Ischaemic stroke MedDRA version: 16.0 Level: PT Classification code 10061256 Term: Ischaemic stroke System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Kineret (anakinra)
Product Name: Kineret
Product Code: EU/1/02/203/001-003
Pharmaceutical Form: Suspension for injection in pre-filled syringe
INN or Proposed INN: Anakinra
CAS Number: 143
Sponsors
Salford Royal NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: PATIENT GROUP •Patients with confirmed ischaemic stroke who are admitted to the Comprehensive Stroke Centre at Salford Royal NHS Foundation Trust (SRFT) where consent can be obtained and drug administered within 6 hours. •National Institutes of Health stroke scale (NIHSS) score between 4 – 26. •No concomitant health problems that, in the opinion of the Principal Investigator (PI) or designee, would interfere with participation, administration of study treatment or assessment of outcomes including safety, for example, pre-existing malignancy. •Renal function within normal limits (=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: PATIENT GROUP •Unconfirmed or uncertain diagnosis of ischaemic stroke or rapid improving symptoms. •Haemorrhagic stroke. •NIHSS 26 •Known allergy to E. coli or any of the constituents of the study medication as established from the patient themselves, reliable representative and clinical records. •Previous or concurrent treatment with recombinant IL-1Ra known at the time of study entry. •Previous or current treatment with medication suspected of interacting with recombinant IL-1Ra, such as TNF-a inhibitors. •Known to have participated in a clinical trial of an investigational agent or device in the previous 30 days or for the period determined by the protocol of the study the patient has taken part in. •Known or planned pregnancy (pregnancy test to be performed in women of child-bearing potential) or breast-feeding. •Clinically significant concurrent medical condition, at the PI’s (or designee’s) discretion, which could affect the safety, tolerability, or efficacy in this study. •Previous inclusion in the current study (known prior to inclusion). •Evidence of current infection or infection within the past 4 wk. •Inability or unwillingness of patient or patient’s personal representative to give written informed consent. HEALTHY VOLUNTEERS (recruited to provide a one-off 20ml blood sample only to act as controls to study participants - no drug will be administered to healthy volunteers) •Current acute medical problems or taking medication for chronic conditions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the effect of a specific type of anti-inflammatory drug (Interleukin-1 receptor antagonist; IL-1Ra), which is administered as an injection into the skin, have on levels of an inflammation-causing protein (Interleukin-6; IL-6) in blood samples taken between 6 hours and 5-7 days after the onset of a stroke. ;Secondary Objective: To determine the effect of SC IL-1Ra on other markers of inflammation in the blood. To determine the effect of SC IL-1Ra on outcome (level of disability and length of hospital stay) at 3 months following stroke. To obtain further feasibility and safety data in patients given SC IL-1Ra. To examine how the body's immune system is affected after stroke, specifically if there is a reduction in the body's ability to fight infection. Using blood samples obtained from the recruited stroke patients and comparing it to blood samples obtained from healthy volunteers we will: i) Confirm whether the ability of specific blood cells (leucocyte) to respond to an infection is dampened down (suppressed) in stroke patients compared to age and sex matched healthy volunteers. ii) Establish whether the suppression is reversed in the stroke patients treated with SC IL-1Ra iii) Identify whether a hormone produced by the body called cortisol may play a role in immune suppression, and if;Primary end point(s): Effect of SC IL-1Ra on levels of IL-6 within 3 days of stroke onset;Timepoint(s) of evaluation of this end point: Within 3 days of stroke onset | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Effect of SC IL-1Ra on levels of IL-6 within 5-7 days of stroke Effect of SC IL-1Ra on other inflammatory biomarkers Effect of SC IL-1Ra on clinical outcome at 3 months following ischaemic stroke To obtain further feasibility and safety data in patients given SC IL-1Ra. To determine the pattern of immune suppression, the effect of IL-1Ra and impact of cortisol, following stroke, compared with age-sex matched healthy volunteers, and if there is any relationship with infection.;Timepoint(s) of evaluation of this end point: 90 days (3 months) from onset of stroke | — |
Countries
United Kingdom
Contacts
Public ContactTyrrell
University of Manchester
Outcome results
None listed