Clinical trial NCT02668640: Real-World Outcome of Adalimumab on Rheumatoid Arthritis Patients in China
Official title: Real-World Outcome of Adalimumab on Rheumatoid Arthritis Patients in China (ROCKI Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: Quality of life (QOL)
Rheumatoid arthritis (RA)
Work productivity
Adalimumab
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2016-01-29
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants with rheumatoid arthritis (RA) in China receiving adalimumab treatment

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Median Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score at Week 24
timeFrame: Baseline and Week 24
Secondary outcomes:
measure: Median Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score at Week 12
timeFrame: Baseline and Week 12
measure: 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
timeFrame: Baseline, Week 12, and Week 24
measure: Median Change From Baseline in EuroQol 5-dimension, 3-level Quality of Life Questionnaire (EQ-5D-3L) Index
timeFrame: Baseline, Week 12, and Week 24
measure: Median Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Overall Work Impairment Score
timeFrame: Baseline, Week 12, and Week 24
measure: Median Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Activity Impairment Score
timeFrame: Baseline, Week 12, and Week 24
measure: Number of Participants Achieving Clinically Meaningful Improvement in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score
timeFrame: Baseline, Week 12, and Week 24
measure: Percentage of Participants Achieving Clinically Meaningful Improvement in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score
timeFrame: Baseline, Week 12, and Week 24
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: