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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: 16 December 2017
Main ID:  NCT02453607
Date of registration: 21/05/2015
Prospective Registration: No
Primary sponsor: Ernest Seidman
Public title: The Impact of 6MP Metabolite Levels on Infliximab Pharmacokinetics and Anti-infliximab Antibodies in Crohn's Disease
Scientific title: The Impact of 6MP Metabolite Levels on Infliximab Pharmacokinetics and Anti-infliximab Antibodies in Crohn's Disease
Date of first enrolment: November 17, 2014
Target sample size: 225
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT02453607
Study type:  Observational
Study design:   
Phase:  N/A
Countries of recruitment
Canada
Contacts
Name:     Melissa Diamond, BSc. JD/MSEL
Address: 
Telephone: 5149341934
Email: melissa.diamond@mail.mcgill.ca
Affiliation: 
Name:     Melissa Diamond, BSc.,JD/MSEL
Address: 
Telephone: 5149341934
Email: melissa.diamond@mail.mcgill.ca
Affiliation: 
Name:     Ernest Seidman, MDCM
Address: 
Telephone:
Email:
Affiliation:  McGill University Health Center
Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients with a diagnosis of CD ,

- age 18-70 years,

- who are treated with IFX (standard 5 mg/kg/q8 weeks maintenance dose) or IFX (standard
maintenance dose)/thiopurine (stable dose for at least 3 months) combination for <12
months.-

Exclusion Criteria:

- Age< 18 years;

- Patients treated with IFX at non-standard doses;

- diagnosis of ulcerative colitis, pouchitis, indeterminate colitis or Crohn's disease
involving the upper GI tract or perianal disease without involvement of small bowel or
colon;

- concomitant therapy with cyclosporine, methotrexate or other immunosuppressant other
than thiopurine and IFX, treatment with IFX or IFX/thiopurine combination for > 12
months;

- pregnancy



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All
Health Condition(s) or Problem(s) studied
Crohn's Disease
Inflammatory Bowel Disease
Intervention(s)
Drug: Infliximab
Drug: thiopurine
Primary Outcome(s)
Correlation of 6-TGN serum levels with IFX serum trough levels [Time Frame: 52 weeks]
Secondary Outcome(s)
6 TGN levels and dose escalation or disconinuation of IFX [Time Frame: 52 plus 6 months for data calculation]
Evaluation of 6-TGN serum levels and IFX trough levels [Time Frame: 52 weeks]
Vitamin D levels and efficacy of anti-TNF therapy [Time Frame: duration of study and 1 additional year for data analysis]
Vitamin D status and effect on ATI levels [Time Frame: duration of study and 1 additional year for data analysis]
Secondary ID(s)
14-158-GEN
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
University of Alberta
University of Calgary
University of Toronto
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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