EUCTR2017-001389-10-GB
Active, not recruiting
Phase 1
A phase II randomised placebo controlled double blinded trial of Interleukin 1 blockade in Acute Severe Colitis - IASO
Cambridge University Hospitals NHS Foundation Trust & University of Cambridge0 sites214 target enrollmentAugust 17, 2017
ConditionsAcute Severe Ulcerative ColitisMedDRA version: 20.0 Level: LLT Classification code 10066678 Term: Acute ulcerative colitis System Organ Class: 100000016670Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
DrugsAnakinra
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Acute Severe Ulcerative Colitis
- Sponsor
- Cambridge University Hospitals NHS Foundation Trust & University of Cambridge
- Enrollment
- 214
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Patients aged 16\-80 inclusive
- •\- Have given written informed consent to participate
- •\- Hospitalised patients with clinically confirmed or suspected acute severe ulcerative colitis and a Modified Truelove Witts Severity Index score \=11
- •\- Requirement for treatment with IV corticosteroids in the judgement of the treating clinician, with the possibility to receive a first dose of IMP within 36 hours of commencement of IV corticosteroids
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 4
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 200
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 10
Exclusion Criteria
- •\- Pregnant or breast\-feeding women
- •\- Oral corticosteroid dosing for a duration of 8 weeks or more immediately prior to commencement of IV corticosteroid dosing
- •\- History of severe hepatic impairment (e.g. Child\-Pugh \= Grade C)
- •\- Moderate or severe renal impairment (eGFR \<50ml/minute)
- •\- Neutropenia (neutrophil count \<1\.5x109/l)
- •\- Previous treatment with anakinra for any indication
- •\- Evidence (from blood cultures etc) or clinical suspicion of systemic infection
- •\- Current or previous cytomegalovirus (CMV) infection requiring treatment with anti\-viral agents
- •\- Current treatment with anti\-TNF\-a therapy or anti\-TNF\-a discontinuation within previous 16 weeks
- •\- A history of pulmonary TB infection
Outcomes
Primary Outcomes
Not specified
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