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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01768858
• Date of registration: 14/01/2013
• Prospective Registration: Yes
• Primary sponsor: AbbVie
• Public 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 Adherence
• Scientific 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
• Date of first enrolment: February 5, 2013
• Target sample size: 96
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01768858
• Study type: Observational

Countries of recruitment

Austria

Contacts

• Name: Alexander P Dorr, PhD
• Affiliation: AbbVie Austria

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 99 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn´s Disease

Psoriatic Arthritis

Ulcerative Colitis

Plaque Psoriasis

Rheumatoid Arthritis

Ankylosing Spondylitis

Intervention(s)

Drug: Adalimumab

Primary Outcome(s)

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 [Time Frame: Baseline and 12 months]

Change From Baseline in the Beliefs About Medicines Questionnaire (BMQ) Specific Score at 12 Months [Time Frame: Baseline and 12 months]

Secondary Outcome(s)

Change in Rheumatoid Arthritis Disease Activity Index (RADAI) Scores Over Time [Time Frame: Baseline, Month 3, Month 6, Month 9, Month 12]

Change in the Treatment Satisfaction Questionnaire for Medication (TSQM) Scores From Month 3 to Month 12 [Time Frame: At Month 3 and Month 12]

Change in Psoriasis Area and Severity Index (PASI) Score Over Time [Time Frame: Baseline, Month 3, Month 6, Month 9, Month 12]

Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score Over Time [Time Frame: Baseline, Month 3, Month 6, Month 9, Month 12]

Change in C-reactive Protein (CRP) Concentration Over Time [Time Frame: Baseline, Month 3, Month 6, Month 9, Month 12]

Changes in Erythrocyte Sedimentation Rate (ESR) Over Time [Time Frame: Baseline, Month 3, Month 6, Month 9, Month 12]

Change in Morisky Medication Adherence Scale (MMAS) Scores From Month 3 to Month 12 [Time Frame: At Month 3 and Month 12]

Secondary ID(s)

P13-562

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Raffeiner GmbH

Results

• Results available: Yes
• Date Posted: 28/01/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01768858