NL-OMON43846已完成4 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. - Infliximab serum concentration of Remsima* after switch from Remicade
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Mundipharma
- 入组人数
- 129
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
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
排除标准
- •1. Subjects with evidence of the following major comorbidities such as: severe diabetic mellitus, tuberculosis, 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 adjustments 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 drug concentration measurements.
- •6. Simultaneous treatment with another biological or a not registered New Chemical Entity.
- •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.
研究者
相似试验
进行中（未招募）
1 期
A clinical 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.Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA).EUCTR2014-004904-31-NLMundipharma Pharmaceuticals B.V.
进行中（未招募）
1 期
A clinical 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.EUCTR2014-004904-31-BEMundipharma Pharmaceuticals B.V.156
进行中（未招募）
1 期
ong-term hepatitis A and B antibody persistence in healthy adult subjects, primed 16 to 20 years earlier with GSK Biologicals’ combined hepatitis A and B vaccine, Twinrix® (SB208127) in study HAB-084 (208127/084).Healthy volunteers (Vaccination against hepatitis A and hepatitis B in healthy adults)MedDRA version: 16.1Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestationsEUCTR2013-004586-13-CZGlaxoSmithKline Biologicals s.a.180
已完成
不适用
Persistence of antibodies six years after priming immunisation with Meningococcal C conjugate vaccine and response to the Hib-MenC (Menitorix®) vaccine in healthy childreMeningococcal C and Haemophilus influenzae type B diseasesInfections and InfestationsISRCTN72858898niversity of Oxford (UK)250
进行中（未招募）
不适用
Evaluation of the long-term persistence of hepatitis A antibodies in healthy adults who were vaccinated 21-25 years earlier with GlaxoSmithKline (GSK) Biologicals’ hepatitis A vaccine, Havrix®.Healthy volunteers (Vaccination against hepatitis A in healthy adults)MedDRA version: 16.1Level: LLTClassification code 10052551Term: Hepatitis A virusSystem Organ Class: 100000004848EUCTR2013-001918-15-BEGlaxoSmithKline Biologicals