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Clinical Trials/NCT02627924
NCT02627924CompletedNot Applicable

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

AbbVie0 sites91 target enrollmentStarted: November 18, 2015Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
91
Primary Endpoint
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 24
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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 Korea.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 99 Years (Adult, Older Adult)
Sex
All
Accepts 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 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.

Outcomes

Primary Outcomes

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

  • Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 12(Baseline and week 12)
  • Healthcare Resource Utilization: Number of Participants With Surgery Related to Rheumatoid Arthritis(24 weeks)
  • Percentage of Participants Achieving a Clinically Meaningful Improvement on the HAQ-DI at Weeks 12 and 24(Baseline, week 12 and week 24)
  • Patient Treatment Satisfaction(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(Baseline, week 12, and week 24)
  • Healthcare Resource Utilization: Number of Participants With Visits to Healthcare Professionals for Treatment of Rheumatoid Arthritis(24 weeks)
  • Healthcare Resource Utilization: Number of Participants With Hospitalization Related to Rheumatoid Arthritis(24 weeks)
  • Change From Baseline in EuroQol 5-Dimension 3-Level (EQ-5D-3L) Index at Weeks 12 and 24(Baseline, week 12, and week 24)
  • Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) at Weeks 12 and 24(Baseline, week 12, and week 24)
  • Healthcare Resource Utilization: Number of Participants Who Underwent Procedures Related to Treatment of Rheumatoid Arthritis(24 weeks)
  • Healthcare Resource Utilization: Number of Participants Who Received Concomitant Medications for Rheumatoid Arthritis(24 weeks)

Investigators

Sponsor
AbbVie
Sponsor Class
Industry
Responsible Party
Sponsor

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