- ICH GCP
- US Clinical Trials Registry
- 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 (Adherence)
January 25, 2019 updated by: AbbVie
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.
Study Overview
Status
Completed
Conditions
Intervention / 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).
Study Type
Observational
Enrollment (Actual)
96
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Participants currently being managed in a specialist rheumatology practice or respective hospital department
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Participants receiving adalimumab
Adults with rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), plaque psoriasis (PS), Crohn´s disease (CD), or ulcerative colitis (UC) received 40 mg adalimumab every two weeks.
|
Adalimumab administered by subcutaneous injection, via pre-filled syringe or autoinjector pen
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in the Beliefs About Medicines Questionnaire (BMQ) Specific Score at 12 Months
Time Frame: Baseline and 12 months
|
The BMQ-Specific Scale 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, long-term toxicity, and the disruptive effects of medication (Specific-Concerns).
Individual items are scored on a 5-point scale from 1 (strongly disagree) to 5 (strongly agree).
The total score ranges from 10 (lowest score) to 50 (highest score).
Higher scores indicate stronger beliefs.
|
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
|
The BMQ-Specific Scale 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, long-term toxicity, and the disruptive effects of medication (Specific-Concerns).
Individual items are scored on a 5-point scale from 1 (strongly disagree) to 5 (strongly agree).
The total score ranges from 10 (lowest score) to 50 (highest score).
Higher scores indicate stronger beliefs.
The MMAS is a 4-item self-reported measure of medication-taking behavior.
It measures intentional and non-intentional non-adherence (based on forgetting, carelessness, stopping medication when feeling better, or stopping medication when feeling worse).
The MMAS consists of 4 questions which can be answered with yes (0) and no (1).
The MMAS score is the sum of all four questions and ranges from 0 (non-adherent) to 4 (adherent).
|
Baseline and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Morisky Medication Adherence Scale (MMAS) Scores From Month 3 to Month 12
Time Frame: At Month 3 and Month 12
|
The MMAS is a 4-item self-reported measure of medication-taking behavior.
It measures intentional and non-intentional non-adherence (based on forgetting, carelessness, stopping medication when feeling better, or stopping medication when feeling worse).
The MMAS consists of 4 questions which can be answered with yes (0) and no (1).
The MMAS score is the sum of all four questions and ranges from 0 (non-adherent) to 4 (adherent).
|
At Month 3 and 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
|
The 11-item Treatment Satisfaction Questionnaire for Medication (TSQM) Version II is an instrument to assess participants' satisfaction with medication, providing scores on four scales (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 (ranging from very unsatisfied to satisfied).
TSQM Scale scores range from 0 to 100 and higher scores represent higher satisfaction.
|
At Month 3 and Month 12
|
Change in Rheumatoid Arthritis Disease Activity Index (RADAI) Scores Over Time
Time Frame: Baseline, Month 3, Month 6, Month 9, Month 12
|
The RADAI is a questionnaire for participants used for measuring disease activity.
The index consists of 6 questions.
The items ask the participants about (1) global disease activity in the last 6 months, (2) disease activity in terms of current swollen and tender joints, (3) arthritis pain, (4) the current status of health, (5) duration of morning stiffness, and (6) tender joints rated on a joint list.
The joint list asks about pain in the left and right shoulders, elbows, wrists, fingers, hips, knees, ankles and toes.
The first 4 items are rated on a numeric rating scale from 0 to 10, where higher scores indicate more disease activity.
The scores on the last 2 items range from 0 to 6 and 0 to 48, respectively, but are transformed on the same scale of 0 to 10.
The RADAI total score is the sum of individual items divided by 5 (range 0-10), with a higher score signifying more disease activity.
|
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
|
The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) assesses disease activity by asking the participant to answer 6 questions (each on a 10 point numeric rating scale [NRS]) pertaining to symptoms experienced for the past week.
For 5 questions (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (≥ 2 hours).
The overall BASDAI score ranges from 0 to 10. Lower scores indicate less disease activity.
|
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
|
C-reactive protein (CRP) was measured from blood samples as a marker for inflammation.
Higher levels are indicative of more inflammation.
Normal concentration in healthy individuals is usually lower than 1 mg/dL, slightly increasing with age, and increased in a variety of disorders such as rheumatic diseases.
|
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
|
Erythrocyte sedimentation rate (ESR) indirectly measures how much inflammation is in the body, and is based on the sedimentation and aggregation of erythrocytes (red blood cells).
A higher ESR is indicative of increased inflammation.
The normal range in healthy individuals is 0 - 10 mm/h for men and 0-15 mm/h for women.
|
Baseline, Month 3, Month 6, Month 9, Month 12
|
Change in Psoriasis Area and Severity Index (PASI) Score Over Time
Time Frame: Baseline, Month 3, Month 6, Month 9, Month 12
|
The Psoriasis Area and Severity Index (PASI) is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs.
The total PASI score ranges from 0 to 72.
The higher the total score, the more severe the disease.
|
Baseline, Month 3, Month 6, Month 9, Month 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Alexander P Dorr, PhD, AbbVie Austria
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 5, 2013
Primary Completion (Actual)
August 13, 2017
Study Completion (Actual)
August 13, 2017
Study Registration Dates
First Submitted
January 14, 2013
First Submitted That Met QC Criteria
January 14, 2013
First Posted (Estimate)
January 16, 2013
Study Record Updates
Last Update Posted (Actual)
January 28, 2019
Last Update Submitted That Met QC Criteria
January 25, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Skin Diseases
- Infections
- Immune System Diseases
- Autoimmune Diseases
- Gastrointestinal Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Gastroenteritis
- Colonic Diseases
- Intestinal Diseases
- Skin Diseases, Papulosquamous
- Spinal Diseases
- Bone Diseases
- Inflammatory Bowel Diseases
- Spondylarthropathies
- Bone Diseases, Infectious
- Ankylosis
- Ulcer
- Arthritis
- Arthritis, Rheumatoid
- Psoriasis
- Crohn Disease
- Arthritis, Psoriatic
- Colitis
- Colitis, Ulcerative
- Spondylitis
- Spondylarthritis
- Spondylitis, Ankylosing
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Adalimumab
Other Study ID Numbers
- P13-562
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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