Rheumatoid ArthritisNCT01277328
An Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis, run by Hoffmann-La Roche at 1 site in Romania.
Trial summary
This observational, prospective, open-label, multi-center study will evaluate the effectiveness in disease reduction and the safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Data will be collected for 11 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 95 participants
- Where
- 1 siteRomania
- Study dates
- May 2010to Aug 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with rheumatoid arthritis receiving RoActemra/Actemra
Who may be able to join
- Adult patients >/=18 years of age
- Patients with rheumatoid arthritis eligible for RoActemra
Who cannot join
- Hypersensitivity to RoActemra
- Active, severe infections
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tocilizumab (RoActemra) poST Marketing Observational Study in DMARD-IR Patients to Assess Efficacy and Safety in routiNE Clinical Practice - STONE
This observational, prospective, open-label, multi-center study will evaluate the effectiveness in disease reduction and the safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Data will be collected for 11 months.
- 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 | Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in Disease Activity Score 28 (DAS28)
Measured: 11 months
Secondary outcomes (5)
Proportion of patients with a change in Disease Activity Score 28 (DAS28)
Measured: 5 months
European League Against Rheumatism (EULAR) response rates
Measured: 20 weeks
Proportion of patients with disease remission
Measured: 20 weeks
Proportion of patients with low disease activity
Measured: 20 weeks
Incidence of adverse events
Measured: 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2011 (estimated)
- Study startMay 2010
- Primary completionAug 2014
- Study completionAug 2014
Why it stopped: Contract terminated with Site Management Organization
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
- Prospective
- Enrolment
- 95 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
- NCT01277328
- Sponsor's protocol ID
- ML25332
- Status last verified
- Sep 2016
- First submitted
- 13 Jan 2011
- Last updated
- 15 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tocilizumab (RoActemra) poST Marketing Observational Study in DMARD-IR Patients to Assess Efficacy and Safety in routiNE Clinical Practice - STONE
- ClinicalTrials.gov ID
- NCT01277328
- Acronym / sponsor ID
- ML25332
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Contract terminated with Site Management Organization
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 14 Jan 2011 (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 observational, prospective, open-label, multi-center study will evaluate the effectiveness in disease reduction and the safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Data will be collected for 11 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | –Cohort |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with rheumatoid arthritis receiving RoActemra/Actemra
Key inclusion criteria (2 listed)
- Adult patients >/=18 years of age
- Patients with rheumatoid arthritis eligible for RoActemra
Key exclusion criteria (2 listed)
- Hypersensitivity to RoActemra
- Active, severe infections
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
Mean change in Disease Activity Score 28 (DAS28)
Time frame: 11 months
5 secondary outcomes
Proportion of patients with a change in Disease Activity Score 28 (DAS28)
Time frame: 5 months
European League Against Rheumatism (EULAR) response rates
Time frame: 20 weeks
Proportion of patients with disease remission
Time frame: 20 weeks
Proportion of patients with low disease activity
Time frame: 20 weeks
Incidence of adverse events
Time frame: 11 months
Results and safety
The study was stopped early (reason given: Contract terminated with Site Management Organization). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2016.
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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
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 Romania.
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 2 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: stopped early, as of the sponsor's last update on 15 Sep 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 Romania. 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 was stopped early (reason given: Contract terminated with Site Management Organization). Results are not available in the source record.
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?
Mean change in Disease Activity Score 28 (DAS28) (time frame: 11 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 15 Sep 2016.