Clinical trial NCT02564770: A Retrospective Chart Review of MabThera (Rituximab) Treatment in Rheumatoid Arthritis (RA) Participants in Australia
Official title: A Retrospective Chart Review of the Use of MabThera (Rituximab) for the Treatment of Rheumatoid Arthritis (RA) in Australian Rheumatology Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: Roche Products Pty Ltd (Australia)
First posted: 2015-10-01
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Rheumatoid arthritis (RA) participants who have been treated with rituximab

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.


Eligibility criteria: 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

Primary outcomes:
measure: Factors leading to Therapeutic decision to use rituximab
timeFrame: Up to end of study (approximately 1 month)
Secondary outcomes:
measure: Change in Erythrocyte sedimentation rate
timeFrame: Baseline and most recent visits (approximately 1 month)
measure: Change in Immunoglobulin levels
timeFrame: Baseline and most recent visits (approximately 1 month)
measure: Percentage of participants with positive or negative results for rheumatoid factor
timeFrame: Up to end of study (approximately 1 month)
measure: Percentage of participants with positive or negative results for anti-cyclic citrullinated peptide antibody
timeFrame: Up to end of study (approximately 1 month)
measure: Percentage of participants with positive or negative results for anti-nuclear antibodies
timeFrame: Up to end of study (approximately 1 month)
measure: Disease activity score (DAS28)
timeFrame: At baseline visit (most recent visit prior to MabThera treatment) and at most recent visit prior to chart review (approximately 1 month)
measure: Tender joint count (TJC)
timeFrame: At baseline visit (most recent visit prior to MabThera treatment) and at most recent visit prior to chart review (approximately 1 month)
measure: Swollen joint count (SJC)
timeFrame: At baseline visit (most recent visit prior to MabThera treatment) and at most recent visit prior to chart review (approximately 1 month)
measure: Duration of treatment with rituximab
timeFrame: From first dose to most recent rituximab infusion (approximately 1 month)
measure: Change in C-reactive protein
timeFrame: Baseline and most recent visits (approximately 1 month)
Other outcomes:
Locations:
city: Geelong
country: Australia
state: Victoria
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: