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
Results First Received: June 28, 2011  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Rheumatoid Arthritis
Ankylosing Spondylitis
Psoriatic Arthritis

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 162 participants were screened for this study. Of those, 161 are included in the analysis as one participant was a screen failure.

Reporting Groups
  Description
Rheumatoid Arthritis (RA) Rheumatoid Arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
Psoriasis Arthritis (PsA) Psoriatic Arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
Ankylosing Spondylitis (AS) Ankylosing Spondylitis participants with unsustainable clinical response to nonsteroidal antiinflammatory drugs and or biological disease modifying antirheumatic drugs.

Participant Flow:   Overall Study
    Rheumatoid Arthritis (RA)     Psoriasis Arthritis (PsA)     Ankylosing Spondylitis (AS)  
STARTED     93     28     40  
COMPLETED     73     22     33  
NOT COMPLETED     20     6     7  
Adverse Event                 1                 1                 0  
Lost to Follow-up                 2                 0                 2  
Lack of effectiveness                 13                 2                 2  
Patient Moved                 0                 1                 0  
Complete remission                 0                 1                 0  
Other medical condition/surgery                 1                 1                 0  
Withdrawal by Subject                 3                 0                 2  
Reason unknown                 0                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Rheumatoid Arthritis (RA) Rheumatoid Arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
Psoriasis Arthritis (PsA) Psoriatic Arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
Ankylosing Spondylitis (AS) Ankylosing Spondylitis participants with unsustainable clinical response to nonsteroidal antiinflammatory drugs and or biological disease modifying antirheumatic drugs.
Total Total of all reporting groups

Baseline Measures
    Rheumatoid Arthritis (RA)     Psoriasis Arthritis (PsA)     Ankylosing Spondylitis (AS)     Total  
Number of Participants  
[units: participants]
  93     28     40     161  
Age  
[units: years]
Mean ± Standard Deviation
  55.7  ± 14.2     47.9  ± 8.1     42.0  ± 12.9     50.9  ± 14.3  
Gender  
[units: participants]
       
Female     75     9     17     101  
Male     18     19     23     60  
Region of Enrollment  
[units: participants]
       
Austria     93     28     40     161  
Duration of underlying disease [1]
[units: years]
Mean ± Standard Deviation
  7.6  ± 7.4     6.2  ± 6.8     8.9  ± 11.4     7.7  ± 8.5  
[1] Average duration (years) of underlying disease



  Outcome Measures
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1.  Primary:   RA and if Reasonable for PsA Patients Health Assessment Questionnaire Disability Index HAQ-DI   [ Time Frame: Baseline, months 3,6,9,12 ]

2.  Primary:   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 ]

3.  Primary:   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 ]

4.  Secondary:   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 ]

5.  Secondary:   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 ]

6.  Secondary:   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 ]

7.  Secondary:   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 ]

8.  Secondary:   Erythrocyte Sedimentation Rate   [ Time Frame: Baseline, months 3,6,9,12 ]

9.  Secondary:   C-Reactive Protein   [ Time Frame: Baseline, months 3,6,9,12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Global Medical Services
Organization: Abbott
phone: 1-800-633-9110


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