A Retrospective Chart Review of MabThera (Rituximab) Treatment in Rheumatoid Arthritis (RA) Participants in Australia
1 other identifier
observational
167
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2012
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 11, 2015
CompletedFirst Posted
Study publicly available on registry
October 1, 2015
CompletedNovember 2, 2016
November 1, 2016
1 month
August 11, 2015
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Factors leading to Therapeutic decision to use rituximab
Up to end of study (approximately 1 month)
Secondary Outcomes (10)
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)
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)
- +5 more secondary outcomes
Study Arms (1)
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.
Eligibility Criteria
Rheumatoid arthritis (RA) participants who have been treated with rituximab
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hoffmann-La Rochelead
- Roche Products Pty Ltd (Australia)collaborator
Study Sites (1)
Unknown Facility
Geelong, Victoria, 3220, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2015
First Posted
October 1, 2015
Study Start
January 1, 2012
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
November 2, 2016
Record last verified: 2016-11