EUCTR2014-004904-31-BE进行中（未招募）1 期
An open-label, multicentre, phase IV study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission.
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 156
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.Male or female, age =18 years.
- •2.Subject will have a confirmed diagnosis of RA, UC or CD.
- •3.Stable remission defined as HBI=4, SCCAI<3, DAS 28<3.2 at screening.
- •4.Stable and continuous treatment with Remicade during the last 30 weeks, and no foreseen dose adjustment for the coming 2 months for infliximab.
- •5.Stable concomitant treatment; if concomitant drugs than stable for 4 months and no foreseen changes in drugs.
- •For RA: stable and continuous treatment with MTX.
- •6.Non-pregnant, non-nursing female.
- •7.Subject capable of understanding and signing an informed consent form.
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •1.Subjects with evidence of the following major co-morbidities such as: severe diabetic mellitus, tuberculosis (TB), severe infections, uncontrollable hypertension, severe cardiovascular disease (New York Heart Association [NYHA] class 3 or 4) and/or severe respiratory diseases.
- •2.Any other condition/disease, which in the opinion of the investigator makes the subject ineligible for the study.
- •3.Any clinically relevant hypersensitivity to (anaphylaxis or infusion related reactions) infliximab or to other murine proteins
- •4.Change of major co-medication during the last 4 months prior to screening and foreseen dose adjustment during the next 2 months:
- •RA: Initiation of systemic corticosteroids or synthetic DMARDs or other medication, which according to the investigator would interfere with the stability of the disease.
- •UC and CD: Initiation of systemic corticosteroids or an immunosuppressant or other medication, which according to the investigator would interfere with the stability of the disease.
- •5.Change in treatment with Remicade during the last 30 weeks due to disease related factors, not including dose/frequency adjustments due to serum infliximab concentration measurements.
- •6.Simultaneous treatment with another biological or a not registered NCE.
- •7.Psychiatric or mental disorders, alcohol abuse or other substance abuse (and/or history of opioid abuse), language barriers or other factors which makes adherence to the study protocol impossible.
- •8.Inadequate birth control, pregnancy, and/or breastfeeding.
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