Effectiveness Evaluation of PALFORZIA RMP Educational Materials
Research type
Research Study
Full title
Effectiveness Evaluation of PALFORZIA Risk Management Plan Educational Materials
IRAS ID
299763
Contact name
John Chapman
Contact email
Sponsor organisation
Aimmune Therapeutics Ireland Limited
Clinicaltrials.gov Identifier
ATC code: V01AA08, Product reference; EU/1/20/1495 - EMEA/H/C/004917, Procedure number
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
The Sponsor, Aimmune Therapeutics, Inc. has developed PALFORZIA for patients with peanut allergy. In Europe, PALFORZIA is indicated for the treatment of patients aged 4 to 17 years of age with a confirmed peanut allergy and may be continued in patients 18 years of age and older. PALFORZIA was approved on 17 December 2020 for use in European Union through centralised procedure (included United Kingdom and later on validated by MHRA on 9 April 2021).
As part of the European/UK Risk Management Plan (RMP), the sponsor Aimmune has designed three types of educational materials to help educate and train healthcare professionals (HCPs), parents/caregivers, and patients on the safe use of PALFORZIA:
A. Age-appropriate booklets and videos designed for children (aged 4-6, 7-11, and 12-17) and caregivers to learn about peanut allergy and PALFORZIA,
B. A patient alert card to be filled out by prescribing HCPs and then provided to patients and/or parents/caregivers, and
C. An HCP instruction manual for HCPs.This post-authorisation study is being conducted in the European Union and UK to evaluate the effectiveness of the PALFORZIA RMP educational materials are at informing HCPs, parents/caregivers, and patients about how to use PALFORZIA, how to identify and treat the risks when using PALFORZIA, and the importance and proper use of self-injectable adrenaline when needed. The study will also monitor adherence to the educational material distribution plan.
Within each country, data will be collected from a convenience sample consisting of 5 qualified PALFORZIA prescribing HCPs, 25 patients between the ages of 12 and 17 who have been prescribed PALFORZIA, and 25 parents/caregivers of 4-11 year-old patients have been prescribed PALFORZIA.
Completion of the electronic survey is expected to last approximately 15 minutes.
REC name
London - Brent Research Ethics Committee
REC reference
21/PR/1753
Date of REC Opinion
17 Jan 2022
REC opinion
Favourable Opinion