World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03209232
Date of registration: 01/07/2017
Prospective Registration: Yes
Primary sponsor: Schneider Children's Medical Center, Israel
Public title: Infliximab Accelerated Induction in Moderate to Severe Pediatric UC INDUCE
Scientific title: Infliximab Accelerated Induction for Moderate to Severe Ulcerative Colitis in Children (INDUCE) Trial
Date of first enrolment: April 16, 2018
Target sample size: 84
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT03209232
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
Israel
Contacts
Name:     Amit Assa, MD
Address: 
Telephone: 972543522211
Email: dr.amit.assa@gmail.com
Affiliation: 
Name:     Amit Assa, MD
Address: 
Telephone: 972543522211
Email: dr.amit.assa@gmail.com
Affiliation: 
Name:     Amit Assa, MD
Address: 
Telephone:
Email:
Affiliation:  Schneider Children's Medical Center, Israel
Key inclusion & exclusion 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.



Age minimum: 6 Years
Age maximum: 18 Years
Gender: All
Health Condition(s) or Problem(s) studied
Ulcerative Colitis
Intervention(s)
Drug: Infliximab
Primary Outcome(s)
Clinical remission on infliximab [Time Frame: 20 weeks]
Secondary Outcome(s)
Adverse events [Time Frame: 20 weeks]
Calprotectin level [Time Frame: 20 weeks]
Clinical remission on infliximab [Time Frame: 52 weeks]
Colectomy free rate [Time Frame: 52 weeks]
Drug levels prior to last study infusion [Time Frame: 14 weeks]
Secondary ID(s)
INDUCE
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history