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

Ongoing
Research institution and networks

Institutions

Contact details

Peter Egger

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
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

English (2.29 MB - PDF)View document
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)