Clinical trial NCT01387789: A Study of Rheumatoid Arthritis Patients on Adalimumab to Evaluate Quality of Life Variables, Effects on Work Productivity and Functional Outcomes in Malaysia
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: Product Surveillance
Postmarketing
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2011-07-06
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Rheumatology clinic

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.

Detailed description: This study was designed to evaluate adalimumab therapy in Malaysia on participants' Quality of Life (QoL) using non-invasive epidemiological methods like the Health Assessment Questionnaire - Disability Index (HAQ-DI), the Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS), and the Health Assessment Questionnaire Short Form 36 (SF-36). The primary objective of the study was to evaluate the changes in QoL outcomes in anti -TNF naïve Malaysian RA patients after 6 months of adalimumab treatment. The secondary objectives of this study were to evaluate the changes on QoL outcomes after 1 month and 3 months of adalimumab treatment; and provide an assessment of the safety and tolerability of adalimumab in anti TNF naïve Malaysian Rheumatoid Arthritis patients.

Eligibility criteria: Inclusion Criteria:

* 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 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-TNF 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)

Primary outcomes:
measure: Change in Overall Health Assessment Questionnaire Disability Index (HAQ-DI) Scores From Baseline to 6 Months
timeFrame: Baseline and 6 months
measure: Change in Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS) Scores From Baseline to 6 Months
timeFrame: Baseline and 6 months
measure: Change in Health Assessment Questionnaire Short Form 36 (SF-36) Scores From Baseline to 6 Months
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Change in Overall Health Assessment Questionnaire Disability Index (HAQ-DI) Scores From Baseline to 1 Month
timeFrame: Baseline and 1 month
measure: Change in Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS) Scores From Baseline to 1 Month
timeFrame: Baseline and 1 month
measure: Change in Mean Health Assessment Questionnaire Short Form 36 (SF-36) Scores From Baseline to 1 Month
timeFrame: Baseline and 1 month
measure: Change in Overall Health Assessment Questionnaire Disability Index (HAQ-DI) Scores From Baseline to 3 Months
timeFrame: Baseline and 3 months
measure: Change in Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS) Scores From Baseline to 3 Months
timeFrame: Baseline and 3 months
measure: Change in Health Assessment Questionnaire Short Form 36 (SF-36) Scores From Baseline to 3 Months
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
city: Batu Caves
country: Malaysia
facility: Site Reference ID/Investigator# 36098
city: Ipoh
country: Malaysia
facility: Site Reference ID/Investigator# 57914
city: Johor Bahru
country: Malaysia
facility: Site Reference ID/Investigator# 57923
city: Klang
country: Malaysia
facility: Site Reference ID/Investigator# 67602
city: Kota Kinabalu
country: Malaysia
facility: Site Reference ID/Investigator# 57925
city: Kuala Lumpur
country: Malaysia
facility: Site Reference ID/Investigator# 57916
city: Kuantan
country: Malaysia
facility: Site Reference ID/Investigator# 57928
city: Kuching
country: Malaysia
facility: Site Reference ID/Investigator# 57924
city: Melaka
country: Malaysia
facility: Site Reference ID/Investigator# 57927
city: Penang
country: Malaysia
facility: Site Reference ID/Investigator# 57913
city: Putrajaya
country: Malaysia
facility: Site Reference ID/Investigator# 57915
city: Serdang
country: Malaysia
facility: Site Reference ID/Investigator# 57926
city: Seremban
country: Malaysia
facility: Site Reference ID/Investigator# 57922
Study officials:
affiliation: AbbVie
name: Mogana Sivalingam, MD
role: STUDY_DIRECTOR
References: