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
Results First Received: June 24, 2011  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Rheumatoid Arthritis

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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
  Hide Baseline Characteristics

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
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
  Show All Outcome Measures

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

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

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

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

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


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

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.


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