EUCTR2016-001409-18-NO进行中（未招募）1 期
A prospective, open randomized, parallel-group study to evaluate the outcome of discontinuing or continuing anti-tumor necrosis factor treatment in patients with ulcerative colitis in sustained clinical remission. - The Biostop study
Helse More og Romsdal Hospital Trust0 个研究点开始时间: 2016年5月9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
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.A confirmed diagnosis of ulcerative colitis
- •2.Male or non-pregnant, non-nursing female
- •3.>18 years of age at inclusion
- •4.Patients treated for minimum 1 year with first-line anti-TNF treatment in sustained clinical remission during the last 3 months
- •5.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 160
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •1.Discontinuation of systemic 5-ASA or immunomodulatory therapy or other medication that could affect disease activity during the last 3 months prior to randomization
- •2.Any treatment of systemic corticosteroids due to disease exacerbation during the last 3 months (i.e. patients being in steroid free clinical remission)
- •3.Patients on anti-TNF monotherapy with intolerance to both 5-ASA and immunomodulatory therapy
- •4.Change in the anti-TNF treatment during the last 3 months due to disease related factors, not including dose/frequency adjustments due to drug concentration measurements
- •5.Use of any second-line anti-TNF medication irrespective of reason for stopping first-line anti-TNF
- •6.Previous failed attempts of anti-TNF discontinuation of more than 4 months’ duration, with the exception of discontinuation due to pregnancy
- •7.Detection of anti-TNF antibodies in moderate-high titers prior to randomization
- •8.Psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers or other factors which makes adherence to the study protocol impossible
- •9.Participation in any other IMP studies
研究者
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