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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01387789
First received: July 1, 2011
Last updated: May 10, 2013
Last verified: May 2013
  Purpose

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


Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Study of Rheumatoid Arthritis Patients on Adalimumab to Evaluate Quality of Life Variables, Effects on Work Productivity and Functional Outcomes in Malaysia

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Changes of the Quality of Life of patient. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Changes in the Quality of life of patient is assessed using the Health Assessment Questionnaire Disability Index (HAQ-DI), Health Assessment Questionnaire Visual Analog Score (HAQ-VAS) and Health Assessment Questionnaire Short Form 36 (SF-36) after 6 months of Adalimumab treatment by comparison versus the baseline.


Secondary Outcome Measures:
  • Changes of the Quality of Life of patient. [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Changes in the Quality of life of patient is assessed using the Health Assessment Questionnaire Disability Index (HAQ-DI), Health Assessment Questionnaire Visual Analog Score (HAQ-VAS) and Health Assessment Questionnaire Short Form 36 (SF-36) after 1 month of Adalimumab treatment by comparison versus the baseline.

  • Changes of the Quality of Life of patient. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Changes in the Quality of life of patient is assessed using the Health Assessment Questionnaire Disability Index (HAQ-DI), Health Assessment Questionnaire Visual Analog Score (HAQ-VAS) and Health Assessment Questionnaire Short Form 36 (SF-36) after 3 months of Adalimumab treatment by comparison versus the baseline.


Enrollment: 70
Study Start Date: August 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Scheduled to start adalimumab therapy.
Patients diagnosed with rheumatoid arthritis for at least 3 months that previously not received prior anti-TNF agents.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Rheumatology clinic

Criteria

Inclusion Criteria:

  • Patient more than 18 years of age with diagnosis of Rheumatoid Arthritis for at least 3 months according to the American College of Rheumatology (ACR) criteria
  • Patients who have not been instituted on any anti -Tumour Necrosis Factor (anti-TNF) agents prior to inclusion into this study (anti-TNF naïve patients). Only Anti Tumour Necrosis Factor Naive Rheumatoid Arthritis patients who are scheduled to begin HUMIRA treatment, according to the relevant Summary of Product Characteristics, on the basis of their own physician's judgment (and on the current clinical practice), will be selected for inclusion in this study
  • Patients not included in other clinical/observational trials
  • Patients providing a written informed consent before the enrollment in the study

Exclusion Criteria:

  • 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01387789

Locations
Malaysia
Site Reference ID/Investigator# 36098
Batu Caves, Malaysia, 68100
Site Reference ID/Investigator# 57914
Ipoh, Malaysia, 30990
Site Reference ID/Investigator# 57923
Johor Bahru, Malaysia, 81100
Site Reference ID/Investigator# 67602
Klang, Malaysia, 41200
Site Reference ID/Investigator# 57925
Kota Kinabalu, Malaysia, 88586
Site Reference ID/Investigator# 57916
Kuala Lumpur, Malaysia, 50586
Site Reference ID/Investigator# 57928
Kuantan, Malaysia, 25100
Site Reference ID/Investigator# 57924
Kuching, Malaysia, 93590
Site Reference ID/Investigator# 57927
Melaka, Malaysia, 75400
Site Reference ID/Investigator# 57913
Penang, Malaysia, 10450
Site Reference ID/Investigator# 57915
Putrajaya, Malaysia, 62250
Site Reference ID/Investigator# 57926
Serdang, Malaysia, 43300
Site Reference ID/Investigator# 57922
Seremban, Malaysia, 70300
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Mogana Sivalingam, MD AbbVie
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01387789     History of Changes
Other Study ID Numbers: P12-265
Study First Received: July 1, 2011
Last Updated: May 10, 2013
Health Authority: Malaysia: Ministry of Health

Keywords provided by AbbVie:
Product Surveillance
Postmarketing

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Adalimumab
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 15, 2014