A study assessing the use of GOlimumab in current clinical PRACTICE and its impact on patients with chronic inflammatory arthritis (MK-8259-020) (GO-PRACTICE)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/47243
• EU PAS number:
  EUPAS7527
• Study ID:
  47243
• Official title and acronym:
  A study assessing the use of GOlimumab in current clinical PRACTICE and its impact on patients with chronic inflammatory arthritis (MK-8259-020) (GO-PRACTICE)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  This study has been designed to comply with the February 2012 request from the French Health Authorities, in light of the Simponi® reevaluation scheduled for 2017. The Authorities asked for additional long-term data in patients with chronic inflammatory rheumatic diseases in the form of a post-regulation study. The primary objective of this study is to assess the persistence of golimumab treatment 24 months after the initial prescription in adult patients with chronic inflammatory rheumatic diseases, in routine clinical practice in France.
• Study status:
  Finalised

Research institutions and networks

Institutions

Merck & Co.

Chru De Lille - Hopital B Roger Salengro Rue Emile Laine 59037 Lille CEDEX

Study timelines

Date when funding contract was signed

Planned: 30/09/2014

Actual: 18/12/2014

Study start date

Planned: 30/11/2014

Actual: 12/01/2015

Data analysis start date

Planned: 31/07/2018

Actual: 10/08/2018

Date of final study report

Planned: 31/08/2019

Actual: 12/09/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck Sharp & Dohme LLC

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable