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The purpose of this study is to explore the differences in productivity loss and costs between patients being treated for rheumatoid arthritis (RA) with biologic disease-modifying antirheumatic drugs (bDMARDs) compared to patients treated with conventional DMARDs.
Time Perspective: Prospective with some retrospective analysis of claims data
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RA patients who are new bDMARD users | |||
| RA patients who are existing DMARD users |
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| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported productivity loss using the Work Limitations Questionnaire (WLQ) | At baseline (6-12 months after starting index bDMARD; variable for DMARD) and at 6 months (12-18 months after starting index bDMARD; variable for DMARD) |
| Measure | Description | Time Frame |
|---|---|---|
| Direct and Indirect costs associated with lost productivity (as measured by WLQ) | At baseline (6-12 months after starting index bDMARD; variable for DMARD) and at 6 months (12-18 months after starting index bDMARD; variable for DMARD) | |
| Healthcare utilization and costs (total and RA-related) |
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Inclusion Criteria:
Exclusion Criteria:
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Commercial health plan members
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
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| Label | URL |
|---|---|
| BMS Clinical Trials Disclosure | View source |
| For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm | View source |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| At baseline (6-12 months after starting index bDMARD; variable for DMARD) and at 6 months (12-18 months after starting index bDMARD; variable for DMARD) |
| Functionality (as measured by HAQ-DI) | At baseline (6-12 months after starting index bDMARD; variable for DMARD) and at 6 months (12-18 months after starting index bDMARD; variable for DMARD) |
| RA severity (as measured by RAPID3) | At baseline (6-12 months after starting index bDMARD; variable for DMARD) and at 6 months (12-18 months after starting index bDMARD; variable for DMARD) |
| Patient reported quality of life | At baseline (6-12 months after starting index bDMARD; variable for DMARD) and at 6 months (12-18 months after starting index bDMARD; variable for DMARD) |
| Patient reported treatment satisfaction | At baseline (6-12 months after starting index bDMARD; variable for DMARD) and at 6 months (12-18 months after starting index bDMARD; variable for DMARD) |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |