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A Study of Rheumatoid Arthritis Patients on Adalimumab to Evaluate Quality of Life Variables, Effects on Work Productivity and Functional Outcomes in Malaysia (RELIVE)

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ClinicalTrials.gov Identifier: NCT01387789
Recruitment Status : Completed
First Posted : July 6, 2011
Results First Posted : April 21, 2014
Last Update Posted : May 5, 2014
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

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

  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
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Reporting Groups
  Description
Scheduled to Start Adalimumab Therapy Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.

Participant Flow:   Overall Study
    Scheduled to Start Adalimumab Therapy
STARTED   71 
COMPLETED   63 
NOT COMPLETED   8 
Adverse Event                5 
Lack of Efficacy                2 
Lost to Follow-up                1 



  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
Scheduled to Start Adalimumab Therapy Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.

Baseline Measures
   Scheduled to Start Adalimumab Therapy 
Overall Participants Analyzed 
[Units: Participants]
 71 
Age, Customized 
[Units: Participants]
 
<30 years of age   4 
30-39 years of age   18 
40-49 years of age   16 
50-59 years of age   26 
60-69 years of age   7 
Gender 
[Units: Participants]
 
Female   62 
Male   9 
Region of Enrollment 
[Units: Participants]
 
Malaysia   71 


  Outcome Measures

1.  Primary:   Change in Overall Health Assessment Questionnaire Disability Index (HAQ-DI) Scores From Baseline to 6 Months   [ Time Frame: Baseline and 6 months ]

2.  Primary:   Change in Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS) Scores From Baseline to 6 Months   [ Time Frame: Baseline and 6 months ]

3.  Primary:   Change in Health Assessment Questionnaire Short Form 36 (SF-36) Scores From Baseline to 6 Months   [ Time Frame: Baseline and 6 months ]

4.  Secondary:   Change in Overall Health Assessment Questionnaire Disability Index (HAQ-DI) Scores From Baseline to 1 Month   [ Time Frame: Baseline and 1 month ]

5.  Secondary:   Change in Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS) Scores From Baseline to 1 Month   [ Time Frame: Baseline and 1 month ]

6.  Secondary:   Change in Mean Health Assessment Questionnaire Short Form 36 (SF-36) Scores From Baseline to 1 Month   [ Time Frame: Baseline and 1 month ]

7.  Secondary:   Change in Overall Health Assessment Questionnaire Disability Index (HAQ-DI) Scores From Baseline to 3 Months   [ Time Frame: Baseline and 3 months ]

8.  Secondary:   Change in Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS) Scores From Baseline to 3 Months   [ Time Frame: Baseline and 3 months ]

9.  Secondary:   Change in Health Assessment Questionnaire Short Form 36 (SF-36) Scores From Baseline to 3 Months   [ Time Frame: Baseline and 3 months ]


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.


  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.


Results Point of Contact:  
Name/Title: Global Medical Services
Organization: AbbVie (prior sponsor, Abbott)
phone: 800-633-9110



Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01387789     History of Changes
Other Study ID Numbers: P12-265
First Submitted: July 1, 2011
First Posted: July 6, 2011
Results First Submitted: March 14, 2014
Results First Posted: April 21, 2014
Last Update Posted: May 5, 2014