Time to DMARD (Disease-Modifying Anti-Rheumatic Drug) Treatment and Actual Work Limitation of Patients With Rheumatoid Arthritis in Turkey

Time to DMARD Treatment and Actual Work Limitation of Patients With Rheumatoid Arthritis in Turkey

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis

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.

• Study Type: Observational
• Enrollment (Actual): 356

Contacts and Locations

Study Locations

• Turkey
  • Adana, Turkey, 01330
    • Site Reference ID/Investigator# 39111
  • Ankara, Turkey, 06018
    • Site Reference ID/Investigator# 39102
  • Ankara, Turkey, 06100
    • Site Reference ID/Investigator# 39104
  • Ankara, Turkey, 06100
    • Site Reference ID/Investigator# 39109
  • Ankara, Turkey, 06490
    • Site Reference ID/Investigator# 52448
  • Antalya, Turkey, 07058
    • Site Ref # / Investigator 52451
  • Aydin, Turkey, 09010
    • Site Reference ID/Investigator# 52442
  • Bursa, Turkey, 16059
    • Site Reference ID/Investigator# 52447
  • Bursa, Turkey, 16350
    • Site Reference ID/Investigator# 52446
  • Denizli, Turkey, 20070
    • Site Ref # / Investigator 52443
  • Denizli, Turkey, 20125
    • Site Reference ID/Investigator# 52444
  • Gaziantep, Turkey, 27310
    • Site Reference ID/Investigator# 52449
  • Gaziantep, Turkey, 27310
    • Site Reference ID/Investigator# 52450
  • Istanbul, Turkey, 34093
    • Site Reference ID/Investigator# 39107
  • Istanbul, Turkey, 34098
    • Site Reference ID/Investigator# 39106
  • Istanbul, Turkey, 34899
    • Site Reference ID/Investigator# 39103
  • Izmir, Turkey, 35000
    • Site Reference ID/Investigator# 39108
  • Izmir, Turkey, 35340
    • Site Reference ID/Investigator# 36442
  • Izmir, Turkey, 35360
    • Site # / Investigator 59224
  • Izmir, Turkey, 35360
    • Site Ref # / Investigator 59225
  • Izmir, Turkey, 35360
    • Site Ref # / Investigator 59226

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Turkish patients with rheumatoid arthritis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
Biologics Usage	Biologic treatments participants were taking for their rheumatoid arthritis.	Day 1
Stiffness Duration	Participants' duration of morning joint stiffness.	Day 1
Number of Comorbidities	Number of comorbid (coexisting) medical conditions of the study participants.	Day 1
Rheumatoid Factor	Rheumatoid factor test results.	Day 1
Anti-cyclic Citrullinated Peptide	Anti-cyclic citrullinated peptide (anti-CCP) test results.	Day 1
Sedimentation Rate	The erythrocyte (red blood cell) sedimentation rates of study participants were assessed.	Day 1
Number of Deformities at Inspection	The number of joint deformities of the study participants.	Day 1
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

Collaborators and Investigators

• Sponsor: Abbott
• Investigators: Study Director: Mahmut Gucuk, MD, Abbott

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: May 28, 2010
• First Submitted That Met QC Criteria: June 14, 2010
• First Posted (Estimate): June 15, 2010

Study Record Updates

• Last Update Posted (Estimate): October 2, 2012
• Last Update Submitted That Met QC Criteria: September 21, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: Rheumatoid Arthritis; Disease-Modifying Anti-Rheumatic Drug; Work Limitation
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: P12-087