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Trial record 9 of 2725 for:    Rheumatoid Arthritis

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

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ClinicalTrials.gov Identifier: NCT01144598
Recruitment Status : Completed
First Posted : June 15, 2010
Results First Posted : September 19, 2012
Last Update Posted : October 2, 2012
Sponsor:
Information provided by (Responsible Party):
Abbott

Study Type Observational
Study Design Time Perspective: Cross-Sectional
Condition Rheumatoid Arthritis
Enrollment 356
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Turkish Patients With Rheumatoid Arthritis
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 356
Analysis Population 356
Completed 356
Not Completed 0
Arm/Group Title Turkish Patients With Rheumatoid Arthritis
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 356
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 356 participants
Less than 30 years 49
30 to 40 years 122
41 to 50 years 120
51 to 60 years 53
Over 60 years 12
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 356 participants
Female
216
  60.7%
Male
140
  39.3%
1.Primary Outcome
Title Evaluation of Disease Duration: Time From Diagnosis to Disease-Modifying Anti-Rheumatic Drug Treatment in Rheumatoid Arthritis
Hide Description The time elapsed from diagnosis of rheumatoid arthritis to initiation of treatment with disease-modifying anti-rheumatic drugs (DMARDs).
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with available information were included in the analysis.
Arm/Group Title Turkish Patients With Rheumatoid Arthritis
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 355
Mean (Standard Deviation)
Unit of Measure: Months
11.7177  (22.513)
2.Secondary Outcome
Title Work Limitation: Health Assessment Questionnaire-Disability Index (HAQ-DI)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who completed the rating scales were included in the analysis.
Arm/Group Title Turkish Patients With Rheumatoid Arthritis
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 356
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0.96  (0.7)
3.Secondary Outcome
Title Work Limitation: Work Productivity and Activity Impairment (WPAI) Questionnaire
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who completed the rating scales were included in the analysis.
Arm/Group Title Turkish Patients With Rheumatoid Arthritis
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 356
Mean (Standard Deviation)
Unit of Measure: Units on a scale
WPAI (Absenteeism) 12.3  (25.2)
WPAI (Presenteeism) 39.1  (29.2)
WPAI (Work Productivity Loss) 42.3  (32.2)
WPAI (Activity Impairment) 38.7  (27.9)
4.Secondary Outcome
Title Evaluation of Global Rheumatoid Arthritis Severity Scale
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with available information were included in the analysis.
Arm/Group Title Turkish Patients With Rheumatoid Arthritis
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 356
Mean (Standard Deviation)
Unit of Measure: Units on a scale
4.07  (2.50)
5.Secondary Outcome
Title Evaluation of Disease Activity Score 28 (DAS28)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with available information were included in the analysis.
Arm/Group Title Turkish Patients With Rheumatoid Arthritis
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 353
Measure Type: Number
Unit of Measure: Participants
DAS28 less than 2.6 84
DAS28 2.6 to less than 3.2 64
DAS28 3.2 to less than or equal to 5.1 129
DAS28 greater than 5.1 76
6.Secondary Outcome
Title Evaluation of Visual Analog Scale (VAS) for Pain and Fatigue
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who provided a visual analog scale rating for pain and fatigue were included in the analysis.
Arm/Group Title Turkish Patients With Rheumatoid Arthritis
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 355
Mean (Standard Deviation)
Unit of Measure: Units on a scale
4.24  (2.77)
7.Secondary Outcome
Title Number of Disease Modifying Anti-Rheumatic Drugs
Hide Description The number of disease-modifying anti-rheumatic drugs (DMARDs) that participants were taking to treat their rheumatoid arthritis.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with available information were included in the analysis.
Arm/Group Title Turkish Patients With Rheumatoid Arthritis
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 356
Measure Type: Number
Unit of Measure: Participants
Taking 1 DMARD 44
Taking 2 DMARDs 94
Taking 3 DMARDs 78
Taking more than 3 DMARDs 35
8.Secondary Outcome
Title Biologics Usage
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with available information were included in the analysis.
Arm/Group Title Turkish Patients With Rheumatoid Arthritis
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 356
Measure Type: Number
Unit of Measure: Participants
Taking 1 biologic plus 1 DMARD 85
Taking 2 biologics plus 1 DMARD 16
Taking more than 2 biologics plus 1 DMARD 4
9.Secondary Outcome
Title Stiffness Duration
Hide Description Participants' duration of morning joint stiffness.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with available information were included in the analysis.
Arm/Group Title Turkish Patients With Rheumatoid Arthritis
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 355
Measure Type: Number
Unit of Measure: Participants
0 to 10 minutes 161
11 to 30 minutes 78
31 to 60 minutes 54
61 minutes or longer 62
10.Secondary Outcome
Title Number of Comorbidities
Hide Description Number of comorbid (coexisting) medical conditions of the study participants.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with available information were included in the analysis.
Arm/Group Title Turkish Patients With Rheumatoid Arthritis
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 356
Measure Type: Number
Unit of Measure: Participants
No comorbid conditions 259
One comorbid condition 72
Two comorbid conditions 22
Three or more comorbid conditions 3
11.Secondary Outcome
Title Rheumatoid Factor
Hide Description Rheumatoid factor test results.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with available information were included in the analysis.
Arm/Group Title Turkish Patients With Rheumatoid Arthritis
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 344
Measure Type: Number
Unit of Measure: Participants
Rheumatoid factor positive 248
Rheumatoid factor negative 96
12.Secondary Outcome
Title Anti-cyclic Citrullinated Peptide
Hide Description Anti-cyclic citrullinated peptide (anti-CCP) test results.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with available information were included in the analysis.
Arm/Group Title Turkish Patients With Rheumatoid Arthritis
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 256
Measure Type: Number
Unit of Measure: Participants
Anti-CCP positive 181
Anti-CCP negative 75
13.Secondary Outcome
Title Sedimentation Rate
Hide Description The erythrocyte (red blood cell) sedimentation rates of study participants were assessed.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with available information were included in the analysis.
Arm/Group Title Turkish Patients With Rheumatoid Arthritis
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 350
Mean (Standard Deviation)
Unit of Measure: millimeters/hour
27.53  (21.67)
14.Secondary Outcome
Title Number of Deformities at Inspection
Hide Description The number of joint deformities of the study participants.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with available information were included in the analysis.
Arm/Group Title Turkish Patients With Rheumatoid Arthritis
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 354
Measure Type: Number
Unit of Measure: Participants
No deformities 221
One deformity 34
Two deformities 33
Three or more deformities 66
15.Secondary Outcome
Title Evaluation of Rheumatoid Arthritis Treatments Duration
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with available information were included in the analysis.
Arm/Group Title Turkish Patients With Rheumatoid Arthritis
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 355
Mean (Standard Deviation)
Unit of Measure: Months
Time from symptoms to diagnosis (n=355) 16.2468  (28.680)
Time from diagnosis to anti-TNF treatment (n=104) 68.57  (90.22)
Time Frame Participants were interviewed during a single visit. Adverse events which were observed/reported during this single visit were to be subject to local pharmacovigilance requirements, however, no adverse event or serious adverse event reports were made.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Turkish Patients With Rheumatoid Arthritis
Hide Arm/Group Description 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.
All-Cause Mortality
Turkish Patients With Rheumatoid Arthritis
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Turkish Patients With Rheumatoid Arthritis
Affected / at Risk (%)
Total   0/356 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Turkish Patients With Rheumatoid Arthritis
Affected / at Risk (%)
Total   0/356 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
Results Point of Contact
Name/Title: Global Medical Services
Organization: Abbott
Phone: 1-800-633-9110
Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01144598     History of Changes
Other Study ID Numbers: P12-087
First Submitted: May 28, 2010
First Posted: June 15, 2010
Results First Submitted: August 17, 2012
Results First Posted: September 19, 2012
Last Update Posted: October 2, 2012