Clinical trial NCT01144598: Time to DMARD (Disease-Modifying Anti-Rheumatic Drug) Treatment and Actual Work Limitation of Patients With Rheumatoid Arthritis in Turkey
Official title: Time to DMARD Treatment and Actual Work Limitation of Patients With Rheumatoid Arthritis in Turkey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Disease-Modifying Anti-Rheumatic Drug
Work Limitation
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2010-06-15
Enrollment: 356
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of Disease Duration: Time From Diagnosis to Disease-Modifying Anti-Rheumatic Drug Treatment in Rheumatoid Arthritis
timeFrame: Day 1
Secondary outcomes:
measure: Work Limitation: Health Assessment Questionnaire-Disability Index (HAQ-DI)
timeFrame: Day 1
measure: Work Limitation: Work Productivity and Activity Impairment (WPAI) Questionnaire
timeFrame: Day 1
measure: Evaluation of Global Rheumatoid Arthritis Severity Scale
timeFrame: Day 1
measure: Evaluation of Disease Activity Score 28 (DAS28)
timeFrame: Day 1
measure: Evaluation of Visual Analog Scale (VAS) for Pain and Fatigue
timeFrame: Day 1
measure: Number of Disease Modifying Anti-Rheumatic Drugs
timeFrame: Day 1
measure: Biologics Usage
timeFrame: Day 1
measure: Stiffness Duration
timeFrame: Day 1
measure: Number of Comorbidities
timeFrame: Day 1
measure: Rheumatoid Factor
timeFrame: Day 1
measure: Anti-cyclic Citrullinated Peptide
timeFrame: Day 1
measure: Sedimentation Rate
timeFrame: Day 1
measure: Number of Deformities at Inspection
timeFrame: Day 1
measure: Evaluation of Rheumatoid Arthritis Treatments Duration
timeFrame: Day 1
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Site Reference ID/Investigator# 39111
city: Ankara
country: Turkey
facility: Site Reference ID/Investigator# 39102
city: Ankara
country: Turkey
facility: Site Reference ID/Investigator# 39104
city: Ankara
country: Turkey
facility: Site Reference ID/Investigator# 39109
city: Ankara
country: Turkey
facility: Site Reference ID/Investigator# 52448
city: Antalya
country: Turkey
facility: Site Ref # / Investigator 52451
city: Aydin
country: Turkey
facility: Site Reference ID/Investigator# 52442
city: Bursa
country: Turkey
facility: Site Reference ID/Investigator# 52447
city: Bursa
country: Turkey
facility: Site Reference ID/Investigator# 52446
city: Denizli
country: Turkey
facility: Site Ref # / Investigator 52443
city: Denizli
country: Turkey
facility: Site Reference ID/Investigator# 52444
city: Gaziantep
country: Turkey
facility: Site Reference ID/Investigator# 52449
city: Gaziantep
country: Turkey
facility: Site Reference ID/Investigator# 52450
city: Istanbul
country: Turkey
facility: Site Reference ID/Investigator# 39107
city: Istanbul
country: Turkey
facility: Site Reference ID/Investigator# 39106
city: Istanbul
country: Turkey
facility: Site Reference ID/Investigator# 39103
city: Izmir
country: Turkey
facility: Site Reference ID/Investigator# 39108
city: Izmir
country: Turkey
facility: Site Reference ID/Investigator# 36442
city: Izmir
country: Turkey
facility: Site # / Investigator 59224
city: Izmir
country: Turkey
facility: Site Ref # / Investigator 59225
city: Izmir
country: Turkey
facility: Site Ref # / Investigator 59226
Study officials:
affiliation: Abbott
name: Mahmut Gucuk, MD
role: STUDY_DIRECTOR
References: