ClinicalTrials.gg
CompletedNCT02564770Updated Nov 2, 2016

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

An observational study in Rheumatoid Arthritis, sponsored by Hoffmann-La Roche. Completed at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-02.

Sponsored by Hoffmann-La Roche · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
167
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Rheumatoid Arthritis
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In context

Arthritis, Rheumatoid

2,962 studies on the registry are indexed under Arthritis, Rheumatoid; 396 are open to participants now.

This study's enrollment of 167 is close to the median of 176 across 854 observational studies indexed under Arthritis, Rheumatoid.

Browse Arthritis, Rheumatoid studies →

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,099 studies on the registry; 87 are open to participants now.

Of its 324 completed or terminated interventional studies of FDA-regulated products, 245 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
167 participants (actual)

Groups and cohorts

  • 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.

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What researchers measure

Primary outcomes

  1. Factors leading to Therapeutic decision to use rituximab

    Time frame: Up to end of study (approximately 1 month)

Secondary outcomes

  1. Change in Erythrocyte sedimentation rate

    Time frame: Baseline and most recent visits (approximately 1 month)

  2. Change in Immunoglobulin levels

    Time frame: Baseline and most recent visits (approximately 1 month)

  3. Percentage of participants with positive or negative results for rheumatoid factor

    Time frame: Up to end of study (approximately 1 month)

  4. Percentage of participants with positive or negative results for anti-cyclic citrullinated peptide antibody

    Time frame: Up to end of study (approximately 1 month)

  5. Percentage of participants with positive or negative results for anti-nuclear antibodies

    Time frame: Up to end of study (approximately 1 month)

  6. 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)

  7. 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)

  8. 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)

  9. Duration of treatment with rituximab

    Time frame: From first dose to most recent rituximab infusion (approximately 1 month)

  10. Change in C-reactive protein

    Time frame: Baseline and most recent visits (approximately 1 month)

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Study locations

1 site
  • Geelong, Victoria 3220, Australia
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02564770
Lead sponsor
Hoffmann-La Roche
Collaborators
Roche Products Pty Ltd (Australia)
Responsible party
Sponsor
First posted
Oct 1, 2015
Start date
Jan 2012
Primary completion
Feb 2012
Completion
Feb 2012
Last update
Nov 2, 2016

Study contacts

Clinical Trials
study director · Hoffmann-La Roche
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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