A Prospective Non-interventional Multicenter Study to Evaluate the Effectiveness of Adalimumab in Korean Patients With Ulcerative Colitis (UC) and Identify Potential Predictors of Clinical Response in Routine Clinical Practice

Study Identifier
P15-346
CT.gov Identifier
NCT02499263
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Statistical Analysis Plan
Available Language(s): English
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Protocol
Available Language(s): English
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Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Ulcerative Colitis (UC)
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    19+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Participant must be an adult ≥19 years * Participant with active moderate to severe ulcerative colitis with Mayo score of ≥ 6 points and endoscopic sub-score of ≥ 2 points despite treatment with corticosteroids and/or immunosuppressants. * Participant must have tuberculosis (TB) Screening Assessment in accordance Korean reimbursement guidelines. * Participants who had started on adalimumab treatment in normal clinical practice setting by their physician. * Participant must provide written authorization form to use personal and/or health data prior to the entry into the study.
    Exclusion Criteria:
    * Female participants who are pregnant or breast feeding * Participant with any contraindication to adalimumab * Participant that is participating in other clinical trials

    Protocol Summary

    This is a prospective, single country, multi-center study in participants with ulcerative colitis (UC) treated with adalimumab. Up to 147 participants are enrolled at approximately 20 sites. The baseline assessment is performed prior to the first dose of adalimumab (Visit 1). Study visits are conducted at weeks 8, 16, 24, 32, 40, 48 and 56 after baseline in accordance with clinical practice. All participants will have one Follow-up for safety approximately 70 days after the last dose of adalimumab.

    Study Locations

    Location
    Status
    Location
    Kyungpook National Univ Hosp /ID# 153133
    Daegu, Daegu Gwang Yeogsi, Republic of Korea, 41944
    Status
    Not applicable
    Location
    St. Vincent's Hospital /ID# 138455
    Suwon, Gyeonggido, Republic of Korea, 16247
    Status
    Not applicable
    Location
    Ajou University Hospital /ID# 138457
    Suwon, Gyeonggido, Republic of Korea, 16499
    Status
    Not applicable
    Location
    Inje University Busan Paik Hospital /ID# 138451
    Pusan, Gyeongsangbuk-do, Republic of Korea, 47392
    Status
    Not applicable
    Location
    Inha University Hospital /ID# 150176
    Junggu, Incheon Gwang Yeogsi, Republic of Korea, 22332
    Status
    Not applicable
    Location
    Chonnam National University Hospital /ID# 138450
    Gwangju, Jeonranamdo, Republic of Korea, 61469
    Status
    Not applicable
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