Progress at Work - The Impact of Adalimumab on Work Related Productivity in Patients With Rheumatoid Arthritis

Study Overview
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Brief Summary
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The purpose of this study is to describe the impact of treatment with adalimumab on work related productivity and economic burden in patients with Rheumatoid Arthritis (RA) treated in Canada.

Official Title
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Progress at Work - The Impact of Adalimumab on Work Related Productivity in Patients With Rheumatoid Arthritis.

Conditions
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Rheumatoid Arthritis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with moderate to severe RA for whom the physician has decided to initiate treatment with adalimumab Adult male or female ≥ 18 years old that has been newly prescribed adalimumab therapy according to the local product label and are with PROGRESS Subjects should be evaluated for tuberculosis (TB) exposure/risk factors for active and latent TB Subject is able to give written patient authorization and is willing to comply with the requirements of this study protocol. Exclusion Criteria: Subject cannot or will not sign a patient authorization Subject with a known hypersensitivity to Adalimumab, or any of its components Presence of any condition that, in the opinion of the treating physician, prohibits the subject from participating in the study or obscures the assessment of the treatment of RA Subjects currently participating in an investigational clinical trial Subjects treated with >1 prior biologic disease-modifying antirheumatic drugs (DMARDs) for RA. Any prior treatment with adalimumab is prohibited Subjects previously treated with targeted synthetic disease modifying agent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adalimumab subjects<br>Subjects starting Adalimumab treatment at time of enrollment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Rheumatoid Arthritis-Work Instability Scale (RA-WIS) | This is patient-reported assessment on the impact of adalimumab on the work status of RA patients. | From Month 0 to Month 6 | 
| Change in Financial Loss | This is patient reported assessment of financial burden of RA. | From Month 0 to Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Rheumatoid Arthritis-Work Instability (RA-WIS) | This is patient-reported assessment on the impact of adalimumab on the work status of RA patients. | From Month 0 to Month 12, 18 and 24 | 
| Change in the Financial Loss | This is patient reported assessment of financial burden of RA. | From Month 0 to Month 12, 18 and 24 | 
| Change in patient pain | Pain is assessed using Visual Analogue Scale (VAS) | From Month 0 to Month 24 | 
| Change in Tender Joint Count (TJC) | This is assessed by the physician. | From Month 0 to Month 24 | 
| Change in Disease Activity Score (DAS) 28 | Disease activity assessment is done by the physician. | From Month 0 to Month 24 | 
| Change in patient assessment of Global Disease Activity | It is assessed using VAS. | From Month 0 to Month 24 | 
| Change in Swollen Joint Count (SJC) | This is assessed by the physician. | From Month 0 to Month 24 | 
| Change in physician's assessment of Global Disease Activity | It is assessed using VAS. | From Month 0 to Month 24 | 
| Change in Health Assessment Questionnaire (HAQ) | This is patient reported functional assessment. | From Month 0 to Month 24 | 
| Change in c-reactive protein (CRP)/erythrocyte sedimentation rate (ESR) | CRP/ESR values are measured as an inflammatory parameter. Low CRP and ESR values mean less inflammation. | From Month 0 to Month 24 | 
| Rate of Remission per Disease Activity Scale (DAS) 28 | The DAS28 is a validated index of rheumatoid arthritis disease activity. Scores on the DAS28 range from 0 to 10. A DAS28 score less than 2.6 indicates clinical remission. | From Month 0 to Month 24 | 
| Rate of Achieving Low Disease Activity (LDA) per Disease Activity Score (DAS) 28 | The DAS28 is a validated index of rheumatoid arthritis disease activity. Scores range from 0 to 10 with LDA defined as a score from 2.6 to < 3.2. | From Month 0 to Month 24 | 
| Rate of Remission Per Clinical Disease Activity Index (CDAI) | The CDAI is used to evaluate disease activity in patients with Rheumatoid Arthritis. | From Month 0 to Month 24 | 
| Rate of Achieving Low Disease Activity (LDA) per CDAI | The CDAI is a composite index for assessing disease activity. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10. | From Month 0 to Month 24 | 
| Rate of Remission per Simplified Disease Activity Index (SDAI) | The SDAI is a validated measure of rheumatoid arthritis disease activity. Scores on the SDAI range from 0 to 86 with a SDAI score ≤3.3 indicating clinical remission. | From Month 0 to Month 24 | 
| Rate of Achieving Low Disease Activity (LDA) per SDAI | The SDAI is a validated measure of rheumatoid arthritis disease activity. Scores on the SDAI range from 0 to 86 with a SDAI score <11 indicating LDA. | From Month 0 to Month 24 |