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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02564770
• Other study ID #: ML28321
• Status: Completed
• Phase: N/A
• First received: August 11, 2015
• Last updated: November 1, 2016
• Start date: January 2012
• Est. completion date: February 2012

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Therapeutic Goods Administration (TGA)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hoffmann-La Roche	Roche Products Pty Ltd (Australia)

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Factors leading to Therapeutic decision to use rituximab		Up to end of study (approximately 1 month)	No
Secondary	Change in Erythrocyte sedimentation rate		Baseline and most recent visits (approximately 1 month)	No
Secondary	Change in Immunoglobulin levels		Baseline and most recent visits (approximately 1 month)	No
Secondary	Percentage of participants with positive or negative results for rheumatoid factor		Up to end of study (approximately 1 month)	No
Secondary	Percentage of participants with positive or negative results for anti-cyclic citrullinated peptide antibody		Up to end of study (approximately 1 month)	No
Secondary	Percentage of participants with positive or negative results for anti-nuclear antibodies		Up to end of study (approximately 1 month)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	Duration of treatment with rituximab		From first dose to most recent rituximab infusion (approximately 1 month)	No
Secondary	Change in C-reactive protein		Baseline and most recent visits (approximately 1 month)	No