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Rheumatoid ArthritisAdherenceNCT01768858

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

An observational study of Rheumatoid Arthritis and Ankylosing Spondylitis, run by AbbVie.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 99 years
What is being tested?
Adalimumab
Type of treatment
Injection or infusion
How many people
96 participants
Where
No sites listed yet
Study dates
5 Feb 2013to 13 Aug 2017
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Participants currently being managed in a specialist rheumatology practice or respective hospital department

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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

About this study

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.

Read the 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).

Being tested
Adalimumab
Keywords
Arthritis, Morbus Crohn, Adherence, Spondylitis, Ulcerative colitis, Monoclonals, Rheumatoid, Antibodies, Ankylosing, Plaque psoriasis, Psoriatic, Crohn´s disease, Antirheumatic Agents
Medical subject headings
Arthritis, Rheumatoid, Spondylitis, Ankylosing, Arthritis, Psoriatic, Crohn Disease, Colitis, Ulcerative, Arthritis, Spondylitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AdalimumabDrug

    Also called Humira, ABT-D2E7

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

Study groups in NCT01768858
Study groupRoleWhat they receive
Participants receiving adalimumabAdults 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.
Receives: Drug: Adalimumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and 12 months

  2. 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).

    Measured: Baseline and 12 months

Secondary outcomes (7)

  1. 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).

    Measured: At Month 3 and Month 12

  2. 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.

    Measured: At Month 3 and Month 12

  3. 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.

    Measured: Baseline, Month 3, Month 6, Month 9, Month 12

  4. 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.

    Measured: Baseline, Month 3, Month 6, Month 9, Month 12

  5. 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.

    Measured: Baseline, Month 3, Month 6, Month 9, Month 12

  6. 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.

    Measured: Baseline, Month 3, Month 6, Month 9, Month 12

  7. 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.

    Measured: Baseline, Month 3, Month 6, Month 9, Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2013 (estimated)
  2. Study start5 Feb 2013
  3. Primary completion13 Aug 2017
  4. Study completion13 Aug 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01768858
Sponsor's protocol ID
P13-562
Acronym
Adherence
Status last verified
Jan 2019
First submitted
14 Jan 2013
Last updated
28 Jan 2019
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Rheumatoid Arthritis and Ankylosing Spondylitis, run by AbbVie.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in the Beliefs About Medicines Questionnaire (BMQ) Specific Score at 12 Months (time frame: Baseline and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01768858.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2019.

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