ISRCTN43717130已完成2 期
A phase II randomised placebo controlled double blinded trial of Interleukin 1 blockade in Acute Severe Colitis
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 113
研究概览
简要总结
2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30772849 protocol (added 04/03/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Be aged 16–80 years inclusive
- •2. Have given written informed consent to participate
- •3. Be hospitalised with clinically confirmed or suspected diagnosis of acute severe ulcerative colitis and a MTWSI score =11
- •4. Have a requirement for treatment with IV corticosteroids in the judgement of the treating clinician, with the possibility to receive a first dose of trial drug within 36 hours of commencement of IV corticosteroids
排除标准
- •Current exclusion criteria as of 21/02/2018:
- •1. Pregnant or breast-feeding women
- •2. Oral corticosteroid dosing for a duration of 8 weeks or more immediately prior to commencement of IV corticosteroid dosing
- •3. History of severe hepatic impairment (e.g. Child-Pugh = Grade C)
- •4. Moderate or Severe renal impairment (estimated glomerular filtration rate [eGFR] <60ml/min/1.73m2)
- •5. Neutropenia (neutrophil count < 1.5x109/l)
- •6. Previous treatment with anakinra for any indication
- •7. Evidence (from blood cultures etc) or clinical suspicion of systemic infection
- •8. Current or previous cytomegalovirus (CMV) infection requiring treatment with anti-viral agents
- •9. Current treatment with anti-TNF-a therapy or anti-TNF-a discontinuation within previous 16 weeks
- •10. A history of pulmonary TB infection
- •11. History of malignancy (with the exception of non-melanoma skin cancer) or colonic dysplasia
- •12. Receipt of another IMP as part of a CTIMP within the previous 16 weeks
- •Previous exclusion criteria:
- •1. Pregnant or breast-feeding women
- •2. Oral corticosteroid dosing for a duration of 8 weeks or more immediately prior to commencement of IV corticosteroid dosing
- •3. History of severe hepatic impairment (e.g. Child-Pugh = Grade C)
- •4. Moderate or severe renal impairment (eGFR < 50ml/minute)
- •5. Neutropenia (neutrophil count < 1.5x109/l)
- •6. Previous treatment with anakinra for any indication
- •7. Evidence (from blood cultures etc) or clinical suspicion of systemic infection
- •8. Current or previous cytomegalovirus (CMV) infection requiring treatment with anti-viral agents
- •9. Current treatment with anti-TNF-a therapy or anti-TNF-a discontinuation within previous 16 weeks
- •10. A history of pulmonary TB infection
- •11. History of malignancy (with the exception of non-melanoma skin cancer) or colonic dysplasia
- •12. Receipt of another IMP as part of a CTIMP within the previous 16 weeks
研究者
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