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 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 1:19 AM
NCT ID:
NCT01802593
Eligibility Criteria:
Inclusion Criteria:
1. Crohns disease
2. Age: 6 - 18 years ( inclusive)
3. Active disease PCDAI \>10, or any steroid dependence despite thiopurine use for \>10 weeks.
4. Naïve to biologics
5. Informed consent
6. CRP ≥0.6 mg/dl
7. Neg. TB-Test, negative HBV- S Ag
8. Use of IMM at present or in past for at least 10 weeks ( for Withdraw only).
9. Negative stool culture, parasites and clostridium toxin current flare
Inclusion criteria Comments:
1. Patients receiving corticosteroids may be included if the disease is active and CRP elevated.
2. All other treatments such as 5ASA , , must be discontinued immediately after the first IFX infusion.
3. Patients may receive an antihistamine prior to any infusion.Use of corticosteroid pretreatment is allowed only during the first two infusions (single infusion on day of infliximab), or if an infusion reaction has occurred.
4. Partial enteral nutrition, accounting for less than 50% of daily required calories, may be supplied as needed.
5. Patients receiving antibiotics must cease use of antibiotics within the 14 days of receiving the first infusion.
6. ESR \>20 can be alternative if the CRP \<0.6.
7. Negative stool culture, parasites and clostridium toxin current flare will examined only if the patient has diarrhea.
8. Patients may be enrolled directly in to the Predict study , in which case duration of IMM is irrelevant , but patients must have received an IMM until week 2 as in the withdraw
Exclusion Criteria:
1. Intolerance to thiopurines/methotrexate
2. Pregnancy
3. Contraindication for any of the drugs.
4. Leukopenia \<4000 or absolute neutrophil count below 1200 on two consecutive tests during screening.
5. Hepatocellular Liver disease ( ALT \> 60 ) or cirrhosis.
6. Renal Failure
7. Prior idiosyncratic side effects with thiopurines ( pancreatitis etc).
8. Current abscess ( \< 14 days of antibiotics) or perforation of the bowel( \<14 days antibiotics).
9. Small bowel obstruction within the last 3 months
10. Fixed non inflammatory stricture with predilatation with symptoms related to stricture
11. Complicated or heavily draining perianal fistula ( indolent non draining or scant draining fistula are not exclusion criteria)
12. Prior treatment with infliximab
13. Previous malignancy
14. Toxic Megacolon
15. Sepsis
16. Surgery related to Crohn's disease in previous 8 weeks.
17. Positive Hepatitis B surface antigen or evidence for TB.
18. Current bacterial infection
19. IBD unclassified
Exclusion criteria Comments:
1\. Prior surgery or post operative recurrence are not exclusion criteria.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
18 Years
Study:
NCT01802593
Study Brief:
Protocol Section:
NCT01802593