NCT02326155

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

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 470 (actual)
• Sponsor: Celltrion · Industry
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

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)

Detailed 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.

Conditions

• Crohn's Disease
• Ulcerative Colitis

Timeline

• Start date: 2014-12-08
• Primary completion: 2020-02-28
• Completion: 2020-02-28
• First posted: 2014-12-25
• Last updated: 2022-02-21
• Results posted: 2022-02-21