Does Kineret, an anti-inflammatory drug, administered under the skin reduce levels of inflammation, compared to dummy-drug (placebo)?

Phase 1

• Conditions: Ischaemic stroke; MedDRA version: 16.0Level: PTClassification code 10061256Term: Ischaemic strokeSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2013-001757-28-GB
• Lead Sponsor: Salford Royal NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-10-10
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

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 (< 177 µmol/l).
•Willing and able to give informed consent or consent available from a patient representative (personal-legal) for study inclusion including agreement in principle to receive study intervention and undergo all study assessments.
•Aged 18 years or above.

HEALTHY VOLUNTEERS (recruited to provide a one-off 20ml blood sample only)
•Between 18 and 80 years, in good health.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

PATIENT GROUP
•Unconfirmed or uncertain diagnosis of ischaemic stroke or rapid improving symptoms.
•Haemorrhagic stroke.
•NIHSS <4 or >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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified