Clinical trial NCT01768858: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Ankylosing Spondylitis
Psoriatic Arthritis
Crohn´s Disease
Ulcerative Colitis
Plaque Psoriasis
Keywords: Arthritis
Morbus Crohn
Adherence
Spondylitis
Ulcerative colitis
Monoclonals
Rheumatoid
Antibodies
Ankylosing
Plaque psoriasis
Psoriatic
Crohn´s disease
Antirheumatic Agents
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Raffeiner GmbH
First posted: 2013-01-16
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants currently being managed in a specialist rheumatology practice or respective hospital department

Brief summary: The purpose of this non-interventional, multicenter, post-marketing observational study (PMOS) was to assess rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), plaque psoriasis (PS), Crohn's disease (CD) and ulcerative colitis (UC) patients' adherence attitudes (beliefs) to maintenance therapy with adalimumab monotherapy or combination therapy with methotrexate (in participants with RA) and to investigate whether there were correlations between such beliefs and adherence to maintenance treatment.

Detailed description: Adalimumab was 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 a participant to an adalimumab-containing regimen was decided in advance and was to be current practice. The prescribing of adalimumab was clearly separated from the decision to include the participant in the study. Participants were observed for a maximum of 12 months, with a total of 5 study visits (Screening = Visit 1).

Eligibility criteria: Inclusion Criteria:

* Participants ≥18 years of age with rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), plaque psoriasis (PS), Crohn´s disease (CD), or ulcerative colitis (UC)
* Participants must fulfill international and national guidelines for the use of a biologic disease-modifying antirheumatic drug (bDMARD) in RA, PsA, AS, PS, CD, or UC (chest X-ray and interferon gamma release assay (IGRA) or purified protein derivative (PPD) skin test negative for tuberculosis)
* In addition one of the following criteria must be fulfilled:

  1. unsatisfactory DMARD response defined as treatment failure with at least two DMARDs including methotrexate in participants with RA or PsA
  2. unsatisfactory nonsteroidal anti-inflammatory drug (NSAID) response in participants with AS
  3. unsatisfactory response to prior bDMARDs in participants with RA, PsA, or AS
  4. unsatisfactory response to, contraindication to, or intolerance to other systemic therapy including cyclosporine, methotrexate, or psoralen with ultraviolet A light (PUVA) in participants with PS
  5. 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
  6. 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:

* Participants who are not covered in the latest version of the adalimumab Summary of Product Characteristics (SPC) for the syringe and pen
* Participants currently enrolled in another study program or clinical trial
* Participants who have been treated with adalimumab before

Primary outcomes:
measure: Change From Baseline in the Beliefs About Medicines Questionnaire (BMQ) Specific Score at 12 Months
timeFrame: Baseline and 12 months
measure: Correlation Between Beliefs About Medicines Questionnaire (BMQ) Specific Score and Adherence to Treatment as Measured by the Morisky Medication Adherence Scale (MMAS) at 12 Months
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Change in Morisky Medication Adherence Scale (MMAS) Scores From Month 3 to Month 12
timeFrame: At Month 3 and Month 12
measure: Change in the Treatment Satisfaction Questionnaire for Medication (TSQM) Scores From Month 3 to Month 12
timeFrame: At Month 3 and Month 12
measure: Change in Rheumatoid Arthritis Disease Activity Index (RADAI) Scores Over Time
timeFrame: Baseline, Month 3, Month 6, Month 9, Month 12
measure: Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score Over Time
timeFrame: Baseline, Month 3, Month 6, Month 9, Month 12
measure: Change in C-reactive Protein (CRP) Concentration Over Time
timeFrame: Baseline, Month 3, Month 6, Month 9, Month 12
measure: Changes in Erythrocyte Sedimentation Rate (ESR) Over Time
timeFrame: Baseline, Month 3, Month 6, Month 9, Month 12
measure: Change in Psoriasis Area and Severity Index (PASI) Score Over Time
timeFrame: Baseline, Month 3, Month 6, Month 9, Month 12
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie Austria
name: Alexander P Dorr, PhD
role: STUDY_DIRECTOR
References: