Rheumatoid ArthritisPhase 3NCT00380601
PhaseⅢOpen-label Study of MRA for Rheumatoid Arthritis(RA)
A Phase 3 study testing MRA(Tocilizumab) in people with Rheumatoid Arthritis, run by Chugai Pharmaceutical at 10 sites in Japan.
Trial summary
An open-label, PhaseⅢ study to evaluate the efficacy and safety of MRA in patients with RA Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- MRA(Tocilizumab)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 10 sitesJapan
- Study dates
- May 2006to Feb 2009
- Phase
- Phase 3
- 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
Who may be able to join
- Diagnosed as having RA, on the basis of the criteria stipulated by the American Conference on Rheumatism(ACR) in 1987
- Active RA despite at least one DMARDs or immunosuppressants or Infliximab or Etanercept.Active disease is defined as having at least 6 tender and 6 swollen joints among DAS28 (Modified Disease Activity Scores that include twenty eight joint counts) and ESR at least 30 mm/hr or CRP not less than 2.0mg/dL
- Active RA despite over 10mg adrenocortical steroids within 2 weeks before entry of this study
Who cannot join
- Shown to have class-Ⅳ Steinbrocker's functional activity in an evaluation carried out within 4 weeks before administration of the study drug
- Treated with Infliximab within 3 months before and with Etanercept within 2 weeks before administration of the study drug
- Subjected to any of the following within 4 weeks before administration of the study drug:
- Surgical treatment (operations,etc.).
- Plasma exchange method
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Japan10 sites
Chugoku region
Chugoku
Chukyo region
Chukyo
Hokkaido region
Hokkaido
Hokuriku region
Hokuriku
Kansai region
Kansai
Kanto region
Kanto
Kousinetsu region
Kousinetsu
Kyushu region
Kyushu
Sikoku region
Sikoku
Tohoku region
Tōhoku
About this study
Official title: An Open-label, PhaseⅢ Study to Evaluate the Efficacy and Safety of MRA in Patients With RA
An open-label, PhaseⅢ study to evaluate the efficacy and safety of MRA in patients with RA
- Conditions
- Rheumatoid Arthritis
- Being tested
- MRA(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.
MRA(Tocilizumab)Drug
8mg/kg/4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: MRA(Tocilizumab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of ACR 20％ improvement at the final visit
Measured: throughout study
Secondary outcomes (3)
Time course of the frequency of ACR 20％, 50％ and 70％ improvement,time course of individual items within the ACR core set.
Measured: throughout study
Time course of DAS28 to the final visit.
Measured: throughout study
Time course of steroid sparing effect from first visit to final visit.
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 posted26 Sep 2006 (estimated)
- Study startMay 2006
- Primary completionAug 2008
- Study completionFeb 2009
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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chugai Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Yuji Kimura, Study director, Chugai Pharmaceutical Co., Ltd. Research Dept.1
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00380601
- Sponsor's protocol ID
- MRA225JP
- Status last verified
- Dec 2009
- First submitted
- 25 Sep 2006
- Last updated
- 23 Dec 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, PhaseⅢ Study to Evaluate the Efficacy and Safety of MRA in Patients With RA
- ClinicalTrials.gov ID
- NCT00380601
- Acronym / sponsor ID
- MRA225JP
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Chugai PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 26 Sep 2006 (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.
An open-label, PhaseⅢ study to evaluate the efficacy and safety of MRA in patients with RA
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MRA(Tocilizumab) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed as having RA, on the basis of the criteria stipulated by the American Conference on Rheumatism(ACR) in 1987
- Active RA despite at least one DMARDs or immunosuppressants or Infliximab or Etanercept.Active disease is defined as having at least 6 tender and 6 swollen joints among DAS28 (Modified Disease Activity Scores that include twenty eight joint counts) and ESR at least 30 mm/hr or CRP not less than 2.0mg/dL
- Active RA despite over 10mg adrenocortical steroids within 2 weeks before entry of this study
Key exclusion criteria (5 listed)
- Shown to have class-Ⅳ Steinbrocker's functional activity in an evaluation carried out within 4 weeks before administration of the study drug
- Treated with Infliximab within 3 months before and with Etanercept within 2 weeks before administration of the study drug
- Subjected to any of the following within 4 weeks before administration of the study drug:
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 |
|---|---|---|
| MRA(Tocilizumab)8mg/kg/4 weeks | Drug | 1 |
Primary outcome
Frequency of ACR 20％ improvement at the final visit
Time frame: throughout study
3 secondary outcomes
Time course of the frequency of ACR 20％, 50％ and 70％ improvement,time course of individual items within the ACR core set.
Time frame: throughout study
Time course of DAS28 to the final visit.
Time frame: throughout study
Time course of steroid sparing effect from first visit to final visit.
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 23 Dec 2009.
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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 director
Chugai Pharmaceutical Co., Ltd. Research Dept.1
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MRA(Tocilizumab) in people with Rheumatoid Arthritis, run by Chugai Pharmaceutical at 10 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 3 inclusion and 5 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 23 Dec 2009. 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 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Frequency of ACR 20％ improvement at the final visit (time frame: throughout study). 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 23 Dec 2009.