Assessment of Pain Management in Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis Patients Who Are About to be Treated With Adalimumab

Study Identifier
P12-585
CT.gov Identifier
NCT01273519
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
  • Rheumatoid Arthritis
  • Axial Spondyloarthritis (axSpA)
  • Psoriatic Arthritis (PsA)
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Patients aged ≥ 18 years for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis * Patients must fulfill international and national guidelines for the use of a biological disease modifying antirheumatic drug in rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis (chest x-ray and interferon gamma release assay or purified protein derivative-skin test negative for tuberculosis). In addition one of the following criteria must be fulfilled: * unsatisfactory disease modifying antirheumatic drug response defined as failure to treatment with at least two disease modifying antirheumatic drugs including Methotrexate in patients with rheumatoid arthritis or psoriatic arthritis * unsatisfactory non steroidal antiinflammatory drug response in patients with ankylosing spondylitis or unsatisfactory response to prior biological disease modifying antirheumatic drugs in patients with rheumatoid arthritis or psoriatic arthritis or ankylosing spondylitis
    Exclusion Criteria:
    * Patients who meet contraindications as outlined in the latest version of the Humira syringe® summary of product characteristics and Humira Pen® summary of product characteristics * Patients participating in another study program or clinical trial * Patients who have been treated with Humira before

    Protocol Summary

    The purpose of this study is to assess whether or not adalimumab (Humira®) can influence pain medication in participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) with or without comorbidities, which do not constitute a contraindication for adalimumab as stated in the released summary of product characteristics. Therefore it shall be evaluated if pain medication which is used in these participants is changed, reduced or stopped due to adalimumab treatment.

    Study Locations

    Location
    Status
    Location
    Site Reference ID/Investigator# 52144
    Bludenz, Austria, 6700
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 44915
    Fürstenfeld, Austria, 8280
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 44910
    Gloggnitz, Austria, A-2640
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 44914
    Graz, Austria, A-8020
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 52143
    Innsbruck, Austria, 6020
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 44916
    Klagenfurt, Austria, A-9020
    Status
    Not applicable
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