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

November 1, 2016 updated by: Hoffmann-La Roche

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

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

167

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Geelong, Victoria, Australia, 3220

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Rheumatoid arthritis (RA) participants who have been treated with rituximab

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Rheumatoid arthritis (RA) participants
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?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Erythrocyte sedimentation rate
Time Frame: Baseline and most recent visits (approximately 1 month)
Baseline and most recent visits (approximately 1 month)
Change in Immunoglobulin levels
Time Frame: Baseline and most recent visits (approximately 1 month)
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)
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)
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)
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)
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)
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)
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
Time Frame: From first dose to most recent rituximab infusion (approximately 1 month)
From first dose to most recent rituximab infusion (approximately 1 month)
Change in C-reactive protein
Time Frame: Baseline and most recent visits (approximately 1 month)
Baseline and most recent visits (approximately 1 month)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Collaborators

Roche Products Pty Ltd (Australia)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

August 11, 2015

First Submitted That Met QC Criteria

September 29, 2015

First Posted (Estimate)

October 1, 2015

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML28321

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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