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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 Practice (Adherence)

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ClinicalTrials.gov Identifier: NCT01768858
Recruitment Status : Completed
First Posted : January 16, 2013
Last Update Posted : October 19, 2017
Sponsor:
Collaborator:
Raffeiner GmbH
Information provided by (Responsible Party):
AbbVie

Study Description
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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.

Condition or disease
Rheumatoid Arthritis Ankylosing Spondylitis Psoriatic Arthritis Crohn´s Disease Ulcerative Colitis Plaque Psoriasis

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 Design
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Study Type : Observational
Actual Enrollment : 96 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : February 5, 2013
Actual Primary Completion Date : August 13, 2017
Actual Study Completion Date : August 13, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

Groups and Cohorts
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Group/Cohort
Chronic inflammatory diseases (RA, PsA, AS, PsO, CD, UC)
Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque psoriasis, Crohn´s disease and ulcerative colitis.


Outcome Measures
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Primary Outcome Measures :
  1. 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): [ Time Frame: from Day 0 to month 12 ]
    The BMQ-Specific comprises two 5-item factors assessing beliefs about the necessity of prescribed medication (Specific-Necessity) and concerns about prescribed medication based on beliefs about the danger of dependence and long-term toxicity and the disruptive effects of medication (Specific-Concern) The BMQ-General comprises two 4-item factors assessing beliefs that medicines are harmful, addictive, poisons which should not be taken continuously(General-Harm) and that medicines are over used by doctors (General-Overcure). The total score, the sum of all the points from the Specific AND General questions range from 17 (lowest score) to 85 (highest score). Patients who have positive beliefs about medicine have a score < 47 and patients who have negative beliefs have a score > 47.


Secondary Outcome Measures :
  1. Changes of the Treatment Satisfaction Questionaire for Medication (TSQM) over time. [ Time Frame: from month 3 to month 12 ]
    The 11-item Treatment Satisfaction Questionnaire for Medication (TSQM) Version II is an instrument to assess patients' satisfaction with medication, providing scores on four scales â€" side effects, effectiveness, convenience and global satisfaction. The 11 questions can be answered either with yes/no or by means of a five or seven stage scale (e.g. ranging from very unsatisfied to satisfied). SCALE SCORING ALGORITHM: TSQM Scale scores range from 0 to 100 and no computed score should be lower or higher than these limits. Higher scores represent higher satisfaction.

  2. Changes in Rheumatoid Arthritis Disease Activity Index in patients with rheumatoid arthritis and if reasonable in patients with psoriasis arthritis [ Time Frame: from day 0 to month 12 ]
    The Rheumatoid Arthritis Disease Activity Index is a questionnaire which measures disease activity

  3. Changes in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in patients with ankylosing spondylitis [ Time Frame: from Day 0 to month 12 ]
    The Bath Ankylosing Spondylitis Disease Activity Index consists of 6 questions pertaining to the 5 major symptoms of ankylosing spondylitis: fatigue, spinal pain, joint pain/swelling, areas of localized tenderness (=enthesitis), duration of morning stiffness, severity of morning stiffness

  4. Changes in Erythrocyte Sedimentation Rate (ESR) over time [ Time Frame: from Day 0 to month 12 ]
    The ESR is a practicable and sensitive but not specific parameter for measuring disease progression. By means of the ESR it can be generally distinguished between an active and non active chronic inflammatory disease.

  5. Changes in C-reactive protein (CRP) over time [ Time Frame: from Day 0 to month 12 ]
    The CRP is an acute phase reactant plasma protein, normally produced by the liver, which is commonly used as an indirect measure of the extent and activity of an inflammation.

  6. Changes in Morisky Medication Adherence Scale (MMAS) for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis patients. [ Time Frame: from month 3 to month 12 ]
    The MMAS is a 4-item Self-Report Measure of Medication-Taking Behavior. It measures both intentional and nonintentional non-adherence (based on forgetting, carelessness, stopping medication when feeling better, or stopping medication when feeling worse). The 4-item MMAS-4-item consists of 4 questions which can be answered with yes (=0 point) and no (=1point). The MMAS score is the sum of all four question and range from 0 (=non-adherent) to 4 (=adherent).

  7. Changes in Psoriasis Area and Severity Index (PASI) in patients with plaque psoriasis [ Time Frame: From Day 0 till month 12 ]
    The PASI provides quantitative assessment of psoriasis lesional burden based on the amount of BSA (Body Surface Area) involved and degree of severity of erythema, induration, and scale, weighted by body part

  8. Changes in Harvey-Bradshaw Index (HBI) for patients with CD. [ Time Frame: From Day 0 to Month 12 ]
    The Harvey-Bradshaw index is a score for quantification of symptoms in patients with CD.

  9. Changes in Partial Mayo Score (PMS) for patients with UC. [ Time Frame: From Day 0 to Month 12 ]
    The partial Mayo Score is a noninvasive measure to evaluate disease activity in adults with UC.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
primary care clinic and medical practice specialized in rheumatology
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01768858


Locations
Austria
KH d.Barmh. Br. Graz-Eggenberg /ID# 69653
Graz, Austria, A-8020
Dr. Horst Just, Klagenfurt, AT /ID# 69655
Klagenfurt, Austria, A-9020
Dr. Wilhelm Kaiser, Linz, Austria /ID# 69650
Linz, Austria, 4030
Dr. Gabriela Eichbauer-Sturm, Linz, Austria /ID# 69652
Linz, Austria, A-4020
Dr. Thomas Schwingenschloegl, Neudorf, Austria /ID# 69645
Neudorf, Austria, A-2351
Dr. Thomas Nothnagel, Spitz, Austria /ID# 69649
Spitz, Austria, 3620
Dr. Bernhard Rintelen, Vienna, Austria /ID# 69646
Vienna, Austria, 1030
Medical University of Vienna /ID# 138660
Vienna, Austria, 1090
Medical University of Vienna /ID# 138663
Vienna, Austria, 1090
Hospital Hietzing with Neurological Center Rosenhugel /ID# 158027
Vienna, Austria, 1130
Wilhelminenspital der stadt Wien /ID# 138662
Vienna, Austria, 1160
Regional Hospital Voecklabruck /ID# 69658
Voecklabruck, Austria, A-4840
Klinikum Wels - Grieskirchen GmbH /ID# 138661
Wels, Austria, 4600
Sponsors and Collaborators
AbbVie
Raffeiner GmbH
Investigators
Study Director: Alexander P Dorr, PhD AbbVie Austria
More Information
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT01768858     History of Changes
Other Study ID Numbers: P13-562
First Posted: January 16, 2013    Key Record Dates
Last Update Posted: October 19, 2017
Last Verified: October 2017

Keywords provided by AbbVie:
Crohn´s disease
Arthritis
Morbus Crohn
Adherence
Spondylitis
Ulcerative colitis
Monoclonals
 Rheumatoid
Antibodies
Ankylosing
Plaque psoriasis
Psoriatic
Antirheumatic Agents

Additional relevant MeSH terms:
Crohn Disease
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colonic Diseases
Bone Diseases, Infectious
 Bone Diseases
Spinal Diseases
Arthritis
Arthritis, Rheumatoid
Psoriasis
Colitis
Ulcer
Colitis, Ulcerative
Spondylitis
Spondylitis, Ankylosing
Arthritis, Psoriatic
Gastroenteritis
Pathologic Processes
Infection
Spondylarthropathies