Undifferentiated ArthritisNCT03466814
Study of the Safety of Orencia in Japanese Children and Adolescents With Active Juvenile Arthritis of Unknown Origin
An observational study of Undifferentiated Arthritis, run by Bristol-Myers Squibb at 1 site in Japan.
Trial summary
Observational study of abatacept in the treatment of JIA in Japan. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Undifferentiated Arthritis
- What is being tested?
- Non-Interventional
- How many people
- 82 participants
- Where
- 1 siteJapan
- Study dates
- 6 Apr 2018to 21 Jul 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study is a local, prospective, non-interventional, non-controlled, multicenter, observational study for authorization of abatacept in the treatment of JIA
Who may be able to join
- All JIA participants who initiate treatment with Orencia in accordance with the prescribing information
Who cannot join
- Participants receiving Orencia for an off-label indication
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ORENCIA Safety Surveillance in Japanese Children and Adolescents With Active Juvenile Idiopathic Arthritis (JIA)
Observational study of abatacept in the treatment of JIA in Japan.
- Conditions
- Undifferentiated Arthritis
- Being tested
- Non-Interventional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-InterventionalOther
Non-Interventional
| Study group | Role | What they receive |
|---|---|---|
| JIA participants | Not described Receives: Other: Non-Interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events
Measured: 1 year
Secondary outcomes (2)
Safety measured by number of participants who receive at least 1 dose of Orencia
Measured: 1 year
Efficacy measured by number of participants who receive at least 1 dose of Orencia
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2018
- Study start6 Apr 2018
- Primary completion21 Jul 2021
- Study completion21 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Undifferentiated ArthritisStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ono Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03466814
- Sponsor's protocol ID
- IM101-635
- Status last verified
- Jun 2022
- First submitted
- 9 Mar 2018
- Last updated
- 16 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ORENCIA Safety Surveillance in Japanese Children and Adolescents With Active Juvenile Idiopathic Arthritis (JIA)
- ClinicalTrials.gov ID
- NCT03466814
- Acronym / sponsor ID
- IM101-635
- Conditions
- Undifferentiated Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Ono Pharmaceutical Co., Ltd.
- Study start
- 6 Apr 2018 (actual)
- Primary completion
- 21 Jul 2021 (actual)
- Study completion
- 21 Jul 2021 (actual)
- First posted
- 15 Mar 2018 (actual)
- 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.
Observational study of abatacept in the treatment of JIA in Japan.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JIA participants | – | Other: Non-Interventional |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study is a local, prospective, non-interventional, non-controlled, multicenter, observational study for authorization of abatacept in the treatment of JIA
Key inclusion criteria (1 listed)
- All JIA participants who initiate treatment with Orencia in accordance with the prescribing information
Key exclusion criteria (2 listed)
- Participants receiving Orencia for an off-label indication
- Other protocol defined inclusion/exclusion criteria could apply
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 |
|---|---|---|
| Non-InterventionalNon-Interventional | Other | JIA participants |
Primary outcome
Number of adverse events
Time frame: 1 year
2 secondary outcomes
Safety measured by number of participants who receive at least 1 dose of Orencia
Time frame: 1 year
Efficacy measured by number of participants who receive at least 1 dose of Orencia
Time frame: 1 Year
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 16 Jun 2022.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Undifferentiated Arthritis, run by Bristol-Myers Squibb at 1 site 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 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 16 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Number of adverse events (time frame: 1 year). 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 16 Jun 2022.