A non-interventional observational study assessing the safety and tolerability of ACARIZAX® in adults (18-65 years of age) (RELIEF)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/43754
• EU PAS number:
  EUPAS43753
• Study ID:
  43754
• Official title and acronym:
  A non-interventional observational study assessing the safety and tolerability of ACARIZAX® in adults (18-65 years of age) (RELIEF)
• DARWIN EU® study:
  No
• Study countries:
  Netherlands
• Study description:
  ACARIZAX® has been approved by the Dutch regulatory authorities in August 2016 for treatment of allergic rhinoconjunctivitis caused by housedustmites. This non-interventional study in adults is conducted in order to obtain information of use of ACARIZAX® in a real life setting. The number of patients to be included in the study will add to the existing safety data for the product. So far Dutch physicians don’t have any experience with use of ACARIZAX®. This study will gain initial experience with this new treatment under routine conditions of everyday practice. Primary objective: To investigate the safety and tolerability of ACARIZAX® in adults. Non-interventional, observational, multi-centric, open-label study. Study design: A total number of 3 visits is planned during the study and a phone contact approximately 1 week after first administration Study population:Adult patients treated with Acarizax according to standard practise (SmPC Acarizax) for their allergic rhinitis and/or conjunctivitis. Assessments: Adverse Events (AE)/ Adverse Drug Reactions (ADR)/ Serious Adverse Events (SAE), Patient’s satisfaction/Convenience and Compliance.
• Study status:
  Planned

Research institution and networks

Institutions

ALK-Abelló

University Medical Center Utrecht (UMCU)

Netherlands

Jeroen Bosch Ziekenhuis, Henri Dunantweg 1, Den Bosch, The Netherlandsweg Department of Allergology, University Medical Center Utrecht, Heidelberglaan 100, Utrecht, The Netherlands

Study timelines

Date when funding contract was signed

Planned: 02/10/2017

Study start date

Planned: 03/04/2017

Data analysis start date

Planned: 03/06/2019

Date of final study report

Planned: 13/10/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

ALK-Abello BV

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable