Polyarticular Juvenile Idiopathic ArthritisPhase 3NCT00144625
Long-term Treatment Study of MRA for Polyarticular Juvenile Idiopathic Arthritis (pJIA)
A Phase 3 study testing MRA(Tocilizumab) in people with Polyarticular Juvenile Idiopathic Arthritis, run by Chugai Pharmaceutical.
Trial summary
This is an open-label, extension, Phase III study to evaluate the long-term safety, efficacy and PK of MRA in patients with pJIA who participated in Study MRA318JP. Read more about this study
- Who is it for?
- Ages 2 to 19 years
- Conditions the study is for
- Polyarticular 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
- Feb 2005to 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 2 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Of the patients who received three infusions with MRA in the previous study and for whom a last observation was conducted
- the patients who did not have problems with safety in the previous study"
Who cannot join
- Patients who were not enrolled by 3 months after completion of the previous study
- Patients who received any of the following since completion of the previous study until initiation of treatment in the present study
- DMARDs or immunosuppressants
- Intravenous and intramuscular injection of corticosteroids
- Plasma exchange therapy
- Other drugs and therapies that may affect evaluation of drug efficacy
About this study
Official title: An Open-label, Extension, Phase III Study to Evaluate the Long-term Safety, Efficacy and PK of MRA in Patients With pJIA Who Participated in Study MRA318JP
This is an open-label, extension, Phase III study to evaluate the long-term safety, efficacy and PK of MRA in patients with pJIA who participated in Study MRA318JP.
- 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
8mg/kg/4weeks
| 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:Percentage of patients showing 30% improvement in the JIA core set every 3M, LOBS
Measured: every 3 months
Safety:Incidence and severity of adverse events and adverse drug reactions
Measured: whole period
Pharmacokinetics:The time course of the trough values for the 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 variable of the JIA core set, CRP, pain every 3M, LOBS
Measured: every 3 months
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 startFeb 2005
- Primary completionJul 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 Polyarticular 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
- NCT00144625
- Sponsor's protocol ID
- MRA319JP
- 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, Efficacy and PK of MRA in Patients With pJIA Who Participated in Study MRA318JP
- ClinicalTrials.gov ID
- NCT00144625
- Acronym / sponsor ID
- MRA319JP
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Chugai PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Feb 2005
- Primary completion
- Jul 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, efficacy and PK of MRA in patients with pJIA who participated in Study MRA318JP.
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
- 2 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Of the patients who received three infusions with MRA in the previous study and for whom a last observation was conducted
- the patients who did not have problems with safety in the previous study"
Key exclusion criteria (6 listed)
- Patients who were not enrolled by 3 months after completion of the previous study
- Patients who received any of the following since completion of the previous study until initiation of treatment in the present study
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/4weeks | Drug | 1 |
Primary outcome
Efficacy:Percentage of patients showing 30% improvement in the JIA core set every 3M, LOBS
Time frame: every 3 months
Safety:Incidence and severity of adverse events and adverse drug reactions
Time frame: whole period
Pharmacokinetics:The time course of the trough values for the 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 variable of the JIA core set, CRP, pain every 3M, LOBS
Time frame: every 3 months
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 Polyarticular 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 2 inclusion and 6 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:Percentage of patients showing 30% improvement in the JIA core set every 3M, LOBS (time frame: every 3 months). 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.