Cryopyrin-Associated Periodic SyndromesNCT02326376
Kineret CAPS Post Authorisation Study
An observational study of Cryopyrin-Associated Periodic Syndromes, run by Swedish Orphan Biovitrum at 2 sites in 2 countries.
Trial summary
A non-interventional, post authorization safety study to evaluate the safety of Kineret in the treatment of Cryopyrin Associated Periodic Syndromes (CAPS) in routine clinical care with regard to serious infections, malignancies, injection site reactions, allergic reactions and medication errors, including re-use of… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cryopyrin-Associated Periodic Syndromes
- What is being tested?
- anakinra (Kineret)
- Type of treatment
- Injection or infusion
- How many people
- 12 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 24 Apr 2015to 12 Sep 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: All CAPS patients treated with Kineret at the selected sites.
Who may be able to join
- Informed consent by the patient and/or caregiver
- Kineret treatment will be according to the Summary of Product Characteristics (SmPC), as confirmed by the Investigator
Who cannot join
- None
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United Kingdom1 site
Swedish Orphan Biovitrum Investigational Site
London
About this study
Official title: Non-interventional PASS to Evaluate Safety of Kineret in Treatment of CAPS in Routine Clinical Care With Regard to Serious Infections, Malignancies, Injection Site Reactions, Allergic Reactions, Medication Errors Including Re-use of Syringe
A non-interventional, post authorization safety study to evaluate the safety of Kineret in the treatment of Cryopyrin Associated Periodic Syndromes (CAPS) in routine clinical care with regard to serious infections, malignancies, injection site reactions, allergic reactions and medication errors, including re-use of syringe.
- Conditions
- Cryopyrin-Associated Periodic Syndromes
- Being tested
- anakinra (Kineret)
- Medical subject headings
- Cryopyrin-Associated Periodic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anakinra (Kineret)Drug
Also called Kineret
| Study group | Role | What they receive |
|---|---|---|
| CAPS patients | CAPS patients treated with anakinra, using the Kineret graduated syringe Receives: Drug: anakinra (Kineret) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of serious infections
Measured: 3 years
Rate of new malignancies
Measured: 3 years
Rate of injection site reactions
Measured: 3 years
Rate of allergic reactions
Measured: 3 years
Rate of medication errors including re-use of syringe
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2014 (estimated)
- Study start24 Apr 2015
- Primary completion12 Sep 2019
- Study completion12 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cryopyrin-Associated Periodic SyndromesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swedish Orphan Biovitrum
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pediatric Rheumatology International Trials Organization
- Responsible party
- Sponsor
- Investigators
- Marco Gattorno, MD, Principal investigator, IRCCS Istituto Giannina GasliniTorbjörn Kullenberg, MD, Study director, Swedish Orphan Biovitrum AB (publ)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02326376
- Sponsor's protocol ID
- Sobi.Anakin-201
- Other IDs
- ENCEPP/SDPP/6366
- Status last verified
- Jan 2020
- First submitted
- 1 Dec 2014
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional PASS to Evaluate Safety of Kineret in Treatment of CAPS in Routine Clinical Care With Regard to Serious Infections, Malignancies, Injection Site Reactions, Allergic Reactions, Medication Errors Including Re-use of Syringe
- ClinicalTrials.gov ID
- NCT02326376
- Acronym / sponsor ID
- Sobi.Anakin-201
- Conditions
- Cryopyrin-Associated Periodic Syndromes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Swedish Orphan BiovitrumIndustry (pharma, biotech, devices)
- Collaborators
- Pediatric Rheumatology International Trials Organization
- Study start
- 24 Apr 2015 (actual)
- Primary completion
- 12 Sep 2019 (actual)
- Study completion
- 12 Sep 2019 (actual)
- First posted
- 29 Dec 2014 (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.
A non-interventional, post authorization safety study to evaluate the safety of Kineret in the treatment of Cryopyrin Associated Periodic Syndromes (CAPS) in routine clinical care with regard to serious infections, malignancies, injection site reactions, allergic reactions and medication errors, including re-use of syringe.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAPS patients | – | Drug: anakinra (Kineret)CAPS patients treated with anakinra, using the Kineret graduated syringe |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All CAPS patients treated with Kineret at the selected sites.
Key inclusion criteria (2 listed)
- Informed consent by the patient and/or caregiver
- Kineret treatment will be according to the Summary of Product Characteristics (SmPC), as confirmed by the Investigator
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| anakinra (Kineret)Also: Kineret | Drug | CAPS patients |
Primary outcome
Rate of serious infections
Time frame: 3 years
Rate of new malignancies
Time frame: 3 years
Rate of injection site reactions
Time frame: 3 years
Rate of allergic reactions
Time frame: 3 years
Rate of medication errors including re-use of syringe
Time frame: 3 years
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 18 Jan 2020.
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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.
Marco Gattorno, MD principal investigator
IRCCS Istituto Giannina Gaslini
Torbjörn Kullenberg, MD study director
Swedish Orphan Biovitrum AB (publ)
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cryopyrin-Associated Periodic Syndromes, run by Swedish Orphan Biovitrum at 2 sites in 2 countries.
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 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 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands, United Kingdom. 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?
Rate of serious infections (time frame: 3 years). The study lists 5 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 18 Jan 2020.