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

Hoffmann-La Roche167 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

167

Conditions

Rheumatoid Arthritis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Geelong, Victoria, Australia

Outcomes

Primary Outcomes

Factors leading to Therapeutic decision to use rituximab

Time frame: Up to end of study (approximately 1 month)

Secondary Outcomes

Change in Erythrocyte sedimentation rate

Time frame: Baseline and most recent visits (approximately 1 month)

Change in Immunoglobulin levels

Time frame: Baseline and most recent visits (approximately 1 month)

Percentage of participants with positive or negative results for rheumatoid factor

Time frame: Up to end of study (approximately 1 month)

Percentage of participants with positive or negative results for anti-cyclic citrullinated peptide antibody

Time frame: Up to end of study (approximately 1 month)

Percentage of participants with positive or negative results for anti-nuclear antibodies

Time frame: Up to end of study (approximately 1 month)

Disease activity score (DAS28)

Time frame: 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)

Time frame: 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)

Time frame: At baseline visit (most recent visit prior to MabThera treatment) and at most recent visit prior to chart review (approximately 1 month)

Data from ClinicalTrials.gov

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