PASSPORT

Korábbi kezelés

• Combination therapy with an immunomodulator except for patients suffering from anal suppuration related to CD.
• 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-γ release assay (IGRA) or latent tuberculosis (TB) prior to initiation of biologic therapy.

Más betegség

• 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.
• Person deprived of liberty for judicial or administrative decision, person under psychiatric care as referred in articles L. 3212-1 and L. 3213-1.

Egyéb

• 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.

• 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.