Systemic Juvenile Idiopathic ArthritisPhase 3NCT02334748

A Study of Canakinumab in Patients With Systemic Juvenile Idiopathic Arthritis or Hereditary Periodic Fevers Who Participated in the CACZ885G2301E1, CACZ885G2306 or CACZ885N2301 Studies

A Phase 3 study testing canakinumab in people with Systemic Juvenile Idiopathic Arthritis and Hereditary Periodic Fevers, run by Novartis Pharmaceuticals at 3 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of this extension protocol is to collect safety data (serious and non-serious adverse events) and to provide continuous canakinumab to patients in France who completed study CACZ885G2301E1(NCT00891046), CACZ885G2306 (NCT02296424) or CACZ885N2301 (NCT02059291) until a decision regarding reimbursement in… Read more about this study

Who is it for?: Ages 5 to 20 years
Conditions the study is for: Systemic Juvenile Idiopathic Arthritis, Hereditary Periodic Fevers
What is being tested?: canakinumab
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 31 participants
Where: 3 sitesFrance
Study dates: 3 Nov 2014to 31 Aug 2018
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 5 to 20 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Criteria applicable for patients with Systemic Juvenil Idiopathic Arthritis SJIA):
Patients who have completed the international studies CACZ885G2301E1 or CACZ885G2306 without any significant safety issue according to Investigator's opinion.
Patients who have completed the international CACZ885G2306 study and who successfully withdrew canakinumab treatment per protocol but with a disease relapse after the end of study visit will be allowed to participate in CACZ885GFR01 study (whatever the time of relapse from the end of study visit), if the investigator states that there is an indication to resume canakinumab.
Patients who have participated in the international CACZ885G2306 study but could not be randomized and then have continued canakinumab in part I until the end of the study at a dose of 4 mg/kg every 4 weeks may be switched to CACZ885GFR01 study if the investigator thinks that, in the interest of the patient, there is an indication to taper off canakinumab dose after a prolonged remission.
Criteria applicable for patients with HPF (TRAPS, HIDS, crFMF):
Patients who have completed the international CACZ885N2301 study without any significant safety issue according to Investigator's opinion.
Criteria applicable for all patients:
Parent's or legal guardian's written informed consent and child's assent, if appropriate, or patient's written informed consent for patients ≥ 18 years of age must be obtained before any study related activity or assessment is performed.

Who cannot join

History of recurring infections
Hypersensitivity to the active substance or to any of the excipients
other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

3 sites in 1 country.

France3 sites

Novartis Investigative Site
Bron, 69677
Novartis Investigative Site
Le Kremlin-Bicêtre, 94275
Novartis Investigative Site
Paris, 75015

Other trials in France

About this study

Official title: A French Open-label Extension Study of Canakinumab in Patients Who Participated in International Phase III Studies CACZ885G2301E1 or CACZ885G2306 in Systemic Juvenile Idiopathic Arthritis and CACZ885N2301 in Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF)

Conditions: Systemic Juvenile Idiopathic Arthritis, Hereditary Periodic Fevers
Being tested: canakinumab
Keywords: Juvenile Rheumatoid arthritis (JRA) chronic, systemic inflammatory disorder, painful joints, inflammation of the synovial membrane, auto-immune rheumatoid disease, reactive rheumatoid arthritis, Systemic Juvenile Rheumatoid arthritis (SJRA), Hereditary Periodic Fevers, Hereditary periodic fever syndrome(HPFS), Familial Mediterranean fever syndrome(FMFS), Hyperimmunoglobulinemia D, Tumor necrosis factor (TNF) receptor-associated periodic syndrome (TRAPS), Muckle-Wells syndrome (MWS), Familial cold auto inflammatory syndrome
Medical subject headings: Arthritis, Juvenile, Bronchiolitis Obliterans Syndrome, Arthralgia, Rheumatoid Arthritis, Systemic Juvenile, Mevalonate Kinase Deficiency, Cryopyrin-Associated Periodic Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

canakinumabDrug
canakinumab

Study groups in NCT02334748
Study group	Role	What they receive
canakinumab	Experimental	Patients will continue the same dose as their last dose administered in the study CACZ885G2301E1, CACZ885N2301 or CACZ885G2306. For all indications, the maximum canakinumab dose is 4 mg/kg or 300 mg for patients ≥ 40 kg. Ilaris® dosage may be adjusted (or interrupted) according to the clinical response and to investigators judgment. Receives: Drug: canakinumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Adverse Events
The objective of this protocol was to collect additional safety data (serious and non serious AEs) and to provide continuous Ilaris® (canakinumab) treatment to patients in France who completed CACZ885G2301E1, CACZ885N2301 or CACZ885G2306 studies.
Measured: every 4 weeks up to 1 year
All-cause Mortality
Number of participants who died for any reason during the study
Measured: uo to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Nov 201431 Aug 2018

First posted8 Jan 2015 (estimated)
Study start3 Nov 2014
Primary completion31 Aug 2018
Study completion31 Aug 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Systemic Juvenile Idiopathic ArthritisStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe 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: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02334748
Sponsor's protocol ID: CACZ885GFR01
Other IDs: 2014-002872-95, 2014
Status last verified: May 2020
First submitted: 23 Dec 2014
Last updated: 19 May 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Systemic Juvenile Idiopathic Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A French Open-label Extension Study of Canakinumab in Patients Who Participated in International Phase III Studies CACZ885G2301E1 or CACZ885G2306 in Systemic Juvenile Idiopathic Arthritis and CACZ885N2301 in Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF)
ClinicalTrials.gov ID: NCT02334748
Acronym / sponsor ID: CACZ885GFR01
Conditions: Systemic Juvenile Idiopathic Arthritis, Hereditary Periodic Fevers
Keywords: Juvenile Rheumatoid arthritis (JRA) chronic, systemic inflammatory disorder, painful joints, inflammation of the synovial membrane, auto-immune rheumatoid disease, reactive rheumatoid arthritis, Systemic Juvenile Rheumatoid arthritis (SJRA), Hereditary Periodic Fevers
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 3 Nov 2014 (actual)
Primary completion: 31 Aug 2018 (actual)
Study completion: 31 Aug 2018 (actual)
First posted: 8 Jan 2015 (estimated)
Results: Posted 19 May 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
canakinumab	Experimental	Drug: canakinumabPatients will continue the same dose as their last dose administered in the study CACZ885G2301E1, CACZ885N2301 or CACZ885G2306. For all indications, the maximum canakinumab dose is 4 mg/kg or 300 mg for patients ≥ 40 kg. Ilaris® dosage may be adjusted (or interrupted) according to the clinical response and to investigators judgment.

Who may qualify

Ages: 5 to 20 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (8 listed)

Patients who have completed the international studies CACZ885G2301E1 or CACZ885G2306 without any significant safety issue according to Investigator's opinion.
Patients who have completed the international CACZ885G2306 study and who successfully withdrew canakinumab treatment per protocol but with a disease relapse after the end of study visit will be allowed to participate in CACZ885GFR01 study (whatever the time of relapse from the end of study visit), if the investigator states that there is an indication to resume canakinumab.
Patients who have participated in the international CACZ885G2306 study but could not be randomized and then have continued canakinumab in part I until the end of the study at a dose of 4 mg/kg every 4 weeks may be switched to CACZ885GFR01 study if the investigator thinks that, in the interest of the patient, there is an indication to taper off canakinumab dose after a prolonged remission.
Patients who have completed the international CACZ885N2301 study without any significant safety issue according to Investigator's opinion.
Parent's or legal guardian's written informed consent and child's assent, if appropriate, or patient's written informed consent for patients ≥ 18 years of age must be obtained before any study related activity or assessment is performed.

Key exclusion criteria (3 listed)

History of recurring infections
Hypersensitivity to the active substance or to any of the excipients
other protocol-defined inclusion/exclusion criteria may 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
canakinumabcanakinumab	Drug	canakinumab

Primary outcome

Number of Participants With Adverse Events
Time frame: every 4 weeks up to 1 year
The objective of this protocol was to collect additional safety data (serious and non serious AEs) and to provide continuous Ilaris® (canakinumab) treatment to patients in France who completed CACZ885G2301E1, CACZ885N2301 or CACZ885G2306 studies.
All-cause Mortality
Time frame: uo to 1 year
Number of participants who died for any reason during the study

Results and safety

Results posted to the registry on 19 May 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Canakinumab	31	23

Primary outcome: Number of Participants With Adverse Events

Time frame: every 4 weeks up to 1 year. Count of participants. Unit: Participants

Measure	Canakinumab n = 31
Serious adverse events	7
Treatment emergent adverse events	29

Population analysed: Safety set: Safety set consisted of all patients who received at least one dose of study drug and had at least one post-treatment safety assessment in the study.

Primary outcome: All-cause Mortality

Time frame: uo to 1 year. Count of participants. Unit: Participants

Measure	Canakinumab n = 31
Value	0

Population analysed: Safety set

Adverse events

Time frame: AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 1 year. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Canakinumab (ACZ885)	7 of 31 (22.6%)	28 of 31 (90.3%)	0 of 31

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided. Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Related trials for Systemic Juvenile Idiopathic Arthritis

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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.

Novartis Pharmaceuticals study director

Novartis Pharmaceuticals

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing canakinumab in people with Systemic Juvenile Idiopathic Arthritis and Hereditary Periodic Fevers, run by Novartis Pharmaceuticals at 3 sites in France.

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 8 inclusion and 3 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 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. 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.

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?

Yes. Results are posted in the registry (first posted 19 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Participants With Adverse Events (time frame: every 4 weeks up to 1 year). The study lists 2 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 NCT02334748.

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 May 2020.