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Preemptive HLA Genotyping for the Safe Use of Infliximab-combination Therapy in Inflammatory Bowel Disease (INHERIT Trial)
N/A
Waitlist Available
Led By Aze A Wilson, MD, PhD
Research Sponsored by Western University, Canada
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial looks at whether a gene test can help predict who will form antibodies to a certain drug, which would then help guide clinicians in deciding whether to put patients on combination therapy.
Eligible Conditions
- Inflammatory Bowel Disease
- Crohn's Disease
- Colitis
- Perianal Fistulas
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
incidence of infliximab anti-drug antibodies
Secondary study objectives
incidence of combination therapy (infliximab and one of methotrexate or azathioprine) -related adverse drug events
Adverse reaction to drug
incidence of infliximab discontinuation
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: preemptive screeningExperimental Treatment1 Intervention
prospective HLADQA1\*05A\>G screening and targeted administration of combination therapy of infliximab with one of either methotrexate or azathioprine.
Group II: standard of careActive Control1 Intervention
administration of combination therapy with infliximab and one of methotrexate or azathioprine is at the discretion of the treating physician. HLADQA1\*05A\>G genotyping will be performed retrospectively.
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Who is running the clinical trial?
Western University, CanadaLead Sponsor
254 Previous Clinical Trials
59,124 Total Patients Enrolled
Aze A Wilson, MD, PhDPrincipal InvestigatorWestern University