Inflamatory Bowel Disease (IBD) MedDRA version: 20.1 Level: LLT Classification code 10021973 Term: Inflammatory bowel disease NOS System Organ Class: 100000004856
Conditions
Interventions
Trade Name: Inflectra
Product Name: CT-P13
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: INFLIXIMAB
Sponsors
Hospira UK Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To characterise the population and drug utilisation patterns of patients treated with CT-P13 for CD or UC in the context of SOC Remicade. • To explore the long-term safety profile of CT-P13 in the treatment of patients with CD or UC in the context of SOC Remicade. ;Secondary Objective: • To assess the effectiveness1 of CT-P13 in the treatment of patients with CD or UC in the context of SOC Remicade. Effectiveness is a measure of the extent to which a specific intervention, procedure, regimen, or service when deployed in the field in routine circumstances, does what it is intended to do for a specified population. ‘Effectiveness’ should be distinguished from ‘efficacy’, which is a measure of the extent to which a specific intervention, procedure, regimen, or service produces a beneficial result under ideal conditions.; Primary end point(s): • Patients’ demographic characteristics • Clinical and diagnostic characteristics o Relevant medical history for CD or UC including prior treatments • CT-P13 treatment o CT-P13 or Remicade switches and reasons for switch o Dose and frequency, augmentation/reduction and reasons for changes • Co-therapy(ies) for the management of CD or UC • All adverse Events (AEs), Serious Adverse Events (SAEs) or Adverse Events of Special Interest (AESI), and events in a special situation (eg, pregnancy, exposure during breast feeding, medication error, overdose, misuse, extravasation; lack of efficacy; and occupational exposure) during patient study participation. ;Timepoint(s) of evaluation of this end point: As per Protocol | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: As per Protocol; Secondary end point(s): • Clinical assessment of disease activity o Data relating to Harvey Bradshaw Index (HBI) for patients with CD o Data relating to Partial Mayo Scoring System for Assessment of UC Activity, i.e., abbreviated version without the endoscopy sub-score o Data relating to the Montreal classification index for CD o Data relating to the Montreal classification index for UC: - classification by extent - classification by severity o Data relating to the fistula drainage assessment index for CD • Laboratory results related to the treatment or assessment of CD or UC • Imaging results related to the treatment or assessment of CD or UC | — |
Countries
Belgium, Czech Republic, Finland, France, Germany, Greece, Hungary, Italy, Netherlands, Portugal, Slovakia, Spain, United Kingdom
Contacts
Public ContactEU Regulatory Affairs
United Biosource Corporation
Outcome results
None listed