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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01144598
First received: May 28, 2010
Last updated: September 21, 2012
Last verified: September 2012
  Purpose

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.


Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Time to DMARD Treatment and Actual Work Limitation of Patients With Rheumatoid Arthritis in Turkey

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Evaluation of Disease Duration: Time From Diagnosis to Disease-Modifying Anti-Rheumatic Drug Treatment in Rheumatoid Arthritis [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    The time elapsed from diagnosis of rheumatoid arthritis to initiation of treatment with disease-modifying anti-rheumatic drugs (DMARDs).


Secondary Outcome Measures:
  • Work Limitation: Health Assessment Questionnaire-Disability Index (HAQ-DI) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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.

  • Work Limitation: Work Productivity and Activity Impairment (WPAI) Questionnaire [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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.

  • Evaluation of Global Rheumatoid Arthritis Severity Scale [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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).

  • Evaluation of Disease Activity Score 28 (DAS28) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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.

  • Evaluation of Visual Analog Scale (VAS) for Pain and Fatigue [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Participants rated their pain and fatigue using a visual analog scale from 0 to 10, where 10 was the worst case.

  • Number of Disease Modifying Anti-Rheumatic Drugs [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    The number of disease-modifying anti-rheumatic drugs (DMARDs) that participants were taking to treat their rheumatoid arthritis.

  • Biologics Usage [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Biologic treatments participants were taking for their rheumatoid arthritis.

  • Stiffness Duration [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Participants' duration of morning joint stiffness.

  • Number of Comorbidities [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Number of comorbid (coexisting) medical conditions of the study participants.

  • Rheumatoid Factor [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Rheumatoid factor test results.

  • Anti-cyclic Citrullinated Peptide [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Anti-cyclic citrullinated peptide (anti-CCP) test results.

  • Sedimentation Rate [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    The erythrocyte (red blood cell) sedimentation rates of study participants were assessed.

  • Number of Deformities at Inspection [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    The number of joint deformities of the study participants.

  • Evaluation of Rheumatoid Arthritis Treatments Duration [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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.


Enrollment: 356
Study Start Date: February 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Turkish patients with 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01144598

Locations
Turkey
Site Reference ID/Investigator# 39111
Adana, Turkey, 01330
Site Reference ID/Investigator# 39102
Ankara, Turkey, 06018
Site Reference ID/Investigator# 39104
Ankara, Turkey, 06100
Site Reference ID/Investigator# 39109
Ankara, Turkey, 06100
Site Reference ID/Investigator# 52448
Ankara, Turkey, 06490
Site Ref # / Investigator 52451
Antalya, Turkey, 07058
Site Reference ID/Investigator# 52442
Aydin, Turkey, 09010
Site Reference ID/Investigator# 52447
Bursa, Turkey, 16059
Site Reference ID/Investigator# 52446
Bursa, Turkey, 16350
Site Ref # / Investigator 52443
Denizli, Turkey, 20070
Site Reference ID/Investigator# 52444
Denizli, Turkey, 20125
Site Reference ID/Investigator# 52449
Gaziantep, Turkey, 27310
Site Reference ID/Investigator# 52450
Gaziantep, Turkey, 27310
Site Reference ID/Investigator# 39103
Istanbul, Turkey, 34899
Site Reference ID/Investigator# 39106
Istanbul, Turkey, 34098
Site Reference ID/Investigator# 39107
Istanbul, Turkey, 34093
Site # / Investigator 59224
Izmir, Turkey, 35360
Site Ref # / Investigator 59225
Izmir, Turkey, 35360
Site Ref # / Investigator 59226
Izmir, Turkey, 35360
Site Reference ID/Investigator# 36442
Izmir, Turkey, 35340
Site Reference ID/Investigator# 39108
Izmir, Turkey, 35000
Sponsors and Collaborators
Abbott
Investigators
Study Director: Mahmut Gucuk, MD Abbott
  More Information

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01144598     History of Changes
Other Study ID Numbers: P12-087
Study First Received: May 28, 2010
Results First Received: August 17, 2012
Last Updated: September 21, 2012
Health Authority: Turkey: Ministry of Health

Keywords provided by Abbott:
Rheumatoid Arthritis
Disease-Modifying Anti-Rheumatic Drug
Work Limitation

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Antirheumatic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014