Rheumatoid ArthritisNCT02721004
Efficacy and Safety Study of RoActemra (Tocilizumab) in Participants With Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis, run by Hoffmann-La Roche at 1 site in Austria.
Trial summary
This is an open-label, non-interventional study to evaluate efficacy and safety in rheumatoid arthritis participants receiving tocilizumab as per the product label. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Tocilizumab
- Type of treatment
- Injection or infusion
- How many people
- 592 participants
- Where
- 1 siteAustria
- Study dates
- Mar 2009to Dec 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants with rheumatoid arthritis will be enrolled in this trial.
Who may be able to join
- Participants with rheumatoid arthritis receiving tocilizumab as per product label
Who cannot join
- No specific exclusion criteria were specified for this non-interventional trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Documentation of the Efficacy and Safety of RoActemra in the Treatment of Rheumatoid Arthritis
This is an open-label, non-interventional study to evaluate efficacy and safety in rheumatoid arthritis participants receiving tocilizumab as per the product label.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Tocilizumab
- Keywords
- Rheumatoid arthritis, RoActemra, Tocilizumab
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TocilizumabDrug
Also called RoActemra
Tocilizumab administered as an intravenous infusion every 4 weeks according to product label/per standard practice for a maximum of 12 months will be observed in this study.
| Study group | Role | What they receive |
|---|---|---|
| Rheumatoid arthritis participants | Rheumatoid arthritis participants receiving tocilizumab intravenous infusion every 4 weeks according to product label/per standard practice for a maximum of 12 months will be observed in this study. Receives: Drug: Tocilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Activity Score Based on 28-joints Count (DAS28)
Measured: Month 12
Simplified Disease Activity Index (SDAI) Score
Measured: Month 12
Clinical Disease Activity Index (CDAI) Score
Measured: Month 12
Percentage of Participants Achieving American College of Rheumatology (ACR) Response
Measured: Month 12
Tender Joint Count (TJC)
Measured: Month 12
Swollen Joint Count (SJC)
Measured: Month 12
Secondary outcomes (1)
Percentage of Participants with any Adverse Event (AE)
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2016 (estimated)
- Study startMar 2009
- Primary completionDec 2014
- Study completionDec 2014
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
- Cross-sectional
- Enrolment
- 592 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
- NCT02721004
- Sponsor's protocol ID
- ML22551
- Status last verified
- Jul 2016
- First submitted
- 2 Mar 2016
- Last updated
- 4 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Documentation of the Efficacy and Safety of RoActemra in the Treatment of Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT02721004
- Acronym / sponsor ID
- ML22551
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid arthritis, RoActemra, Tocilizumab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 592 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 28 Mar 2016 (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 an open-label, non-interventional study to evaluate efficacy and safety in rheumatoid arthritis participants receiving tocilizumab as per the product label.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rheumatoid arthritis participants | – | Drug: TocilizumabRheumatoid arthritis participants receiving tocilizumab intravenous infusion every 4 weeks according to product label/per standard practice for a maximum of 12 months will be observed in this study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants with rheumatoid arthritis will be enrolled in this trial.
Key inclusion criteria (1 listed)
- Participants with rheumatoid arthritis receiving tocilizumab as per product label
Key exclusion criteria (1 listed)
- No specific exclusion criteria were specified for this non-interventional trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TocilizumabAlso: RoActemraTocilizumab administered as an intravenous infusion every 4 weeks according to product label/per standard practice for a maximum of 12 months will be observed in this study. | Drug | Rheumatoid arthritis participants |
Primary outcome
Disease Activity Score Based on 28-joints Count (DAS28)
Time frame: Month 12
Simplified Disease Activity Index (SDAI) Score
Time frame: Month 12
Clinical Disease Activity Index (CDAI) Score
Time frame: Month 12
Percentage of Participants Achieving American College of Rheumatology (ACR) Response
Time frame: Month 12
Tender Joint Count (TJC)
Time frame: Month 12
Swollen Joint Count (SJC)
Time frame: Month 12
1 secondary outcome
Percentage of Participants with any Adverse Event (AE)
Time frame: Up to 36 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 4 Jul 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 Austria.
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 1 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 4 Jul 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 Austria. 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?
Disease Activity Score Based on 28-joints Count (DAS28) (time frame: Month 12). The study lists 6 primary outcomes in all. 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 4 Jul 2016.