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

NCT02668640 | Completed Results

• 1 other identifier: P15-776
• Study Type: observational
• Target: 55
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rheumatoid Arthritis

Keywords

Quality of life (QOL); Rheumatoid arthritis (RA); Work productivity; Adalimumab

Outcome Measures

Primary Outcomes (1)

• Median Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score at Week 24

  The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response 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 to 3, where zero represents no disability and three very severe, high-dependency disability. A negative median indicates improvement from baseline.

  Baseline and Week 24

Secondary Outcomes (7)

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

  Baseline and Week 12

• 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

  Baseline, Week 12, and Week 24

• Median Change From Baseline in EuroQol 5-dimension, 3-level Quality of Life Questionnaire (EQ-5D-3L) Index

  Baseline, Week 12, and Week 24

• Median Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Overall Work Impairment Score

  Baseline, Week 12, and Week 24

• Median Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Activity Impairment Score

  Baseline, Week 12, and Week 24

Study Arms (1)

Participants with RA receiving adalimumab

40 mg adalimumab via subcutaneous (SC) injection every other week (eow) for 24 weeks

Biological: Adalimumab

Interventions

Adalimumab BIOLOGICAL

Pre-filled syringe, administered by subcutaneous injection

Also known as: Humira, ABT-D2E7

Participants with RA receiving adalimumab

Eligibility Criteria

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

Study Population

Adult participants with rheumatoid arthritis (RA) in China receiving adalimumab treatment

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie: lead

Related Links

• Related Info

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

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: January 27, 2016
• First Posted: January 29, 2016
• Study Start: May 1, 2016
• Primary Completion: June 12, 2018
• Study Completion: August 13, 2018
• Last Updated: September 13, 2019
• Results First Posted: September 13, 2019

Record last verified: 2019-08