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Completed

NCT Number: NCT02627924

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

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 12

    Time frame: Baseline and 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.

  2. 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

    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.

  3. 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

    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.

  4. 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

    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.

  5. Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) at Weeks 12 and 24

    Time frame: Baseline, week 12, and week 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.

  6. Patient Treatment Satisfaction

    Time frame: Baseline, week 12 and week 24

    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

  7. Healthcare Resource Utilization: Number of Participants With Visits to Healthcare Professionals for Treatment of Rheumatoid Arthritis

    Time frame: 24 weeks

    The healthcare resource utilization (HCRU) questionnaire collected data on the healthcare resources used over the course of the study.

  8. Healthcare Resource Utilization: Number of Participants Who Underwent Procedures Related to Treatment of Rheumatoid Arthritis

    Time frame: 24 weeks

    The healthcare resource utilization (HCRU) questionnaire collected data on the healthcare resources used over the course of the study.

  9. Healthcare Resource Utilization: Number of Participants With Hospitalization Related to Rheumatoid Arthritis

    Time frame: 24 weeks

    The healthcare resource utilization (HCRU) questionnaire collected data on the healthcare resources used over the course of the study.

  10. Healthcare Resource Utilization: Number of Participants With Surgery Related to Rheumatoid Arthritis

    Time frame: 24 weeks

    The healthcare resource utilization (HCRU) questionnaire collected data on the healthcare resources used over the course of the study.

  11. Healthcare Resource Utilization: Number of Participants Who Received Concomitant Medications for Rheumatoid Arthritis

    Time frame: 24 weeks

    The healthcare resource utilization (HCRU) questionnaire collected data on the healthcare resources used over the course of the study.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

Real-World Outcome of Rheumatoid Arthritis Patients in Korea on Adalimumab (ROCKA Study)

Acronym: ROCKA

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 11, 2015
Registry last updated
Mar 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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