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To Evaluate the Safety and Efficacy of Remsima™ in Patients With Crohn's Disease (CD) or Ulcerative Colitis (UC)

Ulcerative Colitis Clinical Trial

Official title:
An Observational, Prospective Cohort Study to Evaluate the Safety and Efficacy of Remsima™ in Patients With Crohn's Disease (CD) or Ulcerative Colitis (UC)

Clinical Trial Summary

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

Clinical Trial Description

This is a longitudinal, observational, prospective cohort study to assess the safety and efficacy of Remsima™ in patients with IBD, who have active Crohn's disease (CD), fistulizing Crohn's disease (CD), or Ulcerative Colitis (UC). Patients will be included in this registry who are receiving treatment with 5 mg/kg of Remsima™ by IV infusion at weeks 0, 2, 6, and every 8 weeks thereafter in accordance with the product label. If a patient has been treated with infliximab prior to enrollment, his or her dosing schedule will be continued appropriately. Patients will undergo safety and efficacy assessments in accordance with routine medical practice. The decision to treat with RemsimaTM will be independent of the decision to enroll the patient in this registry. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02326155
Study type Observational [Patient Registry]
Source Celltrion
Contact
Status Terminated
Phase
Start date December 8, 2014
Completion date February 28, 2020
View Details
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