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Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Inflammatory Bowel Disease

Last updated on February 16, 2019

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Study Location
UZ Leuven Campus Gasthuisberg
Leuven, Vlaams Brabant, 3000 Belgium
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn's Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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1. At least 12 years of age at the time of initial confirmed diagnosis of CD or UC and at
least 18 years of age at the time of enrolment to the study.

2. Patients who are prescribed CT-P13 or Remicade for the treatment of CD or UC
prescribed according to the corresponding summary of product characteristics (SmPC) as
determined by the Investigator. Patients with stomas or surgery/pouch will be
included.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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1. Any reported contraindications for CT-P13 or Remicade, according to the SmPC.

2. Known hypersensitivity (including severe, acute infusion reactions) to infliximab, its
excipients or other murine proteins, at the time of enrolment.

3. Prior history of failure to respond to Remicade or CT-P13.

NCT02539368
Pfizer
Completed
Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Inflammatory Bowel Disease

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