Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT06274294
Eligibility Criteria:
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:
* moderately to severely active CD (Crohn's disease)
* moderately to severely active 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.
9. ► Inclusion criteria for Women of Childbearing Age:
Women of childbearing age should consider the use of appropriate contraception to prevent pregnancy and continue its use for at least 6 months after the last infliximab treatment. Women should choose one of the following methods of contraception:
* Combined hormonal contraception containing estrogen and progesterone (oral, IUD, transdermal, injectable) combined with ovulation inhibition.
* Initiated at least 30 days before Baseline Day 1.
* Progestin-only hormonal contraception (oral, injectable, implantable) associated with ovulation inhibition initiated at least 30 days before the first injection.
* Bilateral tubal occlusion (can be performed by hysteroscopy, provided that hysterosalpingography confirms the success of the procedure).
* Intrauterine device (IUD).
* Practicing true abstinence, defined as: abstaining from heterosexual intercourse when this corresponds to the subject's preferred and usual lifestyle (periodic abstinence \[e.g. calendar method, ovulation method, symptothermal method, post-ovulation methods\] and withdrawal are not acceptable)
* Inclusion Criteria for Women Not of Childbearing Age:
Women do not need to use contraception during or after treatment with study drug if they are considered not of childbearing age due to one of the following situations:
* Premenopausal women with permanent infertility following hysterectomy, bilateral salpingectomy or bilateral oophorectomy.
* Postmenopausal women
* Age \> 55 years without menstruation for 12 months or more without alternative medical cause.
* Age ≤ 55 years without menstruation for 12 months or more without alternative medical cause AND a folliculostimulin (FSH) level \> 30 IU/L.
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. Patients with moderate or severe heart failure (NYHA class III/IV).
7. 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.
8. Person deprived of liberty for judicial or administrative decision, person under psychiatric care as referred in articles L. 3212-1 and L. 3213-1.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06274294
Study Brief:
Protocol Section:
NCT06274294