E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Inflamatory Bowel Disease (IBD) |
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E.1.1.1 | Medical condition in easily understood language |
Inflamatory Bowel Disease (IBD) |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10021973 |
E.1.2 | Term | Inflammatory bowel disease NOS |
E.1.2 | System Organ Class | 100000004856 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
• 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. |
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E.2.2 | Secondary objectives of the trial |
• 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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 155 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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LPLV - Patients will be followed up to 2-years, or until the end of the last patient 1-year follow-up period, whichever occurs first. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 7 |
E.8.9.2 | In all countries concerned by the trial days | 0 |