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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01105507
First received: March 25, 2010
Last updated: September 30, 2012
Last verified: September 2012
  Purpose

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 Intervention Phase
Cryopyrin Associated Periodic Syndrome
Drug: canakinumab (company code: ACZ885D)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Treatment adherence with canakinumab for the duration of the study. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 4
Study Start Date: August 2010
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: canakinumab arm Drug: canakinumab (company code: ACZ885D)

  Eligibility

Ages Eligible for Study:   4 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01105507

Locations
Canada
Alberta Children's Hospital, Department of Pediatrics
Calgary, Canada
Queen Elizabeth II Hospital
Halifax, Canada
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01105507     History of Changes
Other Study ID Numbers: CACZ885DCA01
Study First Received: March 25, 2010
Last Updated: September 30, 2012
Health Authority: Canada: Health Canada

Keywords provided by Novartis:
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:
Hereditary Autoinflammatory Diseases
Cryopyrin-Associated Periodic Syndromes
Syndrome
Disease
Genetic Diseases, Inborn
Pathologic Processes
Skin Diseases
Skin Diseases, Genetic
Antibodies, Monoclonal
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014