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An Extention Study of Safety of Canakinumab in Japanese Patients With Periodic Fever Syndromes

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ClinicalTrials.gov Identifier: NCT02911857
Recruitment Status : Completed
First Posted : September 22, 2016
Results First Posted : August 20, 2018
Last Update Posted : August 20, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
The primary objective of this study was to evaluate safety and tolerability of ACZ885 in this extension study. This extension study offered the opportunity for participants who completed Epoch 4 of the preceding CACZ885N2301 (NCT02059291) study to continue to be treated with ACZ885 until approval in Japan of the drug in Periodic Fever Syndromes or until development of ACZ885 in Periodic Fever Syndromes was suspended.

Condition or disease Intervention/treatment Phase
Periodic Fevers Syndrome Biological: Canakinumab (AIN457) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Extension Study of CACZ885N2301 (NCT02059291), Multi-center, Open Label Study of Canakinumab in Japanese Patients With Periodic Fever Syndromes (Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS), Hyper Immunoglobulin D Syndrome ((Also Known as Mevalonate Kinase Deficiency) (HIDS/MKD), or Colchicine Resistant/Intolerant Familial Mediterranean Fever (crFMF))
Actual Study Start Date : October 3, 2016
Actual Primary Completion Date : January 27, 2017
Actual Study Completion Date : January 27, 2017


Arm Intervention/treatment
Experimental: Canakinumab (ACZ885)
Participants continued the study drug based on the final dose and regimen administered at the end of the CACZ885N2301 study. All participants received 1 or 2 ACZ885 subcutaneous injections every 4 or 8 weeks.
Biological: Canakinumab (AIN457)
Canakinumab solution for subcutaneous injection in vial which contained 150mg/mL canakinumab in 1 mL solution




Primary Outcome Measures :
  1. Number of Participants With Non-serious Adverse Events, Serious Adverse Events and Deaths [ Time Frame: Participants were followed for the duration until approval, an expected average of 3 months. ]
    Participants were monitored for safety throughout the study.



Information from the National Library of Medicine

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

Inclusion Criteria:

  • Completed Epoch 4 of the CACZ885N2301 study in Japan before the approval of canakinumab in Japan
  • Written informed consent. Parent or legal guardian's written informed consent and child's assent, if appropriate, are required before any assessment is performed for patients < 20 years of age

Exclusion Criteria:

  • Any conditions or significant medical problems in which the investigator judges the patient should not enter this extension study

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): NCT02911857


Locations
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Japan
Novartis Investigative Site
Fukuoka city, Fukuoka, Japan, 812-8582
Novartis Investigative Site
Yokohama-city, Kanagawa, Japan, 236-0004
Novartis Investigative Site
Kyoto-city, Kyoto, Japan, 606-8507
Sponsors and Collaborators
Novartis Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Novartis ( Novartis Pharmaceuticals ):
Study Protocol  [PDF] June 3, 2016
Statistical Analysis Plan  [PDF] September 12, 2016


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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02911857     History of Changes
Other Study ID Numbers: CACZ885N2301E2
First Posted: September 22, 2016    Key Record Dates
Results First Posted: August 20, 2018
Last Update Posted: August 20, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect 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 ):
Canakinumab,
interleukin-1
Periodic Fevers Syndrome
TRAPS
HIDS
crFMF
auto-inflammatory diseases
extension study

Additional relevant MeSH terms:
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Syndrome
Fever
Familial Mediterranean Fever
Amyloidosis
Mevalonate Kinase Deficiency
Disease
Pathologic Processes
Body Temperature Changes
Signs and Symptoms
Hereditary Autoinflammatory Diseases
Genetic Diseases, Inborn
Proteostasis Deficiencies
Metabolic Diseases
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hypergammaglobulinemia
Blood Protein Disorders
Hematologic Diseases
Metabolism, Inborn Errors
Peroxisomal Disorders
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs