Is it useful to monitor thiopurine metabolites in pediatric patients with Crohn’s disease on combination therapy? A multicenter prospective observational study

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/40080
• EU PAS number:
  EUPAS38918
• Study ID:
  40080
• Official title and acronym:
  Is it useful to monitor thiopurine metabolites in pediatric patients with Crohn’s disease on combination therapy? A multicenter prospective observational study
• DARWIN EU® study:
  No
• Study countries:
  Czechia
• Study status:
  Ongoing

Research institutions and networks

Institutions

Motol University Hospital (FNM)

2nd Faculty of medicine,Charles University

Department of Pediatrics, Faculty of Medicine and Dentistry, Palacky University and University Hospital Olomouc, Czech Republic

Study timelines

Date when funding contract was signed

Actual: 01/01/2012

Study start date

Actual: 15/01/2016

Date of final study report

Planned: 13/01/2021

Sources of funding

Other

More details on funding

Ministry of Health, CZ 00064203, University Hospital Motol, Prague, CZ, and 0098892, University Hospital, Olomouc, CZ, Ministry of Education, Youth and Sports, CZ OP VVV ENOCH CZ.02.1.01/0.0/0.0/16_019/0000868

Study protocol

Initial protocol

PROTOKOL_AZA

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable