Real-World Outcome of Rheumatoid Arthritis Patients in Korea on Adalimumab

Real-World Outcome of Rheumatoid Arthritis Patients in Korea on Adalimumab (ROCKA Study)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02627924

Acronym

ROCKA

Enrollment

Registered

2015-12-11

Start date

2015-11-18

Completion date

2017-12-28

Last updated

2019-03-22

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

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis, Work productivity, patient-reported QoL(Quality of Life)

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

Inclusion criteria

* Subject has a diagnosis of RA as defined by the 1987 revised American College of Rheumatology (ACR) classification criteria and/or the ACR/the European League against Rheumatism (EULAR) 2010 classification criteria (any duration since diagnosis). * Male or female subject ≥ 18 years of age (local definition according to adalimumab label) who is in compliance with eligibility for adalimumab based on the local label. * Patients with moderate to severe RA defined as Disease Activity Score in 28 Joints (DAS28) (ESR) or DAS28 (CRP) \> 3.2 * Biologically treatment naïve and initiated adalimumab at baseline visit * Availability of clinical data of the previous 12 weeks prior to baseline * Ability to self-complete patient questionnaires * Subject must be able and willing to provide written informed consent and comply with the requirements of this study protocol.

Exclusion criteria

* Patients who are pregnant or breast feeding at enrolment or wish to become pregnant in the next 24 weeks. * Participation in any RA-related clinical trial at the time of enrolment, at baseline or at any point during the past 24 weeks prior to baseline * Patients who in the clinician's view, may not be able to accurately report their QoL or prior resource utilization * Patients who in the clinician's view, may not be able to adhere to adalimumab therapy over 24 weeks.

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 24	Baseline and 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.

Secondary

Measure	Time frame	Description
Percentage of Participants Achieving a Clinically Meaningful Improvement on the HAQ-DI at Weeks 12 and 24	Baseline, week 12 and 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. A clinically meaningful improvement was defined as an improvement of -0.22 points or greater in the HAQ-DI score.
Change From Baseline in Short-Form 36 (SF-36) Physical Component Summary and Mental Component Summary Scores at Weeks 12 and 24	Baseline, week 12, and week 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.
Change From Baseline in EuroQol 5-Dimension 3-Level (EQ-5D-3L) Index at Weeks 12 and 24	Baseline, week 12, and week 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.
Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) at Weeks 12 and 24	Baseline, week 12, and week 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.
Patient Treatment Satisfaction	Baseline, week 12 and week 24	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
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 12	Baseline and 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.
Healthcare Resource Utilization: Number of Participants Who Underwent Procedures Related to Treatment of Rheumatoid Arthritis	24 weeks	The healthcare resource utilization (HCRU) questionnaire collected data on the healthcare resources used over the course of the study.
Healthcare Resource Utilization: Number of Participants With Hospitalization Related to Rheumatoid Arthritis	24 weeks	The healthcare resource utilization (HCRU) questionnaire collected data on the healthcare resources used over the course of the study.
Healthcare Resource Utilization: Number of Participants With Surgery Related to Rheumatoid Arthritis	24 weeks	The healthcare resource utilization (HCRU) questionnaire collected data on the healthcare resources used over the course of the study.
Healthcare Resource Utilization: Number of Participants Who Received Concomitant Medications for Rheumatoid Arthritis	24 weeks	The healthcare resource utilization (HCRU) questionnaire collected data on the healthcare resources used over the course of the study.
Healthcare Resource Utilization: Number of Participants With Visits to Healthcare Professionals for Treatment of Rheumatoid Arthritis	24 weeks	The healthcare resource utilization (HCRU) questionnaire collected data on the healthcare resources used over the course of the study.

Participant flow

Recruitment details

Ninety-one patients diagnosed with rheumatoid arthritis (RA) were enrolled at nine different sites in Korea.

Participants by arm

Arm	Count
Adalimumab Participants diagnosed with rheumatoid arthritis who were prescribed adalimumab according to their physician's discretion and routine clinical practice.	91
Total	91

Baseline characteristics

Characteristic	Adalimumab	—
Age, Continuous	55.7 years STANDARD_DEVIATION 13.3	—
Heath Assessment Questionnaire - Disability Index (HAQ-DI)	1.33 units on a scale STANDARD_DEVIATION 0.73	—
Race and Ethnicity Not Collected	—	— Participants
Sex: Female, Male Female	64 Participants	—
Sex: Female, Male Male	27 Participants	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 91
other Total, other adverse events	6 / 91
serious Total, serious adverse events	6 / 91

Outcome results

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.

Time frame: Baseline and week 24

Population: Participants who were still receiving adalimumab at week 24 and with available HAQ-DI data at baseline and week 24.

Arm	Measure	Value (MEAN)	Dispersion
Adalimumab	Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 24	-0.67 units on a scale	Standard Deviation 0.67

p-value: <0.0001Paired t-test

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.

Time frame: Baseline, week 12, and week 24

Population: Participants still receiving adalimumab and with available data at each time point.

Arm	Measure	Group	Value (MEAN)	Dispersion
Adalimumab	Change From Baseline in EuroQol 5-Dimension 3-Level (EQ-5D-3L) Index at Weeks 12 and 24	Week 12	0.15 units on a scale	Standard Deviation 0.24
Adalimumab	Change From Baseline in EuroQol 5-Dimension 3-Level (EQ-5D-3L) Index at Weeks 12 and 24	Week 24	0.18 units on a scale	Standard Deviation 0.25

Comparison: Change from Baseline in EQ-5D-3L at 12 weeksp-value: <0.0001Paired t-test

Comparison: Change from Baseline in EQ-5D-3L at 24 weeksp-value: <0.0001Paired t-test

Secondary

Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 12

Time frame: Baseline and week 12

Population: Participants who were still receiving adalimumab at week 24 and with available HAQ-DI data at baseline and week 12.

Arm	Measure	Value (MEAN)	Dispersion
Adalimumab	Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 12	-0.46 units on a scale	Standard Deviation 0.6

p-value: <0.0001Paired t-test

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.

Time frame: Baseline, week 12, and week 24

Population: Participants still receiving adalimumab and with available data at each time point.

Arm	Measure	Group	Value (MEAN)	Dispersion
Adalimumab	Change From Baseline in Short-Form 36 (SF-36) Physical Component Summary and Mental Component Summary Scores at Weeks 12 and 24	Physical Component Score at Week 12	6.56 units on a scale	Standard Deviation 6.98
Adalimumab	Change From Baseline in Short-Form 36 (SF-36) Physical Component Summary and Mental Component Summary Scores at Weeks 12 and 24	Physical Component Score at Week 24	9.51 units on a scale	Standard Deviation 7.77
Adalimumab	Change From Baseline in Short-Form 36 (SF-36) Physical Component Summary and Mental Component Summary Scores at Weeks 12 and 24	Mental Component Score at Week 12	5.26 units on a scale	Standard Deviation 11.62
Adalimumab	Change From Baseline in Short-Form 36 (SF-36) Physical Component Summary and Mental Component Summary Scores at Weeks 12 and 24	Mental Component Score at Week 24	6.63 units on a scale	Standard Deviation 12.31

Comparison: Change From Baseline in Physical Component Score at Week 12p-value: <0.0001Paired t-test

Comparison: Change From Baseline in Physical Component Score at Week 24p-value: <0.0001Paired t-test

Comparison: Change From Baseline in Mental Component Score at Week 12p-value: 0.0001Paired t-test

Comparison: Change From Baseline in Mental Component Score at Week 24p-value: <0.0001Paired t-test

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.

Time frame: Baseline, week 12, and week 24

Population: Participants still receiving adalimumab and with available data at each time point. Overall work impairment was only assessed in participants who were employed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Adalimumab	Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) at Weeks 12 and 24	Overall Work Impairment at Week 12	-19 percent impairment	Standard Deviation 32
Adalimumab	Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) at Weeks 12 and 24	Overall Work Impairment at Week 24	-25 percent impairment	Standard Deviation 31
Adalimumab	Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) at Weeks 12 and 24	Activity Impairment at Week 12	-15 percent impairment	Standard Deviation 31
Adalimumab	Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) at Weeks 12 and 24	Activity Impairment at Week 24	-25 percent impairment	Standard Deviation 34

Comparison: Change From Baseline in Overall Work Impairment at Week 12p-value: 0.0098Paired t-test

Comparison: Change From Baseline in Overall Work Impairment at Week 24p-value: 0.0015Paired t-test

Comparison: Change From Baseline in Activity Impairment at Week 12p-value: <0.0001Paired t-test

Comparison: Change From Baseline in Activity Impairment at Week 24p-value: <0.0001Paired t-test

Secondary