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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by AbbVie
Sponsor:
Collaborator:
Raffeiner GmbH
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT01768858
First received: January 14, 2013
Last updated: August 27, 2014
Last verified: August 2014
  Purpose

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

Study Type: Observational
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

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), 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.


Secondary Outcome Measures:
  • 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 inflammatory 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.


Estimated Enrollment: 140
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)
Groups/Cohorts
Chronic inflammatory diseases (RA, PsA, AS, PsO, CD, UC)
Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque psoriasis, Crohn´s disease and ulcerative colitis.

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.

  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, 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:

    • 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.
    • 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. *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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01768858

Contacts
Contact: Gerhard Närr, PharmD +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# 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# 69651 Withdrawn
Linz, Austria, A-4020
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# 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
Sponsors and Collaborators
AbbVie
Raffeiner GmbH
Investigators
Study Director: Astrid Dworan-Timler, MD AbbVie Austria
  More Information

No publications provided

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT01768858     History of Changes
Other Study ID Numbers: P13-562
Study First Received: January 14, 2013
Last Updated: August 27, 2014
Health Authority: Austria: Federal Office for Safety in Health Care

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

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

ClinicalTrials.gov processed this record on October 23, 2014