/A

Phase 1

• Conditions: Inflamatory Bowel Disease (IBD); Therapeutic area: Diseases [C] - Digestive System Diseases [C06]; MedDRA version: 20.1 Level: LLT Classification code 10021973 Term: Inflammatory bowel disease NOS System Organ Class: 100000004856

• Registration Number: EUCTR2014-005192-89-FI
• Lead Sponsor: Hospira UK Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-04-08
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 2500

Inclusion Criteria

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 according to the corresponding summary of product characteristics (SmPC) as determined by the Investigator. Patients with stomas or surgery/pouch will be included.
3. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2380
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120

Exclusion Criteria

1. Any reported contraindications for CT-P13 or Remicade, according to the SmPC/Product Label.
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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified