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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: 12 December 2020
Main ID:  NCT02269358
Date of registration: 30/09/2014
Prospective Registration: Yes
Primary sponsor: Prof. Arie Levine
Public title: Salvage Therapy With High/Low Methotrexate for Loss of Response to Infliximab Dose Escalation
Scientific title: Phase 4, Open Lable Non Randomized un Controlled Study. Salvage Therapy With High/Low Methotrexate for Loss of Response to Infliximab Dose Escalation
Date of first enrolment: July 2015
Target sample size: 22
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02269358
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 4
Countries of recruitment
Israel
Contacts
Name:     Arie Levine, MD
Address: 
Telephone:
Email:
Affiliation:  Pediatric Gastroenterology and Nutrition Unit, The E. Wolfson MC, Tel-Aviv University, Holon, Israel
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Informed consent

2. Established diagnosis of Crohns disease.

3. Age: 8 - 18 years ( inclusive)

4. Active disease PCDAI >10 at least two weeks after infusion.

5. On Infliximab with at least 3 prior infusions, and still active despite a decreased
dose interval ( = 6 weeks) or increased dose of infliximab (=7.5 mg/kg /dose q 8
weeks).

Comment: Patients who are on combination therapy with a stable thiopurine>8 weeks can also
be included ( thiopurine will be stopped at enrollment).

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Exclusion Criteria:

1. Patients who are primary non responders after first two doses 2. Patients who have had
to stop infliximab due to side effects. 3. Patients with known intolerance to methotrexate.
4. Elevated ALT >1.5 normal. 5. Pregnancy. 6. Patients who have insulin-dependent diabetes
7. Patients who have significantly impaired renal function 8. Current bacterial infection/
inflammation including Hepatitis B or C and Pneumonia.

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Age minimum: 8 Years
Age maximum: 18 Years
Gender: All
Health Condition(s) or Problem(s) studied
Crohn's Disease
Intervention(s)
Drug: METHOTREXATE
Primary Outcome(s)
remission [Time Frame: at 12 weeks]
Secondary Outcome(s)
ATIs [Time Frame: week 12]
Remission [Time Frame: 6 months]
Trough levels [Time Frame: week 12]
Secondary ID(s)
0143-14-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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