Open Label Study of Adalimumab in Subjects Who Have a Sub-optimal Response to Systemic Therapy or Phototherapy

Study Identifier
M10-238
CT.gov Identifier
NCT00566722
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

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
  • Dermatology - Psoriasis (PsO)
    • Study Drug
  • adalimumab
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Diagnosis of chronic plaque psoriasis with disease duration of at least 6 months - Sub-optimal response to treatment with etanercept, methotrexate, or narrow-band UVB phototherapy
    Exclusion Criteria:
    - Prior treatment with adalimumab - Multiple concomitant therapy restrictions and/or washouts (topicals, ultraviolet, other systemic psoriasis therapies) - Prior treatment with natalizumab - Concurrent active skin diseases/infections - Poorly controlled medical conditions - History of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease - History of certain cancers

    Protocol Summary

    The objective of this study was to evaluate the safety and efficacy profile of Humira

    (adalimumab) in patients who had a sub-optimal response to prior systemic therapy. This

    open-label study was conducted in a patient population of moderate to severe chronic plaque

    psoriasis patients, which is an approved patient population for adalimumab.

    Study Locations

    Location
    Status
    Location
    Total Skin and Beauty Dermatology Centers
    Birmingham, Alabama, United States, 35205
    Status
    Not applicable
    Location
    Dermatology Research of Arkansas
    Little Rock, Arkansas, United States, 72205
    Status
    Not applicable
    Location
    Therapeutics Clinical Research
    San Diego, California, United States, 92123
    Status
    Not applicable
    Location
    Florida Academic Dermatology Centers
    Miami, Florida, United States, 33136
    Status
    Not applicable
    Location
    Peachtree Dermatology Associates
    Atlanta, Georgia, United States, 30327
    Status
    Not applicable
    Location
    Dawes Fretzin Clinical Research Group
    Indianapolis, Indiana, United States, 46256
    Status
    Not applicable
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