An Observational Study of Fecal Calprotectin as Clinical Tool in Monitoring Moderate-to-severe Crohn's Disease on Adalimumab Induction Therapy: a KoRean Experience (FAIR)

Study Identifier
P13-974
CT.gov Identifier
NCT01759264
EudraCT Identifier
Not available
EUCTIS ID
Not available
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844-663-3742 or [email protected]

Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Crohn's Disease (CD)
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    19+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    1\. Crohn's Disease participants were defined as: 1. Active luminal, moderate-to-severe Crohn's Disease with Crohn's disease activity index (CDAI) greater than 220, who started Adalimumab treatment in a normal clinical practice setting. 2. Fecal Calprotectin greater than or equal to 150 microgram/g. 3. Ileocolonic or colonic disease, with or without involvement of proximal gastrointestinal areas.
    Exclusion Criteria:
    1. Disease restricted to proximal (small bowel, gastroduodenal) gastrointestinal tract. 2. Participants who had undergone colectomy other than ileocecal resection. 3. Pregnancy or breast feeding. 4. Contraindication to any anti-tumor necrosis factors (TNF) agent. 5. Any drug dependency.

    Protocol Summary

    The objective of this observational study was to assess changes in fecal calprotectin levels and its suitability as a monitoring tool in participants with moderate-to-severe Crohn's Disease who were treated with adalimumab.

    Study Locations

    No locations found.