Rheumatoid ArthritisNCT02564770
A Retrospective Chart Review of MabThera (Rituximab) Treatment in Rheumatoid Arthritis (RA) Participants in Australia
An observational study of Rheumatoid Arthritis, run by Hoffmann-La Roche at 1 site in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 167 participants
- Where
- 1 siteAustralia
- Study dates
- Jan 2012to Feb 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Rheumatoid arthritis (RA) participants who have been treated with rituximab
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Factors leading to Therapeutic decision to use rituximab
Measured: Up to end of study (approximately 1 month)
Secondary outcomes (10)
Change in Erythrocyte sedimentation rate
Measured: Baseline and most recent visits (approximately 1 month)
Change in Immunoglobulin levels
Measured: Baseline and most recent visits (approximately 1 month)
Percentage of participants with positive or negative results for rheumatoid factor
Measured: Up to end of study (approximately 1 month)
Percentage of participants with positive or negative results for anti-cyclic citrullinated peptide antibody
Measured: Up to end of study (approximately 1 month)
Percentage of participants with positive or negative results for anti-nuclear antibodies
Measured: Up to end of study (approximately 1 month)
Disease activity score (DAS28)
Measured: 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)
Measured: 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)
Measured: 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
Measured: From first dose to most recent rituximab infusion (approximately 1 month)
Change in C-reactive protein
Measured: Baseline and most recent visits (approximately 1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2015 (estimated)
- Study startJan 2012
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Roche Products Pty Ltd (Australia)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02564770
- Sponsor's protocol ID
- ML28321
- Status last verified
- Nov 2016
- First submitted
- 11 Aug 2015
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Chart Review of the Use of MabThera (Rituximab) for the Treatment of Rheumatoid Arthritis (RA) in Australian Rheumatology Practice
- ClinicalTrials.gov ID
- NCT02564770
- Acronym / sponsor ID
- ML28321
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Collaborators
- Roche Products Pty Ltd (Australia)
- Study start
- Jan 2012
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 1 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Rheumatoid arthritis (RA) participants who have been treated with rituximab
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Factors leading to Therapeutic decision to use rituximab
Time frame: Up to end of study (approximately 1 month)
10 secondary outcomes
Change in Erythrocyte sedimentation rate
Time frame: Baseline and most recent visits (approximately 1 month)
Change in Immunoglobulin levels
Time frame: 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)
Percentage of participants with positive or negative results for anti-cyclic citrullinated peptide antibody
Time frame: 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)
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)
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)
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)
Duration of treatment with rituximab
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
Related trials for Rheumatoid Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Hoffmann-La Roche at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Factors leading to Therapeutic decision to use rituximab (time frame: Up to end of study (approximately 1 month)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.