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:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-24 @ 10:01 PM
NCT ID:
NCT03209232
Eligibility Criteria:
Inclusion Criteria:
1. Ulcerative colitis
2. PUCAI≥35
3. Age: 6 - 17 years (inclusive)
4. Planned to initiate IFX therapy.
5. Naïve to biologics
6. Informed consent
7. Neg. PPD-Test, negative HBV- S Ag
8. Negative stool culture, parasites and clostridium toxin
Exclusion Criteria:
1. Pregnancy.
2. Acute severe colitis.
3. Renal Failure.
4. Toxic megacolon.
5. Patients whose disease is confined to the rectum (i.e. proctitis).
6. Prior treatment with infliximab or adalimumab.
7. Previous malignancy.
8. Sepsis or active bacterial infection.
9. Known immune deficiency.
10. Positive Hepatitis B surface antigen or evidence for TB.
11. IBD unclassified.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
18 Years
Study:
NCT03209232
Study Brief:
Protocol Section:
NCT03209232