Rheumatoid Arthritis Clinical Trial
Official title:
Time to DMARD Treatment and Actual Work Limitation of Patients With Rheumatoid Arthritis in Turkey
Verified date | September 2012 |
Source | Abbott |
Contact | n/a |
Is FDA regulated | No |
Health authority | Turkey: Ministry of Health |
Study type | Observational |
The objective is to measure time delay from onset of symptoms to diagnosis and time to disease-modifying anti-rheumatic drug treatments in Turkish patients with rheumatoid arthritis. The investigators will also evaluate actual work limitation status of patients and impact of demographic and clinical factors on work limitations in rheumatoid arthritis patients.
Status | Completed |
Enrollment | 356 |
Est. completion date | August 2011 |
Est. primary completion date | August 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
Turkey | Site Reference ID/Investigator# 39111 | Adana | |
Turkey | Site Reference ID/Investigator# 39102 | Ankara | |
Turkey | Site Reference ID/Investigator# 39104 | Ankara | |
Turkey | Site Reference ID/Investigator# 39109 | Ankara | |
Turkey | Site Reference ID/Investigator# 52448 | Ankara | |
Turkey | Site Ref # / Investigator 52451 | Antalya | |
Turkey | Site Reference ID/Investigator# 52442 | Aydin | |
Turkey | Site Reference ID/Investigator# 52446 | Bursa | |
Turkey | Site Reference ID/Investigator# 52447 | Bursa | |
Turkey | Site Ref # / Investigator 52443 | Denizli | |
Turkey | Site Reference ID/Investigator# 52444 | Denizli | |
Turkey | Site Reference ID/Investigator# 52449 | Gaziantep | |
Turkey | Site Reference ID/Investigator# 52450 | Gaziantep | |
Turkey | Site Reference ID/Investigator# 39103 | Istanbul | |
Turkey | Site Reference ID/Investigator# 39106 | Istanbul | |
Turkey | Site Reference ID/Investigator# 39107 | Istanbul | |
Turkey | Site # / Investigator 59224 | Izmir | |
Turkey | Site Ref # / Investigator 59225 | Izmir | |
Turkey | Site Ref # / Investigator 59226 | Izmir | |
Turkey | Site Reference ID/Investigator# 36442 | Izmir | |
Turkey | Site Reference ID/Investigator# 39108 | Izmir |
Lead Sponsor | Collaborator |
---|---|
Abbott |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of Disease Duration: Time From Diagnosis to Disease-Modifying Anti-Rheumatic Drug Treatment in Rheumatoid Arthritis | The time elapsed from diagnosis of rheumatoid arthritis to initiation of treatment with disease-modifying anti-rheumatic drugs (DMARDs). | Day 1 | No |
Secondary | Work Limitation: Health Assessment Questionnaire-Disability Index (HAQ-DI) | 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. | Day 1 | No |
Secondary | Work Limitation: Work Productivity and Activity Impairment (WPAI) Questionnaire | 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. | Day 1 | No |
Secondary | Evaluation of Global Rheumatoid Arthritis Severity Scale | 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). | Day 1 | No |
Secondary | Evaluation of Disease Activity Score 28 (DAS28) | 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. | Day 1 | No |
Secondary | Evaluation of Visual Analog Scale (VAS) for Pain and Fatigue | Participants rated their pain and fatigue using a visual analog scale from 0 to 10, where 10 was the worst case. | Day 1 | No |
Secondary | Number of Disease Modifying Anti-Rheumatic Drugs | The number of disease-modifying anti-rheumatic drugs (DMARDs) that participants were taking to treat their rheumatoid arthritis. | Day 1 | No |
Secondary | Biologics Usage | Biologic treatments participants were taking for their rheumatoid arthritis. | Day 1 | No |
Secondary | Stiffness Duration | Participants' duration of morning joint stiffness. | Day 1 | No |
Secondary | Number of Comorbidities | Number of comorbid (coexisting) medical conditions of the study participants. | Day 1 | No |
Secondary | Rheumatoid Factor | Rheumatoid factor test results. | Day 1 | No |
Secondary | Anti-cyclic Citrullinated Peptide | Anti-cyclic citrullinated peptide (anti-CCP) test results. | Day 1 | No |
Secondary | Sedimentation Rate | The erythrocyte (red blood cell) sedimentation rates of study participants were assessed. | Day 1 | No |
Secondary | Number of Deformities at Inspection | The number of joint deformities of the study participants. | Day 1 | No |
Secondary | Evaluation of Rheumatoid Arthritis Treatments Duration | 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. | Day 1 | No |
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