Time to DMARD (Disease-Modifying Anti-Rheumatic Drug) Treatment and Actual Work Limitation of Patients With Rheumatoid Arthritis in Turkey
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| ClinicalTrials.gov Identifier: NCT01144598 |
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Recruitment Status :
Completed
First Posted : June 15, 2010
Results First Posted : September 19, 2012
Last Update Posted : October 2, 2012
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| Condition or disease |
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| Rheumatoid Arthritis |
This post marketing observational study will be conducted in cross-sectional, non-interventional, multi-center format in Turkey. As this is a post marketing observational study, Abbott is not involved in the product supply since the drug is being used according to the approved marketing label and is to be prescribed by the physician under usual and customary practice of physician prescription.
Subjects will be recruited from rheumatology outpatient clinics of university hospitals and/or private offices.
Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data will be included.
Patient data will be collected with a single visit. During the single visit, all required demographic and clinical data will be recorded on the case report forms by the investigators and every subject will be asked to fill out the Work Productivity and Activity Impairment questionnaire and the Health Assessment Questionnaire - Disability Index.
| Study Type : | Observational |
| Actual Enrollment : | 356 participants |
| Time Perspective: | Cross-Sectional |
| Official Title: | Time to DMARD Treatment and Actual Work Limitation of Patients With Rheumatoid Arthritis in Turkey |
| Study Start Date : | February 2010 |
| Actual Primary Completion Date : | August 2011 |
| Actual Study Completion Date : | August 2011 |
| Group/Cohort |
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| Turkish patients with rheumatoid arthritis |
- Evaluation of Disease Duration: Time From Diagnosis to Disease-Modifying Anti-Rheumatic Drug Treatment in Rheumatoid Arthritis [ Time Frame: Day 1 ]The time elapsed from diagnosis of rheumatoid arthritis to initiation of treatment with disease-modifying anti-rheumatic drugs (DMARDs).
- Work Limitation: Health Assessment Questionnaire-Disability Index (HAQ-DI) [ Time Frame: Day 1 ]The HAQ-DI measures physical function by assessing the ability to perform daily living tasks. Each task is rated from 0 (no difficulty) to 3 (unable to do). The total score ranges from 0 to 3. Higher scores indicate impairment.
- Work Limitation: Work Productivity and Activity Impairment (WPAI) Questionnaire [ Time Frame: Day 1 ]The WPAI evaluates the ability to work and perform regular activities. The scale yields 4 types of scores (range 0 to 100): Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Higher scores indicate impairment.
- Evaluation of Global Rheumatoid Arthritis Severity Scale [ Time Frame: Day 1 ]Global rheumatoid arthritis severity was assessed by asking the participants to consider all the ways their rheumatoid arthritis affected them and to rate how they were doing on a scale of 0 (very well) to 10 (very poor).
- Evaluation of Disease Activity Score 28 (DAS28) [ Time Frame: Day 1 ]The DAS28 index measures disease activity in rheumatoid arthritis and is derived from the number of swollen/tender joints, laboratory tests of inflammation, and participant assessment of global health (by marking a 100 mm line from "very good" to "very bad"). A higher score indicates worse control of disease. A DAS28 less than 3.2 indicates low disease activity and a DAS28 greater than 5.1 indicates high disease activity.
- Evaluation of Visual Analog Scale (VAS) for Pain and Fatigue [ Time Frame: Day 1 ]Participants rated their pain and fatigue using a visual analog scale from 0 to 10, where 10 was the worst case.
- Number of Disease Modifying Anti-Rheumatic Drugs [ Time Frame: Day 1 ]The number of disease-modifying anti-rheumatic drugs (DMARDs) that participants were taking to treat their rheumatoid arthritis.
- Biologics Usage [ Time Frame: Day 1 ]Biologic treatments participants were taking for their rheumatoid arthritis.
- Stiffness Duration [ Time Frame: Day 1 ]Participants' duration of morning joint stiffness.
- Number of Comorbidities [ Time Frame: Day 1 ]Number of comorbid (coexisting) medical conditions of the study participants.
- Rheumatoid Factor [ Time Frame: Day 1 ]Rheumatoid factor test results.
- Anti-cyclic Citrullinated Peptide [ Time Frame: Day 1 ]Anti-cyclic citrullinated peptide (anti-CCP) test results.
- Sedimentation Rate [ Time Frame: Day 1 ]The erythrocyte (red blood cell) sedimentation rates of study participants were assessed.
- Number of Deformities at Inspection [ Time Frame: Day 1 ]The number of joint deformities of the study participants.
- Evaluation of Rheumatoid Arthritis Treatments Duration [ Time Frame: Day 1 ]Time elapsed from onset of symptoms to diagnosis of rheumatoid arthritis (that is, from the first rheumatoid arthritis-related symptoms to diagnosis by a related specialist) and the time elapsed from diagnosis with rheumatoid arthritis to initiation of anti-tumor necrosis factor (anti-TNF) treatment.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
As this study is non-randomized, the normal study population and design requirements for power calculations are not met. Therefore, the results of the following should be interpreted as indicative only. Subjects will be recruited from rheumatology outpatient clinics of university hospitals and/or private offices.
Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and are able to provide disease history data will be included.
Inclusion Criteria:
- Diagnosed with rheumatoid arthritis by a specialist or by the treating rheumatologist
- Treated with at least one disease-modifying anti-rheumatic drug or biologics
- Patients over 18 years
- Patients already employed at a paid work
- Patients able to provide data for disease history
- Able to provide written consent to release information for this study
Exclusion Criteria:
- Patients who cannot provide necessary outcome measurements for any reason will be excluded from the study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01144598
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| Study Director: | Mahmut Gucuk, MD | Abbott |
| Responsible Party: | Abbott |
| ClinicalTrials.gov Identifier: | NCT01144598 |
| Other Study ID Numbers: |
P12-087 |
| First Posted: | June 15, 2010 Key Record Dates |
| Results First Posted: | September 19, 2012 |
| Last Update Posted: | October 2, 2012 |
| Last Verified: | September 2012 |
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Rheumatoid Arthritis Disease-Modifying Anti-Rheumatic Drug Work Limitation |
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Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |