Systemic Juvenile Idiopathic ArthritisPhase 3NCT00144664
Study of MRA for Polyarticular Juvenile Idiopathic Arthritis (pJIA)
A Phase 3 study testing MRA(Tocilizumab) in people with Systemic Juvenile Idiopathic Arthritis, run by Chugai Pharmaceutical.
Trial summary
This is an open-label, Phase III study to evaluate the efficacy, safety and PK of MRA in patients with pJIA. Read more about this study
- Who is it for?
- Ages 2 to 19 years
- Conditions the study is for
- Systemic Juvenile Idiopathic Arthritis
- What is being tested?
- MRA(Tocilizumab)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- Nov 2004to Oct 2005
- 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 2 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients who are diagnosed with rheumatoid factor (RF) positive or negative polyarthritic or oligoarthritic JIA according to the ILAR standards (1997)
- Patients aged at least 2 years old and less than 20.
- Patients aged less than 16 years old at time of onset
Who cannot join
- Patients with Class IV Steinbrocker functional disorder at evaluation within 2 weeks before initiation of treatment with the investigational product
- Patients who have been treated for the underlying disease with a biological agent, such as infliximab or etanercept, within 12 weeks before initiation of treatment with the investigational product
About this study
Official title: An Open-Label, Phase III Study to Evaluate the Efficacy, Safety and PK of MRA in Patients With pJIA
This is an open-label, Phase III study to evaluate the efficacy, safety and PK of MRA in patients with pJIA.
- Conditions
- Systemic Juvenile Idiopathic Arthritis
- Being tested
- MRA(Tocilizumab)
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRA(Tocilizumab)Drug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | MRA(Tocilizumab) Receives: Drug: MRA(Tocilizumab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy:Percentage of patients showing 30% improvement in the JIA core set on LOBS
Measured: whole period
Safety:Incidence and severity of adverse events and adverse drug reactions
Measured: whole period
Pharmacokinetics:The Cmax, trough values, AUC, Kel, CL, Vd, Vdss, and t1/2 for serum MRA concentration
Measured: whole period
Secondary outcomes (1)
Efficacy:The time course of the percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set, each evaluation endpoint in the JIA core set, CRP, pain up to LOBS
Measured: whole period
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 startNov 2004
- Primary completionApr 2005
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Juvenile Idiopathic 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
- 19 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
- NCT00144664
- Sponsor's protocol ID
- MRA318JP
- Status last verified
- Jul 2008
- First submitted
- 2 Sep 2005
- Last updated
- 30 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Phase III Study to Evaluate the Efficacy, Safety and PK of MRA in Patients With pJIA
- ClinicalTrials.gov ID
- NCT00144664
- Acronym / sponsor ID
- MRA318JP
- Conditions
- Systemic Juvenile Idiopathic Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Chugai PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Primary completion
- Apr 2005 (actual)
- Study completion
- Oct 2005 (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, Phase III study to evaluate the efficacy, safety and PK of MRA in patients with pJIA.
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)MRA(Tocilizumab) |
Who may qualify
- Ages
- 2 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients who are diagnosed with rheumatoid factor (RF) positive or negative polyarthritic or oligoarthritic JIA according to the ILAR standards (1997)
- Patients aged at least 2 years old and less than 20.
- Patients aged less than 16 years old at time of onset
Key exclusion criteria (2 listed)
- Patients with Class IV Steinbrocker functional disorder at evaluation within 2 weeks before initiation of treatment with the investigational product
- Patients who have been treated for the underlying disease with a biological agent, such as infliximab or etanercept, within 12 weeks before initiation of treatment with the investigational product
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) | Drug | 1 |
Primary outcome
Efficacy:Percentage of patients showing 30% improvement in the JIA core set on LOBS
Time frame: whole period
Safety:Incidence and severity of adverse events and adverse drug reactions
Time frame: whole period
Pharmacokinetics:The Cmax, trough values, AUC, Kel, CL, Vd, Vdss, and t1/2 for serum MRA concentration
Time frame: whole period
1 secondary outcome
Efficacy:The time course of the percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set, each evaluation endpoint in the JIA core set, CRP, pain up to LOBS
Time frame: whole period
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 30 Jul 2008.
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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 Systemic Juvenile Idiopathic 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 3 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: finished, as of the sponsor's last update on 30 Jul 2008. 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:Percentage of patients showing 30% improvement in the JIA core set on LOBS (time frame: whole period). 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 30 Jul 2008.