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The Safety and Efficacy of Canakinumab in Patients Aged 4 Years or Older Diagnosed With Cryopyrin-associated Periodic Syndromes (CAPS) in Canada

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01105507
Recruitment Status : Completed
First Posted : April 16, 2010
Last Update Posted : March 21, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:
This study will assess the safety, tolerability and efficacy of canakinumab treatment in Canadian patient diagnosed with cryopyrin-associated periodic syndrome over a period of 18 months.

Condition or disease Intervention/treatment Phase
Cryopyrin Associated Periodic Syndrome Drug: canakinumab (company code: ACZ885D) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Study to Assess the Safety, Tolerability and Efficacy of Canakinumab (ACZ885) in Patients Aged 4 Years or Older Diagnosed With Cryopyrin-associated Periodic Syndromes (CAPS) in Canada
Study Start Date : August 2010
Actual Primary Completion Date : May 12, 2012
Actual Study Completion Date : May 12, 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Canakinumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: canakinumab arm Drug: canakinumab (company code: ACZ885D)


Outcome Measures
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Primary Outcome Measures :
  1. Safety & tolerability of canakinumab by measuring the maintenance of response over time using the Investigators Clinical Assessment of Disease Activity scale and the evaluation of serum inflammation markers CRP (C-Reactive Protein), SAA (Serum Amyloid A. [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. Change in long term maintenance of Health-Related Quality of Life and productivity measured from baseline to end of study. [ Time Frame: Baseline, 18 months ]
  2. Treatment adherence with canakinumab for the duration of the study. [ Time Frame: 18 months ]

Eligibility Criteria
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Ages Eligible for Study:   4 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female patients at least 4 years of age at the time of the screening visit
  2. Patient's informed consent for > or = 18 years of age before any assessment is performed
  3. Parent or legal guardian's written informed consent and child's assent, if appropriate, are required before any assessment is performed for patients < 18 years of age.
  4. Patients with a diagnosis of CAPS: FCAS/FCU, MWS, or NOMID/CINCA
  5. Body weight > or = 15 kg
  6. Able to communicate with the investigator and comply with the requirements of the study (for children the parent can assist when necessary)

Exclusion Criteria:

  1. Patient is pregnant or breastfeeding. Women of childbearing potential must have a negative urine pregnancy test at baseline
  2. Patient of childbearing potential (man or woman) and unwilling to use double barrier method of contraception. It is required that double barrier method of contraception be used (i.e. condom with spermicide or diaphragm with spermicide) by patients of childbearing potential (man or woman) regardless of whether a hormonal agent is also used as a method of contraception.
  3. Participation in any clinical investigation within 4 weeks prior to dosing
  4. Live vaccinations within 3 months prior to the start of the trial, during the trial and up to 3 months following the last dose.
  5. History of significant medical conditions, which in the Investigator's opinion would exclude the patient from participating in this trial (this can be discussed with Novartis on a case by case basis in case of uncertainty).
  6. History of drug or alcohol abuse within 12 months prior to dosing
  7. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes

"Other protocol-defined inclusion/exclusion criteria may apply"

Contacts and Locations
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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): NCT01105507


Locations
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Canada
Alberta Children's Hospital, Department of Pediatrics
Calgary, Canada
Queen Elizabeth II Hospital
Halifax, Canada
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01105507    
Other Study ID Numbers: CACZ885DCA01
First Posted: April 16, 2010    Key Record Dates
Last Update Posted: March 21, 2017
Last Verified: March 2017
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Canakinumab
Cryopyrin-associated periodic syndromes
Familial Cold Autoinflammatory Syndrome (FCAS)
Familial Cold Urticaria (FCU)
Muckle-Wells Syndrome (MWS)
 Neonatal-Onset Multisystem Inflammatory Disease (NOMID)
Chronic Infantile Neurological
Cutaneous
Articular Syndrome (CINCA)
Treatment of patients diagnosed with CAPS (Cryopyrin associated periodic syndrome)
Additional relevant MeSH terms:
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Cryopyrin-Associated Periodic Syndromes
Syndrome
Disease
Pathologic Processes
 Hereditary Autoinflammatory Diseases
Genetic Diseases, Inborn
Skin Diseases, Genetic
Skin Diseases