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

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ClinicalTrials.gov Identifier: NCT02334748
Recruitment Status : Completed
First Posted : January 8, 2015
Results First Posted : May 19, 2020
Last Update Posted : May 19, 2020
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief 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 France is effective for canakinumab (Ilaris®) in these indications.

Condition or disease Intervention/treatment Phase
Systemic Juvenile Idiopathic Arthritis Hereditary Periodic Fevers Drug: canakinumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : November 3, 2014
Actual Primary Completion Date : August 31, 2018
Actual Study Completion Date : August 31, 2018

Arm Intervention/treatment
Experimental: canakinumab
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.
Drug: canakinumab

Primary Outcome Measures :
  1. 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.

  2. All-cause Mortality [ Time Frame: uo to 1 year ]
    Number of participants who died for any reason during the study

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

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.

Exclusion Criteria:

  • History of recurring infections
  • Hypersensitivity to the active substance or to any of the excipients

other protocol-defined inclusion/exclusion criteria may apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02334748

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Novartis Investigative Site
Bron Cedex, France, 69677
Novartis Investigative Site
Le Kremlin Bicetre, France, 94275
Novartis Investigative Site
Paris, France, 75015
Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Novartis ( Novartis Pharmaceuticals ):
Study Protocol  [PDF] December 15, 2017
Statistical Analysis Plan  [PDF] August 31, 2018

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02334748    
Other Study ID Numbers: CACZ885GFR01
2014-002872-95 ( EudraCT Number )
First Posted: January 8, 2015    Key Record Dates
Results First Posted: May 19, 2020
Last Update Posted: May 19, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
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
Additional relevant MeSH terms:
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Arthritis, Juvenile
Familial Mediterranean Fever
Hereditary Autoinflammatory Diseases
Joint Diseases
Musculoskeletal Diseases
Body Temperature Changes
Heat Stress Disorders
Wounds and Injuries
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Genetic Diseases, Inborn
Proteostasis Deficiencies
Metabolic Diseases
Skin Diseases, Genetic
Skin Diseases