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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 : Active, not recruiting
First Posted : January 8, 2015
Last Update Posted : February 23, 2018
Sponsor:
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, CACZ885G2306 or CACZ885N2301 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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Non-Randomized
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
Estimated Primary Completion Date : December 22, 2018
Estimated Study Completion Date : December 22, 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
canakinumab




Primary Outcome Measures :
  1. adverse events [ Time Frame: every 4 weeks up to 1 year ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Locations
France
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
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02334748     History of Changes
Other Study ID Numbers: CACZ885GFR01
First Posted: January 8, 2015    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018

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:
Arthritis
Fever
Arthritis, Juvenile
Familial Mediterranean Fever
Amyloidosis
Hereditary Autoinflammatory Diseases
Joint Diseases
Musculoskeletal Diseases
Body Temperature Changes
Signs and Symptoms
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Genetic Diseases, Inborn
Proteostasis Deficiencies
Metabolic Diseases
Skin Diseases, Genetic
Skin Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs