Quality of Life Outcomes of HUMIRA in Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS) After Unsustainable Response to Biologicals and Disease Modifying Antirheumatic Drugs

This study has been completed.
Sponsor:
Collaborator:
Group Data Management Biostatistics
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT01083693
First received: February 28, 2010
Last updated: August 9, 2011
Last verified: August 2011
  Purpose

The aim of this post-marketing observational study is to obtain further data on the evaluation of quality of life outcomes of HUMIRA® in routine clinical use in patients with Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA) or Ankylosing Spondylitis (AS) after unsustainable clinical response to disease modifying antirheumatic drugs (DMARD) and or biological disease modifying antirheumatic drugs (BDMARD). Treatment strategies in moderate to severe rheumatoid arthritis, psoriatic arthritis and in severe active ankylosing spondylitis commonly consist of introducing biologics after conventional disease modifying antirheumatic drugs or non steroidal antiinflammatory drugs fail. Although biologic disease modifying antirheumatic drugs are generally well-tolerated, intolerances may develop or efficacy may diminish, at which time another biologic disease modifying antirheumatic drug might be considered. This study shall evaluate the quality of life outcomes of HUMIRA®, given after conventional disease modifying antirheumatic drugs and or non antiinflammatory drug failures and or after biological disease modifying antirheumatic drug failures . Failure in this context means primary or secondary loss of efficacy or intolerance to the initial agent.


Condition
Rheumatoid Arthritis
Ankylosing Spondylitis
Psoriatic Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Open Label Multicenter Post Marketing Observational Study for the Evaluation of Quality of Life Outcomes and Tolerability of HUMIRA in Routine Clinical Use in Patients With RA PsA AS After Unsustainable Response to Disease Modifying Antirheumatic Drugs and or Biologicals

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • RA and if Reasonable for PsA Patients Health Assessment Questionnaire Disability Index HAQ-DI [ Time Frame: Baseline, months 3,6,9,12 ] [ Designated as safety issue: No ]
    The HAQ-DI is a questionnaire that measures functional status (disability) and health-related quality of life. It measures a patient's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene,reach, grip, activities. Each question is evaluated according to the degree of severity on a scale ranging from 0 (without any difficulty) to 3 (unable to do).

  • SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain [ Time Frame: Baseline, months 3,6,9,12 ] [ Designated as safety issue: No ]
    Medical Outcomes Study Short Form 36 (MOS SF-36) is generic assessment of health status that consists of 36 questions within 8 domains including Physical Functioning (PF), Role Functioning - Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role Functioning - Emotional (RE), Mental Health (MH) and Reported Health Transition (HT). Results from each domain are summarized and transformed into a scale ranging from 0 (worst) to 100 (best) with the exception of HT. The score range for HT is 0 (worst) to 5 (best).

  • EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression [ Time Frame: Baseline, months 3,6,9,12 ] [ Designated as safety issue: No ]

    European Quality of Life 5 Dimensions (EQ-5D) is a self-reported health outcome which measures mobility, self care, usual activities, pain discomfort, anxiety depression. An overall score is derived that measures from -0.59 (worst) to +1 (best).

    In addition, health state is measured on the thermometer scale (score 0 to 100) with higher scores representing better health status.



Secondary Outcome Measures:
  • DAS28: Changes in Disease Activity Score 28 in Patients With RA and if Reasonable in PsA: Measures the no. of Swollen and Tender Joints (28 Joints), Erythrocyte Sedimentation Rate, Patients Global Assessment of Disease Activity on a Visual Scale [ Time Frame: Baseline,months 3,6,9,12 ] [ Designated as safety issue: No ]
    The Disease Activity Score 28 measures disease activity based on the number of swollen and tender joints (28 joints), erythrocyte sedimentation rate, and patient's global assessment of disease activity on a visual scale. DAS28 is a unit scale from 0 (best value) to 10.0 (worst value).

  • Changes in Bath Ankylosing Spondylitis Disease Activity Index in Patients With AS: Measures Patients Fatigue, Pain (Neck, Hip, Other Joints), Tender Sensitive Body Sites, Morning Stiffness [ Time Frame: Baseline, months 3,6,9,12 ] [ Designated as safety issue: No ]
    Bath as Disease Activity Index (BASDI) measures fatigue, pain (neck, hip, other joints), tender sensitive body sites, and morning stiffness for patients suffering from AS. Scores range from 0 to 10 with higher scores representing worse disease activity.

  • Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only [ Time Frame: Baseline, months 3,6,9,12 ] [ Designated as safety issue: No ]
    Physician's and Patient's Global Assessment of Disease Activity (PGA) are measured using a visual analogue scale with scores ranging from 0 to 100 (higher scores indicate worse disease activity).

  • Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only [ Time Frame: Baseline, months 3,6,9,12 ] [ Designated as safety issue: No ]
    Physician's and Patient's Global Assessment of State of Health was measured using a visual analogue scale with scores from 0 to 100 (higher scores indicate worse health state).

  • Erythrocyte Sedimentation Rate [ Time Frame: Baseline, months 3,6,9,12 ] [ Designated as safety issue: No ]
    Erythrocyte sedimentation rate (ESR) is a nonspecific lab value that measures inflammation from arthritic disease. A decrease in the level indicates reduction in inflammation and therefore improvement.

  • C-Reactive Protein [ Time Frame: Baseline, months 3,6,9,12 ] [ Designated as safety issue: No ]
    The test for C-Reactive Protein (CRP) is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.


Enrollment: 162
Study Start Date: September 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Rheumatoid, Psoriatic Arthritis, Ankylosing Spondylitis
Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, patients with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic and medical practice specialized in rheumatology

Criteria

Inclusion Criteria:

  • Patients age greater than or equal to 18
  • Patients must fulfill international and national guidelines for use of a BDMARD in RA, PsA and AS (Chest X-ray and purified protein derivative (PPD) skin test negative for tuberculosis).

In addition one of the following criteria must be fulfilled:

  • unsatisfactory DMARD response defined as failure to treatment with at least two DMARDs including Methotrexate in patients with RA or PsA
  • unsatisfactory NSAID response in patients with AS or
  • unsatisfactory response to prior BDMARDs (in this case patients must have received BDMARDs at least 12 weeks before visit 1) in patients with RA or PsA or AS.

Exclusion Criteria:

  • Patients who meet contraindications as outlined in the latest version of the Humira syringe® Summary of Product Characteristics (SmPC) and Humira Pen® SmPC
  • Patients participating in another study or clinical trial.
  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: NCT01083693

Locations
Austria
Site Reference ID/Investigator # 32372
Amstetten, Austria, A-3300
Site Reference ID/Investigator # 32368
Bludenz, Austria, A-6700
Site Reference ID/Investigator # 32367
Gloggnitz, Austria, A-2640
Site Ref # / Investigator 37123
Graz, Austria, A-8020
Site Ref # / Investigator 37125
Innsbruck, Austria, A-6020
Site Reference ID/Investigator # 32375
Klagenfurt, Austria, A-9020
Site Reference ID/Investigator # 32365
Linz, Austria, A-4020
Site Reference ID/Investigator # 32376
Linz, Austria, A-4020
Site Reference ID/Investigator # 32369
Linz, Austria, A-4020
Site Reference ID/Investigator # 32371
Linz, Austria, A-4020
Site Reference ID/Investigator # 32373
Neudorf, Austria, A-2351
Site Reference ID/Investigator # 32364
Salzburg, Austria, A-5020
Site Reference ID/Investigator # 32366
Vienna, Austria, A-1140
Site Reference ID/Investigator # 18782
Vienna, Austria, A-1030
Site Reference ID/Investigator # 32378
Vienna, Austria, A-1100
Site Reference ID/Investigator # 32377
Vienna, Austria, A-1100
Site Reference ID/Investigator # 32363
Vienna, Austria, A-1030
Site Reference ID/Investigator # 32374
Voecklabruck, Austria, A-4840
Site Reference ID/Investigator # 32370
Weiz, Austria, A-8160
Site Ref # / Investigator 37124
Wels, Austria, A-4600
Sponsors and Collaborators
Abbott
Group Data Management Biostatistics
Investigators
Study Director: Astrid Dworan-Timler, MD Abbott AUSTRIA
  More Information

No publications provided

Responsible Party: Dr. Astrid Dworan-Timler, Medical Director, Abbott AUSTRIA
ClinicalTrials.gov Identifier: NCT01083693     History of Changes
Other Study ID Numbers: P10-726
Study First Received: February 28, 2010
Results First Received: June 28, 2011
Last Updated: August 9, 2011
Health Authority: Austria: Federal Office for Safety in Health Care

Keywords provided by Abbott:
Monoclonals
Antibodies
Ankylosing Spondylitis
Antirheumatic Agents
Quality of Life
Adalimumab
rheumatoid arthritis
psoriatic arthritis
quality of life

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

ClinicalTrials.gov processed this record on August 27, 2014