A Non-Interventional Multi-Database Post-Authorisation Study to Assess Pregnancy-Related Safety Data from Women with Severe Asthma Exposed to Tezepelumab (TREATY)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000176
• EU PAS number:
  EUPAS1000000176
• Study ID:
  1000000176
• Official title and acronym:
  A Non-Interventional Multi-Database Post-Authorisation Study to Assess Pregnancy-Related Safety Data from Women with Severe Asthma Exposed to Tezepelumab (TREATY)
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  France

  Sweden

  United States
• Study description:
  This study is an observational cohort study utilising secondary data from multiple data sources from Denmark, France, Sweden, and the United States of America (USA). The study will describe and compare the following outcomes in pregnancies and offspring from women with severe asthma exposed to tezepelumab and women with severe asthma unexposed to tezepelumab, treated with SOC for severe asthma (with or without other biologics) during pregnancy: MCM and mCM, foetal death (composite of miscarriage, stillbirth, and ectopic pregnancy), individual adverse pregnancy outcomes (ectopic pregnancy, miscarriage, stillbirth, TOP, and pre-eclampsia), and individual adverse birth outcomes (EC-section, PTB, SGA, and LBW). The unit of analysis is individual pregnancies in women with severe asthma (i.e., each woman may contribute multiple pregnancies to the study).
• Study status:
  Planned

Research institutions and networks

Institutions

Global Database Studies, IQVIA

Czechia

Finland

Germany

Slovakia

Spain

Study timelines

Date when funding contract was signed

Planned: 19/12/2022

Actual: 28/02/2023

Study start date

Planned: 30/06/2027

Data analysis start date

Planned: 30/06/2027

Date of interim report, if expected

Planned: 30/03/2028

Date of final study report

Planned: 31/03/2034

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

ASTRAZENECA PHARMACEUTICALS LP

Study protocol

Initial protocol

D5180R00010 PASS Protocol v3.0_Redacted.pdf

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)