PASSPORT

Phase 1

Recruiting

• Conditions: Immune Bowel Disease (including Crohn's disease and Ulcerative colitis).; MedDRA version: 20.0Level: PTClassification code: 10009900Term: Colitis ulcerative Class: 100000004856; MedDRA version: 20.0Level: PTClassification code: 10011401Term: Crohn's disease Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: CTIS2023-508584-72-00
• Lead Sponsor: Centre Medico Chirurgical Ambroise Pare Hartmann

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-05
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

Male or female, aged at least 18 years old., Diagnosis of inflammatory bowel disease according to the ECCO criteria for at least 3 months: ? CD (Crohn’s disease) ? UC (Ulcerative colitis), Patients had received conventional therapy for active UC (corticosteroids alone or in combination with thiopurines and 5-aminosalicylates) or CD (corticosteroids and/or immunomodulators) but had not responded despite an adequate course of therapy., Patient has active CD or UC with at least one objective sign of disease activity on biology, endoscopy or imaging., Initiation of infliximab CT-P13 as part of standard of care., Patient suffering from anal suppuration related to CD can be included., Person who has received full information about the organization of the research, who has not objected to his or her participation and to the use of his or her data., Person affiliated to or beneficiary of a social security plan.

Exclusion Criteria

Combination therapy with an immunomodulator except for patients suffering from anal suppuration related to CD., Patient who has allergies to any of the excipients of infliximab CT-P13 or any other murine and/or human proteins or patient with a hypersensitivity to immunoglobulin product., Patient who had current or past history of chronic infection with hepatitis C or human immunodeficiency virus (HIV)-1 or -2 or current infection with hepatitis B., Patient who had acute infection requiring oral antibiotics within 2 weeks or parenteral injection of antibiotics within 4 weeks prior to the first administration of the study drug, other serious infection within 6 months prior to the first administration of study drug or recurrent herpes zoster or other chronic or recurrent infection within 6 weeks prior to the first administration of the study drug., Patients with a positive interferon-? release assay (IGRA) or latent tuberculosis (TB) prior to initiation of biologic therapy., Person referred in articles L.1121-5, L. 1121-7 and L.1121-8 of the Public Health Code: pregnant woman, parturient, or breastfeeding woman, minor person (non-emancipated), adult person under legal protection (any form of public guardianship), adult person incapable of giving consent., Person deprived of liberty for judicial or administrative decision, person under psychiatric care as referred in articles L. 3212-1 and L. 3213-1.

Study & Design

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