Main
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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:
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ClinicalTrials.gov |
Last refreshed on:
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4 January 2016 |
Main ID: |
NCT01802593 |
Date of registration:
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24/12/2012 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Comparison of 2 Immunomodulator Withdrawal Schemes for Infliximab Monotherapy in Active Pediatric Crohn's Disease After Thiopurine Failure
WITHDRAW |
Scientific title:
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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:
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February 2013 |
Target sample size:
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20 |
Recruitment status: |
Terminated |
URL:
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https://clinicaltrials.gov/show/NCT01802593 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Israel
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Contacts
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Name:
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Dan Turner, MD, PhD |
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Affiliation:
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Pediatric Gastroenterology and Nutrition Unit, The Hebrew University of Jerusalem, Shaare Zedek MC, Jerusalem, Israel |
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Name:
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Raanan Shamir, MD |
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Affiliation:
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Schneider Childrens Hospital |
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Name:
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Efrat Broide, MD |
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Email:
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Affiliation:
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Asaf Harofe Medical Center |
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Name:
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Batia Weiss, MD |
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Affiliation:
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Sheba Medical Center |
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Name:
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Sarit Peleg, MD |
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Affiliation:
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Afula Hospital |
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Name:
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Ron Shaoul, MD |
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Affiliation:
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Meyer Childrens Hospital Rambam, Haifa, Israel |
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Name:
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Hussein Chemali, MD |
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Email:
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Affiliation:
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Nazheret Hospital |
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Name:
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Avi On, MD |
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Email:
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Affiliation:
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Poriah Hospital |
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Name:
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Aharon Lerner, MD |
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Email:
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Affiliation:
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Carmel Hospital |
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Name:
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Arie Levine, MD |
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Telephone:
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Email:
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Affiliation:
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Pediatric Gastroenterology and Nutrition Unit, The E. Wolfson MC, Tel-Aviv University, Holon, Israel |
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Name:
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Michael Wilshanski, MD |
Address:
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Email:
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Affiliation:
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Hadassah Medical Center |
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Name:
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Shlomi Cohen, MD |
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Email:
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Affiliation:
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Tel Aviv Medical Center |
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Name:
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Michal Kori, MD |
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Email:
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Affiliation:
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Kaplan Medical Center |
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Name:
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Baruch Yerushalmi, MD |
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Email:
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Affiliation:
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Soroka Medical Center |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Crohn's Disease
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Intervention(s)
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Drug: AZATHIOPRINE or METHOTREXATE
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Primary Outcome(s)
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Complete or partial LAR (lack of remission)
[Time Frame: 76 weeks]
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Secondary Outcome(s)
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Corticosteroid free remission
[Time Frame: 14 weeks]
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Hospitalizations for LOR (loss of response) or failure to obtain remission
[Time Frame: Up to 76 weeks]
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Medication associated adverse events
[Time Frame: Up to 76 weeks]
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Mean trough level
[Time Frame: 14 and 52 weeks]
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Presence of ATI
[Time Frame: 52 weeks]
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Sustained steroid free remission
[Time Frame: 52 and 76 weeks]
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Secondary ID(s)
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0169-12-WOMC
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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