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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

71 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Scheduled to start adalimumab therapy

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

No interventions assigned to this group

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No