Observational Study to Explore the Effectiveness of Adalimumab Treatment in Conjunction With Utilization of a Patient Support Program (PSP)

Study Identifier
P12-072
CT.gov Identifier
NCT01383421
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
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    18 - 99 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Male or female aged at least 18 years that has been newly prescribed adalimumab therapy according to the local product label, with the first dose corresponding to the Enrollment/Baseline visit. * Patient with a diagnosis of moderate to severe RA, who has had insufficient response to one or more disease-modifying antirheumatic drugs (DMARDs), and has a prescription of adalimumab according to the local regulations. * Patients should be evaluated for tuberculosis (TB) exposure/risk factors for active and latent TB (per local requirements and according to the local product label). * Patients must be able and willing to provide written authorization to disclose and use personal health information (and informed consent where applicable) and comply with the requirements of this study protocol as well as agree to data being collected and provided to AbbVie.
    Exclusion Criteria:
    * Patients should not be enrolled if they cannot be treated in accordance with the local adalimumab product label. * Patients treated with \> 1 prior biologic DMARD for RA. Any prior treatment with adalimumab is prohibited.

    Protocol Summary

    This study is a non-confirmatory post-marketing observational study to explore and describe the effectiveness of adalimumab on rheumatoid arthritis (RA) treatment course and participant satisfaction over time in context with utilization of a patient support program (PSP). The core elements of the PSP were call centers (in and outbound)/hotlines, nursing services, starter packs, provision of educational materials (print and digital) regarding RA and adalimumab, and injection guides. Other elements of the PSP, which varied between countries, included (but were not limited to) refill reminders, email contacts, support groups, and newsletters.

    Study Locations

    No locations found.