Study identification

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

Contact details

Reginald Ewesuedo

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

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

More details on funding

Pfizer
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable