To Evaluate the Safety and Efficacy of Remsima™ in Patients With Crohn's Disease (CD) or Ulcerative Colitis (UC)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Crohn's Disease
- Ulcerative Colitis
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 6 years and 125 years
- Gender
- Both males and females
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 o...
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
Tracking Information
- NCT #
- NCT02326155
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Pavel Svoboda Ostrava, Morvskoslezsky kraj, Czech Republic, 708 52