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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02616380
Acronym
ROCKI
Enrollment
100
Registered
2015-11-26
Start date
2015-11-05
Completion date
2017-11-23
Last updated
2019-03-14

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

Conditions

Rheumatoid Arthritis

Keywords

Quality of life (QOL), Work productivity, Rheumatoid arthritis (RA)

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 Taiwan.

Interventions

None listed

Sponsors

AbbVie
Lead SponsorINDUSTRY

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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 subjects \>= 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) Erythrocyte Sedimentation Rate (ESR) or DAS28 C- Reactive Protein (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

MeasureTime frameDescription
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 24Baseline and Week 24The 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

MeasureTime frameDescription
Change From Baseline in EuroQol 5-Dimension 3-Level (EQ-5D-3L) Index at Weeks 12 and 24Baseline, week 12, and week 24The EQ-5D-5L descriptive system comprises 5 dimensions of health-related quality of life states (mobility, self-care, 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 24Baseline, week 12, and week 24The 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.
Change From Baseline in HAQ DI Score at Week 12Week 0 and Week 12The 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.
Percentage of Participants Achieving a Clinically Meaningful Improvement on the HAQ-DI at Weeks 12 and 24Baseline, week 12 and week 24The 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 24Baseline, week 12, and week 24The 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.
Healthcare Resource Utilization: Number of Participants Who Underwent Procedures Related to Treatment of Rheumatoid Arthritis24 weeksThe 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 Arthritis24 weeksThe 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 Arthritis24 weeksThe 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 Arthritis24 weeksThe healthcare resource utilization (HCRU) questionnaire collected data on the healthcare resources used over the course of the study.

Participant flow

Recruitment details

One hundred participants with rheumatoid arthritis (RA) were enrolled at 7 sites in Taiwan.

Participants by arm

ArmCount
Adalimumab
Participants diagnosed with rheumatoid arthritis who were prescribed adalimumab according to their physician's discretion and routine clinical practice.
100
Total100

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyLost to Follow-up1
Overall StudyOther2

Baseline characteristics

CharacteristicAdalimumab
Age, Continuous54.0 years
STANDARD_DEVIATION 12.2
Heath Assessment Questionnaire - Disability Index1.06 units on a scale
STANDARD_DEVIATION 0.72
Race and Ethnicity Not Collected— Participants
Sex: Female, Male
Female
87 Participants
Sex: Female, Male
Male
13 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 100
other
Total, other adverse events
1 / 100
serious
Total, serious adverse events
1 / 100

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.

ArmMeasureValue (MEAN)Dispersion
AdalimumabChange From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 24-0.44 units on a scaleStandard Deviation 0.59
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, self-care, 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.

ArmMeasureGroupValue (MEAN)Dispersion
AdalimumabChange From Baseline in EuroQol 5-Dimension 3-Level (EQ-5D-3L) Index at Weeks 12 and 2412 weeks0.23 units on a scaleStandard Deviation 0.3
AdalimumabChange From Baseline in EuroQol 5-Dimension 3-Level (EQ-5D-3L) Index at Weeks 12 and 2424 weeks0.33 units on a scaleStandard Deviation 0.38
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 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: Week 0 and Week 12

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

ArmMeasureValue (MEAN)Dispersion
AdalimumabChange From Baseline in HAQ DI Score at Week 12-0.34 units on a scaleStandard Deviation 0.46
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.

ArmMeasureGroupValue (MEAN)Dispersion
AdalimumabChange From Baseline in Short-Form 36 (SF-36) Physical Component Summary and Mental Component Summary Scores at Weeks 12 and 24Physical Component Score at Week 125.72 units on a scaleStandard Deviation 5.78
AdalimumabChange From Baseline in Short-Form 36 (SF-36) Physical Component Summary and Mental Component Summary Scores at Weeks 12 and 24Physical Component Score at Week 248.09 units on a scaleStandard Deviation 7.13
AdalimumabChange From Baseline in Short-Form 36 (SF-36) Physical Component Summary and Mental Component Summary Scores at Weeks 12 and 24Mental Component Score at Week 123.67 units on a scaleStandard Deviation 7.94
AdalimumabChange From Baseline in Short-Form 36 (SF-36) Physical Component Summary and Mental Component Summary Scores at Weeks 12 and 24Mental Component Score at Week 245.85 units on a scaleStandard Deviation 7.99
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.

ArmMeasureGroupValue (MEAN)Dispersion
AdalimumabChange From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) at Weeks 12 and 24Overall Work Impairment at Week 12-18 percent impairmentStandard Deviation 23
AdalimumabChange From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) at Weeks 12 and 24Overall Work Impairment at Week 24-19 percent impairmentStandard Deviation 23
AdalimumabChange From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) at Weeks 12 and 24Activity Impairment at Week 12-14 percent impairmentStandard Deviation 22
AdalimumabChange From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) at Weeks 12 and 24Activity Impairment at Week 24-24 percent impairmentStandard Deviation 25
Comparison: Change From Baseline in Overall Work Impairment at Week 12p-value: <0.0001Paired t-test
Comparison: Change From Baseline in Overall Work Impairment at Week 24p-value: <0.0001Paired 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

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

Population: All enrolled participants

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
AdalimumabHealthcare Resource Utilization: Number of Participants Who Received Concomitant Medications for Rheumatoid ArthritisAny Concomitant Medication100 Participants
AdalimumabHealthcare Resource Utilization: Number of Participants Who Received Concomitant Medications for Rheumatoid ArthritisDisease Modifying Antirheumatic Drug (DMARD)96 Participants
AdalimumabHealthcare Resource Utilization: Number of Participants Who Received Concomitant Medications for Rheumatoid ArthritisNon-steroidal Anti-inflammatory Drug (NSAID)73 Participants
AdalimumabHealthcare Resource Utilization: Number of Participants Who Received Concomitant Medications for Rheumatoid ArthritisOthers59 Participants
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.

Time frame: 24 weeks

Population: All enrolled participants

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
AdalimumabHealthcare Resource Utilization: Number of Participants Who Underwent Procedures Related to Treatment of Rheumatoid ArthritisAny Procedure95 Participants
AdalimumabHealthcare Resource Utilization: Number of Participants Who Underwent Procedures Related to Treatment of Rheumatoid ArthritisBlood Sample Taken87 Participants
AdalimumabHealthcare Resource Utilization: Number of Participants Who Underwent Procedures Related to Treatment of Rheumatoid ArthritisChest X-Ray27 Participants
AdalimumabHealthcare Resource Utilization: Number of Participants Who Underwent Procedures Related to Treatment of Rheumatoid ArthritisUrine Test11 Participants
AdalimumabHealthcare Resource Utilization: Number of Participants Who Underwent Procedures Related to Treatment of Rheumatoid ArthritisLiverfunction Test11 Participants
AdalimumabHealthcare Resource Utilization: Number of Participants Who Underwent Procedures Related to Treatment of Rheumatoid ArthritisElectroardiogram9 Participants
AdalimumabHealthcare Resource Utilization: Number of Participants Who Underwent Procedures Related to Treatment of Rheumatoid ArthritisHand X-Ray5 Participants
AdalimumabHealthcare Resource Utilization: Number of Participants Who Underwent Procedures Related to Treatment of Rheumatoid ArthritisSpine X-Ray4 Participants
AdalimumabHealthcare Resource Utilization: Number of Participants Who Underwent Procedures Related to Treatment of Rheumatoid ArthritisBone Scan3 Participants
AdalimumabHealthcare Resource Utilization: Number of Participants Who Underwent Procedures Related to Treatment of Rheumatoid ArthritisShoulder X-Ray1 Participants
AdalimumabHealthcare Resource Utilization: Number of Participants Who Underwent Procedures Related to Treatment of Rheumatoid ArthritisKnee X-Ray1 Participants
AdalimumabHealthcare Resource Utilization: Number of Participants Who Underwent Procedures Related to Treatment of Rheumatoid ArthritisMagnetic Resonance Imaging (MRI)1 Participants
AdalimumabHealthcare Resource Utilization: Number of Participants Who Underwent Procedures Related to Treatment of Rheumatoid ArthritisEndoscopy1 Participants
AdalimumabHealthcare Resource Utilization: Number of Participants Who Underwent Procedures Related to Treatment of Rheumatoid ArthritisTuberculin Skin Test1 Participants
AdalimumabHealthcare Resource Utilization: Number of Participants Who Underwent Procedures Related to Treatment of Rheumatoid ArthritisSputum Tests1 Participants
AdalimumabHealthcare Resource Utilization: Number of Participants Who Underwent Procedures Related to Treatment of Rheumatoid ArthritisOther8 Participants
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.

Time frame: 24 weeks

Population: All enrolled participants

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
AdalimumabHealthcare Resource Utilization: Number of Participants With Hospitalization Related to Rheumatoid Arthritis1 Participants
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.

Time frame: 24 weeks

Population: All enrolled participants

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
AdalimumabHealthcare Resource Utilization: Number of Participants With Visits to Healthcare Professionals for Treatment of Rheumatoid ArthritisAny healthcare professional99 Participants
AdalimumabHealthcare Resource Utilization: Number of Participants With Visits to Healthcare Professionals for Treatment of Rheumatoid ArthritisRheumatologist97 Participants
AdalimumabHealthcare Resource Utilization: Number of Participants With Visits to Healthcare Professionals for Treatment of Rheumatoid ArthritisTraditional medicine7 Participants
AdalimumabHealthcare Resource Utilization: Number of Participants With Visits to Healthcare Professionals for Treatment of Rheumatoid ArthritisOrthopaedist5 Participants
AdalimumabHealthcare Resource Utilization: Number of Participants With Visits to Healthcare Professionals for Treatment of Rheumatoid ArthritisRehabilitation medicine5 Participants
AdalimumabHealthcare Resource Utilization: Number of Participants With Visits to Healthcare Professionals for Treatment of Rheumatoid ArthritisFamily medicine3 Participants
AdalimumabHealthcare Resource Utilization: Number of Participants With Visits to Healthcare Professionals for Treatment of Rheumatoid ArthritisInternist2 Participants
AdalimumabHealthcare Resource Utilization: Number of Participants With Visits to Healthcare Professionals for Treatment of Rheumatoid ArthritisEmergency department1 Participants
AdalimumabHealthcare Resource Utilization: Number of Participants With Visits to Healthcare Professionals for Treatment of Rheumatoid ArthritisOther11 Participants
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.

Time frame: Baseline, week 12 and week 24

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

ArmMeasureGroupValue (NUMBER)
AdalimumabPercentage of Participants Achieving a Clinically Meaningful Improvement on the HAQ-DI at Weeks 12 and 24Week 1260.4 percentage of participants
AdalimumabPercentage of Participants Achieving a Clinically Meaningful Improvement on the HAQ-DI at Weeks 12 and 24Week 2459.6 percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026