Rheumatoid ArthritisPhase 3NCT00144534
Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA213JP
A Phase 3 study testing MRA (Tocilizumab) in people with Rheumatoid Arthritis, run by Chugai Pharmaceutical.
Trial summary
This is an open-label, extension, Phase III study to evaluate the long-term safety and efficacy of MRA in patients with RA who participated in Study MRA213JP. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- 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
- 115 participants
- Where
- No sites listed yet
- Study dates
- Jun 2004to Jun 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Either MRA or placebo was administered at least 3 times in the preceding study, and there were confirmed to be no problems with respect to safety.
- In the case of Patients whose participation in the current study was judged to be inappropriate because of problems in the preceding study with respect to safety, these Patients must have been in the methotrexate dose group in the preceding study.
Who cannot join
- Administered drugs such as infliximab, etanercept, and leflunomide within 12 weeks before administration of the study drug
- Evaluated as belonging to Steinbrocker's class IV within 4 weeks before administration of the study drug
- Have not been registered by 3 months after the full code-breaking of the preceding study
- Were administered plasma exchange therapy between initiation of the preceding study and the initial administration in the current study
- Treated surgically (except for local surgery) within 4 weeks before administration of the study drug
About this study
Official title: An Open-label, Extension, Phase III Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With RA Who Participated in Study MRA213JP
This is an open-label, extension, Phase III study to evaluate the long-term safety and efficacy of MRA in patients with RA who participated in Study MRA213JP.
- 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.
Efficacy:the frequency of amelioration of at least 20% in terms of the ACR criteria
Measured: throughout study
Frequency and degree (severity and seriousness) of adverse events and adverse drug reactions
Measured: throughout study
Pharmacokinetics of the serum MRA concentration
Measured: 0W,4W,8W,12W,LOBS
Secondary outcomes (1)
Efficacy:time courses of DAS28, frequencies of amelioration of at least 20%, 50%, and 70% in terms of the ACR criteria, each item in the ACR core set
Measured: 0W,4W,8W,12W,LOBS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2005 (estimated)
- Study startJun 2004
- Primary completionAug 2005
- Study completionJun 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
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chugai Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Takahiro Kakehi, Study director, Chugai Pharmaceutical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00144534
- Sponsor's protocol ID
- MRA215JP
- Status last verified
- Dec 2009
- First submitted
- 2 Sep 2005
- 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, Extension, Phase III Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With RA Who Participated in Study MRA213JP
- ClinicalTrials.gov ID
- NCT00144534
- Acronym / sponsor ID
- MRA215JP
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Chugai PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Primary completion
- Aug 2005 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 5 Sep 2005 (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, extension, Phase III study to evaluate the long-term safety and efficacy of MRA in patients with RA who participated in Study MRA213JP.
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 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Either MRA or placebo was administered at least 3 times in the preceding study, and there were confirmed to be no problems with respect to safety.
- In the case of Patients whose participation in the current study was judged to be inappropriate because of problems in the preceding study with respect to safety, these Patients must have been in the methotrexate dose group in the preceding study.
Key exclusion criteria (5 listed)
- Administered drugs such as infliximab, etanercept, and leflunomide within 12 weeks before administration of the study drug
- Evaluated as belonging to Steinbrocker's class IV within 4 weeks before administration of the study drug
- Have not been registered by 3 months after the full code-breaking of the preceding study
- Were administered plasma exchange therapy between initiation of the preceding study and the initial administration in the current study
- Treated surgically (except for local surgery) 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
Efficacy:the frequency of amelioration of at least 20% in terms of the ACR criteria
Time frame: throughout study
Frequency and degree (severity and seriousness) of adverse events and adverse drug reactions
Time frame: throughout study
Pharmacokinetics of the serum MRA concentration
Time frame: 0W,4W,8W,12W,LOBS
1 secondary outcome
Efficacy:time courses of DAS28, frequencies of amelioration of at least 20%, 50%, and 70% in terms of the ACR criteria, each item in the ACR core set
Time frame: 0W,4W,8W,12W,LOBS
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.
Takahiro Kakehi study director
Chugai Pharmaceutical
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.
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 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.
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?
Efficacy:the frequency of amelioration of at least 20% in terms of the ACR criteria (time frame: throughout study). The study lists 3 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 23 Dec 2009; AzTrials last refreshed its copy on 7 Nov 2026.