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

NCT02627924 | Completed Results

• 1 other identifier: P15-777
• Study Type: observational
• Target: 91
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis; Work productivity; patient-reported QoL(Quality of Life)

Outcome Measures

Primary Outcomes (1)

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

  Baseline and week 24

Secondary Outcomes (11)

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

  Baseline and week 12

• Percentage of Participants Achieving a Clinically Meaningful Improvement on the HAQ-DI at Weeks 12 and 24

  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

• 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

Study Arms (1)

Adalimumab

Participants diagnosed with rheumatoid arthritis who were prescribed adalimumab according to their physician's discretion and routine clinical practice.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects receiving Adalimumab with Rheumatoid Arthritis (RA) in Korea

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Related Links

• Related Info

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• AbbVie Inc.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2015
• First Posted: December 11, 2015
• Study Start: November 18, 2015
• Primary Completion: December 28, 2017
• Study Completion: December 28, 2017
• Last Updated: March 22, 2019
• Results First Posted: March 22, 2019

Record last verified: 2018-11