Assessment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis Patients`Adherence Attitudes to Maintenance Therapy With a Scheduled Adalimumab Treatment in Routine Clinical Practice
This study is currently recruiting participants.
Verified April 2013 by AbbVie
Sponsor:
AbbVie (prior sponsor, Abbott)
Collaborators:
Raffeiner GmbH
BIOCONSULT GmbH
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01768858
First received: January 14, 2013
Last updated: April 11, 2013
Last verified: April 2013
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Purpose
The main purpose of this study is to assess patients`adherence attitudes (beliefs) to maintenance the therapy with a scheduled Adalimumab mono therapy or a combination therapy with methotrexate and to investigate whether there are correlations between such beliefs and adherence to maintenance treatment.
| Condition |
|---|
|
Rheumatoid Arthritis Ankylosing Spondylitis Psoriatic Arthritis |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Assessment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis Patient`s Adherence Attitudes to Maintenance Therapy With a Scheduled Adalimumab Treatment in Routine Clinical Practice |
Resource links provided by NLM:
Further study details as provided by AbbVie:
Primary Outcome Measures:
- Changes in the Beliefs about Medicines Questionnaire (BMQ) for rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis patients (AS) [ 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.
Secondary Outcome Measures:
- Changes in Treatment Satisfaction Questionnaire for Medication for rheumatoid arthritis and if reasonable in patients with psoriatic arthritis 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 rheumatic 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).
| Estimated Enrollment: | 80 |
| Study Start Date: | February 2013 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Rheumatoid,-Psoriatic Arthritis, Bechterew
Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, unsatisfactory disease modifying antirheumatic drugs response and or biological disease modifying antirheumatic drugs
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
- Patients must fulfill international and national guidelines for the use of a BDMARD in RA,
PsA, AS (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:
- unsatisfactory DMARD response defined as failure to treatment with at least two DMARDs including Methotrexate in patients with RA or PsA
- unsatisfactory NSAID response in patients with AS
- unsatisfactory response to prior BDMARDs in patients with RA or PsA or AS.
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 Humira® before
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01768858
Contacts
| Contact: Gerhard Närr | +43-1-20589-373 | gerhard.naerr@abbvie.com |
| Contact: Astrid Dworan-Timler, MD | +43-1-20589-391 | astrid.dworan-timler@abbvie.com |
Locations
| Austria | |
| Site Reference ID/Investigator# 69645 | Recruiting |
| Neudorf, Austria, A-2351 | |
| Principal Investigator: Site Reference ID/Investigator# 69645 | |
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Raffeiner GmbH
BIOCONSULT GmbH
Investigators
| Study Director: | Astrid Dworan-Timler, MD | AbbVie Austria |
More Information
Additional Information:
No publications provided
| Responsible Party: | AbbVie ( AbbVie (prior sponsor, Abbott) ) |
| ClinicalTrials.gov Identifier: | NCT01768858 History of Changes |
| Other Study ID Numbers: | P13-562 |
| Study First Received: | January 14, 2013 |
| Last Updated: | April 11, 2013 |
| Health Authority: | Austria: Federal Office for Safety in Health Care |
Keywords provided by AbbVie:
|
Ankylosing Rheumatoid Antibodies Arthritis Adherence |
Antirheumatic Agents Psoriatic Spondylitis Monoclonals |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Psoriatic Arthritis, Rheumatoid Spondylitis Spondylitis, Ankylosing Joint Diseases Musculoskeletal Diseases Spondylarthropathies Spondylarthritis Spinal Diseases Bone Diseases Psoriasis Skin Diseases, Papulosquamous |
Skin Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Bone Diseases, Infectious Infection Ankylosis Adalimumab Antirheumatic Agents Therapeutic Uses Pharmacologic Actions Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 16, 2013