Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis, Disease-Modifying Anti-Rheumatic Drug, Work Limitation
Brief 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.
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.
Interventions
None listed
Sponsors
Abbott
Study design
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Disease Duration: Time From Diagnosis to Disease-Modifying Anti-Rheumatic Drug Treatment in Rheumatoid Arthritis | Day 1 | The time elapsed from diagnosis of rheumatoid arthritis to initiation of treatment with disease-modifying anti-rheumatic drugs (DMARDs). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Work Limitation: Work Productivity and Activity Impairment (WPAI) Questionnaire | 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. |
| Evaluation of Global Rheumatoid Arthritis Severity Scale | 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). |
| Evaluation of Disease Activity Score 28 (DAS28) | 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. |
| Evaluation of Visual Analog Scale (VAS) for Pain and Fatigue | Day 1 | 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 | Day 1 | The number of disease-modifying anti-rheumatic drugs (DMARDs) that participants were taking to treat their rheumatoid arthritis. |
| Biologics Usage | Day 1 | Biologic treatments participants were taking for their rheumatoid arthritis. |
| Work Limitation: Health Assessment Questionnaire-Disability Index (HAQ-DI) | 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. |
| Number of Comorbidities | Day 1 | Number of comorbid (coexisting) medical conditions of the study participants. |
| Rheumatoid Factor | Day 1 | Rheumatoid factor test results. |
| Anti-cyclic Citrullinated Peptide | Day 1 | Anti-cyclic citrullinated peptide (anti-CCP) test results. |
| Sedimentation Rate | Day 1 | The erythrocyte (red blood cell) sedimentation rates of study participants were assessed. |
| Number of Deformities at Inspection | Day 1 | The number of joint deformities of the study participants. |
| Evaluation of Rheumatoid Arthritis Treatments Duration | 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. |
| Stiffness Duration | Day 1 | Participants' duration of morning joint stiffness. |
Countries
Turkey (Türkiye)
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Turkish Patients With Rheumatoid Arthritis 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. | 356 |
| Total | 356 |
Baseline characteristics
| Characteristic | Turkish Patients With Rheumatoid Arthritis |
|---|---|
| Age, Customized 30 to 40 years | 122 participants |
| Age, Customized 41 to 50 years | 120 participants |
| Age, Customized 51 to 60 years | 53 participants |
| Age, Customized Less than 30 years | 49 participants |
| Age, Customized Over 60 years | 12 participants |
| Sex: Female, Male Female | 216 Participants |
| Sex: Female, Male Male | 140 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 356 |
| serious Total, serious adverse events | 0 / 356 |
Outcome results
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).
Time frame: Day 1
Population: All participants with available information were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Turkish Patients With Rheumatoid Arthritis | Evaluation of Disease Duration: Time From Diagnosis to Disease-Modifying Anti-Rheumatic Drug Treatment in Rheumatoid Arthritis | 11.7177 Months | Standard Deviation 22.513 |
Secondary
Anti-cyclic Citrullinated Peptide
Anti-cyclic citrullinated peptide (anti-CCP) test results.
Time frame: Day 1
Population: All participants with available information were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Turkish Patients With Rheumatoid Arthritis | Anti-cyclic Citrullinated Peptide | Anti-CCP positive | 181 Participants |
| Turkish Patients With Rheumatoid Arthritis | Anti-cyclic Citrullinated Peptide | Anti-CCP negative | 75 Participants |
Secondary
Biologics Usage
Biologic treatments participants were taking for their rheumatoid arthritis.
Time frame: Day 1
Population: All participants with available information were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Turkish Patients With Rheumatoid Arthritis | Biologics Usage | Taking 1 biologic plus 1 DMARD | 85 Participants |
| Turkish Patients With Rheumatoid Arthritis | Biologics Usage | Taking 2 biologics plus 1 DMARD | 16 Participants |
| Turkish Patients With Rheumatoid Arthritis | Biologics Usage | Taking more than 2 biologics plus 1 DMARD | 4 Participants |
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.
Time frame: Day 1
Population: All participants with available information were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Turkish Patients With Rheumatoid Arthritis | Evaluation of Disease Activity Score 28 (DAS28) | DAS28 less than 2.6 | 84 Participants |
| Turkish Patients With Rheumatoid Arthritis | Evaluation of Disease Activity Score 28 (DAS28) | DAS28 2.6 to less than 3.2 | 64 Participants |
| Turkish Patients With Rheumatoid Arthritis | Evaluation of Disease Activity Score 28 (DAS28) | DAS28 3.2 to less than or equal to 5.1 | 129 Participants |
| Turkish Patients With Rheumatoid Arthritis | Evaluation of Disease Activity Score 28 (DAS28) | DAS28 greater than 5.1 | 76 Participants |
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).
Time frame: Day 1
Population: All participants with available information were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Turkish Patients With Rheumatoid Arthritis | Evaluation of Global Rheumatoid Arthritis Severity Scale | 4.07 Units on a scale | Standard Deviation 2.5 |
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.
Time frame: Day 1
Population: All participants with available information were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Turkish Patients With Rheumatoid Arthritis | Evaluation of Rheumatoid Arthritis Treatments Duration | Time from symptoms to diagnosis (n=355) | 16.2468 Months | Standard Deviation 28.68 |
| Turkish Patients With Rheumatoid Arthritis | Evaluation of Rheumatoid Arthritis Treatments Duration | Time from diagnosis to anti-TNF treatment (n=104) | 68.57 Months | Standard Deviation 90.22 |
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.
Time frame: Day 1
Population: Participants who provided a visual analog scale rating for pain and fatigue were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Turkish Patients With Rheumatoid Arthritis | Evaluation of Visual Analog Scale (VAS) for Pain and Fatigue | 4.24 Units on a scale | Standard Deviation 2.77 |
Secondary
Number of Comorbidities
Number of comorbid (coexisting) medical conditions of the study participants.
Time frame: Day 1
Population: All participants with available information were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Turkish Patients With Rheumatoid Arthritis | Number of Comorbidities | One comorbid condition | 72 Participants |
| Turkish Patients With Rheumatoid Arthritis | Number of Comorbidities | Two comorbid conditions | 22 Participants |
| Turkish Patients With Rheumatoid Arthritis | Number of Comorbidities | Three or more comorbid conditions | 3 Participants |
| Turkish Patients With Rheumatoid Arthritis | Number of Comorbidities | No comorbid conditions | 259 Participants |
Secondary
Number of Deformities at Inspection
The number of joint deformities of the study participants.
Time frame: Day 1
Population: All participants with available information were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Turkish Patients With Rheumatoid Arthritis | Number of Deformities at Inspection | No deformities | 221 Participants |
| Turkish Patients With Rheumatoid Arthritis | Number of Deformities at Inspection | One deformity | 34 Participants |
| Turkish Patients With Rheumatoid Arthritis | Number of Deformities at Inspection | Two deformities | 33 Participants |
| Turkish Patients With Rheumatoid Arthritis | Number of Deformities at Inspection | Three or more deformities | 66 Participants |
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.
Time frame: Day 1
Population: All participants with available information were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Turkish Patients With Rheumatoid Arthritis | Number of Disease Modifying Anti-Rheumatic Drugs | Taking 1 DMARD | 44 Participants |
| Turkish Patients With Rheumatoid Arthritis | Number of Disease Modifying Anti-Rheumatic Drugs | Taking 2 DMARDs | 94 Participants |
| Turkish Patients With Rheumatoid Arthritis | Number of Disease Modifying Anti-Rheumatic Drugs | Taking 3 DMARDs | 78 Participants |
| Turkish Patients With Rheumatoid Arthritis | Number of Disease Modifying Anti-Rheumatic Drugs | Taking more than 3 DMARDs | 35 Participants |
Secondary
Rheumatoid Factor
Rheumatoid factor test results.
Time frame: Day 1
Population: All participants with available information were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Turkish Patients With Rheumatoid Arthritis | Rheumatoid Factor | Rheumatoid factor negative | 96 Participants |
| Turkish Patients With Rheumatoid Arthritis | Rheumatoid Factor | Rheumatoid factor positive | 248 Participants |
Secondary
Sedimentation Rate
The erythrocyte (red blood cell) sedimentation rates of study participants were assessed.
Time frame: Day 1
Population: All participants with available information were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Turkish Patients With Rheumatoid Arthritis | Sedimentation Rate | 27.53 millimeters/hour | Standard Deviation 21.67 |
Secondary
Stiffness Duration
Participants' duration of morning joint stiffness.
Time frame: Day 1
Population: All participants with available information were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Turkish Patients With Rheumatoid Arthritis | Stiffness Duration | 0 to 10 minutes | 161 Participants |
| Turkish Patients With Rheumatoid Arthritis | Stiffness Duration | 11 to 30 minutes | 78 Participants |
| Turkish Patients With Rheumatoid Arthritis | Stiffness Duration | 31 to 60 minutes | 54 Participants |
| Turkish Patients With Rheumatoid Arthritis | Stiffness Duration | 61 minutes or longer | 62 Participants |
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.
Time frame: Day 1
Population: All participants who completed the rating scales were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Turkish Patients With Rheumatoid Arthritis | Work Limitation: Health Assessment Questionnaire-Disability Index (HAQ-DI) | 0.96 Units on a scale | Standard Deviation 0.7 |
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.
Time frame: Day 1
Population: All participants who completed the rating scales were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Turkish Patients With Rheumatoid Arthritis | Work Limitation: Work Productivity and Activity Impairment (WPAI) Questionnaire | WPAI (Absenteeism) | 12.3 Units on a scale | Standard Deviation 25.2 |
| Turkish Patients With Rheumatoid Arthritis | Work Limitation: Work Productivity and Activity Impairment (WPAI) Questionnaire | WPAI (Presenteeism) | 39.1 Units on a scale | Standard Deviation 29.2 |
| Turkish Patients With Rheumatoid Arthritis | Work Limitation: Work Productivity and Activity Impairment (WPAI) Questionnaire | WPAI (Work Productivity Loss) | 42.3 Units on a scale | Standard Deviation 32.2 |
| Turkish Patients With Rheumatoid Arthritis | Work Limitation: Work Productivity and Activity Impairment (WPAI) Questionnaire | WPAI (Activity Impairment) | 38.7 Units on a scale | Standard Deviation 27.9 |