Rheumatoid ArthritisNCT02668640
Real-World Outcome of Adalimumab on Rheumatoid Arthritis Patients in China
An observational study of Rheumatoid Arthritis, run by AbbVie.
Trial summary
The objective of this study was to assess the effectiveness of adalimumab on health and disability outcomes in participants with rheumatoid arthritis (RA) in China. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Adalimumab
- Type of treatment
- Injection or infusion
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2016to 13 Aug 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult participants with rheumatoid arthritis (RA) in China receiving adalimumab treatment
Who may be able to join
- Participant had a diagnosis of rheumatoid arthritis (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)
- Participants with moderate to severe RA defined as a Disease Activity Score in 28 Joints (DAS28) Erythrocyte Sedimentation Rate (ESR) or DAS28 C-Reactive Protein (CRP) score >3.2
- Biologically treatment naïve and initiated adalimumab at baseline visit, as per standard daily clinical practice
- Availability of clinical data of the previous 12 weeks prior to baseline
- Ability to self-complete participant questionnaires.
- Participants had signed the authorization (or informed consent where applicable) to disclose and use personal health information after having been prescribed adalimumab
Who cannot join
- Participants who were pregnant or breastfeeding at enrollment or wished to become pregnant in the next 24 weeks.
- Participation in any RA-related clinical trial at the time of enrollment, at baseline, or at any point during the past 24 weeks prior to baseline
- Participants, who in the clinician's view, may not have been able to accurately report their quality of life (QoL) or prior resource utilization
- Participants, who in the clinician's view, may not have been able to adhere to adalimumab therapy over 24 weeks
About this study
Official title: Real-World Outcome of Adalimumab on Rheumatoid Arthritis Patients in China (ROCKI Study)
The objective of this study was to assess the effectiveness of adalimumab on health and disability outcomes in participants with rheumatoid arthritis (RA) in China.
Read the detailed description
This was a prospective, multicenter, observational study to assess the effectiveness of adalimumab on health-related quality of life (QoL) and work productivity in participants with rheumatoid arthritis (RA) in routine clinical practice in China. The decision to prescribe adalimumab for RA was based on clinical practice criteria without taking participation in this study into account. Participants were included in the study after a physician's decision of initiating adalimumab treatment. Participants were followed for 24 weeks, with scheduled study visits at baseline, Week 12 and Week 24.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Adalimumab
- Keywords
- Quality of life (QOL), Rheumatoid arthritis (RA), Work productivity, Adalimumab
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdalimumabBiological
Also called Humira, ABT-D2E7
Pre-filled syringe, administered by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Participants with RA receiving adalimumab | 40 mg adalimumab via subcutaneous (SC) injection every other week (eow) for 24 weeks Receives: Biological: Adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score at Week 24
The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response 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 to 3, where zero represents no disability and three very severe, high-dependency disability. A negative median indicates improvement from baseline.
Measured: Baseline and Week 24
Secondary outcomes (7)
Median Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score at Week 12
The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response 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 to 3, where zero represents no disability and three very severe, high-dependency disability. A negative median indicates improvement from baseline.
Measured: Baseline and Week 12
Median Change From Baseline in Short Form 36-Item Health Survey (SF-36) Physical Component Summary (PCS) Score and Mental Component Summary (MCS) Scores at Weeks 12 and 24
The SF-36v2 is a non-disease specific Health Related Quality of Life (HRQoL) instrument. The SF-36v2 comprises 36 total items (questions) targeting a subject's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) with a recall period of four weeks. Domain scores are aggregated into a Physical Component Summary (PCS) score and a Mental Component Summary (MCS) score. SF-36v2 PCS and MCS scores range from 1-100: higher scores indicate a better state of health and an increase from baseline represents improvement.
Measured: Baseline, Week 12, and Week 24
Median Change From Baseline in EuroQol 5-dimension, 3-level Quality of Life Questionnaire (EQ-5D-3L) Index
The EQ-5D-3L measures the participant's overall health state in a descriptive system of health-related quality of life (QoL) states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which has three response choices. The responses record three levels of severity ('no problems', 'having some or moderate problems', and 'being unable to do/extreme problems') within a particular EQ-5D-3L dimension. In addition, a 20 cm visual analogue scale (VAS) measures the participant's self-rated current health state on a scale from 0-100, from 0 (worst imaginable health state) to 100 ('best imaginable health state). 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
Median Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Overall Work Impairment Score
The Work Productivity and Activity Impairment Questionnaire (WPAI) is a participant-reported questionnaire to measure work and activity impairment during the past seven days. The 'overall work impairment due to health problem' was calculated based on three items: (Q2) the number of hours missed from work due to health problems in the past seven days from visit; (Q4) the number of actual work hours in the past seven days from visit; and (Q5) to what degree did the participant's rheumatoid arthritis impair the productivity while working past seven days from visit). Data were calculated using the formula Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4))x(Q5/10)] and converted to percent, with higher numbers indicating greater impairment and less productivity. Negative values indicate improvement from baseline.
Measured: Baseline, Week 12, and Week 24
Median Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Activity Impairment Score
The Work Productivity and Activity Impairment Questionnaire (WPAI) is a participant-reported questionnaire to measure work and activity impairment during the past seven days. Activity impairment was calculated via WPAI question 6, the participant's rating of how much rheumatoid arthritis affected their ability to do regular daily activities, other than working at a job (0 = no effect; 10 = completely impacted productivity) / 10 * 100. Negative values indicate improvement from baseline.
Measured: Baseline, Week 12, and Week 24
Number of Participants Achieving Clinically Meaningful Improvement in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score
The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response 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 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is ≥ 0.22.
Measured: Baseline, Week 12, and Week 24
Percentage of Participants Achieving Clinically Meaningful Improvement in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score
The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response 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 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is ≥ 0.22.
Measured: Baseline, Week 12, and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study start1 May 2016
- Primary completion12 Jun 2018
- Study completion13 Aug 2018
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
- 55 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
- NCT02668640
- Sponsor's protocol ID
- P15-776
- Status last verified
- Aug 2019
- First submitted
- 27 Jan 2016
- Last updated
- 13 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Outcome of Adalimumab on Rheumatoid Arthritis Patients in China (ROCKI Study)
- ClinicalTrials.gov ID
- NCT02668640
- Acronym / sponsor ID
- P15-776
- Conditions
- Rheumatoid Arthritis
- Keywords
- Quality of life (QOL), Rheumatoid arthritis (RA), Work productivity, Adalimumab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 1 May 2016 (actual)
- Primary completion
- 12 Jun 2018 (actual)
- Study completion
- 13 Aug 2018 (actual)
- First posted
- 29 Jan 2016 (estimated)
- Results
- Posted 13 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study was to assess the effectiveness of adalimumab on health and disability outcomes in participants with rheumatoid arthritis (RA) in China.
Detailed description
This was a prospective, multicenter, observational study to assess the effectiveness of adalimumab on health-related quality of life (QoL) and work productivity in participants with rheumatoid arthritis (RA) in routine clinical practice in China. The decision to prescribe adalimumab for RA was based on clinical practice criteria without taking participation in this study into account. Participants were included in the study after a physician's decision of initiating adalimumab treatment. Participants were followed for 24 weeks, with scheduled study visits at baseline, Week 12 and Week 24.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with RA receiving adalimumab | – | Biological: Adalimumab40 mg adalimumab via subcutaneous (SC) injection every other week (eow) for 24 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants with rheumatoid arthritis (RA) in China receiving adalimumab treatment
Key inclusion criteria (6 listed)
- Participant had a diagnosis of rheumatoid arthritis (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)
- Participants with moderate to severe RA defined as a Disease Activity Score in 28 Joints (DAS28) Erythrocyte Sedimentation Rate (ESR) or DAS28 C-Reactive Protein (CRP) score >3.2
- Biologically treatment naïve and initiated adalimumab at baseline visit, as per standard daily clinical practice
- Availability of clinical data of the previous 12 weeks prior to baseline
- Ability to self-complete participant questionnaires.
Key exclusion criteria (4 listed)
- Participants who were pregnant or breastfeeding at enrollment or wished to become pregnant in the next 24 weeks.
- Participation in any RA-related clinical trial at the time of enrollment, at baseline, or at any point during the past 24 weeks prior to baseline
- Participants, who in the clinician's view, may not have been able to accurately report their quality of life (QoL) or prior resource utilization
- Participants, who in the clinician's view, may not have been 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdalimumabAlso: Humira, ABT-D2E7Pre-filled syringe, administered by subcutaneous injection | Biological | Participants with RA receiving adalimumab |
Primary outcome
Median Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score at Week 24
Time frame: Baseline and Week 24
The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response 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 to 3, where zero represents no disability and three very severe, high-dependency disability. A negative median indicates improvement from baseline.
7 secondary outcomes
Median Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score at Week 12
Time frame: Baseline and Week 12
Median Change From Baseline in Short Form 36-Item Health Survey (SF-36) Physical Component Summary (PCS) Score and Mental Component Summary (MCS) Scores at Weeks 12 and 24
Time frame: Baseline, Week 12, and Week 24
Median Change From Baseline in EuroQol 5-dimension, 3-level Quality of Life Questionnaire (EQ-5D-3L) Index
Time frame: Baseline, Week 12, and Week 24
Median Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Overall Work Impairment Score
Time frame: Baseline, Week 12, and Week 24
Median Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Activity Impairment Score
Time frame: Baseline, Week 12, and Week 24
Number of Participants Achieving Clinically Meaningful Improvement in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score
Time frame: Baseline, Week 12, and Week 24
Percentage of Participants Achieving Clinically Meaningful Improvement in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score
Time frame: Baseline, Week 12, and Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 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 6 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 13 Sep 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 13 Sep 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?
Median 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 13 Sep 2019.