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

History of Changes

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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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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8. Secondary:

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

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9. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.

Limitations and Caveats

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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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

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