Post-Market Claims-Based Study of Serious Allergic Reactions and Eosinophilic Esophagitis in Marketed Use of RAGWITEK? in the United States (MK-3641-010)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/25096
• EU PAS number:
  EUPAS17248
• Study ID:
  25096
• Official title and acronym:
  Post-Market Claims-Based Study of Serious Allergic Reactions and Eosinophilic Esophagitis in Marketed Use of RAGWITEK? in the United States (MK-3641-010)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The purpose of this study is to estimate the incidence of serious allergic events and eosinophilic esophagitis in participants exposed to RAGWITEK? in usual care. The objectives of this study are to: 1) Describe characteristics of participants initiating RAGWITEK withrespect to demographics, concomitant medications and co-morbidities, 2) Estimate the incidence of serious allergic reactions in participants newly receiving RAGWITEK resulting in hospitalization, emergency department care or epinephrine injection in the ambulatorysetting, 3) Estimate the incidence of eosinophilic esophagitis (EoE) in participants newly receiving RAGWITEK, and 4) Conduct an analysis of exposed participants to describe potential baseline risk factors for serious allergic events or EoE.
• Study status:
  Ongoing

Research institutions and networks

Institutions

ALK-Abelló

Study timelines

Date when funding contract was signed

Planned: 30/06/2015

Actual: 28/08/2014

Study start date

Planned: 30/09/2016

Actual: 19/05/2016

Date of final study report

Planned: 30/12/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

ALK-Abelló A/S

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)