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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02564770

Enrollment

167

Registered

2015-10-01

Start date

2012-01-31

Completion date

2012-02-29

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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)
Change in Erythrocyte sedimentation rate	Baseline and most recent visits (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)
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)

Countries

Australia

Outcome results