The "PASSPORT Trial": Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous as Induction Therapy in Patients With Active Crohn's Disease or Ulcerative Colitis.

2023/12

The goal of this clinical trial is to compare induction treatment with CT-P13 SC to induction treatment with CT-P13 IV in terms of pharmacokinetics in adult patients with inflammatory bowel disease (IBD) who have been diagnosed for at least 3 months and for whom the physician has decided to initiate treatment with infliximab CT-P13 as part of the standard of care. The main aim of this study is to demonstrate that induction treatment with CT-P13 SC is non-inferior to CT-P13 IV in terms of pharmacokinetics at Week 6.

2024-03-01

2025-01-01

2025-01-01

Not yet recruiting

Early phase I

130

Inclusion Criteria: 1. Male or female, aged at least 18 years old. 2. Diagnosis of inflammatory bowel disease according to the ECCO criteria for at least 3 months: * CD (Crohn's disease) * UC (Ulcerative colitis) 3. 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. 4. Patient has active CD or UC with at least one objective sign of disease activity on biology, endoscopy or imaging. 5. Initiation of infliximab CT-P13 as part of standard of care. 6. Patient suffering from anal suppuration related to CD can be included. 7. 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. 8. Person affiliated to or beneficiary of a social security plan. Exclusion Criteria: 1. Combination therapy with an immunomodulator except for patients suffering from anal suppuration related to CD. 2. 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. 3. 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. 4. 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. 5. Patients with a positive interferon-γ release assay (IGRA) or latent tuberculosis (TB) prior to initiation of biologic therapy. 6. 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. 7. Person deprived of liberty for judicial or administrative decision, person under psychiatric care as referred in articles L. 3212-1 and L. 3213-1.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The full sample size comprises 130 patients, with 65 patients allocated to each arm. The arms are defined as follows:\n\n* Experimental Arm: Patients receive CT-P13 SC at weeks 0, 1, 2, 3, 4, and 6, followed by subcutaneous administration every two weeks until week 24.\n* Control Arm: Patients receive CT-P13 IV at weeks 0 and 2, followed by subcutaneous administration every two weeks until week 24.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 130, 'type': 'ESTIMATED'}}

2024-02-23