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| Name | Class |
|---|---|
| Roche Products Pty Ltd (Australia) | UNKNOWN |
This is a cross-sectional, observational study examining the factors leading to the therapeutic decision to use MabThera (rituximab) in participants with RA. Routine rheumatology clinical practice data of participants who are being or have been treated with rituximab for RA will be collected and analysed in this chart review.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rheumatoid arthritis (RA) participants | Participants who had been treated with rituximab for RA are reviewed retrospectively using chart review from Baseline until and their most recent visit to the rheumatologist prior to the conduct of the chart review. |
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| Measure | Description | Time Frame |
|---|---|---|
| Factors leading to Therapeutic decision to use rituximab | Up to end of study (approximately 1 month) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Erythrocyte sedimentation rate | Baseline and most recent visits (approximately 1 month) | |
| Change in Immunoglobulin levels | Baseline and most recent visits (approximately 1 month) | |
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Inclusion Criteria:
Exclusion Criteria:
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Rheumatoid arthritis (RA) participants who have been treated with rituximab
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geelong | Victoria | 3220 | Australia |
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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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| Percentage of participants with positive or negative results for rheumatoid factor |
| Up to end of study (approximately 1 month) |
| Percentage of participants with positive or negative results for anti-cyclic citrullinated peptide antibody | Up to end of study (approximately 1 month) |
| Percentage of participants with positive or negative results for anti-nuclear antibodies | Up to end of study (approximately 1 month) |
| Disease activity score (DAS28) | At baseline visit (most recent visit prior to MabThera treatment) and at most recent visit prior to chart review (approximately 1 month) |
| Tender joint count (TJC) | At baseline visit (most recent visit prior to MabThera treatment) and at most recent visit prior to chart review (approximately 1 month) |
| Swollen joint count (SJC) | At baseline visit (most recent visit prior to MabThera treatment) and at most recent visit prior to chart review (approximately 1 month) |
| Duration of treatment with rituximab | From first dose to most recent rituximab infusion (approximately 1 month) |
| Change in C-reactive protein | Baseline and most recent visits (approximately 1 month) |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |