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

August 9, 2011 updated by: Abbott

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

162

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Amstetten, Austria, A-3300
        • Site Reference ID/Investigator # 32372
      • Bludenz, Austria, A-6700
        • Site Reference ID/Investigator # 32368
      • Gloggnitz, Austria, A-2640
        • Site Reference ID/Investigator # 32367
      • Graz, Austria, A-8020
        • Site Ref # / Investigator 37123
      • Innsbruck, Austria, A-6020
        • Site Ref # / Investigator 37125
      • Klagenfurt, Austria, A-9020
        • Site Reference ID/Investigator # 32375
      • Linz, Austria, A-4020
        • Site Reference ID/Investigator # 32365
      • 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 # 32376
      • Neudorf, Austria, A-2351
        • Site Reference ID/Investigator # 32373
      • Salzburg, Austria, A-5020
        • Site Reference ID/Investigator # 32364
      • Vienna, Austria, A-1030
        • Site Reference ID/Investigator # 18782
      • Vienna, Austria, A-1030
        • Site Reference ID/Investigator # 32363
      • Vienna, Austria, A-1100
        • Site Reference ID/Investigator # 32377
      • Vienna, Austria, A-1100
        • Site Reference ID/Investigator # 32378
      • Vienna, Austria, A-1140
        • Site Reference ID/Investigator # 32366
      • Voecklabruck, Austria, A-4840
        • Site Reference ID/Investigator # 32374
      • Weiz, Austria, A-8160
        • Site Reference ID/Investigator # 32370
      • Wels, Austria, A-4600
        • Site Ref # / Investigator 37124

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary care clinic and medical practice specialized in rheumatology

Description

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.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RA and if Reasonable for PsA Patients Health Assessment Questionnaire Disability Index HAQ-DI
Time Frame: Baseline, months 3,6,9,12
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).
Baseline, months 3,6,9,12
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
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).
Baseline, months 3,6,9,12
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

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.
Baseline, months 3,6,9,12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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).
Baseline,months 3,6,9,12
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
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.
Baseline, months 3,6,9,12
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
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).
Baseline, months 3,6,9,12
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
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).
Baseline, months 3,6,9,12
Erythrocyte Sedimentation Rate
Time Frame: Baseline, months 3,6,9,12
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.
Baseline, months 3,6,9,12
C-Reactive Protein
Time Frame: Baseline, months 3,6,9,12
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.
Baseline, months 3,6,9,12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Collaborators

Group Data Management Biostatistics

Investigators

  • Study Director: Astrid Dworan-Timler, MD, Abbott Austria

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

September 1, 2008

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

February 28, 2010

First Submitted That Met QC Criteria

March 8, 2010

First Posted (Estimate)

March 10, 2010

Study Record Updates

Last Update Posted (Estimate)

August 11, 2011

Last Update Submitted That Met QC Criteria

August 9, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P10-726

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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