EValuation of HumIRA® in Patients With Active Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis in EASTern European Countries

Study Identifier
P10-919
CT.gov Identifier
NCT01078402
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Axial Spondyloarthritis (axSpA)
  • Psoriatic Arthritis (PsA)
  • Rheumatoid Arthritis
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    \- Adult patients with active RA, PsA or AS for whom Humira therapy is indicated according to the local product label and who meet the following criteria: * Are newly prescribed Humira therapy (no prior history of treatment with Humira), including patients with infliximab or etanercept treatment history OR * Completed Abbott sponsored interventional clinical trials and are continuing treatment with commercial Humira thereafter.
    Exclusion Criteria:
    * Patients who are being treated or will be treated with drugs at risk of interactions with Humira (see Humira Summary of Product Characteristics) * Patients currently participating in another clinical trial * Patients with diagnosis of active tuberculosis

    Protocol Summary

    This is a non-interventional, post-marketing, observational study (PMOS) in which Humira (adalimumab) is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication. No data currently exists to characterize patient populations being prescribed Humira in Eastern Europe. Further, it is important to establish the clinical outcome and tolerability of Humira in Eastern European patients, as well as their compliance with Humira treatment, in particular the acceptability of self-injection, which may influence all of the above in routine clinical practice.

    Study Locations

    Location
    Status
    Location
    Site Reference ID/Investigator# 43283
    Opatija, Croatia, 51410
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 43282
    Osijek, Croatia, 31000
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 43286
    Rijeka, Croatia, 51 000
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 43284
    Split, Croatia, 21000
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 22405
    Zagreb, Croatia, 10000
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 43285
    Zagreb, Croatia, 10000
    Status
    Not applicable
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