Trial Outcomes & Findings for Time to DMARD (Disease-Modifying Anti-Rheumatic Drug) Treatment and Actual Work Limitation of Patients With Rheumatoid Arthritis in Turkey (NCT NCT01144598)

Results Overview

The time elapsed from diagnosis of rheumatoid arthritis to initiation of treatment with disease-modifying anti-rheumatic drugs (DMARDs).

Recruitment status

COMPLETED

Target enrollment

356 participants

Primary outcome timeframe

Day 1

Results posted on

2012-10-02

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	356
Overall Study Analysis Population	356
Overall Study COMPLETED	356
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Turkish Patients With Rheumatoid Arthritis n=356 Participants 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.
Age, Customized Less than 30 years	49 participants n=93 Participants
Age, Customized 30 to 40 years	122 participants n=93 Participants
Age, Customized 41 to 50 years	120 participants n=93 Participants
Age, Customized 51 to 60 years	53 participants n=93 Participants
Age, Customized Over 60 years	12 participants n=93 Participants
Sex: Female, Male Female	216 Participants n=93 Participants
Sex: Female, Male Male	140 Participants n=93 Participants

PRIMARY outcome

Timeframe: Day 1

Population: All participants with available information were included in the analysis.

The time elapsed from diagnosis of rheumatoid arthritis to initiation of treatment with disease-modifying anti-rheumatic drugs (DMARDs).

Outcome measures

Outcome measures
Measure	Turkish Patients With Rheumatoid Arthritis n=355 Participants 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.
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 outcome

Timeframe: Day 1

Population: All participants who completed the rating scales were included in the analysis.

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.

Outcome measures

Outcome measures
Measure	Turkish Patients With Rheumatoid Arthritis n=356 Participants 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.
Work Limitation: Health Assessment Questionnaire-Disability Index (HAQ-DI)	0.96 Units on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: Day 1

Population: All participants who completed the rating scales were included in the analysis.

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.

Outcome measures

Outcome measures
Measure	Turkish Patients With Rheumatoid Arthritis n=356 Participants 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.
Work Limitation: Work Productivity and Activity Impairment (WPAI) Questionnaire WPAI (Absenteeism)	12.3 Units on a scale Standard Deviation 25.2
Work Limitation: Work Productivity and Activity Impairment (WPAI) Questionnaire WPAI (Presenteeism)	39.1 Units on a scale Standard Deviation 29.2
Work Limitation: Work Productivity and Activity Impairment (WPAI) Questionnaire WPAI (Work Productivity Loss)	42.3 Units on a scale Standard Deviation 32.2
Work Limitation: Work Productivity and Activity Impairment (WPAI) Questionnaire WPAI (Activity Impairment)	38.7 Units on a scale Standard Deviation 27.9

SECONDARY outcome

Timeframe: Day 1

Population: All participants with available information were included in the analysis.

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).

Outcome measures

Outcome measures
Measure	Turkish Patients With Rheumatoid Arthritis n=356 Participants 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.
Evaluation of Global Rheumatoid Arthritis Severity Scale	4.07 Units on a scale Standard Deviation 2.50

SECONDARY outcome

Timeframe: Day 1

Population: All participants with available information were included in the analysis.

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.

Outcome measures

Outcome measures
Measure	Turkish Patients With Rheumatoid Arthritis n=353 Participants 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.
Evaluation of Disease Activity Score 28 (DAS28) DAS28 less than 2.6	84 Participants
Evaluation of Disease Activity Score 28 (DAS28) DAS28 2.6 to less than 3.2	64 Participants
Evaluation of Disease Activity Score 28 (DAS28) DAS28 3.2 to less than or equal to 5.1	129 Participants
Evaluation of Disease Activity Score 28 (DAS28) DAS28 greater than 5.1	76 Participants

SECONDARY outcome

Timeframe: Day 1

Population: Participants who provided a visual analog scale rating for pain and fatigue were included in the analysis.

Participants rated their pain and fatigue using a visual analog scale from 0 to 10, where 10 was the worst case.

Outcome measures

Outcome measures
Measure	Turkish Patients With Rheumatoid Arthritis n=355 Participants 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.
Evaluation of Visual Analog Scale (VAS) for Pain and Fatigue	4.24 Units on a scale Standard Deviation 2.77

SECONDARY outcome

Timeframe: Day 1

Population: All participants with available information were included in the analysis.

The number of disease-modifying anti-rheumatic drugs (DMARDs) that participants were taking to treat their rheumatoid arthritis.

Outcome measures

Outcome measures
Measure	Turkish Patients With Rheumatoid Arthritis n=356 Participants 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.
Number of Disease Modifying Anti-Rheumatic Drugs Taking 1 DMARD	44 Participants
Number of Disease Modifying Anti-Rheumatic Drugs Taking 2 DMARDs	94 Participants
Number of Disease Modifying Anti-Rheumatic Drugs Taking 3 DMARDs	78 Participants
Number of Disease Modifying Anti-Rheumatic Drugs Taking more than 3 DMARDs	35 Participants

SECONDARY outcome

Timeframe: Day 1

Population: All participants with available information were included in the analysis.

Biologic treatments participants were taking for their rheumatoid arthritis.

Outcome measures

Outcome measures
Measure	Turkish Patients With Rheumatoid Arthritis n=356 Participants 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.
Biologics Usage Taking 1 biologic plus 1 DMARD	85 Participants
Biologics Usage Taking 2 biologics plus 1 DMARD	16 Participants
Biologics Usage Taking more than 2 biologics plus 1 DMARD	4 Participants

SECONDARY outcome

Timeframe: Day 1

Population: All participants with available information were included in the analysis.

Participants' duration of morning joint stiffness.

Outcome measures

Outcome measures
Measure	Turkish Patients With Rheumatoid Arthritis n=355 Participants 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.
Stiffness Duration 0 to 10 minutes	161 Participants
Stiffness Duration 11 to 30 minutes	78 Participants
Stiffness Duration 31 to 60 minutes	54 Participants
Stiffness Duration 61 minutes or longer	62 Participants

SECONDARY outcome

Timeframe: Day 1

Population: All participants with available information were included in the analysis.

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

Outcome measures

Outcome measures
Measure	Turkish Patients With Rheumatoid Arthritis n=356 Participants 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.
Number of Comorbidities No comorbid conditions	259 Participants
Number of Comorbidities One comorbid condition	72 Participants
Number of Comorbidities Two comorbid conditions	22 Participants
Number of Comorbidities Three or more comorbid conditions	3 Participants

SECONDARY outcome

Timeframe: Day 1

Population: All participants with available information were included in the analysis.

Rheumatoid factor test results.

Outcome measures

Outcome measures
Measure	Turkish Patients With Rheumatoid Arthritis n=344 Participants 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.
Rheumatoid Factor Rheumatoid factor positive	248 Participants
Rheumatoid Factor Rheumatoid factor negative	96 Participants

SECONDARY outcome

Timeframe: Day 1

Population: All participants with available information were included in the analysis.

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

Outcome measures

Outcome measures
Measure	Turkish Patients With Rheumatoid Arthritis n=256 Participants 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.
Anti-cyclic Citrullinated Peptide Anti-CCP positive	181 Participants
Anti-cyclic Citrullinated Peptide Anti-CCP negative	75 Participants

SECONDARY outcome

Timeframe: Day 1

Population: All participants with available information were included in the analysis.

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

Outcome measures

Outcome measures
Measure	Turkish Patients With Rheumatoid Arthritis n=350 Participants 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.
Sedimentation Rate	27.53 millimeters/hour Standard Deviation 21.67

SECONDARY outcome

Timeframe: Day 1

Population: All participants with available information were included in the analysis.

The number of joint deformities of the study participants.

Outcome measures

Outcome measures
Measure	Turkish Patients With Rheumatoid Arthritis n=354 Participants 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.
Number of Deformities at Inspection No deformities	221 Participants
Number of Deformities at Inspection One deformity	34 Participants
Number of Deformities at Inspection Two deformities	33 Participants
Number of Deformities at Inspection Three or more deformities	66 Participants

SECONDARY outcome

Timeframe: Day 1

Population: All participants with available information were included in the analysis.

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.

Outcome measures

Outcome measures
Measure	Turkish Patients With Rheumatoid Arthritis n=355 Participants 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.
Evaluation of Rheumatoid Arthritis Treatments Duration Time from symptoms to diagnosis (n=355)	16.2468 Months Standard Deviation 28.680
Evaluation of Rheumatoid Arthritis Treatments Duration Time from diagnosis to anti-TNF treatment (n=104)	68.57 Months Standard Deviation 90.22

Adverse Events

Turkish Patients With Rheumatoid Arthritis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Global Medical Services

Abbott

Phone: 1-800-633-9110

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER