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CompletedNCT02627924ROCKAUpdated Mar 22, 2019Results posted

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

An observational study in Rheumatoid Arthritis, sponsored by AbbVie. Completed. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2019-03-22.

Sponsored by AbbVie · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
91
Ages
18 Years to 99 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Rheumatoid Arthritis

Keywords

  • Rheumatoid Arthritis
  • Work productivity
  • patient-reported QoL(Quality of Life)
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 91 is below the median of 155 across 1,057 observational studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.

Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Subjects receiving Adalimumab with Rheumatoid Arthritis (RA) in Korea

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

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.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
91 participants (actual)

Groups and cohorts

  • Adalimumab

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

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

    Time frame: Baseline and week 12

  2. 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.

    Time frame: Baseline, week 12 and week 24

  3. 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

  4. 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

  5. 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

  6. 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

    Time frame: Baseline, week 12 and week 24

  7. 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.

    Time frame: 24 weeks

  8. 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.

    Time frame: 24 weeks

  9. 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.

    Time frame: 24 weeks

  10. 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.

    Time frame: 24 weeks

  11. 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.

    Time frame: 24 weeks

07

Results

Posted Mar 22, 2019

Participant flow

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

Participant flow — Overall Study
MilestoneAdalimumab
Started91
Completed79
Not completed12

Outcome measures

PrimaryChange 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
Reported as:
Mean · units on a scale
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 24
units on a scaleAdalimumab
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 24-0.67 ± 0.67
Statistical analysis
  • Adalimumab · Paired t-test · p = <0.0001The mean change was tested with a paired t-test without adjusting for baseline disease severity.
SecondaryChange 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.

Time frame:
Baseline and week 12
Reported as:
Mean · units on a scale
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 12
units on a scaleAdalimumab
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 12-0.46 ± 0.60
Statistical analysis
  • Adalimumab · Paired t-test · p = <0.0001The mean change was tested with a paired t-test without adjusting for baseline disease severity.
SecondaryPercentage 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.

Time frame:
Baseline, week 12 and week 24
Reported as:
Number · percentage of participants
Percentage of Participants Achieving a Clinically Meaningful Improvement on the HAQ-DI at Weeks 12 and 24
percentage of participantsAdalimumab
Week 1265.8
Week 2477.5
SecondaryChange 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
Reported as:
Mean · units on a scale
Change From Baseline in Short-Form 36 (SF-36) Physical Component Summary and Mental Component Summary Scores at Weeks 12 and 24
units on a scaleAdalimumab
Physical Component Score at Week 126.56 ± 6.98
Physical Component Score at Week 249.51 ± 7.77
Mental Component Score at Week 125.26 ± 11.62
Mental Component Score at Week 246.63 ± 12.31
Statistical analysis
  • Adalimumab · Paired t-test · p = <0.0001
  • Adalimumab · Paired t-test · p = <0.0001
  • Adalimumab · Paired t-test · p = 0.0001
  • Adalimumab · Paired t-test · p = <0.0001
SecondaryChange 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
Reported as:
Mean · units on a scale
Change From Baseline in EuroQol 5-Dimension 3-Level (EQ-5D-3L) Index at Weeks 12 and 24
units on a scaleAdalimumab
Week 120.15 ± 0.24
Week 240.18 ± 0.25
Statistical analysis
  • Adalimumab · Paired t-test · p = <0.0001
  • Adalimumab · Paired t-test · p = <0.0001
SecondaryChange 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
Reported as:
Mean · percent impairment
Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) at Weeks 12 and 24
percent impairmentAdalimumab
Overall Work Impairment at Week 12-19 ± 32
Overall Work Impairment at Week 24-25 ± 31
Activity Impairment at Week 12-15 ± 31
Activity Impairment at Week 24-25 ± 34
Statistical analysis
  • Adalimumab · Paired t-test · p = 0.0098
  • Adalimumab · Paired t-test · p = 0.0015
  • Adalimumab · Paired t-test · p = <0.0001
  • Adalimumab · Paired t-test · p = <0.0001
SecondaryPatient 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

Time frame:
Baseline, week 12 and week 24
Reported as:
Count of participants · Participants
Patient Treatment Satisfaction
ParticipantsBaselineWeek 12Week 24
Question 1 - morning stiffness — Very satisfied92730
Question 1 - morning stiffness — Somewhat satisfied152419
Question 1 - morning stiffness — Neither satisfied nor dissatisfied261714
Question 1 - morning stiffness — Somewhat dissatisfied2576
Question 1 - morning stiffness — Very dissatisfied1342
Question 2 - Mobility — Very satisfied62727
Question 2 - Mobility — Somewhat satisfied252422
Question 2 - Mobility — Neither satisfied nor dissatisfied261813
Question 2 - Mobility — Somewhat dissatisfied2177
Question 2 - Mobility — Very dissatisfied1032
Question 3 - Fine motor skills — Very satisfied122733
Question 3 - Fine motor skills — Somewhat satisfied122416
Question 3 - Fine motor skills — Neither satisfied nor dissatisfied251915
Question 3 - Fine motor skills — Somewhat dissatisfied2176
Question 3 - Fine motor skills — Very dissatisfied1821
Question 4 - Treatment overall — Very satisfied93232
Question 4 - Treatment overall — Somewhat satisfied142217
Question 4 - Treatment overall — Neither satisfied nor dissatisfied321616
Question 4 - Treatment overall — Somewhat dissatisfied2176
Question 4 - Treatment overall — Very dissatisfied1220
SecondaryHealthcare 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.

Time frame:
24 weeks
Reported as:
Count of participants · Participants
Healthcare Resource Utilization: Number of Participants With Visits to Healthcare Professionals for Treatment of Rheumatoid Arthritis
ParticipantsAdalimumab
Family medicine2
Rheumatologist87
Orthopaedist4
Internist6
Emergency department0
Traditional Medicine3
Rehabilitation Medicine2
Other2
Any healthcare professional87
SecondaryHealthcare 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.

Time frame:
24 weeks
Reported as:
Count of participants · Participants
Healthcare Resource Utilization: Number of Participants Who Underwent Procedures Related to Treatment of Rheumatoid Arthritis
ParticipantsAdalimumab
Chest X-Ray19
Spine X-Ray5
Neck X-Ray2
Shoulder X-Ray4
Hand X-Ray4
Knee X-Ray5
Magnetic resonance imaging (MRI)0
Computed tomography (CT) scan4
Electrocardiogram4
Blood sample taken61
Urine test35
Endoscopy2
Bone scan1
Liver function test8
Tuberculin Skin Test3
Sputum tests2
Other8
Any Procedure67
SecondaryHealthcare 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.

Time frame:
24 weeks
Reported as:
Count of participants · Participants
Healthcare Resource Utilization: Number of Participants With Hospitalization Related to Rheumatoid Arthritis
ParticipantsAdalimumab
Healthcare Resource Utilization: Number of Participants With Hospitalization Related to Rheumatoid Arthritis3
SecondaryHealthcare 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.

Time frame:
24 weeks
Reported as:
Count of participants · Participants
Healthcare Resource Utilization: Number of Participants With Surgery Related to Rheumatoid Arthritis
ParticipantsAdalimumab
Healthcare Resource Utilization: Number of Participants With Surgery Related to Rheumatoid Arthritis0
SecondaryHealthcare 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.

Time frame:
24 weeks
Reported as:
Count of participants · Participants
Healthcare Resource Utilization: Number of Participants Who Received Concomitant Medications for Rheumatoid Arthritis
ParticipantsAdalimumab
Disease-modifying Antirheumatic Drug (DMARD)36
Anti-inflammatory Drug (NSAID)32
Others26
Any Concomitant Medication44

Adverse events

Collected over Up to 34 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Adalimumab0/91 (0%)6/91 (6.6%)6/91 (6.6%)
Most frequent serious events
Most frequent serious events
EventAdalimumab
ArthralgiaMusculoskeletal and connective tissue disorders1/91
ArthritisMusculoskeletal and connective tissue disorders1/91
Intervertebral disc protrusionMusculoskeletal and connective tissue disorders1/91
Spinal column stenosisNervous system disorders1/91
Pneumonia bacterialInfections and infestations1/91
Deep vein thrombosisVascular disorders1/91
Diabetes mellitusMetabolism and nutrition disorders1/91
Drug ineffectiveGeneral disorders1/91
Rheumatoid arthritisImmune system disorders1/91
Most frequent other events
Showing 10 of 11
Most frequent other events
EventAdalimumab
RashSkin and subcutaneous tissue disorders2/91
Injection site erythemaGeneral disorders2/91
Injection site pruritusGeneral disorders2/91
RosaceaSkin and subcutaneous tissue disorders1/91
Antinuclear antibody increasedInvestigations1/91
C-reactive protein increasedInvestigations1/91
Diabetes mellitusMetabolism and nutrition disorders1/91
Drug ineffectiveGeneral disorders1/91
Haemoglobin decreasedInvestigations1/91
Injection site rashGeneral disorders1/91

Baseline characteristics

All enrolled participants

Age, Continuous
Age, Continuous(years)Adalimumab
Mean55.7 ± 13.3
Sex: Female, Male
Sex: Female, Male(Participants)Adalimumab
Female64
Male27
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Adalimumab
Heath Assessment Questionnaire - Disability Index (HAQ-DI)
Heath Assessment Questionnaire - Disability Index (HAQ-DI)(units on a scale)Adalimumab
Mean1.33 ± 0.73
08

Study locations

No study locations are listed for this record.

09

References and documents

Related links

Study documents

  • Study protocol · Dec 26, 2017
  • Statistical analysis plan · Jan 2, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 22, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02627924
Lead sponsor
AbbVie
Responsible party
Sponsor
First posted
Dec 11, 2015
Start date
Nov 18, 2015
Primary completion
Dec 28, 2017
Completion
Dec 28, 2017
Results posted
Mar 22, 2019
Last update
Mar 22, 2019

Study contacts

AbbVie Inc.
study director · AbbVie

Oversight

Data monitoring committee
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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