N/A
Completed N=71
A Study of Rheumatoid Arthritis Patients on Adalimumab to Evaluate Quality of Life Variables, Effects on Work Productivity and Functional Outcomes in Malaysia
Source: ClinicalTrials.gov NCT01387789 ↗Enrolled (actual)
71
Serious AEs
18.3%
Results posted
Apr 2014
Primary outcomePrimary: Change in Overall Health Assessment Questionnaire Disability Index (HAQ-DI) Scores From Baseline to 6 Months — -0.41 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Overall Health Assessment Questionnaire Disability Index (HAQ-DI) Scores From Baseline to 6 Months |
-0.41 | — |
| PRIMARY Change in Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS) Scores From Baseline to 6 Months |
-0.49 | — |
| PRIMARY Change in Health Assessment Questionnaire Short Form 36 (SF-36) Scores From Baseline to 6 Months |
16.06; 12.30 | — |
| SECONDARY Change in Overall Health Assessment Questionnaire Disability Index (HAQ-DI) Scores From Baseline to 1 Month |
-0.30 | — |
| SECONDARY Change in Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS) Scores From Baseline to 1 Month |
-0.46 | — |
| SECONDARY Change in Mean Health Assessment Questionnaire Short Form 36 (SF-36) Scores From Baseline to 1 Month |
11.46; 6.42 | — |
| SECONDARY Change in Overall Health Assessment Questionnaire Disability Index (HAQ-DI) Scores From Baseline to 3 Months |
-0.38 | — |
| SECONDARY Change in Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS) Scores From Baseline to 3 Months |
-0.48 | — |
| SECONDARY Change in Health Assessment Questionnaire Short Form 36 (SF-36) Scores From Baseline to 3 Months |
14.19; 8.77 | — |
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)
Data sourced from ClinicalTrials.gov (NCT01387789). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.