The Impact of 6MP Metabolite Levels on Infliximab Pharmacokinetics and Anti-infliximab Antibodies in Crohn's Disease
Information source: McGill University Health Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Inflammatory Bowel Disease; Crohn's Disease
Intervention: Infliximab (Drug); thiopurine (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Ernest Seidman Official(s) and/or principal investigator(s):
Ernest Seidman, MDCM, Principal Investigator, Affiliation: McGill University Health Center
Overall contact:
Melissa Diamond, BSc.,JD/MSEL, Phone: 5149341934, Ext: 44385, Email: melissa.diamond@mail.mcgill.ca
Summary
In this research proposal, the investigators will focus on methods to optimize the
therapeutic response to anti-TNF antibodies, by determining a correlation of 6-mp metabolite
levels with IFX trough levels, anti-IFX antibody levels and clinical response. The study
will also evaluate (in vitro) the possible impact of vitamin D on the interaction of IFX
with dendritic cells in both healthy subjects and patients with Crohn's disease
(proliferation, maturation, cytokine profile, apoptosis, gene expression).
Clinical Details
Official title: The Impact of 6MP Metabolite Levels on Infliximab Pharmacokinetics and Anti-infliximab Antibodies in Crohn's Disease
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Correlation of 6-TGN serum levels with IFX serum trough levels
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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
Locations and Contacts
Melissa Diamond, BSc.,JD/MSEL, Phone: 5149341934, Ext: 44385, Email: melissa.diamond@mail.mcgill.ca
Montreal General Hospital, Montreal, Quebec H3G 1A4, Canada; Recruiting
Melissa Diamond, BSc. JD/MSEL, Phone: 5149341934, Ext: 44385, Email: melissa.diamond@mail.mcgill.ca
Ernest Seidman, MDCM, Principal Investigator
Additional Information
Starting date: May 2015
Last updated: May 22, 2015
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