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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: 4 January 2016
Main ID:  NCT01802593
Date of registration: 24/12/2012
Prospective Registration: Yes
Primary sponsor: Prof. Arie Levine
Public title: Comparison of 2 Immunomodulator Withdrawal Schemes for Infliximab Monotherapy in Active Pediatric Crohn's Disease After Thiopurine Failure WITHDRAW
Scientific title: Phase 4, Open Label Multicenter Randomized Controlled Trial. Comparison of 2 Immunomodulator Withdrawal Schemes for Infliximab Monotherapy in Active Pediatric Crohn's Disease After Immunomodulator Failure
Date of first enrolment: February 2013
Target sample size: 20
Recruitment status: Terminated
URL:  https://clinicaltrials.gov/show/NCT01802593
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 4
Countries of recruitment
Israel
Contacts
Name:     Sarit Peleg, MD
Address: 
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Affiliation:  Afula Hospital
Name:     Efrat Broide, MD
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Affiliation:  Asaf Harofe Medical Center
Name:     Aharon Lerner, MD
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Affiliation:  Carmel Hospital
Name:     Michael Wilshanski, MD
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Affiliation:  Hadassah Medical Center
Name:     Michal Kori, MD
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Affiliation:  Kaplan Medical Center
Name:     Ron Shaoul, MD
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Affiliation:  Meyer Childrens Hospital Rambam, Haifa, Israel
Name:     Hussein Chemali, MD
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Affiliation:  Nazheret Hospital
Name:     Arie Levine, MD
Address: 
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Email:
Affiliation:  Pediatric Gastroenterology and Nutrition Unit, The E. Wolfson MC, Tel-Aviv University, Holon, Israel
Name:     Dan Turner, MD, PhD
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Affiliation:  Pediatric Gastroenterology and Nutrition Unit, The Hebrew University of Jerusalem, Shaare Zedek MC, Jerusalem, Israel
Name:     Avi On, MD
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Affiliation:  Poriah Hospital
Name:     Raanan Shamir, MD
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Affiliation:  Schneider Childrens Hospital
Name:     Batia Weiss, MD
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Affiliation:  Sheba Medical Center
Name:     Baruch Yerushalmi, MD
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Affiliation:  Soroka Medical Center
Name:     Shlomi Cohen, MD
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Affiliation:  Tel Aviv Medical Center
Key inclusion & exclusion 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.



Age minimum: 6 Years
Age maximum: 18 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Crohn's Disease
Intervention(s)
Drug: AZATHIOPRINE or METHOTREXATE
Primary Outcome(s)
Complete or partial LAR (lack of remission) [Time Frame: 76 weeks]
Secondary Outcome(s)
Corticosteroid free remission [Time Frame: 14 weeks]
Hospitalizations for LOR (loss of response) or failure to obtain remission [Time Frame: Up to 76 weeks]
Mean trough level [Time Frame: 14 and 52 weeks]
Medication associated adverse events [Time Frame: Up to 76 weeks]
Presence of ATI [Time Frame: 52 weeks]
Sustained steroid free remission [Time Frame: 52 and 76 weeks]
Secondary ID(s)
0169-12-WOMC
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:
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