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NCT Number: NCT01144598

Time to DMARD (Disease-Modifying Anti-Rheumatic Drug) 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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Site Reference ID/Investigator# 39111, Adana, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. 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.

  6. 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.

  7. Biologics Usage

    Time frame: Day 1

    Biologic treatments participants were taking for their rheumatoid arthritis.

  8. Stiffness Duration

    Time frame: Day 1

    Participants' duration of morning joint stiffness.

  9. Number of Comorbidities

    Time frame: Day 1

    Number of comorbid (coexisting) medical conditions of the study participants.

  10. Rheumatoid Factor

    Time frame: Day 1

    Rheumatoid factor test results.

  11. Anti-cyclic Citrullinated Peptide

    Time frame: Day 1

    Anti-cyclic citrullinated peptide (anti-CCP) test results.

  12. Sedimentation Rate

    Time frame: Day 1

    The erythrocyte (red blood cell) sedimentation rates of study participants were assessed.

  13. Number of Deformities at Inspection

    Time frame: Day 1

    The number of joint deformities of the study participants.

  14. 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.

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 15, 2010
Registry last updated
Oct 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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