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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
Enrollment 71

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Scheduled to Start Adalimumab Therapy
Hide Arm/Group Description Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
Period Title: Overall Study
Started 71
Completed 63
Not Completed 8
Reason Not Completed
Adverse Event             5
Lack of Efficacy             2
Lost to Follow-up             1
Arm/Group Title Scheduled to Start Adalimumab Therapy
Hide Arm/Group Description Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
Overall Number of Baseline Participants 71
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 71 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
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants
Female
62
  87.3%
Male
9
  12.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Malaysia Number Analyzed 71 participants
71
1.Primary Outcome
Title Change in Overall Health Assessment Questionnaire Disability Index (HAQ-DI) Scores From Baseline to 6 Months
Hide Description The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is ≥ 0.22. HAQ remission indicating normal physical function is defined by HAQ-DI < 0.5. Negative mean changes from baseline in the overall score indicate improvement. Assessments were conducted at baseline and 6 months.
Time Frame Baseline and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Scheduled to Start Adalimumab Therapy
Hide Arm/Group Description:
Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
Overall Number of Participants Analyzed 71
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.41  (0.79)
2.Primary Outcome
Title Change in Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS) Scores From Baseline to 6 Months
Hide Description The Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS) is a patient-reported questionnaire designed to assess the presence or absence of arthritis-related pain and its severity. It consists of a doubly anchored, horizontal VAS, that is scored from 0 (no pain) to 100 (severe pain). Decreases from baseline indicate improvement. Assessments were conducted at baseline and 6 months.
Time Frame Baseline and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Scheduled to Start Adalimumab Therapy
Hide Arm/Group Description:
Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
Overall Number of Participants Analyzed 71
Mean (Standard Deviation)
Unit of Measure: centimeters
-0.49  (0.79)
3.Primary Outcome
Title Change in Health Assessment Questionnaire Short Form 36 (SF-36) Scores From Baseline to 6 Months
Hide Description The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 “worst”-100 “best”). The standard recall period is four weeks. Increases from baseline indicate improvement. Assessments were conducted at baseline and 6 months.
Time Frame Baseline and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Scheduled to Start Adalimumab Therapy
Hide Arm/Group Description:
Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
Overall Number of Participants Analyzed 71
Mean (Standard Deviation)
Unit of Measure: units on a scale
Physical Component Summary 16.06  (23.02)
Mental Component Summary 12.30  (18.21)
4.Secondary Outcome
Title Change in Overall Health Assessment Questionnaire Disability Index (HAQ-DI) Scores From Baseline to 1 Month
Hide Description The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is ≥0.22. HAQ remission indicating normal physical function is defined by HAQ-DI < 0.5. Negative mean changes from baseline in the overall score indicate improvement. Assessments were conducted at baseline and 1 month.
Time Frame Baseline and 1 month
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Scheduled to Start Adalimumab Therapy
Hide Arm/Group Description:
Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
Overall Number of Participants Analyzed 71
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.30  (0.52)
5.Secondary Outcome
Title Change in Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS) Scores From Baseline to 1 Month
Hide Description The Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS) is a patient-reported questionnaire designed to assess the presence or absence of arthritis-related pain and its severity. It consists of a doubly anchored, horizontal VAS, that is scored from 0 (no pain) to 100 (severe pain). Decreases from baseline indicate improvement. Assessments were conducted at baseline and 1 month.
Time Frame Baseline and 1 month
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with available data at this time point
Arm/Group Title Scheduled to Start Adalimumab Therapy
Hide Arm/Group Description:
Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
Overall Number of Participants Analyzed 70
Mean (Standard Deviation)
Unit of Measure: centimeters
-0.46  (0.51)
6.Secondary Outcome
Title Change in Mean Health Assessment Questionnaire Short Form 36 (SF-36) Scores From Baseline to 1 Month
Hide Description The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 “worst”-100 “best”). The standard recall period is four weeks. Increases from baseline indicate improvement. Assessments were conducted at baseline and 1 month.
Time Frame Baseline and 1 month
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Scheduled to Start Adalimumab Therapy
Hide Arm/Group Description:
Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
Overall Number of Participants Analyzed 71
Mean (Standard Deviation)
Unit of Measure: units on a scale
Physical Component Summary 11.46  (16.50)
Mental Component Summary 6.42  (13.56)
7.Secondary Outcome
Title Change in Overall Health Assessment Questionnaire Disability Index (HAQ-DI) Scores From Baseline to 3 Months
Hide Description The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is ≥0.22. HAQ remission indicating normal physical function is defined by HAQ-DI < 0.5. Negative mean changes from baseline in the overall score indicate improvement. Assessments were conducted at baseline and 3 months.
Time Frame Baseline and 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Scheduled to Start Adalimumab Therapy
Hide Arm/Group Description:
Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
Overall Number of Participants Analyzed 71
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.38  (0.69)
8.Secondary Outcome
Title Change in Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS) Scores From Baseline to 3 Months
Hide Description The Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS) is a patient-reported questionnaire designed to assess the presence or absence of arthritis-related pain and its severity. It consists of a doubly anchored, horizontal VAS, that is scored from 0 (no pain) to 100 (severe pain). Decreases from baseline indicate improvement. Assessments were conducted at baseline and 3 months.
Time Frame Baseline and 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with available data at this time point
Arm/Group Title Scheduled to Start Adalimumab Therapy
Hide Arm/Group Description:
Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
Overall Number of Participants Analyzed 70
Mean (Standard Deviation)
Unit of Measure: centimeters
-0.48  (0.72)
9.Secondary Outcome
Title Change in Health Assessment Questionnaire Short Form 36 (SF-36) Scores From Baseline to 3 Months
Hide Description The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 “worst”-100 “best”). The standard recall period is four weeks. Increases from baseline indicate improvement. Assessments were conducted at baseline and 3 months.
Time Frame Baseline and 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Scheduled to Start Adalimumab Therapy
Hide Arm/Group Description:
Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
Overall Number of Participants Analyzed 71
Mean (Standard Deviation)
Unit of Measure: units on a scale
Physical Component Summary 14.19  (20.54)
Mental Component Summary 8.77  (15.55)
Time Frame SAEs were collected from the time the physician obtained the patient’s informed consent until 30 days or 5 half-lives following the last dose of physician-prescribed treatment, an average of 250 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Scheduled to Start Adalimumab Therapy
Hide Arm/Group Description Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
All-Cause Mortality
Scheduled to Start Adalimumab Therapy
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Scheduled to Start Adalimumab Therapy
Affected / at Risk (%)
Total   13/71 (18.31%) 
Blood and lymphatic system disorders   
Anemia *  2/71 (2.82%) 
Cardiac disorders   
Myocardial infarction *  1/71 (1.41%) 
Ear and labyrinth disorders   
Vertigo *  1/71 (1.41%) 
General disorders   
Pyrexia *  1/71 (1.41%) 
Infections and infestations   
Bronchopneumonia *  1/71 (1.41%) 
Gastroenteritis *  1/71 (1.41%) 
Pneumonia *  1/71 (1.41%) 
Pulmonary tuberculosis *  1/71 (1.41%) 
Musculoskeletal and connective tissue disorders   
Intervertebral disc degeneration *  1/71 (1.41%) 
Rheumatoid arthritis *  1/71 (1.41%) 
Respiratory, thoracic and mediastinal disorders   
Reflux laryngitis *  1/71 (1.41%) 
Surgical and medical procedures   
Antibiotic prophylaxis *  1/71 (1.41%) 
Vascular disorders   
Hypotension *  1/71 (1.41%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Scheduled to Start Adalimumab Therapy
Affected / at Risk (%)
Total   0/71 (0.00%) 
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.
AbbVie 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. AbbVie 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 AbbVie needs to secure patent or proprietary protection.
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