Rheumatoid ArthritisNCT01144598
Time to DMARD (Disease-Modifying Anti-Rheumatic Drug) Treatment and Actual Work Limitation of Patients With Rheumatoid Arthritis in Turkey
An observational study of Rheumatoid Arthritis, run by Abbott at 21 sites in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 356 participants
- Where
- 21 sitesTurkey (Türkiye)
- Study dates
- Feb 2010to Aug 2011
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients who cannot provide necessary outcome measurements for any reason will be excluded from the study
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
Turkey (Türkiye)21 sites
Site Reference ID/Investigator# 39111
Adana, 01330
Site Reference ID/Investigator# 39102
Ankara, 06018
Site Reference ID/Investigator# 39104
Ankara, 06100
Site Reference ID/Investigator# 39109
Ankara, 06100
Site Reference ID/Investigator# 52448
Ankara, 06490
Site Ref # / Investigator 52451
Antalya, 07058
Site Reference ID/Investigator# 52442
Aydin, 09010
Site Reference ID/Investigator# 52447
Bursa, 16059
Site Reference ID/Investigator# 52446
Bursa, 16350
Site Ref # / Investigator 52443
Denizli, 20070
Site Reference ID/Investigator# 52444
Denizli, 20125
Site Reference ID/Investigator# 52449
Gaziantep, 27310
Site Reference ID/Investigator# 52450
Gaziantep, 27310
Site Reference ID/Investigator# 39107
Istanbul, 34093
Site Reference ID/Investigator# 39106
Istanbul, 34098
Site Reference ID/Investigator# 39103
Istanbul, 34899
Site Reference ID/Investigator# 39108
Izmir, 35000
Site Reference ID/Investigator# 36442
Izmir, 35340
Site # / Investigator 59224
Izmir, 35360
Site Ref # / Investigator 59225
Izmir, 35360
Site Ref # / Investigator 59226
Izmir, 35360
About this study
Official title: 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.
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, Disease-Modifying Anti-Rheumatic Drug, Work Limitation
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Turkish patients with rheumatoid arthritis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day 1
Secondary outcomes (14)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1
Biologics Usage
Biologic treatments participants were taking for their rheumatoid arthritis.
Measured: Day 1
Stiffness Duration
Participants' duration of morning joint stiffness.
Measured: Day 1
Number of Comorbidities
Number of comorbid (coexisting) medical conditions of the study participants.
Measured: Day 1
Rheumatoid Factor
Rheumatoid factor test results.
Measured: Day 1
Anti-cyclic Citrullinated Peptide
Anti-cyclic citrullinated peptide (anti-CCP) test results.
Measured: Day 1
Sedimentation Rate
The erythrocyte (red blood cell) sedimentation rates of study participants were assessed.
Measured: Day 1
Number of Deformities at Inspection
The number of joint deformities of the study participants.
Measured: 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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2010 (estimated)
- Study startFeb 2010
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 356 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mahmut Gucuk, MD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01144598
- Sponsor's protocol ID
- P12-087
- Status last verified
- Sep 2012
- First submitted
- 28 May 2010
- Last updated
- 2 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time to DMARD Treatment and Actual Work Limitation of Patients With Rheumatoid Arthritis in Turkey
- ClinicalTrials.gov ID
- NCT01144598
- Acronym / sponsor ID
- P12-087
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, Disease-Modifying Anti-Rheumatic Drug, Work Limitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 356 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 15 Jun 2010 (estimated)
- Results
- Posted 19 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Turkish patients with rheumatoid arthritis | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who cannot provide necessary outcome measurements for any reason will be excluded from the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
14 secondary outcomes
Work Limitation: Health Assessment Questionnaire-Disability Index (HAQ-DI)
Time frame: Day 1
Work Limitation: Work Productivity and Activity Impairment (WPAI) Questionnaire
Time frame: Day 1
Evaluation of Global Rheumatoid Arthritis Severity Scale
Time frame: Day 1
Evaluation of Disease Activity Score 28 (DAS28)
Time frame: Day 1
Evaluation of Visual Analog Scale (VAS) for Pain and Fatigue
Time frame: Day 1
Number of Disease Modifying Anti-Rheumatic Drugs
Time frame: Day 1
Biologics Usage
Time frame: Day 1
Stiffness Duration
Time frame: Day 1
Number of Comorbidities
Time frame: Day 1
Rheumatoid Factor
Time frame: Day 1
Anti-cyclic Citrullinated Peptide
Time frame: Day 1
Sedimentation Rate
Time frame: Day 1
Number of Deformities at Inspection
Time frame: Day 1
Evaluation of Rheumatoid Arthritis Treatments Duration
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmut Gucuk, MD study director
Abbott
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Abbott at 21 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Disease Duration: Time From Diagnosis to Disease-Modifying Anti-Rheumatic Drug Treatment in Rheumatoid Arthritis (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2012.