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
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.
|Study Design:||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|
- 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 ] [ Designated as safety issue: No ]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.
- Changes of the Treatment Satisfaction Questionaire for Medication (TSQM) over time. [ Time Frame: from month 3 to month 12 ] [ Designated as safety issue: No ]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.
- 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 ] [ Designated as safety issue: No ]The Rheumatoid Arthritis Disease Activity Index is a questionnaire which measures disease activity
- Changes in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in patients with ankylosing spondylitis [ Time Frame: from Day 0 to month 12 ] [ Designated as safety issue: No ]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
- Changes in Erythrocyte Sedimentation Rate (ESR) over time [ Time Frame: from Day 0 to month 12 ] [ Designated as safety issue: No ]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 imflammatory disease.
- Changes in C-reactive protein (CRP) over time [ Time Frame: from Day 0 to month 12 ] [ Designated as safety issue: No ]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.
- Changes in Morisky Medication Adherence Scale (MMAS) for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis patients. [ Time Frame: from month 3 to month 12 ] [ Designated as safety issue: No ]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).
- Changes in Psoriasis Area and Severity Index (PASI) in patients with plaque psoriasis [ Time Frame: From Day 0 till month 12 ] [ Designated as safety issue: No ]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
- Changes in Harvey-Bradshaw Index (HBI) for patients with CD. [ Time Frame: From Day 0 to Month 12 ] [ Designated as safety issue: No ]The Harvey-Bradshaw index is a score for quantification of symptoms in patients with CD.
- Changes in Partial Mayo Score (PMS) for patients with UC. [ Time Frame: From Day 0 to Month 12 ] [ Designated as safety issue: No ]The partial Mayo Score is a noninvasive measure to evaluate disease activity in adults with UC.
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||July 2016|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
Chronic inflammatory diseases (RA, PsA, AS, PsO, CD, UC)
Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque psoriasis, Crohn´s disease and ulcerative colitis.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01768858
|Contact: Gerhard Närr, PharmDemail@example.com|
|Contact: Astrid Dworan-Timler, MDfirstname.lastname@example.org|
|Site Reference ID/Investigator# 69657||Withdrawn|
|Bludenz, Austria, 6700|
|Site Reference ID/Investigator# 69654||Withdrawn|
|Fuerstenfeld, Austria, 8280|
|Site Reference ID/Investigator# 69648||Withdrawn|
|Gloggnitz, Austria, A-2640|
|Site Reference ID/Investigator# 69653||Active, not recruiting|
|Graz, Austria, A-8020|
|Site Reference ID/Investigator# 69656||Withdrawn|
|Innsbruck, Austria, 6020|
|Site Reference ID/Investigator# 69655||Active, not recruiting|
|Klagenfurt, Austria, A-9020|
|Site Reference ID/Investigator# 69652||Recruiting|
|Linz, Austria, A-4020|
|Principal Investigator: Site Reference ID/Investigator# 69652|
|Site Reference ID/Investigator# 69650||Active, not recruiting|
|Linz, Austria, 4030|
|Site Reference ID/Investigator# 69651||Withdrawn|
|Linz, Austria, A-4020|
|Site Reference ID/Investigator# 69645||Active, not recruiting|
|Neudorf, Austria, A-2351|
|Site Reference ID/Investigator# 69660||Withdrawn|
|Salzburg, Austria, A-5020|
|Site Reference ID/Investigator# 69649||Active, not recruiting|
|Spitz, Austria, 3620|
|Site Reference ID/Investigator# 69647||Withdrawn|
|St. Poelten, Austria, 3100|
|Site Reference ID/Investigator# 69646||Active, not recruiting|
|Vienna, Austria, 1030|
|Site Reference ID/Investigator# 69659||Withdrawn|
|Vienna, Austria, 1040|
|Site Reference ID/Investigator# 69658||Active, not recruiting|
|Voecklabruck, Austria, A-4840|
|Study Director:||Astrid Dworan-Timler, MD||AbbVie Austria|