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Managing Infliximab Reinduction After Temporary Discontinuation of Drug (NCT02771457)

The primary purpose of the project is to determine what is the best schedule for restarting infliximab in patients with inflammatory bowel disease (IBD) specifically ulcerative colitis and Crohn's disease, who have undergone infliximab infusions before. The primary endpoint would be the failure rate; the need to discontinue infliximab or change treatment. A secondary aim will be to determine if infliximab drug and antibody levels can predict clinical outcomes at 1 year. Other secondary outcomes include comparing short-term and long-term steroid free remission rate, and serum and fecal inflammatory markers in response to infliximab.
  • Drug: Infliximab at weeks 0,2, and 6
    • Drug: Infliximab at weeks 0,4, and 8
      • Drug: Infliximab at weeks 0 and 8
        For physicians who do not feel comfortable enrolling patients in a randomized trial of infliximab re-induction they will have the option of enrolling their patients in an arm that resumes maintenance therapy only instead at 0 and 8 weeks.
        Ages eligible for Study
        18 Years and older
        Genders eligible for Study
        All
        Accepts Healthy Volunteers
        No
        Inclusion Criteria:
        • Subjects 18 years or older who are willing and able to provide informed consent
        • HIstory of IBD (Crohn's disease, ulcerative colitis, indeterminate colitis) by standard clinical, histological, and radiographic date.
        • History of stable clinical response to prior IFX induction and regular maintenance dosing, as determine by enrolling clinician.
        • Prior to drug holiday, was on stable dose of infliximab for at least 3 infusions at regular maintenance intervals
        • Infliximab drug holiday for at least 12 weeks.
        Exclusion Criteria:
        • Inability or unwillingness to provide informed consent
        • Pregnant patients
        • Prior history of serious infusion reaction to IFX
        Status:
        unknown
        Type:
        Interventional
        Phase:
        Start:
        30 June, 2016
        Updated:
        28 June, 2016
        Participants:
        0
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