Assessment of Pain Management in Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis Patients Who Are About to be Treated With Adalimumab

This study has been completed.
Sponsor:
Collaborator:
Raffeiner GmbH
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01273519
First received: January 7, 2011
Last updated: February 25, 2014
Last verified: February 2014
  Purpose

The purpose of this study is to assess whether or not adalimumab (Humira®) can influence pain medication in participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) with or without comorbidities, which do not constitute a contraindication for adalimumab as stated in the released summary of product characteristics. Therefore it shall be evaluated if pain medication which is used in these participants is changed, reduced or stopped due to adalimumab treatment.


Condition
Rheumatoid Arthritis
Ankylosing Spondylitis
Psoriatic Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Pain Management in Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis Patients Who Are About to be Treated With Adalimumab

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Participant Assessment of Present Pain Intensity Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12 [ Time Frame: Baseline, Months 3, 6, 9, 12 ] [ Designated as safety issue: No ]
    Participants measured their present pain intensity on a visual analogue scale (VAS), where the responses were on a continuous range from 0 (no pain) to 100 (worst pain imaginable).

  • Physician Assessment of Present Pain Intensity Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12 [ Time Frame: Baseline, Months 3, 6, 9, 12 ] [ Designated as safety issue: No ]
    Physicians measured participants' present pain intensity on a visual analogue scale (VAS), where the responses were on a continuous range from 0 (no pain) to 100 (worst pain imaginable).

  • Participant Assessment of Present Pain Intensity Recorded on a Likert Scale at Baseline and Month 12 [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
    Participants measured their present pain intensity by specifying their level of pain in response to the question "How intensive is your pain at present?" on a 4-point Likert scale, where 0 = no pain; 1 = mild pain, 2 = moderate pain, 3 = severe pain.

  • Participant Assessment of Pain Intensity in the Past 3 Months Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12 [ Time Frame: Baseline, Months 3, 6, 9, 12 ] [ Designated as safety issue: No ]
    Participants measured their pain intensity in the past 3 months on a visual analogue scale (VAS), where the responses were on a continuous range from 0 (no pain) to 100 (worst pain imaginable).

  • Participant Assessment of Pain Intensity in the Past 3 Months Recorded on a Likert Scale at Baseline and Month 12 [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
    Participants measured their pain intensity in the past 3 months by specifying their level of pain in response to the question "How intensive was your pain on average in the past 3 months?" on a 4-point Likert scale, where 0 = no pain; 1 = mild pain, 2 = moderate pain, 3 = severe pain.

  • Participant Assessment of the Pattern of Pain Progression (Daytime/Nocturnal) in the Past 3 Months at Baseline and Month 12 [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
    Participants assessed the pattern of their pain progression in the past 3 months according to the following descriptors: intermittent (daytime and/or nocturnal); mostly daytime; mostly nocturnal; continuous (daytime and nocturnal).

  • Participant Assessment of the Pattern of Pain Progression (Sudden/Creeping) in the Past 3 Months at Baseline and Month 12 [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
    Participants assessed the pattern of their pain progression in the past 3 months according to the following descriptors: the type of beginning of pain was mostly sudden; the type of beginning of pain was mostly creeping.

  • Participant Assessment of the Presence of Nocturnal Pain Progression in the Past 3 Months at Baseline and Month 12 [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
    Participants assessed how often on average they noted the presence of nocturnal pain in the past 3 month according to the following descriptors: never; rarely (not exceeding once a week), every night (awake from sleep at least once a night), more than once a night per week.

  • Participant Assessment of the Presence of Distress Caused by Pain in the Last 3 Months Recorded on a Likert Scale at Baseline and Month 12 [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
    Participants indicated their perception of average distress caused by pain in the past 3 months on a 5-point Likert scale, where; 0 = no pain, 1 = not distressed, 2 = slightly distressed, 3 = moderately distressed, 4 = greatly distressed by pains.


Secondary Outcome Measures:
  • Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12 [ Time Frame: Baseline, Months 3, 6, 9, 12 ] [ Designated as safety issue: No ]
    The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1 to 4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5 to 8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 [worst] to 100 [best ]). The standard recall period is 4 weeks. Increases from Baseline indicate improvement.

  • Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores at Baseline, and Months 3, 6, 9, and 12 [ Time Frame: Baseline, Months 3, 6, 9, 12 ] [ Designated as safety issue: No ]
    The HAQ-DI is a participant-reported questionnaire. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability. The minimal clinically important difference defined for the HAQ-DI is ≥0.22. HAQ remission, indicating normal physical function, is defined as HAQ-DI < 0.5.

  • Mean Rheumatoid Arthritis Disease Activity Index (RADAI) at Baseline, and Months 3, 6, 9, and 12 [ Time Frame: Baseline, Months 3, 6, 9, 12 ] [ Designated as safety issue: No ]
    The RADAI is a questionnaire for patients 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 to be rated in 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 all 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.

  • Mean Bath Ankylosing Spondylitis Functional Index (BASFI) Scores at Baseline, and Months 3, 6, 9, and 12 [ Time Frame: Baseline, Months 3, 6, 9, 12 ] [ Designated as safety issue: No ]
    The BASFI is a set of 10 questions designed to determine the degree of functional limitation in those with AS. The 10 questions were chosen with a major input from patients with AS. The first 8 questions consider activities related to functional anatomy. The final 2 questions assess the participants' ability to cope with everyday life. A visual analogue scale (with 0 being "easy" and 10 "impossible") is used to answer the questions on the test.

  • Mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for Participants With Ankylosing Spondylitis (AS) at Baseline, and Months 3, 6, 9, and 12 [ Time Frame: Baseline, Months 3, 6, 9, 12 ] [ Designated as safety issue: No ]
    The BASDAI is used for measuring and evaluating disease activity in AS. This index consists of 6 questions pertaining to the 5 major symptoms of AS: fatigue, spinal pain, joint pain/swelling, areas of localized tenderness (or enthesitis, defined as inflammation of tendons and ligaments), duration of morning stiffness, severity of morning stiffness. A visual analogue scale ranging from 0 (none) to 10 (very severe) is used to answer the questions. The final BASDAI score averages the individual assessments for a final score range of 0-10 (0 being no problem and 10 being the worst problem).

  • Mean Erythrocyte Sedimentation Rate (ESR) at Baseline, and Months 3, 6, 9, and 12 [ Time Frame: Baseline, Months 3, 6, 9, 12 ] [ Designated as safety issue: No ]
    The ESR is a practicable and sensitive but not specific parameter for measuring disease progression. By means of the ESR it can be generally distinguished between an active and nonactive rheumatic disease. The normal reference range is, as a rule, 0 to 10 mm/h for men and 0 to 15 mm/h for women. The higher the ESR value out of the normal range, the higher is the disease activity.

  • Mean C-reactive Protein (CRP) at Baseline, and Months 3, 6, 9, and 12 [ Time Frame: Baseline, Months 3, 6, 9, 12 ] [ Designated as safety issue: No ]
    The CRP is an acute phase reactant plasma protein, normally produced by the liver, which is commonly used as an indirect measure of the extent and activity of an inflammation. The CRP normal reference range in the blood is, as a rule, from 0 to 1.0 mg/dL.


Enrollment: 155
Study Start Date: January 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
RA, PsA, AS
Participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.

Detailed Description:

This is a non-interventional, observational study in which Humira (adalimumab) is 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 the patient to a Humira-containing regimen has to be decided in advance and has to be current practice. The prescription of Humira is clearly separated from the decision to include the participant in this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

primary care clinic and medical practice specialized in rheumatology

Criteria

Inclusion Criteria:

  • Patients aged ≥ 18 years for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis
  • Patients must fulfill international and national guidelines for the use of a biological disease modifying antirheumatic drug in rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis (chest x-ray and interferon gamma release assay or purified protein derivative-skin test negative for tuberculosis). In addition one of the following criteria must be fulfilled:

    • unsatisfactory disease modifying antirheumatic drug response defined as failure to treatment with at least two disease modifying antirheumatic drugs including Methotrexate in patients with rheumatoid arthritis or psoriatic arthritis
    • unsatisfactory non steroidal antiinflammatory drug response in patients with ankylosing spondylitis or unsatisfactory response to prior biological disease modifying antirheumatic drugs in patients with rheumatoid arthritis or psoriatic arthritis or ankylosing spondylitis

Exclusion Criteria:

  • Patients who meet contraindications as outlined in the latest version of the Humira syringe® summary of product characteristics and Humira Pen® summary of product characteristics
  • Patients participating in another study program or clinical trial
  • Patients who have been treated with Humira before
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01273519

Locations
Austria
Site Reference ID/Investigator# 52144
Bludenz, Austria, 6700
Site Reference ID/Investigator# 44915
Fuerstenfeld, Austria, 8280
Site Reference ID/Investigator# 44910
Gloggnitz, Austria, A-2640
Site Reference ID/Investigator# 44914
Graz, Austria, A-8020
Site Reference ID/Investigator# 52143
Innsbruck, Austria, 6020
Site Reference ID/Investigator# 44916
Klagenfurt, Austria, A-9020
Site Reference ID/Investigator# 44913
Linz, Austria, A-4020
Site Reference ID/Investigator# 44912
Linz, Austria, A-4020
Site Reference ID/Investigator# 44911
Linz, Austria, 4030
Site Reference ID/Investigator# 44906
Neudorf, Austria, A-2351
Site Reference ID/Investigator# 52145
Spitz, Austria, 3620
Site Reference ID/Investigator# 44909
St. Poelten, Austria, 3100
Site Reference ID/Investigator# 44908
Stockerau, Austria, 2000
Site Reference ID/Investigator# 67062
Vienna, Austria, 1040
Site Reference ID/Investigator# 57304
Voecklabruck, Austria, A-4840
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Raffeiner GmbH
Investigators
Study Director: Astrid Dworan-Timler, MD AbbVie Austria
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01273519     History of Changes
Other Study ID Numbers: P12-585
Study First Received: January 7, 2011
Results First Received: January 9, 2014
Last Updated: February 25, 2014
Health Authority: Austria: Federal Office for Safety in Health Care

Keywords provided by AbbVie:
Ankylosing
Rheumatoid
Antibodies
Arthritis
Pain
Antirheumatic Agents
Psoriatic
Spondylitis
Monoclonals

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Arthritis, Rheumatoid
Spondylitis
Spondylitis, Ankylosing
Ankylosis
Autoimmune Diseases
Bone Diseases
Bone Diseases, Infectious
Connective Tissue Diseases
Immune System Diseases
Infection
Joint Diseases
Musculoskeletal Diseases
Psoriasis
Rheumatic Diseases
Skin Diseases
Skin Diseases, Papulosquamous
Spinal Diseases
Spondylarthritis
Spondylarthropathies
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014