Still Disease, Juvenile OnsetNCT03932344
Long-term Safety Study of Kineret® in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA)
An observational study of Still Disease, Juvenile Onset, run by Swedish Orphan Biovitrum at 1 site in Italy.
Trial summary
The purpose of the study is to evaluate and characterize long-term safety of Kineret when used in standard clinical practice to treat patients with systemic juvenile idiopathic arthritis (SJIA). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Still Disease, Juvenile Onset
- What is being tested?
- Anakinra
- How many people
- 306 participants
- Where
- 1 siteItaly
- Study dates
- 10 Apr 2019to 31 Aug 2019
- 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: Data will be extracted and analyzed for all male and female patients with a diagnosis of SJIA as per the ILAR classification criteria included in the Pharmachild registry and who were ever treated with Kineret subsequently to SJIA diagnosis. That is, all eligible patients participating in the Pharmachild JIA registry study are included in this study.
Who may be able to join
- Male and female patients with a diagnosis of SJIA as per the International League of Associations for Rheumatology (ILAR) classification criteria
- Included in the Pharmachild registry
- Ever treated with Kineret subsequently to SJIA diagnosis
Who cannot join
- No specific exclusion criteria will be applied.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Non-interventional, Post-authorization Safety Study (PASS) to Evaluate Long-term Safety of Anakinra (Kineret®) in Patients With Systemic Juvenile Idiopathic Arthritis
The purpose of the study is to evaluate and characterize long-term safety of Kineret when used in standard clinical practice to treat patients with systemic juvenile idiopathic arthritis (SJIA). The study will be based on already available data from the Pharmachild juvenile idiopathic arthritis (JIA) registry which holds the European Network of Centers for Pharmacoepidemiology and Pharmacovigilance (ENCePP) study seal.
Read the detailed description
This is an international, non-interventional, single-armed, pharmacovigilance registry study on long-term safety of Kineret utilizing already available data from the ENCePP certified Pharmachild JIA registry.
The Paediatric Rheumatology International Trials Organisation (PRINTO) is a non-profit, non-governmental, international research network with the goal to foster, facilitate and co-ordinate the development, conduct, analysis, and reporting of multi-centers, international clinical trials and/or outcome standardization studies in children with paediatric rheumatic diseases.
The Pharmachild JIA registry, maintained by PRINTO, is a registry collecting data from patients with JIA including patients with SJIA. In the Pharmachild JIA registry 40 countries are participating of which 15 countries have collected data on Kineret treatment.
This study includes secondary use of data already available in the Pharmachild JIA registry.
- Conditions
- Still Disease, Juvenile Onset
- Being tested
- Anakinra
- Keywords
- SJIA, Kineret, Anakinra, Long term safety
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnakinraDrug
Also called Kineret
Anakinra according to prescription
| Study group | Role | What they receive |
|---|---|---|
| SJIA patients on Kineret treatment | SJIA patients on Kineret treatment enrolled in the Pharmachild JIA registry Receives: Drug: Anakinra |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence of non-serious adverse events (AEs) of at least moderate severity and serious AEs (SAEs), including macrophage activation syndrome (MAS) as an event of special interest (ESI).
The occurrence of non-serious AEs of at least moderate severity and serious AEs (SAEs), including MAS as an ESI. AEs (SAEs), including MAS as an ESI.
Measured: The Pharmachild registry was set up in December 2011. The first Kineret treatment, retrospectively collected in the registry, occurred in 2004. Data collected in the registry up until September 30, 2018 will be used (secondary use) in this study.
The duration of Kineret treatment in a real-world setting.
The duration of Kineret treatment in a real-world setting.
Measured: The Pharmachild registry was set up in December 2011. The first Kineret treatment, retrospectively collected in the registry, occurred in 2004. Data collected in the registry up until September 30, 2018 will be used (secondary use) in this study.
The reasons for Kineret treatment discontinuation.
The reasons for Kineret treatment discontinuation.
Measured: The Pharmachild registry was set up in December 2011. The first Kineret treatment, retrospectively collected in the registry, occurred in 2004. Data collected in the registry up until September 30, 2018 will be used (secondary use) in this study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study start10 Apr 2019
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Still Disease, Juvenile OnsetStudies of the same condition, open and under way.
- More trials run by Swedish Orphan BiovitrumThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swedish Orphan Biovitrum
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Physician, Study director, Swedish Orphan Biovitrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03932344
- Sponsor's protocol ID
- Sobi.Anakin-302
- Other IDs
- ENCEPP/SDPP/28378
- Status last verified
- Sep 2024
- First submitted
- 16 Apr 2019
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet decided if there will be a plan to make IPD available.
Publications
Giancane G, Papa R, Vastert S, Bagnasco F, Swart JF, Quartier P, Anton J, Kamphuis S, Sanner H, Glerup M, De Benedetti F, Tsitsami E, Remesal A, Moreno E, De Inocencio J, Myrup C, Pallotti C, Kone-Paut I, Franck-Larsson K, Malmstrom H, Cederholm S, Pistorio A, Wulffraat N, Ruperto N; Paediatric Rheumatology International Trials Organisation (PRINTO). Anakinra in Patients With Systemic Juvenile Idiopathic Arthritis: Long-term Safety From the Pharmachild Registry. J Rheumatol. 2022 Apr;49(4):398-407. doi: 10.3899/jrheum.210563. Epub 2022 Feb 1.
PubMed 35105709
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional, Post-authorization Safety Study (PASS) to Evaluate Long-term Safety of Anakinra (Kineret®) in Patients With Systemic Juvenile Idiopathic Arthritis
- ClinicalTrials.gov ID
- NCT03932344
- Acronym / sponsor ID
- Sobi.Anakin-302
- Conditions
- Still Disease, Juvenile Onset
- Keywords
- SJIA, Kineret, Anakinra, Long term safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Swedish Orphan BiovitrumIndustry (pharma, biotech, devices)
- Study start
- 10 Apr 2019 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 30 Apr 2019 (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.
The purpose of the study is to evaluate and characterize long-term safety of Kineret when used in standard clinical practice to treat patients with systemic juvenile idiopathic arthritis (SJIA). The study will be based on already available data from the Pharmachild juvenile idiopathic arthritis (JIA) registry which holds the European Network of Centers for Pharmacoepidemiology and Pharmacovigilance (ENCePP) study seal.
Detailed description
This is an international, non-interventional, single-armed, pharmacovigilance registry study on long-term safety of Kineret utilizing already available data from the ENCePP certified Pharmachild JIA registry.
The Paediatric Rheumatology International Trials Organisation (PRINTO) is a non-profit, non-governmental, international research network with the goal to foster, facilitate and co-ordinate the development, conduct, analysis, and reporting of multi-centers, international clinical trials and/or outcome standardization studies in children with paediatric rheumatic diseases.
The Pharmachild JIA registry, maintained by PRINTO, is a registry collecting data from patients with JIA including patients with SJIA. In the Pharmachild JIA registry 40 countries are participating of which 15 countries have collected data on Kineret treatment.
This study includes secondary use of data already available in the Pharmachild JIA registry.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SJIA patients on Kineret treatment | – | Drug: AnakinraSJIA patients on Kineret treatment enrolled in the Pharmachild JIA registry |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Data will be extracted and analyzed for all male and female patients with a diagnosis of SJIA as per the ILAR classification criteria included in the Pharmachild registry and who were ever treated with Kineret subsequently to SJIA diagnosis. That is, all eligible patients participating in the Pharmachild JIA registry study are included in this study.
Key inclusion criteria (3 listed)
- Male and female patients with a diagnosis of SJIA as per the International League of Associations for Rheumatology (ILAR) classification criteria
- Included in the Pharmachild registry
- Ever treated with Kineret subsequently to SJIA diagnosis
Key exclusion criteria (1 listed)
- No specific exclusion criteria will be applied.
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 |
|---|---|---|
| AnakinraAlso: KineretAnakinra according to prescription | Drug | SJIA patients on Kineret treatment |
Primary outcome
The occurrence of non-serious adverse events (AEs) of at least moderate severity and serious AEs (SAEs), including macrophage activation syndrome (MAS) as an event of special interest (ESI).
Time frame: The Pharmachild registry was set up in December 2011. The first Kineret treatment, retrospectively collected in the registry, occurred in 2004. Data collected in the registry up until September 30, 2018 will be used (secondary use) in this study.
The occurrence of non-serious AEs of at least moderate severity and serious AEs (SAEs), including MAS as an ESI. AEs (SAEs), including MAS as an ESI.
The duration of Kineret treatment in a real-world setting.
Time frame: The Pharmachild registry was set up in December 2011. The first Kineret treatment, retrospectively collected in the registry, occurred in 2004. Data collected in the registry up until September 30, 2018 will be used (secondary use) in this study.
The duration of Kineret treatment in a real-world setting.
The reasons for Kineret treatment discontinuation.
Time frame: The Pharmachild registry was set up in December 2011. The first Kineret treatment, retrospectively collected in the registry, occurred in 2004. Data collected in the registry up until September 30, 2018 will be used (secondary use) in this study.
The reasons for Kineret treatment discontinuation.
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 19 Sep 2024.
- Derived from this study: PubMed 35105709Giancane G, Papa R, Vastert S, Bagnasco F, Swart JF, Quartier P, Anton J, Kamphuis S, Sanner H, Glerup M, De Benedetti F, Tsitsami E, Remesal A, Moreno E, De Inocencio J, Myrup C, Pallotti C, Kone-Paut I, Franck-Larsson K, Malmstrom H, Cederholm S, Pistorio A, Wulffraat N, Ruperto N; Paediatric Rheumatology International Trials Organisation (PRINTO). Anakinra in Patients With Systemic Juvenile Idiopathic Arthritis: Long-term Safety From the Pharmachild Registry. J Rheumatol. 2022 Apr;49(4):398-407. doi: 10.3899/jrheum.210563. Epub 2022 Feb 1.
- Individual participant dataSharing planned: Undecided. It is not yet decided if there will be a plan to make IPD available.
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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.
Study Physician study director
Swedish Orphan Biovitrum
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 Still Disease, Juvenile Onset, run by Swedish Orphan Biovitrum at 1 site in Italy.
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 1 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 19 Sep 2024. 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 Italy. 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?
The occurrence of non-serious adverse events (AEs) of at least moderate severity and serious AEs (SAEs), including macrophage activation syndrome (MAS) as an event of special interest (ESI). (time frame: The Pharmachild registry was set up in December 2011. The first Kineret treatment, retrospectively collected in the registry, occurred in 2004. Data collected in the registry up until September 30, 2018 will be used (secondary use) in this 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?
On the ClinicalTrials.gov record for NCT03932344, which also lists 1 linked publication.
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 19 Sep 2024.