Rheumatoid ArthritisROCKANCT02627924
Real-World Outcome of Rheumatoid Arthritis Patients in Korea on Adalimumab
An observational study of Rheumatoid Arthritis, run by AbbVie.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 91 participants
- Where
- No sites listed yet
- Study dates
- 18 Nov 2015to 28 Dec 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects receiving Adalimumab with Rheumatoid Arthritis (RA) in Korea
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Real-World Outcome of Rheumatoid Arthritis Patients in Korea on Adalimumab (ROCKA Study)
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.
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, Work productivity, patient-reported QoL(Quality of Life)
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adalimumab | Participants diagnosed with rheumatoid arthritis who were prescribed adalimumab according to their physician's discretion and routine clinical practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and week 24
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study start18 Nov 2015
- Primary completion28 Dec 2017
- Study completion28 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AbbVie Inc., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02627924
- Sponsor's protocol ID
- P15-777
- Acronym
- ROCKA
- Status last verified
- Nov 2018
- First submitted
- 9 Dec 2015
- Last updated
- 22 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Outcome of Rheumatoid Arthritis Patients in Korea on Adalimumab (ROCKA Study)
- ClinicalTrials.gov ID
- NCT02627924
- Acronym / sponsor ID
- ROCKA / P15-777
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, Work productivity, patient-reported QoL(Quality of Life)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2015 (actual)
- Primary completion
- 28 Dec 2017 (actual)
- Study completion
- 28 Dec 2017 (actual)
- First posted
- 11 Dec 2015 (estimated)
- Results
- Posted 22 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adalimumab | – | –Participants diagnosed with rheumatoid arthritis who were prescribed adalimumab according to their physician's discretion and routine clinical practice. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects receiving Adalimumab with Rheumatoid Arthritis (RA) in Korea
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 24
Time frame: 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.
11 secondary outcomes
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 12
Time frame: Baseline and week 12
Percentage of Participants Achieving a Clinically Meaningful Improvement on the HAQ-DI at Weeks 12 and 24
Time frame: 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
Time frame: Baseline, week 12, and week 24
Change From Baseline in EuroQol 5-Dimension 3-Level (EQ-5D-3L) Index at Weeks 12 and 24
Time frame: Baseline, week 12, and week 24
Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) at Weeks 12 and 24
Time frame: Baseline, week 12, and week 24
Patient Treatment Satisfaction
Time frame: Baseline, week 12 and week 24
Healthcare Resource Utilization: Number of Participants With Visits to Healthcare Professionals for Treatment of Rheumatoid Arthritis
Time frame: 24 weeks
Healthcare Resource Utilization: Number of Participants Who Underwent Procedures Related to Treatment of Rheumatoid Arthritis
Time frame: 24 weeks
Healthcare Resource Utilization: Number of Participants With Hospitalization Related to Rheumatoid Arthritis
Time frame: 24 weeks
Healthcare Resource Utilization: Number of Participants With Surgery Related to Rheumatoid Arthritis
Time frame: 24 weeks
Healthcare Resource Utilization: Number of Participants Who Received Concomitant Medications for Rheumatoid Arthritis
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AbbVie Inc. study director
AbbVie
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by AbbVie.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 24 (time frame: Baseline and week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2019.