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

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT02564770
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Study First Submitted: 2015-08-11
• Study First Submitted QC: 2015-09-29
• Study First Posted: 2015-10-01
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 167

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Factors leading to Therapeutic decision to use rituximab	Up to end of study (approximately 1 month)

Secondary Outcome Measures

Name	Time	Method
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)
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)
Change in C-reactive protein	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)
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)
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)
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)