Study identification

PURI

https://redirect.ema.europa.eu/resource/27099

EU PAS number

EUPAS19202

Study ID

27099

Official title and acronym

Safety Data on Etoricoxib From Swedish Registries of Spondyloarthropathy/Ankylosing Spondylitis Patients (MK-0663-159; EP07013.013.11.082)

DARWIN EU® study

No

Study countries

Sweden

Study description

This study is a population- and register-based nationwide matched cohort study using data from 1987-2010, with updated linkage and repeat analysis planned for 2013-14. The study period will begin on 01-Jan-2001 and end on 31-Dec-2009 (or the latest date for which data are available from the various registers). This study is being conducted by Merck & Co. Inc. as a post-licensure commitment to the European Medicines Agency (EMA). The rationale for the study is to provide additional post-marketing safety data regarding the use of etoricoxib for the indication of ankylosing spondylitis.The specific project objectives are to: 1) Describe the characteristics of Swedish participants with inflammatory spondyloarthropathy / ankylosing spondylitis (SpA/AS), 2) Describe the use of etoricoxib and other cyclooxygenase-2 (COX-2 inhibitors)/non-selective nonsteroidal anti-inflammatory drugs (nsNSAIDs) in Swedish participants with SpA/AS, and 3) Estimate and compare the rates of clinical outcomes of special interest (gastrointestinal (GI), renovascular, cardiovascular (CV), and cerebrovascular) with use of etoricoxib and other COX-2 inhibitors/nsNSAIDs in Swedish patients with SpA/AS.

Study status

Finalised
Research institution and networks

Institutions

Merck & Co.
First published:
01/02/2024
Institution

Contact details

Clinical Trials Disclosure Merck Sharp & Dohme Corp.

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Data collection

Actual:

Start date of data analysis

Planned:
Actual:

Date of interim report, if expected

Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Merck Sharp & Dohme Corp.
Study protocol
Initial protocol
English (2.05 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)