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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 Practi

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Disease Information

Descriptive Information
Brief Title † 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
Official Title † 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
Brief Summary The main purpose of this study is to assess patients` adherence attitudes (beliefs) to the maintenance therapy with a scheduled Adalimumab monotherapy or a combination therapy with methotrexate and to investigate whether there are correlations between such beliefs and adherence to maintenance treatment.
Detailed Description This is a non-interventional, observational study 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. The assignment of the patient to a Humira-containing regimen has to be decided in advance and has to be current practice. The prescription of Humira is clearly separated from the decision to include the participant in this study.
Study Phase N/A
Study Type † Observational
Study Design †
Primary Outcome Measure † Changes in the Beliefs about Medicines Questionnaire (BMQ) for rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis patients (AS), plaque psoriasis (PsO), Crohn's disease (CD) and ulcerative colitis (UC):
Secondary Outcome Measure † Changes of the Treatment Satisfaction Questionaire for Medication (TSQM) over time.
Condition † Rheumatoid Arthritis Ankylosing Spondylitis Psoriatic Arthritis Crohn´s Disease Ulcerative Colitis Plaque Psoriasis
Intervention †
Study Arms / Comparison Groups Chronic inflammatory diseases (RA, PsA, AS, PsO, CD, UC) Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque psoriasis, Crohn´s disease and ulcerative colitis.
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status †
Estimated Enrollment † 140
Start Date † February 5, 2013
Completion Date September 30, 2017
Primary Completion Date September 30, 2017
Eligibility Criteria † Inclusion Criteria: - Patients aged >=18 years with RA, PsA, AS, PsO, CD, UC - Patients must fulfill international and national guidelines for the use of a BDMARD in RA, - PsA, AS, PsO, CD, UC (Chest X-ray and IGRA interferon gamma release assay or PPD-skin test negative for tuberculosis). In addition one of the following criteria must be fulfilled: 1. unsatisfactory DMARD response defined as failure to treatment with at least two DMARDs including Methotrexate in patients with RA or PsA 2. unsatisfactory NSAID response in patients with AS 3. unsatisfactory response to prior BDMARDs in patients with RA or PsA or AS. 4. unsatisfactory response to or contraindication to, or intolerance to other systemic therapy including cyclosporine, methotrexate or PUVA in patients with PsO. Unsatisfactory response despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or intolerance or medical contraindications for such therapies in CD. 5. unsatisfactory response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or intolerance to or medical contraindications for such therapies in UC. Exclusion Criteria: - Patients who are not covered in the latest version of the Humira syringe® SPC and Humira Pen® SPC; - Patients participating in another study program or clinical trial. - Patients who have been treated with Adalimumab before
Gender All
Ages 18 Years - 99 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries † Austria
Administrative Information
NCT ID † NCT01768858
Organization ID P13-562
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † AbbVie
Collaborators †† Raffeiner GmbH
Investigators † Study Director: Alexander P Dorr, PhD, AbbVie Austria
Information Provided By
Verification Date April 2017
First Received Date † January 14, 2013
Last Updated Date April 20, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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