N/A
N=96
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
Rheumatoid Arthritis · Ankylosing Spondylitis · Psoriatic Arthritis · Crohn´s Disease · Ulcerative Colitis
Bottom Line
View on ClinicalTrials.gov: NCT01768858 ↗Enrolled (actual)
96
Serious AEs
1.0%
Results posted
Jan 2019
Primary outcome: Primary: Change From Baseline in the Beliefs About Medicines Questionnaire (BMQ) Specific Score at 12 Months — -1.4 units on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Adalimumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AbbVie
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Beliefs About Medicines Questionnaire (BMQ) Specific Score at 12 Months |
-1.4 | — |
| PRIMARY 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 |
-.173 | — |
| SECONDARY Change in Morisky Medication Adherence Scale (MMAS) Scores From Month 3 to Month 12 |
0.2 | — |
| SECONDARY Change in the Treatment Satisfaction Questionnaire for Medication (TSQM) Scores From Month 3 to Month 12 |
6.80; 1.95; 3.46; 3.28 | — |
| SECONDARY Change in Rheumatoid Arthritis Disease Activity Index (RADAI) Scores Over Time |
5.52; 3.99; 2.75; 1.83; 1.86 | — |
| SECONDARY Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score Over Time |
5.39; 3.61; 2.98; 1.72; 2.34 | — |
| SECONDARY Change in C-reactive Protein (CRP) Concentration Over Time |
1.60; 0.87; 1.54; 0.47; 0.65 | — |
| SECONDARY Changes in Erythrocyte Sedimentation Rate (ESR) Over Time |
29.3; 24.1; 17.4; 17.8; 16.0 | — |
| SECONDARY Change in Psoriasis Area and Severity Index (PASI) Score Over Time |
18.0; 5.1; 1.5; 1.8; 5.9 | — |
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.
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:
- unsatisfactory DMARD response defined as treatment failure with at least two DMARDs including methotrexate in participants with RA or PsA
- unsatisfactory nonsteroidal anti-inflammatory drug (NSAID) response in participants with AS
- unsatisfactory response to prior bDMARDs in participants with RA, PsA, or AS
- 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
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT01768858). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.