Effectiveness Evaluation of PALFORZIA Risk Management Plan Educational Materials

Study identification

• EU PAS number:
  EUPAS40247
• Study ID:
  44327
• Official title and acronym:
  Effectiveness Evaluation of PALFORZIA Risk Management Plan Educational Materials
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  United Kingdom
• Study description:
  This is a post-authorization cross-sectional descriptive survey study (category 3 PASS Safety Study) required in PALFORZIA RMP approved by EMA. The study is intended to be conducted in the European Union and the UK, with data collected systematically in specific countries when access to PALFORZIA becomes commercially available. After receiving PALFORZIA educational materials distributed according to a defined distribution plan, PALFORZIA prescribing HCPs, parents/caregivers of 4-11 year-old patients who have been prescribed PALFORZIA, and 12 – 17 year old patients who have been prescribed PALFORZIA who provide informed consent will complete an online survey in their local language. Data collection in each country will continue until completed, valid surveys are received from minimum desired sample size of 5 HCPs, 25 parents/caregivers (of 4-11 year-old patients), and 25 patients (age 12-17 years old) in each country.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Aimmune Therapeutics

Stallergenes

Study timelines

Date when funding contract was signed

Planned:18/12/2020

Actual:18/12/2020

Study start date

Planned:30/03/2022

Actual:01/01/2022

Date of interim report, if expected

Actual:14/11/2024

Date of final study report

Planned:31/12/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Marketing Authorization was transferred from Aimmune Therapeutics to Stallergenes

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)