Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02564770




Registration number
NCT02564770
Ethics application status
Date submitted
11/08/2015
Date registered
1/10/2015
Date last updated
2/11/2016

Titles & IDs
Public title
A Retrospective Chart Review of MabThera (Rituximab) Treatment in Rheumatoid Arthritis (RA) Participants in Australia
Scientific title
A Retrospective Chart Review of the Use of MabThera (Rituximab) for the Treatment of Rheumatoid Arthritis (RA) in Australian Rheumatology Practice
Secondary ID [1] 0 0
ML28321
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Factors leading to Therapeutic decision to use rituximab
Timepoint [1] 0 0
Up to end of study (approximately 1 month)
Secondary outcome [1] 0 0
Change in Erythrocyte sedimentation rate
Timepoint [1] 0 0
Baseline and most recent visits (approximately 1 month)
Secondary outcome [2] 0 0
Change in Immunoglobulin levels
Timepoint [2] 0 0
Baseline and most recent visits (approximately 1 month)
Secondary outcome [3] 0 0
Percentage of participants with positive or negative results for rheumatoid factor
Timepoint [3] 0 0
Up to end of study (approximately 1 month)
Secondary outcome [4] 0 0
Percentage of participants with positive or negative results for anti-cyclic citrullinated peptide antibody
Timepoint [4] 0 0
Up to end of study (approximately 1 month)
Secondary outcome [5] 0 0
Percentage of participants with positive or negative results for anti-nuclear antibodies
Timepoint [5] 0 0
Up to end of study (approximately 1 month)
Secondary outcome [6] 0 0
Disease activity score (DAS28)
Timepoint [6] 0 0
At baseline visit (most recent visit prior to MabThera treatment) and at most recent visit prior to chart review (approximately 1 month)
Secondary outcome [7] 0 0
Tender joint count (TJC)
Timepoint [7] 0 0
At baseline visit (most recent visit prior to MabThera treatment) and at most recent visit prior to chart review (approximately 1 month)
Secondary outcome [8] 0 0
Swollen joint count (SJC)
Timepoint [8] 0 0
At baseline visit (most recent visit prior to MabThera treatment) and at most recent visit prior to chart review (approximately 1 month)
Secondary outcome [9] 0 0
Duration of treatment with rituximab
Timepoint [9] 0 0
From first dose to most recent rituximab infusion (approximately 1 month)
Secondary outcome [10] 0 0
Change in C-reactive protein
Timepoint [10] 0 0
Baseline and most recent visits (approximately 1 month)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2012
Sample size
Target
Accrual to date
Final
167
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
- Geelong
Recruitment postcode(s) [1] 0 0
3220 - Geelong

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Roche Products Pty Ltd (Australia)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT02564770
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries