ISRCTN43717130
Completed
Phase 2
A phase II randomised placebo controlled double blinded trial of Interleukin 1 blockade in Acute Severe Colitis
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Acute Severe Colitis
- Sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Enrollment
- 113
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30772849 protocol (added 04/03/2020)
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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