A Nested Case-control Post-authorization Safety Study of Etoricoxib and Other Non-steroidal Anti-inflammatory Therapies in a Cohort of Patients with Ankylosing Spondylitis (AS) in the UK, France and Germany (MK-0663-163)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/19095
• EU PAS number:
  EUPAS19094
• Study ID:
  19095
• Official title and acronym:
  A Nested Case-control Post-authorization Safety Study of Etoricoxib and Other Non-steroidal Anti-inflammatory Therapies in a Cohort of Patients with Ankylosing Spondylitis (AS) in the UK, France and Germany (MK-0663-163)
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  United Kingdom
• Study description:
  This study is a population-based cohort of patients with ankylosing spondylitis (AS) from general medical practices in the UK, France, and Germany with a nested case control component to assess associations between drug exposures of interest and clinical outcomes relevant to patients using cyclooxygenase-2 (COX-2) inhibitors / nonsteroidal anti-inflammatory drugs (NSAIDS).
• Study status:
  Finalised

Research institutions and networks

Institutions

Merck & Co.

Study timelines

Date when funding contract was signed

Actual: 01/08/2009

Study start date

Actual: 17/08/2009

Data analysis start date

Actual: 01/07/2015

Date of final study report

Actual: 11/12/2015

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck Sharp & Dohme Corp.

Study protocol

Initial protocol

MK-0663-163-00 Protocol Summary

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)

Other study registration identification numbers and links

NCT01077843