Rheumatoid ArthritisNCT00661284
A Study of Duration of Maintained Efficacy in Rheumatoid Arthritis (RA) Patients Off Treatment With MRA(a Development Code of Tocilizumab, an Anti IL-6 Receptor Monoclonal Antibody.)
An observational study of Rheumatoid Arthritis, run by Chugai Pharmaceutical at 5 sites in Japan.
Trial summary
A 52-week follow up study to investigate the duration of maintenance of efficacy in patients with RA and achieved low disease activity in clinical trials of MRA and stopped the treatment Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 189 participants
- Where
- 5 sitesJapan
- Study dates
- Apr 2008to May 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subject who have participated in previous studies
Who may be able to join
- Patients who achieved DAS28 of < 3.2 at the last observation and at least one time point among the two previous assessment time points in a previous studies.
Who cannot join
- Patients who receive DMARDs or immunosuppressants between the last observation in a previous studies and the first observation in this study
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Japan5 sites
Chugoku region
Chugoku
Kanto region
Kanto
Kyushu region
Kyushu
Sikoku region
Sikoku
Tohoku region
Tōhoku
About this study
Official title: A Study to Investigate the Duration of Maintained Efficacy in Patients With Rheumatoid Arthritis Who Had Treated With MRA
A 52-week follow up study to investigate the duration of maintenance of efficacy in patients with RA and achieved low disease activity in clinical trials of MRA and stopped the treatment
- 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 |
|---|---|---|
| Ⅰ | Subject who have participated in previous studies and achieved DAS28 of < 3.2 at the last observation and at least one time point among the two previous assessment time points in a previous studies. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who maintained efficacy during 52-weeks after the last infusion of MRA in the previous studies.
Measured: every 4th week up to the 48th week
Relationship between serum IL-6 concentration at the last observation of the previous studies and the duration of maintenance of efficacy
Measured: throughout study
Secondary outcomes (3)
Efficacy: Proportion of patients who maintained efficacy among patients whose DAS28 was <2.6 at the last observation of the previous studies.
Measured: throughout study
Efficacy: Time course of DAS28 during the treatment-free period in the present study
Measured: throughout study
Efficacy: Relationship between serum IL-6 concentration at the last observation of the previous studies and the time course of DAS28 during the treatment-free period in the present study.
Measured: throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionMar 2009
- Study completionMay 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.
- 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
- Prospective
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chugai Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuji Kimura, Study chair, Chugai Pharmaceutical,Clinical Research Department 1
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00661284
- Sponsor's protocol ID
- MRA226JP
- Status last verified
- Jul 2012
- First submitted
- 15 Apr 2008
- Last updated
- 2 Aug 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Investigate the Duration of Maintained Efficacy in Patients With Rheumatoid Arthritis Who Had Treated With MRA
- ClinicalTrials.gov ID
- NCT00661284
- Acronym / sponsor ID
- MRA226JP
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Chugai PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 18 Apr 2008 (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.
A 52-week follow up study to investigate the duration of maintenance of efficacy in patients with RA and achieved low disease activity in clinical trials of MRA and stopped the treatment
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ⅰ | – | –Subject who have participated in previous studies and achieved DAS28 of < 3.2 at the last observation and at least one time point among the two previous assessment time points in a previous studies. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subject who have participated in previous studies
Key inclusion criteria (1 listed)
- Patients who achieved DAS28 of < 3.2 at the last observation and at least one time point among the two previous assessment time points in a previous studies.
Key exclusion criteria (1 listed)
- Patients who receive DMARDs or immunosuppressants between the last observation in a previous studies and the first observation in this study
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 who maintained efficacy during 52-weeks after the last infusion of MRA in the previous studies.
Time frame: every 4th week up to the 48th week
Relationship between serum IL-6 concentration at the last observation of the previous studies and the duration of maintenance of efficacy
Time frame: throughout study
3 secondary outcomes
Efficacy: Proportion of patients who maintained efficacy among patients whose DAS28 was <2.6 at the last observation of the previous studies.
Time frame: throughout study
Efficacy: Time course of DAS28 during the treatment-free period in the present study
Time frame: throughout study
Efficacy: Relationship between serum IL-6 concentration at the last observation of the previous studies and the time course of DAS28 during the treatment-free period in the present study.
Time frame: throughout study
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 Aug 2012.
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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.
Yuji Kimura study chair
Chugai Pharmaceutical,Clinical Research Department 1
5 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 Chugai Pharmaceutical at 5 sites in Japan.
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 2 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Japan. 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?
Proportion of patients who maintained efficacy during 52-weeks after the last infusion of MRA in the previous studies. (time frame: every 4th week up to the 48th week). The study lists 2 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 2 Aug 2012.