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

Study Overview
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Brief Summary
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An observational, non-interventional study on social, economic and quality-of-life outcomes of Adalimumab use in participants with moderate to severe active Rheumatoid Arthritis.

Detailed Description
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This study was designed to evaluate adalimumab therapy in Malaysia on participants' Quality of Life (QoL) using non-invasive epidemiological methods like the Health Assessment Questionnaire - Disability Index (HAQ-DI), the Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS), and the Health Assessment Questionnaire Short Form 36 (SF-36). The primary objective of the study was to evaluate the changes in QoL outcomes in anti -TNF naïve Malaysian RA patients after 6 months of adalimumab treatment. The secondary objectives of this study were to evaluate the changes on QoL outcomes after 1 month and 3 months of adalimumab treatment; and provide an assessment of the safety and tolerability of adalimumab in anti TNF naïve Malaysian Rheumatoid Arthritis patients.

Official Title
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An Observational Study of Rheumatoid Arthritis Patients on Adalimumab to Evaluate Quality of Life Variables, Effects on Work Productivity and Functional Outcomes in Malaysia

Conditions
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Rheumatoid Arthritis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 18 years of age and older with a diagnosis of Rheumatoid Arthritis for at least 3 months according to the American College of Rheumatology (ACR) criteria Patients who have not been instituted on any anti -Tumour Necrosis Factor (anti-TNF) agents prior to inclusion into this study (anti-TNF naïve patients). Only anti-TNF Naive Rheumatoid Arthritis patients who are scheduled to begin HUMIRA treatment, according to the relevant Summary of Product Characteristics, on the basis of their own physician's judgment (and on the current clinical practice), will be selected for inclusion in this study Patients not included in other clinical/observational trials Patients providing a written informed consent before the enrollment in the study Exclusion Criteria: Refusal to participate in the study or to sign the informed consent Contraindications to adalimumab according to the terms of the local marketing authorization (label)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Scheduled to start adalimumab therapy<br>Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Overall Health Assessment Questionnaire Disability Index (HAQ-DI) Scores From Baseline to 6 Months | 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. | Baseline and 6 months | 
| Change in Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS) Scores From Baseline to 6 Months | 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. | Baseline and 6 months | 
| Change in Health Assessment Questionnaire Short Form 36 (SF-36) Scores From Baseline to 6 Months | 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. | Baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Overall Health Assessment Questionnaire Disability Index (HAQ-DI) Scores From Baseline to 1 Month | 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. | Baseline and 1 month | 
| Change in Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS) Scores From Baseline to 1 Month | 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. | Baseline and 1 month | 
| Change in Mean Health Assessment Questionnaire Short Form 36 (SF-36) Scores From Baseline to 1 Month | 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. | Baseline and 1 month | 
| Change in Overall Health Assessment Questionnaire Disability Index (HAQ-DI) Scores From Baseline to 3 Months | 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. | Baseline and 3 months | 
| Change in Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS) Scores From Baseline to 3 Months | 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. | Baseline and 3 months | 
| Change in Health Assessment Questionnaire Short Form 36 (SF-36) Scores From Baseline to 3 Months | 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. | Baseline and 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Product Surveillance, Postmarketing