A Retrospective Chart Review of MabThera (Rituximab) Treatment in Rheumatoid Arthritis (RA) Participants in Australia

Study Overview
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Brief Summary
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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.

Official Title
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A Retrospective Chart Review of the Use of MabThera (Rituximab) for the Treatment of Rheumatoid Arthritis (RA) in Australian Rheumatology Practice

Conditions
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Rheumatoid Arthritis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Greater than or equal to (>=) 18 years of age at the time of data collection RA diagnosed by a rheumatologist Treatment with rituximab for RA Exclusion Criteria: Participants whose primary diagnosis and indication for rituximab treatment is a condition other than RA Participants who have been treated with an experimental agent for RA which is not currently approved for the treatment of RA in Australia

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Rheumatoid arthritis (RA) participants<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Factors leading to Therapeutic decision to use rituximab |  | Up to end of study (approximately 1 month) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| 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) |