EUCTR2016-002061-54-IT进行中（未招募）1 期
Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases.Evaluation of immunogenicity and clinical response - Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®)
IVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLI0 个研究点目标入组 250 人开始时间: 2018年11月15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
- 250
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
- •1.age =18 years
- •2.diagnosis of
- •a.Rheumatoid Arthritis according to ACR criteria (1987 e 2010) OR
- •b.Sieronegative spondiloarthritis (Ankylosing Spondylitis or Sponsiloarthritis (Psoriasic Arthritis) according to ASAS criteria 2009 OR
- •c.Inflammatory Disease confirmed by endoscopic and histological criteria
- •3.Treatment with Infliximab RMP (Remicade®) for at least 6 months with stable dosage at least in the last two infusions.
- •4.Stable clinical response at the time of inclusion in the study (T-1) [stability is defined as reduction =30% of the disease activity scores in comparison with the start of treatment with Infliximab RMP (Remicade®)]
- •5.In case of concomitant therapy with immunosuppressive drugs (azatioprine/6 mercaptopurine, methotrexate o leflunomide), their dosage should be stable at least in the last 2 months.
- •6.In case of concomitant systemic therapy with steroids their dosage should be stable at least in the last 2 months and =7.5 mg/die of prednisone (or equivalent)
- •7.Any concomitant drug for diseases other than those under study should be at a stable dosage for at least 4 weeks before the study inclusion.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 125
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 125
排除标准
- •1.Active Infectious diseases
- •2.Severe comorbidities (known malignancy except for basal cell carcinoma, congestive heart failure NYHA grade III/IV, liver and/or hepatobiliary disease, renal disease)
- •3.Pregnancy or breast feeding
- •4.Any underlying condition which, in the opinion of the Investigator, might contrarindicate the switch to Remsima®
研究者
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