Multi-country Post-Marketing Observational Study on Maintenance of Effectiveness of Adalimumab (Humira®) in Patients With Ankylosing Spondylitis and Psoriatic Arthritis

Study Identifier
P12-768
CT.gov Identifier
NCT01474876
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
  • 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 will be enrolled in this Postmarketing observational study PMOS if they fulfill all of the below criteria: 1. Adult patients with diagnosis of Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA). 2. Eligible for adalimumab therapy according to the local product label and prescription/reimbursement guidelines. 3. Have been prescribed adalimumab within a maximum of one (1) month prior to the study enrolment. 4. Have negative result of Tuberculosis (TB) screening test or TB prophylaxis as per local guidelines. 5. Are willing to provide Authorization to the investigator to use and/or disclose personal and/or health data, or to provide Informed Consent if requested by the Local Regulations, before entry into the study.
    Exclusion Criteria:
    Patients fulfilling below exclusion criteria will not be eligible for this Postmarketing study (PMOS): 1\. Meet contraindications for treatment with adalimumab as outlined in the latest version of the local Summary of Product Characteristics (SmPC)

    Protocol Summary

    This 12-month postmarketing observational study (PMOS) was a prospective, single-arm, multicenter, multi-country study, with follow-up visits at 3, 6, 9, and 12 months after the initial baseline visit. The study was conducted to determine the long-term effectiveness of treatment with adalimumab in routine clinical use in participants with Ankylosing Spondylitis (AS) and Psoriatic Arthritis (PsA) in Central and Eastern European Countries.

    Study Locations

    No locations found.