Rheumatoid ArthritisNCT01194401
An Observational Study on Long-Term Effectiveness and Safety of RoActemra/Actemra (Tocilizumab) in Daily Practice in Patients With Rheumatoid Arthritis (ICHIBAN)
An observational study of Rheumatoid Arthritis, run by Hoffmann-La Roche at 1 site in Germany.
Trial summary
This prospective, multi-center observational study will assess the long-term efficacy and safety of RoActemra/Actemra in daily practice in patients with active moderate to severe rheumatoid arthritis who have an inadequate response or are intolerant to one or more disease-modifying antirheumatic drugs (DMARDs) or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 3,404 participants
- Where
- 1 siteGermany
- Study dates
- Start not givento not given
- 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 inadequate response or intolerant to DMARDs and anti-TNF
Who may be able to join
- Adult patients, >/= 18 years of age
- Active moderate to severe rheumatoid arthritis
- Inadequate response or intolerant to previous therapy with one or more disease-modifying antirheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists
- Prescription of RoActemra/Actemra according to label
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Non-interventional Multi-center Observational Study to Evaluate the Long-term Effectiveness and Safety of Tocilizumab in Patients With Active Rheumatoid Arthritis in Daily Practice
This prospective, multi-center observational study will assess the long-term efficacy and safety of RoActemra/Actemra in daily practice in patients with active moderate to severe rheumatoid arthritis who have an inadequate response or are intolerant to one or more disease-modifying antirheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists. Data will be collected from patients initiated on RoActemra/Actemra treatment according to label by decision of the treating physician. Anticipated time for data collection from each patient will be 2 years.
- 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.
Proportion of patients with clinical remission defined as disease activity score DAS28 < 2.6
Measured: 5 years
Secondary outcomes (8)
Time to DAS28 remission
Measured: 5 years
Proportion of patients with good or moderate response according to EULAR criteria
Measured: 5 years
Time to good or moderate response according to EULAR criteria
Measured: 5 years
Factors related to response (C-reactive protein, rheumatoid factor, inadequate response to DMARDs or anti-TNF, duration of illness)
Measured: 5 years
Dose-modifications and discontinuations of RoActemra/Actemra
Measured: 5 years
Safety: Incidence of adverse events
Measured: 5 years
Efficacy of other possible RA therapies in case of inadequate response to RoActemra/Actemra (DAS28, EULAR criteria)
Measured: 5 years
Safety of other possible RA therapies in case of inadequate response to RoActemra/Actemra (adverse events)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2010 (estimated)
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
- 3,404 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
- NCT01194401
- Sponsor's protocol ID
- ML22928
- Status last verified
- Nov 2016
- First submitted
- 1 Sep 2010
- 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 Prospective, Non-interventional Multi-center Observational Study to Evaluate the Long-term Effectiveness and Safety of Tocilizumab in Patients With Active Rheumatoid Arthritis in Daily Practice
- ClinicalTrials.gov ID
- NCT01194401
- Acronym / sponsor ID
- ML22928
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,404 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- First posted
- 3 Sep 2010 (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 prospective, multi-center observational study will assess the long-term efficacy and safety of RoActemra/Actemra in daily practice in patients with active moderate to severe rheumatoid arthritis who have an inadequate response or are intolerant to one or more disease-modifying antirheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists. Data will be collected from patients initiated on RoActemra/Actemra treatment according to label by decision of the treating physician. Anticipated time for data collection from each patient will be 2 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- 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
- Patients with inadequate response or intolerant to DMARDs and anti-TNF
Key inclusion criteria (4 listed)
- Adult patients, >/= 18 years of age
- Active moderate to severe rheumatoid arthritis
- Inadequate response or intolerant to previous therapy with one or more disease-modifying antirheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists
- Prescription of RoActemra/Actemra according to label
Key exclusion criteria (1 listed)
- N/A
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
Proportion of patients with clinical remission defined as disease activity score DAS28 < 2.6
Time frame: 5 years
8 secondary outcomes
Time to DAS28 remission
Time frame: 5 years
Proportion of patients with good or moderate response according to EULAR criteria
Time frame: 5 years
Time to good or moderate response according to EULAR criteria
Time frame: 5 years
Factors related to response (C-reactive protein, rheumatoid factor, inadequate response to DMARDs or anti-TNF, duration of illness)
Time frame: 5 years
Dose-modifications and discontinuations of RoActemra/Actemra
Time frame: 5 years
Safety: Incidence of adverse events
Time frame: 5 years
Efficacy of other possible RA therapies in case of inadequate response to RoActemra/Actemra (DAS28, EULAR criteria)
Time frame: 5 years
Safety of other possible RA therapies in case of inadequate response to RoActemra/Actemra (adverse events)
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 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 Germany.
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 4 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: status not confirmed, 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 Germany. 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?
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?
Proportion of patients with clinical remission defined as disease activity score DAS28 < 2.6 (time frame: 5 years). 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.