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The study is designed as a prospective, observational study to assess the effect of adalimumab on health-related quality of life (QoL) and work productivity in patients with rheumatoid arthritis (RA) in Korea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adalimumab | Participants diagnosed with rheumatoid arthritis who were prescribed adalimumab according to their physician's discretion and routine clinical practice. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 24 | The HAQ-DI is a patient-reported assessment of physical function that includes 20 items in eight categories representing a comprehensive set of functional activities, including dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Patients were asked about their ability to complete these tasks in the past week using the following 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 (best) to 3 (worst), with a higher score representing a high-dependency disability. | Baseline and week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 12 | The HAQ-DI is a patient-reported assessment of physical function that includes 20 items in eight categories representing a comprehensive set of functional activities, including dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Patients were asked about their ability to complete these tasks in the past week using the following 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 (best) to 3 (worst), with a higher score representing a high-dependency disability. |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects receiving Adalimumab with Rheumatoid Arthritis (RA) in Korea
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
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| Label | URL |
|---|---|
| Related Info | View source |
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Ninety-one patients diagnosed with rheumatoid arthritis (RA) were enrolled at nine different sites in Korea.
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| ID | Title | Description |
|---|---|---|
| FG000 | Adalimumab | Participants diagnosed with rheumatoid arthritis who were prescribed adalimumab according to their physician's discretion and routine clinical practice. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All enrolled participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Adalimumab | Participants diagnosed with rheumatoid arthritis who were prescribed adalimumab according to their physician's discretion and routine clinical practice. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 24 | The HAQ-DI is a patient-reported assessment of physical function that includes 20 items in eight categories representing a comprehensive set of functional activities, including dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Patients were asked about their ability to complete these tasks in the past week using the following 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 (best) to 3 (worst), with a higher score representing a high-dependency disability. | Participants who were still receiving adalimumab at week 24 and with available HAQ-DI data at baseline and week 24. | Posted | Mean | Standard Deviation | units on a scale | Baseline and week 24 |
|
Up to 34 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adalimumab | Participants diagnosed with rheumatoid arthritis who were prescribed adalimumab according to their physician's discretion and routine clinical practice. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 26, 2017 | Dec 6, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 2, 2018 | Dec 6, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Baseline and week 12 |
| Percentage of Participants Achieving a Clinically Meaningful Improvement on the HAQ-DI at Weeks 12 and 24 | The HAQ-DI is a patient-reported assessment of physical function that includes 20 items in eight categories representing a comprehensive set of functional activities, including dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Patients were asked about their ability to complete these tasks in the past week using the following 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 (best) to 3 (worst), with a higher score representing a high-dependency disability. A clinically meaningful improvement was defined as an improvement of -0.22 points or greater in the HAQ-DI score. | Baseline, week 12 and week 24 |
| Change From Baseline in Short-Form 36 (SF-36) Physical Component Summary and Mental Component Summary Scores at Weeks 12 and 24 | The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The summary physical health score included the following subscales: physical functioning, role-physical, bodily pain, and general health. The summary mental health score included the following subscales: vitality, social functioning, role-emotional, and mental health. Each score ranges from 0 to 100 where higher scores indicate a better quality of life. A positive change from Baseline score indicates an improvement. | Baseline, week 12, and week 24 |
| Change From Baseline in EuroQol 5-Dimension 3-Level (EQ-5D-3L) Index at Weeks 12 and 24 | The EQ-5D-5L descriptive system comprises 5 dimensions of health-related quality of life states (mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression) each of which can take one of three responses. The responses record three levels of severity ('no problems', 'some problems', and 'extreme problems') within a particular EQ-5D-3L dimension. The EQ-5D-3L results were converted into a weighted health state index with scores ranging from approximately 0 (death) to 1 (full health). A positive change from baseline indicates improvement. | Baseline, week 12, and week 24 |
| Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) at Weeks 12 and 24 | The Work Productivity and Activity Impairment (WPAI) questionnaire for general health is a validated tool in RA consisting of 6 questions, based on patient recall of the previous 7 days. WPAI assesses work time missed due to illness (absenteeism), impairment at work due to health (presenteeism), overall work impairment due to health (an aggregate measure of both absenteeism and presenteeism), and total non-occupational activity impairment due to health. WPAI scores are expressed as impairment percentages, with higher scores indicating worse outcomes. A negative change from baseline indicates improvement. | Baseline, week 12, and week 24 |
| Patient Treatment Satisfaction | Participants were asked to answer the following four questions as either Very satisfied, Somewhat satisfied, Neither satisfied nor dissatisfied, Somewhat dissatisfied, or Very dissatisfied. Question 1: Satisfaction with RA treatment in improving morning stiffness in and around the joints Question 2: Satisfaction with RA treatment improving mobility Question 3: Satisfaction with RA treatment improving the ability to perform daily living requiring fine motor skills Questions 4: Satisfaction with RA treatment overall | Baseline, week 12 and week 24 |
| Healthcare Resource Utilization: Number of Participants With Visits to Healthcare Professionals for Treatment of Rheumatoid Arthritis | The healthcare resource utilization (HCRU) questionnaire collected data on the healthcare resources used over the course of the study. | 24 weeks |
| Healthcare Resource Utilization: Number of Participants Who Underwent Procedures Related to Treatment of Rheumatoid Arthritis | The healthcare resource utilization (HCRU) questionnaire collected data on the healthcare resources used over the course of the study. | 24 weeks |
| Healthcare Resource Utilization: Number of Participants With Hospitalization Related to Rheumatoid Arthritis | The healthcare resource utilization (HCRU) questionnaire collected data on the healthcare resources used over the course of the study. | 24 weeks |
| Healthcare Resource Utilization: Number of Participants With Surgery Related to Rheumatoid Arthritis | The healthcare resource utilization (HCRU) questionnaire collected data on the healthcare resources used over the course of the study. | 24 weeks |
| Healthcare Resource Utilization: Number of Participants Who Received Concomitant Medications for Rheumatoid Arthritis | The healthcare resource utilization (HCRU) questionnaire collected data on the healthcare resources used over the course of the study. | 24 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Heath Assessment Questionnaire - Disability Index (HAQ-DI) | The HAQ-DI is a patient-reported assessment of physical function that includes 20 items in eight categories including dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Patients were asked about their ability to complete these tasks in the past week using the following 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 (best) to 3 (worst), where higher scores represent a high-dependency disability. | Mean | Standard Deviation | units on a scale |
|
Participants diagnosed with rheumatoid arthritis who were prescribed adalimumab according to their physician's discretion and routine clinical practice. |
|
|
|
| Secondary | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 12 | The HAQ-DI is a patient-reported assessment of physical function that includes 20 items in eight categories representing a comprehensive set of functional activities, including dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Patients were asked about their ability to complete these tasks in the past week using the following 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 (best) to 3 (worst), with a higher score representing a high-dependency disability. | Participants who were still receiving adalimumab at week 24 and with available HAQ-DI data at baseline and week 12. | Posted | Mean | Standard Deviation | units on a scale | Baseline and week 12 |
|
|
|
|
| Secondary | Percentage of Participants Achieving a Clinically Meaningful Improvement on the HAQ-DI at Weeks 12 and 24 | The HAQ-DI is a patient-reported assessment of physical function that includes 20 items in eight categories representing a comprehensive set of functional activities, including dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Patients were asked about their ability to complete these tasks in the past week using the following 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 (best) to 3 (worst), with a higher score representing a high-dependency disability. A clinically meaningful improvement was defined as an improvement of -0.22 points or greater in the HAQ-DI score. | Participants still receiving adalimumab and with available data at each time point. | Posted | Number | percentage of participants | Baseline, week 12 and week 24 |
|
|
|
| Secondary | Change From Baseline in Short-Form 36 (SF-36) Physical Component Summary and Mental Component Summary Scores at Weeks 12 and 24 | The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The summary physical health score included the following subscales: physical functioning, role-physical, bodily pain, and general health. The summary mental health score included the following subscales: vitality, social functioning, role-emotional, and mental health. Each score ranges from 0 to 100 where higher scores indicate a better quality of life. A positive change from Baseline score indicates an improvement. | Participants still receiving adalimumab and with available data at each time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline, week 12, and week 24 |
|
|
|
|
| Secondary | Change From Baseline in EuroQol 5-Dimension 3-Level (EQ-5D-3L) Index at Weeks 12 and 24 | The EQ-5D-5L descriptive system comprises 5 dimensions of health-related quality of life states (mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression) each of which can take one of three responses. The responses record three levels of severity ('no problems', 'some problems', and 'extreme problems') within a particular EQ-5D-3L dimension. The EQ-5D-3L results were converted into a weighted health state index with scores ranging from approximately 0 (death) to 1 (full health). A positive change from baseline indicates improvement. | Participants still receiving adalimumab and with available data at each time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline, week 12, and week 24 |
|
|
|
|
| Secondary | Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) at Weeks 12 and 24 | The Work Productivity and Activity Impairment (WPAI) questionnaire for general health is a validated tool in RA consisting of 6 questions, based on patient recall of the previous 7 days. WPAI assesses work time missed due to illness (absenteeism), impairment at work due to health (presenteeism), overall work impairment due to health (an aggregate measure of both absenteeism and presenteeism), and total non-occupational activity impairment due to health. WPAI scores are expressed as impairment percentages, with higher scores indicating worse outcomes. A negative change from baseline indicates improvement. | Participants still receiving adalimumab and with available data at each time point. Overall work impairment was only assessed in participants who were employed. | Posted | Mean | Standard Deviation | percent impairment | Baseline, week 12, and week 24 |
|
|
|
|
| Secondary | Patient Treatment Satisfaction | Participants were asked to answer the following four questions as either Very satisfied, Somewhat satisfied, Neither satisfied nor dissatisfied, Somewhat dissatisfied, or Very dissatisfied. Question 1: Satisfaction with RA treatment in improving morning stiffness in and around the joints Question 2: Satisfaction with RA treatment improving mobility Question 3: Satisfaction with RA treatment improving the ability to perform daily living requiring fine motor skills Questions 4: Satisfaction with RA treatment overall | Participants still receiving adalimumab and with available data at each time point. | Posted | Count of Participants | Participants | Baseline, week 12 and week 24 |
|
|
|
| Secondary | Healthcare Resource Utilization: Number of Participants With Visits to Healthcare Professionals for Treatment of Rheumatoid Arthritis | The healthcare resource utilization (HCRU) questionnaire collected data on the healthcare resources used over the course of the study. | Enrolled participants who did not discontinue adalimumab during the study | Posted | Count of Participants | Participants | 24 weeks |
|
|
|
| Secondary | Healthcare Resource Utilization: Number of Participants Who Underwent Procedures Related to Treatment of Rheumatoid Arthritis | The healthcare resource utilization (HCRU) questionnaire collected data on the healthcare resources used over the course of the study. | Enrolled participants who did not discontinue adalimumab during the study | Posted | Count of Participants | Participants | 24 weeks |
|
|
|
| Secondary | Healthcare Resource Utilization: Number of Participants With Hospitalization Related to Rheumatoid Arthritis | The healthcare resource utilization (HCRU) questionnaire collected data on the healthcare resources used over the course of the study. | Enrolled participants who did not discontinue adalimumab during the study | Posted | Count of Participants | Participants | 24 weeks |
|
|
|
| Secondary | Healthcare Resource Utilization: Number of Participants With Surgery Related to Rheumatoid Arthritis | The healthcare resource utilization (HCRU) questionnaire collected data on the healthcare resources used over the course of the study. | Enrolled participants who did not discontinue adalimumab during the study | Posted | Count of Participants | Participants | 24 weeks |
|
|
|
| Secondary | Healthcare Resource Utilization: Number of Participants Who Received Concomitant Medications for Rheumatoid Arthritis | The healthcare resource utilization (HCRU) questionnaire collected data on the healthcare resources used over the course of the study. | Enrolled participants who did not discontinue adalimumab during the study | Posted | Count of Participants | Participants | 24 weeks |
|
|
|
| 0 |
| 91 |
| 6 |
| 91 |
| 6 |
| 91 |
| Arthritis | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Spinal column stenosis | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Drug ineffective | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rheumatoid arthritis | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Injection site erythema | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rosacea | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Antinuclear antibody increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| C-reactive protein increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Drug ineffective | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Injection site pruritus | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Injection site rash | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Red blood cell sedimentation rate increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
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.
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
|
|
| Mental Component Score at Week 12 |
|
|
| Mental Component Score at Week 24 |
|
|
| <0.0001 |
| Other |
| Change From Baseline in Mental Component Score at Week 12 | Paired t-test | 0.0001 | Other |
| Change From Baseline in Mental Component Score at Week 24 | Paired t-test | <0.0001 | Other |
|
| <0.0001 |
| Other |
|
| Activity Impairment at Week 12 |
|
|
| Activity Impairment at Week 24 |
|
|
| 0.0015 |
| Other |
| Change From Baseline in Activity Impairment at Week 12 | Paired t-test | <0.0001 | Other |
| Change From Baseline in Activity Impairment at Week 24 | Paired t-test | <0.0001 | Other |
| Neither satisfied nor dissatisfied |
|
| Somewhat dissatisfied |
|
| Very dissatisfied |
|
| Question 2 - Mobility |
|
| Question 3 - Fine motor skills |
|
| Question 4 - Treatment overall |
|
| Title | Measurements |
|---|---|
|
| Internist |
|
| Emergency department |
|
| Traditional Medicine |
|
| Rehabilitation Medicine |
|
| Other |
|
| Any healthcare professional |
|
| Title | Measurements |
|---|---|
|
| Shoulder X-Ray |
|
| Hand X-Ray |
|
| Knee X-Ray |
|
| Magnetic resonance imaging (MRI) |
|
| Computed tomography (CT) scan |
|
| Electrocardiogram |
|
| Blood sample taken |
|
| Urine test |
|
| Endoscopy |
|
| Bone scan |
|
| Liver function test |
|
| Tuberculin Skin Test |
|
| Sputum tests |
|
| Other |
|
| Any Procedure |
|
| Title | Measurements |
|---|---|
|
| Any Concomitant Medication |
|