Post-Marketing Observational Cohort Study of Patients with Inflammatory Bowel Disease (IBD) Treated with CT-P13 in Usual Clinical Practice (CONNECT-IBD)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/31369
• EU PAS number:
  EUPAS22289
• Study ID:
  31369
• Official title and acronym:
  Post-Marketing Observational Cohort Study of Patients with Inflammatory Bowel Disease (IBD) Treated with CT-P13 in Usual Clinical Practice (CONNECT-IBD)
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  Czechia

  Finland

  France

  Germany

  Greece

  Hungary

  Italy

  Netherlands

  Portugal

  Slovakia

  Spain

  United Kingdom
• Study description:
  A multi-national, multi-centre, post-marketing observational cohort study to characterise the population, drug utilisation patterns and assess safety of patients treated with CT-P13 for Crohn’s Disease (CD) or Ulcerative Colitis (UC) in the context of standard of care (SOC) Remicade. The decision to treat with CT-P13 (or Remicade) will be made at the usual care discretion of the physician independent of and before the decision to enrol patients in the study. No specific study visits mandated per the study protocol, patients’ visit schedules will follow local SOC, typically coinciding with the schedule of infusions of CT-P13 or Remicade, with additional visits as needed at the treating physician’s discretion. Data for the study will be entered into an electronic data capture (EDC) system at enrolment and then approximately every 3 months thereafter up to a 2-year follow-up period, or until the end of the last patient 1-year follow-up period, whichever occurs first.
• Study status:
  Finalised

Research institutions and networks

Institutions

NA

Multiple centres: 155 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 01/12/2014

Actual: 01/12/2014

Study start date

Planned: 22/04/2015

Actual: 22/04/2015

Date of final study report

Planned: 17/06/2019

Actual: 21/08/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Study protocol

Initial protocol

C1231001 (ZOB INF 1402)_PROTOCOL AMENDMENT V3.0_06OCT 2017

Regulatory

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