Subcutaneous interleukin-1 receptor antagonist (SC IL-1RA) in Stroke Study

Phase 2

Completed

• Conditions: Topic: Stroke Research Network; Subtopic: Acute Care; Disease: In hospital study; Nervous System Diseases; Stroke

• Registration Number: ISRCTN74236229
• Lead Sponsor: Salford Royal NHS Foundation Trust

Brief Summary

2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29567761

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-07-22
• Study Completion: 2017-02-28
• Last Update Posted: 17 June 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Current primary outcome measures as of 06/04/2017:<br> Level of IL6, using ELISA within 3 days of stroke onset<br><br> Previous primary outcome measures:<br> Reduction in inflammatory biomarkers; Timepoints: Between 6 hours and 5-7 days post stroke<br>

Secondary Outcome Measures

Name	Time	Method
<br> Added 06/04/2017:<br> 1. Levels of other inflammatory markers, measured using ELISA or Luminex at within 3 days of stroke onset<br> 2. Clinical outcome at 3 months following ischaemic stroke, measured using:<br> 2.1. The National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS)<br> 2.2. The modified Rankin Score (mRS)<br> 2.3. Survival (mortality) , measured using hospital records<br> 2.4. Length of hospital stay (LOS), measured using a telephone survey<br>