Adalimumab in Combination With Topical Treatment (Calcipotriol/Betamethasone) in Subjects With Moderate to Severe Psoriasis and Insufficient Response to Classic Systemic Treatment

Study Identifier
M10-060
CT.gov Identifier
NCT00574249
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
  • Calcipotriol/Betamethasone Ointment
  • placebo (vehicle ointment)
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Subject is >= 18 years of age - Subject had a clinical diagnosis of chronic plaque psoriasis for at least 6 months, and has moderate to severe plaque psoriasis - Subject must have been treated and failed to respond to, or has a contraindication to, or is intolerant to at least two different systemic therapies, one of which must be cyclosporine, or methotrexate or oral PUVA - Subject is judged to be in generally good health as determined by the principal investigator
    Exclusion Criteria:
    - Subject has previous exposure to adalimumab - Subject cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot avoid UVB or PUVA phototherapy - Subject is taking or requires oral or injectible corticosteroids - Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, medication-induced or medication-exacerbated psoriasis or new onset guttate psoriasis - Subject considered by the investigator, for any reason, to be an unsuitable candidate - Female subject who is pregnant or breast-feeding or considering becoming pregnant - Subject has a calcium metabolism disorder

    Protocol Summary

    The objective of this study is to assess the efficacy and safety of adalimumab in combination

    with topical psoriasis treatment, calcipotriol/betamethasone, vs. adalimumab in combination

    with matching vehicle in subjects with moderate to severe chronic plaque psoriasis.

    Study Locations

    Location
    Status
    Location
    Graz, Austria, 8036
    Status
    Not applicable
    Location
    Innsbruck, Austria, 6020
    Status
    Not applicable
    Location
    Salzburg, Austria, 5020
    Status
    Not applicable
    Location
    Wein, Austria, 1160
    Status
    Not applicable
    Location
    Wien, Austria, 1030
    Status
    Not applicable
    Location
    Wien, Austria, 1090
    Status
    Not applicable
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