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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
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
Study design:   
Phase: 
Countries of recruitment
Austria
Contacts
Name:     Alexander P Dorr, PhD
Address: 
Telephone:
Email:
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
Ankylosing Spondylitis
Crohn´s Disease
Plaque Psoriasis
Psoriatic Arthritis
Rheumatoid Arthritis
Ulcerative Colitis
Intervention(s)
Drug: Adalimumab
Primary Outcome(s)
Change From Baseline in the Beliefs About Medicines Questionnaire (BMQ) Specific Score at 12 Months [Time Frame: Baseline and 12 months]
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]
Secondary Outcome(s)
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]
Change in Morisky Medication Adherence Scale (MMAS) 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 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]
Changes in Erythrocyte Sedimentation Rate (ESR) Over Time [Time Frame: Baseline, Month 3, Month 6, Month 9, Month 12]
Secondary ID(s)
P13-562
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Raffeiner GmbH
Ethics review
Results
Results available: Yes
Date Posted: 28/01/2019
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT01768858
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