A Long-Term Registry of Humira® (Adalimumab) in Patients With Moderately to Severely Active Ulcerative Colitis (UC)

Study Identifier
P11-282
CT.gov Identifier
NCT01848561
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Recruitment Complete
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Study Details

Medical Condition
  • Ulcerative Colitis (UC)
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    18 - 99 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * For enrollment into the HUMIRA treatment group; adult patients with moderately to severely active UC who has been prescribed HUMIRA therapy according to routine clinical practice and meets one of the following: 1. Is currently taking HUMIRA therapy and has received at least 8 weeks of therapy; OR 2. Is entering after participation in an Abbott or AbbVie sponsored UC study and; has received continuous HUMIRA therapy since initiation of therapy * For enrollment into the IMM treatment group; adult patients with moderately to severely active UC who has been prescribed IMM therapy, is currently taking IMM therapy, and has received at least 12 consecutive weeks of IMM therapy * Patients capable of and willing to grant authorization for use/disclosure of data being collected and provided to AbbVie prior to any registry-related data being collected, and to comply with the requirements of the Registry protocol
    Exclusion Criteria:
    * Patients on IMM therapy without a concurrent biologic if they cannot continue to be treated with IMM therapy or * Patients who are being treated with any investigational agents and/or approved biologics other than Humira.

    Protocol Summary

    This is a registry study to evaluate the long-term safety and effectiveness of adalimumab in patients with moderately to severely active UC who are treated as recommended in the product label.

    Study Locations

    Location
    Status
    Location
    Birmingham Gastroenterology Associates P.C /ID# 102063
    Birmingham, Alabama, United States, 35209
    Status
    Not applicable
    Location
    University of Alabama at Birmingham - Main /ID# 131646
    Birmingham, Alabama, United States, 35233
    Status
    Not applicable
    Location
    Longwood Research /ID# 118662
    Huntsville, Alabama, United States, 35801
    Status
    Not applicable
    Location
    East View Medical Research, LLC /ID# 116259
    Mobile, Alabama, United States, 36606
    Status
    Not applicable
    Location
    Mobile Medical & Diagnostic Center, AL /ID# 102064
    Mobile, Alabama, United States, 36617
    Status
    Not applicable
    Location
    HOPE Research Institute /ID# 127947
    Phoenix, Arizona, United States, 85018
    Status
    Not applicable
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