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Rheumatoid ArthritisNCT02668640

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

An observational study of Rheumatoid Arthritis, run by AbbVie.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

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 groups in NCT02668640
Study groupRoleWhat they receive
Participants with RA receiving adalimumab40 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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.

  1. First posted29 Jan 2016 (estimated)
  2. Study start1 May 2016
  3. Primary completion12 Jun 2018
  4. Study completion13 Aug 2018

Resources

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)
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
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

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