A Study of Rheumatoid Arthritis Patients on Adalimumab to Evaluate Quality of Life Variables, Effects on Work Productivity and Functional Outcomes in Malaysia

NCT01387789 | Completed Results

• 1 other identifier: P12-265
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 13

Brief Summary

An observational, non-interventional study on social, economic and quality-of-life outcomes of Adalimumab use in participants with moderate to severe active Rheumatoid Arthritis.

Conditions

Rheumatoid Arthritis

Keywords

Product Surveillance; Postmarketing

Outcome Measures

Primary Outcomes (3)

• Change in Overall Health Assessment Questionnaire Disability Index (HAQ-DI) Scores From Baseline to 6 Months

  The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-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. The minimal clinically important difference (MCID) defined for the HAQ-DI is ≥ 0.22. HAQ remission indicating normal physical function is defined by HAQ-DI \< 0.5. Negative mean changes from baseline in the overall score indicate improvement. Assessments were conducted at baseline and 6 months.

  Baseline and 6 months

• Change in Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS) Scores From Baseline to 6 Months

  The Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS) is a patient-reported questionnaire designed to assess the presence or absence of arthritis-related pain and its severity. It consists of a doubly anchored, horizontal VAS, that is scored from 0 (no pain) to 100 (severe pain). Decreases from baseline indicate improvement. Assessments were conducted at baseline and 6 months.

  Baseline and 6 months

• Change in Health Assessment Questionnaire Short Form 36 (SF-36) Scores From Baseline to 6 Months

  The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 "worst"-100 "best"). The standard recall period is four weeks. Increases from baseline indicate improvement. Assessments were conducted at baseline and 6 months.

  Baseline and 6 months

Secondary Outcomes (6)

• Change in Overall Health Assessment Questionnaire Disability Index (HAQ-DI) Scores From Baseline to 1 Month

  Baseline and 1 month

• Change in Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS) Scores From Baseline to 1 Month

  Baseline and 1 month

• Change in Mean Health Assessment Questionnaire Short Form 36 (SF-36) Scores From Baseline to 1 Month

  Baseline and 1 month

• Change in Overall Health Assessment Questionnaire Disability Index (HAQ-DI) Scores From Baseline to 3 Months

  Baseline and 3 months

• Change in Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS) Scores From Baseline to 3 Months

  Baseline and 3 months

Study Arms (1)

Scheduled to start adalimumab therapy

Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.

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

Rheumatology clinic

You may qualify if:

• Patients 18 years of age and older with a diagnosis of Rheumatoid Arthritis for at least 3 months according to the American College of Rheumatology (ACR) criteria
• Patients not included in other clinical/observational trials
• Patients providing a written informed consent before the enrollment in the study

You may not qualify if:

• Refusal to participate in the study or to sign the informed consent
• Contraindications to adalimumab according to the terms of the local marketing authorization (label)

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Study Sites (13)

Site Reference ID/Investigator# 36098

Batu Caves, 68100, Malaysia

Location

Site Reference ID/Investigator# 57913

George Town, 10450, Malaysia

Location

Site Reference ID/Investigator# 57914

Ipoh, 30990, Malaysia

Location

Site Reference ID/Investigator# 57923

Johor Bahru, 81100, Malaysia

Location

Site Reference ID/Investigator# 67602

Klang, 41200, Malaysia

Location

Site Reference ID/Investigator# 57925

Kota Kinabalu, 88586, Malaysia

Location

Site Reference ID/Investigator# 57916

Kuala Lumpur, 50586, Malaysia

Location

Site Reference ID/Investigator# 57928

Kuantan, 25100, Malaysia

Location

Site Reference ID/Investigator# 57924

Kuching, 93590, Malaysia

Location

Site Reference ID/Investigator# 57927

Malacca, 75400, Malaysia

Location

Site Reference ID/Investigator# 57915

Putrajaya, 62250, Malaysia

Location

Site Reference ID/Investigator# 57926

Serdang, 43300, Malaysia

Location

Site Reference ID/Investigator# 57922

Seremban, 70300, Malaysia

Location

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 (prior sponsor, Abbott)

800-633-9110

Study Officials

• Mogana Sivalingam, MD

  AbbVie

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: July 1, 2011
• First Posted: July 6, 2011
• Study Start: August 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: May 5, 2014
• Results First Posted: April 21, 2014

Record last verified: 2014-04

Locations

MY (13)