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 Clinical Trial

— Adherence  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01768858
• Other study ID #: P13-562
• Status: Completed
• Start date: February 5, 2013
• Est. completion date: August 13, 2017

Study information

• Verified date: January 2019
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: August 13, 2017
• Est. primary completion date: August 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Arthritis
• Arthritis, Psoriatic
• Arthritis, Rheumatoid
• Colitis
• Colitis, Ulcerative
• Crohn Disease
• Crohn´s Disease
• Plaque Psoriasis
• Psoriasis
• Psoriatic Arthritis
• Rheumatoid Arthritis
• Spondylitis
• Spondylitis, Ankylosing
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Adalimumab
Adalimumab administered by subcutaneous injection, via pre-filled syringe or autoinjector pen

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
AbbVie	Raffeiner GmbH

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in the Beliefs About Medicines Questionnaire (BMQ) Specific Score at 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
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	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	Change in Morisky Medication Adherence Scale (MMAS) Scores From Month 3 to 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
Secondary	Change in the Treatment Satisfaction Questionnaire for Medication (TSQM) Scores From Month 3 to 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
Secondary	Change in Rheumatoid Arthritis Disease Activity Index (RADAI) Scores Over Time	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
Secondary	Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score Over Time	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
Secondary	Change in C-reactive Protein (CRP) Concentration Over Time	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
Secondary	Changes in Erythrocyte Sedimentation Rate (ESR) Over Time	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
Secondary	Change in Psoriasis Area and Severity Index (PASI) Score Over Time	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

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