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 @ 4:56 AM
Ignite Modification Date:
2025-12-25 @ 4:56 AM
NCT ID:
NCT06381518
Eligibility Criteria:
Inclusion Criteria:
* Adult patients (18-75 years) with an confirmed diagnosis of IBD according to usual criteria, including previous endoscopic examination.
* Patients on IV IFX maintenance therapy at a stable dose and dosing interval for at least 16 weeks of 5-10 mg/kg every 6-8 weeks without side effects of IFX.
* IBD in clinical remission for at least 16 weeks without treatment with systemic corticosteroids in the previous 16 weeks. Clinical remission in adult patients is defined as a Harvey-Bradshaw index (HBI) \< 4 for CD \[18\] or a partial Mayo Index (PMI) \<2 for UC \[19\], with faecal calprotectin levels \<250 μg/g faeces and CRP \<10 mg/L.
* Concomitant immunomodulators are allowed, i.e. in stable doses were received for at least 12 weeks prior to study enrolment. These doses will be continued throughout the study, including azathioprine (AZA), 6-mercaptopurine (6-MP), tioguanine (TG) and MTX.
* Written informed consent
Exclusion Criteria:
* Patient \<18 years of age.
* Allergy or hypersensitivity to any of the excipients of SC CT-P13.
* Patient with active perianal fistula.
* Patient with another autoimmune disease in addition to IBD.
* Patient treated concomitantly with another Mab in addition to IFX.
* Patients who, after starting IV IFX, have developed new contraindications to IFX according to European Public Assessment Report (EPAR).\[3\]
* Female patient who is currently pregnant or breastfeeding, or is planning to become pregnant or breastfeed within 6 months of the last dose of IFX.
* Patient has a serious acute or chronic medical or psychiatric condition that might increase the risk associated with study participation or investigational product administration or that might interfere with the interpretation of study results.
* Patients who, in the opinion of their general practitioner or investigator, should not participate in the study (e.g. non-adherence, mental health problems, illiteracy).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06381518
Study Brief:
Protocol Section:
NCT06381518