Crohn's Disease Clinical Trial
Official title:
Optimization of Treatment With Infliximab in a Medical Setting
This is an open-label, interventional study where a subset of participants will be
randomized to one of two treatment-optimization strategies. Participants with moderate to
severe Crohn's disease (CD) will receive induction treatment comprised of 3 infusions of
infliximab at Weeks 0, 2, and 6. The participants will be evaluated at Week 10. Participants
who are in clinical response will enter the observational phase of the study where they will
receive standard of care treatment, as per the infliximab product monograph. Participants
who lose response, may qualify for entry into the interventional phase of the study, where
they will be randomized to one of the following treatment-optimization arms: 1) dose
increase: infliximab 7 mg/kg, every 8 weeks or 2) shortened interval: infliximab 5 mg/kg
every 6 weeks.
Note: Due to early study termination, no statistical analysis was performed for the
interventional part of this study, therefore, endpoints dedicated to this phase of the study
have not been analyzed.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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