Clinical trial NCT02627924: Real-World Outcome of Rheumatoid Arthritis Patients in Korea on Adalimumab
Official title: Real-World Outcome of Rheumatoid Arthritis Patients in Korea on Adalimumab (ROCKA Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Work productivity
patient-reported QoL(Quality of Life)
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2015-12-11
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects receiving Adalimumab with Rheumatoid Arthritis (RA) in Korea

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 24
timeFrame: Baseline and week 24
Secondary outcomes:
measure: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 12
timeFrame: Baseline and week 12
measure: Percentage of Participants Achieving a Clinically Meaningful Improvement on the HAQ-DI at Weeks 12 and 24
timeFrame: Baseline, week 12 and week 24
measure: Change From Baseline in Short-Form 36 (SF-36) Physical Component Summary and Mental Component Summary Scores at Weeks 12 and 24
timeFrame: Baseline, week 12, and week 24
measure: Change From Baseline in EuroQol 5-Dimension 3-Level (EQ-5D-3L) Index at Weeks 12 and 24
timeFrame: Baseline, week 12, and week 24
measure: Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) at Weeks 12 and 24
timeFrame: Baseline, week 12, and week 24
measure: Patient Treatment Satisfaction
timeFrame: Baseline, week 12 and week 24
measure: Healthcare Resource Utilization: Number of Participants With Visits to Healthcare Professionals for Treatment of Rheumatoid Arthritis
timeFrame: 24 weeks
measure: Healthcare Resource Utilization: Number of Participants Who Underwent Procedures Related to Treatment of Rheumatoid Arthritis
timeFrame: 24 weeks
measure: Healthcare Resource Utilization: Number of Participants With Hospitalization Related to Rheumatoid Arthritis
timeFrame: 24 weeks
measure: Healthcare Resource Utilization: Number of Participants With Surgery Related to Rheumatoid Arthritis
timeFrame: 24 weeks
measure: Healthcare Resource Utilization: Number of Participants Who Received Concomitant Medications for Rheumatoid Arthritis
timeFrame: 24 weeks
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: