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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01144598
• Other study ID #: P12-087
• Status: Completed
• Phase: N/A
• First received: May 28, 2010
• Last updated: September 21, 2012
• Start date: February 2010
• Est. completion date: August 2011

Study information

• Verified date: September 2012
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

Turkey, 

Outcome

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