Condition category
Nervous System Diseases
Date applied
22/07/2013
Date assigned
22/07/2013
Last edited
08/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Sharon Hulme

ORCID ID

Contact details

Brain Injury Research Team
CSB
Hope Hospital
Stott Lane
Salford
M6 8HD
United Kingdom
+44 161 206 5137
sharon.hulme@manchester.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

14764

Study information

Scientific title

Does subcutaneous interleukin-1 receptor antagonist reduce inflammation after ischaemic stroke compared to placebo? (SC IL-1Ra in Stroke study)

Acronym

SC IL-1RA in Stroke Study

Study hypothesis

The aim of this study is to investigate whether skin injections of IL-1Ra twice a day for 3 days will reduce inflammation in the blood of stroke patients.

Ethics approval

13/NW/0460

Study design

Randomised interventional trial; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Topic: Stroke Research Network; Subtopic: Acute Care; Disease: In hospital study

Intervention

Participants will receive twice daily, SC injections of either Kineret© or placebo.

Intervention type

Drug

Phase

Phase II

Drug names

Kineret©

Primary outcome measures

Reduction in inflammatory biomarkers; Timepoints: Between 6 hours and 5-7 days post stroke

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/11/2013

Overall trial end date

30/04/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. 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
2. National Institutes of Health stroke scale (NIHSS) score between 4-26
3. 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, preexisting malignancy
4. Renal function within normal limits (< 177 µmol/l)
5. Willing and able to give informed consent or consent available from a patient representative (personallegal) for study inclusion including agreement in principle to receive study intervention and undergo all study assessments
6. Aged 18 years or above

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

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 120; UK Sample Size: 120; Description: Consists of 80 stroke patients and 40 healthy volunteers.

Participant exclusion criteria

Patient group:
1. Unconfirmed or uncertain diagnosis of ischaemic stroke or rapid improving symptoms.
2. Haemorrhagic stroke.
3. NIHSS <4 or >26
4. 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.
5. Previous or concurrent treatment with recombinant IL1Ra known at the time of study entry.
6. Previous or current treatment with medication suspected of interacting with recombinant IL1Ra, such as TNFa inhibitors.
7. 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.
8. Known or planned pregnancy (pregnancy test to be performed in women of childbearing potential) or breastfeeding.
9. Clinically significant concurrent medical condition, at the PI’s (or designee’s) discretion, which could affect the safety, tolerability, or efficacy in this study.
10. Previous inclusion in the current study (known prior to inclusion).
11. Evidence of current infection or infection within the past 4 wk.
12. Inability or unwillingness of patient or patient’s personal representative to give written informed consent.

Healthy volunteers (recruited to provide a oneoff 20ml blood sample only)
1. Current acute medical problems or taking medication for chronic conditions.

Recruitment start date

01/11/2013

Recruitment end date

30/04/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Brain Injury Research Team
Salford
M6 8HD
United Kingdom

Sponsor information

Organisation

Salford Royal NHS Foundation Trust

Sponsor details

R&D Department
Clinical Sciences Building
Stott Lane
Salford
M6 8HD
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.srft.nhs.uk/

Funders

Funder type

Charity

Funder name

Stroke Association (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

professional associations and societies

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

08/03/2016: Verifying study status with principal investigator.