Post-Market Claims-Based Study of Allergic Reactions and Eosinophilic Esophagitis in Marketed Use of GRASTEK? in the United States (MK-7243-025)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/25093
• EU PAS number:
  EUPAS17245
• Study ID:
  25093
• Official title and acronym:
  Post-Market Claims-Based Study of Allergic Reactions and Eosinophilic Esophagitis in Marketed Use of GRASTEK? in the United States (MK-7243-025)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The purpose of this study is to estimate the incidence of serious allergic reactions and eosinophilic esophagitis (EoE) in participants exposed to GRASTEK in a large, United States (US)-based, commercially insured population. The study objectives are to: 1) Describe characteristics of participants using GRASTEK with respect to demographics, concomitantmedications and co-morbidities, 2) Estimate the incidence of serious allergic reactions in participants newly receiving GRASTEK resulting in hospitalization, emergency department care or epinephrine injection in the ambulatory setting, 3) Estimate the incidence of EoE in participants newly receiving GRASTEK, and 4) Conduct an analysis of exposed participants to describe potential baseline risk factors for serious allergic reactions and 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)