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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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01387789
Acronym
RELIVE
Enrollment
71
Registered
2011-07-06
Start date
2011-08-31
Completion date
2013-03-31
Last updated
2014-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

Product Surveillance, Postmarketing

Brief summary

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

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.

Interventions

None listed

Sponsors

AbbVie (prior sponsor, Abbott)
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Change in Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS) Scores From Baseline to 6 MonthsBaseline and 6 monthsThe 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.
Change in Overall Health Assessment Questionnaire Disability Index (HAQ-DI) Scores From Baseline to 6 MonthsBaseline and 6 monthsThe 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.
Change in Health Assessment Questionnaire Short Form 36 (SF-36) Scores From Baseline to 6 MonthsBaseline and 6 monthsThe 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.

Secondary

MeasureTime frameDescription
Change in Overall Health Assessment Questionnaire Disability Index (HAQ-DI) Scores From Baseline to 3 MonthsBaseline and 3 monthsThe 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.
Change in Overall Health Assessment Questionnaire Disability Index (HAQ-DI) Scores From Baseline to 1 MonthBaseline and 1 monthThe 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.
Change in Health Assessment Questionnaire Short Form 36 (SF-36) Scores From Baseline to 3 MonthsBaseline and 3 monthsThe 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.
Change in Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS) Scores From Baseline to 3 MonthsBaseline and 3 monthsThe 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.
Change in Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS) Scores From Baseline to 1 MonthBaseline and 1 monthThe 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.
Change in Mean Health Assessment Questionnaire Short Form 36 (SF-36) Scores From Baseline to 1 MonthBaseline and 1 monthThe 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.

Countries

Malaysia

Participant flow

Participants by arm

ArmCount
Scheduled to Start Adalimumab Therapy
Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
71
Total71

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyAdverse Event5
Overall StudyLack of Efficacy2
Overall StudyLost to Follow-up1

Baseline characteristics

CharacteristicScheduled to Start Adalimumab Therapy
Age, Customized
30-39 years of age
18 participants
Age, Customized
<30 years of age
4 participants
Age, Customized
40-49 years of age
16 participants
Age, Customized
50-59 years of age
26 participants
Age, Customized
60-69 years of age
7 participants
Region of Enrollment
Malaysia
71 participants
Sex: Female, Male
Female
62 Participants
Sex: Female, Male
Male
9 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 71
serious
Total, serious adverse events
13 / 71

Outcome results

Primary

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.

Time frame: Baseline and 6 months

ArmMeasureGroupValue (MEAN)Dispersion
Scheduled to Start Adalimumab TherapyChange in Health Assessment Questionnaire Short Form 36 (SF-36) Scores From Baseline to 6 MonthsPhysical Component Summary16.06 units on a scaleStandard Deviation 23.02
Scheduled to Start Adalimumab TherapyChange in Health Assessment Questionnaire Short Form 36 (SF-36) Scores From Baseline to 6 MonthsMental Component Summary12.30 units on a scaleStandard Deviation 18.21
Primary

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.

Time frame: Baseline and 6 months

ArmMeasureValue (MEAN)Dispersion
Scheduled to Start Adalimumab TherapyChange in Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS) Scores From Baseline to 6 Months-0.49 centimetersStandard Deviation 0.79
Primary

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.

Time frame: Baseline and 6 months

ArmMeasureValue (MEAN)Dispersion
Scheduled to Start Adalimumab TherapyChange in Overall Health Assessment Questionnaire Disability Index (HAQ-DI) Scores From Baseline to 6 Months-0.41 units on a scaleStandard Deviation 0.79
Secondary

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.

Time frame: Baseline and 3 months

ArmMeasureGroupValue (MEAN)Dispersion
Scheduled to Start Adalimumab TherapyChange in Health Assessment Questionnaire Short Form 36 (SF-36) Scores From Baseline to 3 MonthsPhysical Component Summary14.19 units on a scaleStandard Deviation 20.54
Scheduled to Start Adalimumab TherapyChange in Health Assessment Questionnaire Short Form 36 (SF-36) Scores From Baseline to 3 MonthsMental Component Summary8.77 units on a scaleStandard Deviation 15.55
Secondary

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.

Time frame: Baseline and 1 month

Population: Participants with available data at this time point

ArmMeasureValue (MEAN)Dispersion
Scheduled to Start Adalimumab TherapyChange in Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS) Scores From Baseline to 1 Month-0.46 centimetersStandard Deviation 0.51
Secondary

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.

Time frame: Baseline and 3 months

Population: Participants with available data at this time point

ArmMeasureValue (MEAN)Dispersion
Scheduled to Start Adalimumab TherapyChange in Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS) Scores From Baseline to 3 Months-0.48 centimetersStandard Deviation 0.72
Secondary

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.

Time frame: Baseline and 1 month

ArmMeasureGroupValue (MEAN)Dispersion
Scheduled to Start Adalimumab TherapyChange in Mean Health Assessment Questionnaire Short Form 36 (SF-36) Scores From Baseline to 1 MonthPhysical Component Summary11.46 units on a scaleStandard Deviation 16.5
Scheduled to Start Adalimumab TherapyChange in Mean Health Assessment Questionnaire Short Form 36 (SF-36) Scores From Baseline to 1 MonthMental Component Summary6.42 units on a scaleStandard Deviation 13.56
Secondary

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.

Time frame: Baseline and 1 month

ArmMeasureValue (MEAN)Dispersion
Scheduled to Start Adalimumab TherapyChange in Overall Health Assessment Questionnaire Disability Index (HAQ-DI) Scores From Baseline to 1 Month-0.30 units on a scaleStandard Deviation 0.52
Secondary

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.

Time frame: Baseline and 3 months

ArmMeasureValue (MEAN)Dispersion
Scheduled to Start Adalimumab TherapyChange in Overall Health Assessment Questionnaire Disability Index (HAQ-DI) Scores From Baseline to 3 Months-0.38 units on a scaleStandard Deviation 0.69

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026