Assessment of Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis, Crohn's Disease and Ulcerative Colitis Patients´ Adherence Attitudes to Maintenance Therapy With a Scheduled Adalimumab Treatment in Routine Clinical Practice

Last updated: January 25, 2019
Sponsor: AbbVie
Overall Status: Completed

Phase

N/A

Condition

Ankylosing Spondylitis

Rheumatoid Arthritis

Warts

Treatment

N/A

Clinical Study ID

NCT01768858
P13-562
  • Ages 18-99
  • All Genders

Study Summary

The purpose of this non-interventional, multicenter, post-marketing observational study (PMOS) was to assess rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), plaque psoriasis (PS), Crohn's disease (CD) and ulcerative colitis (UC) patients' adherence attitudes (beliefs) to maintenance therapy with adalimumab monotherapy or combination therapy with methotrexate (in participants with RA) and to investigate whether there were correlations between such beliefs and adherence to maintenance treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants ≥18 years of age with rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), plaque psoriasis (PS), Crohn´s disease (CD), orulcerative colitis (UC)

  • Participants must fulfill international and national guidelines for the use of abiologic disease-modifying antirheumatic drug (bDMARD) in RA, PsA, AS, PS, CD, or UC (chest X-ray and interferon gamma release assay (IGRA) or purified protein derivative (PPD) skin test negative for tuberculosis)

  • In addition one of the following criteria must be fulfilled:

  1. unsatisfactory DMARD response defined as treatment failure with at least twoDMARDs including methotrexate in participants with RA or PsA

  2. unsatisfactory nonsteroidal anti-inflammatory drug (NSAID) response inparticipants with AS

  3. unsatisfactory response to prior bDMARDs in participants with RA, PsA, or AS

  4. unsatisfactory response to, contraindication to, or intolerance to other systemictherapy including cyclosporine, methotrexate, or psoralen with ultraviolet Alight (PUVA) in participants with PS

  5. unsatisfactory response despite a full and adequate course of therapy with acorticosteroid and/or an immunosuppressant; or intolerance or medicalcontraindications for such therapies in CD

  6. unsatisfactory response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or intolerance to or medicalcontraindications for such therapies in UC

Exclusion

Exclusion Criteria:

  • Participants who are not covered in the latest version of the adalimumab Summary ofProduct Characteristics (SPC) for the syringe and pen

  • Participants currently enrolled in another study program or clinical trial

  • Participants who have been treated with adalimumab before

Study Design

Total Participants: 96
Study Start date:
February 05, 2013
Estimated Completion Date:
August 13, 2017

Study Description

Adalimumab was prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication. The assignment of a participant to an adalimumab-containing regimen was decided in advance and was to be current practice. The prescribing of adalimumab was clearly separated from the decision to include the participant in the study. Participants were observed for a maximum of 12 months, with a total of 5 study visits (Screening = Visit 1).

Connect with a study center

  • Site Reference ID/Investigator# 69657

    Bludenz, 6700
    Austria

    Site Not Available

  • Site Reference ID/Investigator# 138664

    Carinthia, 9020
    Austria

    Site Not Available

  • Site Reference ID/Investigator# 69654

    Fuerstenfeld, 8280
    Austria

    Site Not Available

  • Site Reference ID/Investigator# 69648

    Gloggnitz, A-2640
    Austria

    Site Not Available

  • KH d.Barmh. Br. Graz-Eggenberg /ID# 69653

    Graz, A-8020
    Austria

    Site Not Available

  • Site Reference ID/Investigator# 69656

    Innsbruck, 6020
    Austria

    Site Not Available

  • Dr. Horst Just, Klagenfurt, AT /ID# 69655

    Klagenfurt, A-9020
    Austria

    Site Not Available

  • Dr. Gabriela Eichbauer-Sturm, Linz, Austria /ID# 69652

    Linz, A-4020
    Austria

    Site Not Available

  • Dr. Thomas Schwingenschloegl, Neudorf, Austria /ID# 69645

    Neudorf, A-2351
    Austria

    Site Not Available

  • Site Reference ID/Investigator# 69660

    Salzburg, A-5020
    Austria

    Site Not Available

  • Dr. Thomas Nothnagel, Spitz, Austria /ID# 69649

    Spitz, 3620
    Austria

    Site Not Available

  • Site Reference ID/Investigator# 69647

    St. Poelten, 3100
    Austria

    Site Not Available

  • Medical University of Vienna /ID# 138660

    Vienna, 1090
    Austria

    Site Not Available

  • Regional Hospital Voecklabruck /ID# 69658

    Voecklabruck, A-4840
    Austria

    Site Not Available

  • Klinikum Wels - Grieskirchen GmbH /ID# 138661

    Wels, 4600
    Austria

    Site Not Available

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