An observational, prospective cohort study to evaluate the safety and efficacy of Remsima in patients with Crohn's disease (CD) and Ulcerative Colitis (UC)

Study identification

• EU PAS number:
  EUPAS9917
• Study ID:
  28169
• Official title and acronym:
  An observational, prospective cohort study to evaluate the safety and efficacy of Remsima in patients with Crohn's disease (CD) and Ulcerative Colitis (UC)
• DARWIN EU® study:
  No
• Study countries:
  Czechia

  Italy

  Korea, Republic of

  Netherlands

  Poland

  Portugal

  Romania

  Sweden

  United Kingdom
• Study description:
  The primary objective of this study is to assess the safety of Remsima™ by evaluation of Events of Special Interest (ESI) in IBD patients, who have active Crohn’s disease (CD), fistulizing Crohn’s disease (CD), or Ulcerative Colitis (UC) for up to 5 years for each patient.The secondary objectives of this study are to evaluate additional safety and efficacy of Remsima™ in IBD patients, who have active CD, fistulizing CD or UC. Health-economic parameters will also be assessed.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Fakultni nemocnice Ostrava Hospital

Study timelines

Date when funding contract was signed

Actual: 26/11/2014

Study start date

Planned: 16/12/2014

Actual: 16/12/2014

Data analysis start date

Planned: 31/01/2016

Date of interim report, if expected

Planned: 31/05/2016

Date of final study report

Planned: 31/12/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Celltrion

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)