Rheumatoid ArthritisNCT01921478
A Retrospective, Observational Study of RoActemra/Actemra (Tocilizumab) in Clinical Practice in Patients With Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis, run by Hoffmann-La Roche at 10 sites in Belgium.
Trial summary
This retrospective, multi-centre, observational study will assess the daily practice patterns and outcomes of the management of rheumatoid arthritis in patients treated with RoActemra/Actemra (tocilizumab). No actual patient will be enrolled in this study; data will be collected from medical records. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 77 participants
- Where
- 10 sitesBelgium
- Study dates
- Aug 2010to Nov 2010
- 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: Retrospective survey of medical records from patients with moderate to severe rheumatoid arthritis treated with RoActemra/Actemra (tocilizumab) who did not have documented erosions at the start of RoACTEMRA treatment .
Who may be able to join
- Adult patients, >=18 years of age
- Diagnosed with rheumatoid arthritis and moderate to severe disease activity defined as a DAS28 >=5.1
- Inadequate responder to at least 2 non-biological DMARDs
- Absence of documented erosions at start of RoActemra/Actemra treatment
- Received RoActemra/Actemra treatment for at least 6 months
- Availability of data from at least the RoActemra/Actemra treatment initiation visit and the 6 months visit
Who cannot join
- Contraindications for treatment with RoActemra/Actemra
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Belgium10 sites
Study site
Aalst, 9300
Study site
Antwerp, 2020
Study site
Bruges, 8000
Study site
Brussels, 1020
Study site
Ghent, 9000
Study site
Gilly, 6060
Study site
Seraing, 4100
Study site
Verviers, 4800
Study site
Westmalle, 2390
Study site
Wilrijk, 2610
About this study
Official title: Retrospective, Multi-center, Observational Study of Daily Practice Patterns and Outcomes of the Management of Rheumatoid Arthritis Patients Without Documented Erosions Treated With RoACTEMRA in Belgium
This retrospective, multi-centre, observational study will assess the daily practice patterns and outcomes of the management of rheumatoid arthritis in patients treated with RoActemra/Actemra (tocilizumab). No actual patient will be enrolled in this study; data will be collected from medical records.
- 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 |
|---|---|---|
| Cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Joint erosion assessment in clinical practice
Measured: 6 months
Secondary outcomes (7)
Disease Activity Score 28
Measured: 6 months
C-reactive protein assessment
Measured: 6 months
Swollen joint counts
Measured: 6 months
Tender joint counts
Measured: 6 months
Erythrocyte Sedimentation Rate
Measured: 6 months
Evolution of the pattern of joint erosion
Measured: 6 months
Patient's global assessment of disease activity (Visual Analogue Scale)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2013 (estimated)
- Study startAug 2010
- Primary completionNov 2010
- Study completionNov 2010
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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01921478
- Sponsor's protocol ID
- ML25271
- Status last verified
- Aug 2013
- First submitted
- 9 Aug 2013
- Last updated
- 13 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective, Multi-center, Observational Study of Daily Practice Patterns and Outcomes of the Management of Rheumatoid Arthritis Patients Without Documented Erosions Treated With RoACTEMRA in Belgium
- ClinicalTrials.gov ID
- NCT01921478
- Acronym / sponsor ID
- ML25271
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 13 Aug 2013 (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 retrospective, multi-centre, observational study will assess the daily practice patterns and outcomes of the management of rheumatoid arthritis in patients treated with RoActemra/Actemra (tocilizumab). No actual patient will be enrolled in this study; data will be collected from medical records.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Retrospective survey of medical records from patients with moderate to severe rheumatoid arthritis treated with RoActemra/Actemra (tocilizumab) who did not have documented erosions at the start of RoACTEMRA treatment .
Key inclusion criteria (6 listed)
- Adult patients, >=18 years of age
- Diagnosed with rheumatoid arthritis and moderate to severe disease activity defined as a DAS28 >=5.1
- Inadequate responder to at least 2 non-biological DMARDs
- Absence of documented erosions at start of RoActemra/Actemra treatment
- Received RoActemra/Actemra treatment for at least 6 months
Key exclusion criteria (1 listed)
- Contraindications for treatment with RoActemra/Actemra
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
Joint erosion assessment in clinical practice
Time frame: 6 months
7 secondary outcomes
Disease Activity Score 28
Time frame: 6 months
C-reactive protein assessment
Time frame: 6 months
Swollen joint counts
Time frame: 6 months
Tender joint counts
Time frame: 6 months
Erythrocyte Sedimentation Rate
Time frame: 6 months
Evolution of the pattern of joint erosion
Time frame: 6 months
Patient's global assessment of disease activity (Visual Analogue Scale)
Time frame: 6 months
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 13 Aug 2013.
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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
10 sites 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 10 sites in Belgium.
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 6 inclusion and 1 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 13 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Belgium. 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?
Joint erosion assessment in clinical practice (time frame: 6 months). 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 13 Aug 2013.