Cost Utility Analyses of Adalimumab Treatment in Patients With Rheumatoid Arthritis (RA) (HEOR)

This study has been completed.

Sponsor:

Collaborator:

Institute of Political Economical & Social Researches, Greece

Information provided by:

Abbott

ClinicalTrials.gov Identifier:

NCT01078116

First received: February 26, 2010

Last updated: August 9, 2011

Last verified: August 2011

History of Changes

Results First Received: June 24, 2011

Study Type:	Observational
Study Design:	Observational Model: Cohort; Time Perspective: Prospective
Condition:	Rheumatoid 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
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Reporting Groups

	Description
Adalimumab Treatment	Male or female participants with moderate to severe active rheumatoid arthritis treated with adalimumab according to the approved Summary of Product Characteristics (SmPC) in European Union

Participant Flow: Overall Study

	Adalimumab Treatment
STARTED	124 ^[1]
COMPLETED	76
NOT COMPLETED	48
Lost to Follow-up	17
Adverse Event	5
Withdrawal by Subject	8
Lack of effectiveness	15
Case report form not completed	3

[1]	121 participants were included in analysis (3 were excluded due to missing case report form data).

Baseline Characteristics

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Reporting Groups

	Description
Adalimumab Treatment	Male or female participants with moderate to severe active rheumatoid arthritis treated with adalimumab according to the approved Summary of Product Characteristics (SmPC) in European Union

Baseline Measures

	Adalimumab Treatment
Number of Participants [units: participants]	121
Age ^[1] [units: years] Mean ± Standard Deviation	56.2 ± 12.9
Gender ^[1] [units: participants]
Female	100
Male	21
Region of Enrollment ^[1] [units: participants]
Greece	121

[1]	Based on population of 121 participants analyzed.

Outcome Measures

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1. Primary:

Estimation of the Direct and Indirect Cost Incurred by Adalimumab Treatment [ Time Frame: Enrollment visit (Baseline), month 3, month 6, month 12 ]

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2. Primary:

Health Related Quality of Life (European Quality of Life 5 Dimensions) [ Time Frame: Enrollment visit (Baseline), month 3, month 6, month 12 ]

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3. Primary:

Health Related Quality of Life (Health Assessment Questionnaire) [ Time Frame: Enrollment visit (Baseline), month 3, month 6, month 12 ]

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4. Primary:

Health Related Quality of Life (Medical Outcome Study Short Form 36) [ Time Frame: Enrollment visit (Baseline), month 3, month 6, month 12 ]

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5. Primary:

Cost-Utility Relationship of Rheumatoid Arthritis Patients Treated With Adalimumab Using Incremental Cost-Effectiveness Approach (ICER) [ Time Frame: 12 months ]

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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
Study NCT 01078116 (P10-159) is a substudy of NCT 01086033(GREC-2004-06). Adverse events were not recorded in this study but will be reported in the main study upon completion. Only adverse events leading to withdrawal are reported in this substudy.

Results Point of Contact:

Name/Title: Global Medical Services
Organization: Abbott
phone: 1-800-633-9110

No publications provided

Responsible Party:	Tina Antachopoulou / Medical Director, Abbott Laboratories Hellas S.A.
ClinicalTrials.gov Identifier:	NCT01078116 History of Changes
Other Study ID Numbers:	P10-159
Study First Received:	February 26, 2010
Results First Received:	June 24, 2011
Last Updated:	August 9, 2011
Health Authority:	Greece: National Organization of Medicines

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