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The Impact of 6MP Metabolite Levels on Infliximab Pharmacokinetics and Anti-infliximab Antibodies in Crohn's Disease

NCT02453607 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 225

Last updated 2017-02-16

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Infliximab

Drug is prescribed by treating physician and is not a part of the study. This study is non-interventional. Patients, to be elgibile, are being prescribed either monotherapy inlfiximab or combo therapy infliximab with azathiopurine.

DRUG

thiopurine

Drug is prescribed by treating physician and is not a part of the study. This study is non-interventional. Patients, to be elgibile, are being prescribed either monotherapy inlfiximab or combo therapy infliximab with azathiopurine.

Sponsors & Collaborators

  • University of Toronto

    collaborator OTHER

  • University of Calgary

    collaborator OTHER

  • University of Alberta

    collaborator OTHER

  • Ernest Seidman

    lead OTHER

Principal Investigators

  • Ernest Seidman, MDCM · McGill University Health Centre/Research Institute of the McGill University Health Centre

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-11-17
Primary Completion
2019-06-30
Completion
2020-06-30

Countries

  • Canada

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02453607 on ClinicalTrials.gov