
Active Comparator
- Etanercept if initial failure to monoclonal antibodies: infliximab, adalimumab, golimumab or certolizumab OR
- Infliximab, adalimumab, golimumab or certolizumab if initial failure to the receptor fusion protein, etanercept.
干预措施: Etanercept (Drug)
"Switching" strategy
Experimental
Tocilizumab [RoActemra®] [ATC: L04AC07] 8 mg/kg i.v. every 4 weeks OR 162 mg s.c every seven days
干预措施: Tocilizumab (Drug)
"Cycling" strategy
Active Comparator
- Etanercept if initial failure to monoclonal antibodies: infliximab, adalimumab, golimumab or certolizumab OR
- Infliximab, adalimumab, golimumab or certolizumab if initial failure to the receptor fusion protein, etanercept.
干预措施: Infliximab (Drug)
"Cycling" strategy
Active Comparator
- Etanercept if initial failure to monoclonal antibodies: infliximab, adalimumab, golimumab or certolizumab OR
- Infliximab, adalimumab, golimumab or certolizumab if initial failure to the receptor fusion protein, etanercept.
干预措施: Adalimumab (Drug)
"Cycling" strategy
Active Comparator
- Etanercept if initial failure to monoclonal antibodies: infliximab, adalimumab, golimumab or certolizumab OR
- Infliximab, adalimumab, golimumab or certolizumab if initial failure to the receptor fusion protein, etanercept.
干预措施: Golimumab (Drug)
"Cycling" strategy
Active Comparator
- Etanercept if initial failure to monoclonal antibodies: infliximab, adalimumab, golimumab or certolizumab OR
- Infliximab, adalimumab, golimumab or certolizumab if initial failure to the receptor fusion protein, etanercept.
干预措施: Certolizumab Pegol (Drug)
结局指标
主要结局
Proportion of patients with good EULAR
时间窗: 24 weeks
the proportion of patients with good EULAR response
次要结局
- Proportion of patients with ACR20/50/70 response(24 weeks)
- Proportion of patients with a good/moderate EULAR(24 weeks)
- Proportion of patients with a remission according to DAS28/SDAI/CDAI(96 weeks)
- Van Der Heijde Modified Total Sharp Score [X-ray score](96 weeks)
- Health Assessment Questionnaire (HAQ) score(96 weeks)
研究者
研究点 (22)
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