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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

March 25, 2010
September 30, 2012
August 2010
May 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01105507 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
The Safety and Efficacy of Canakinumab in Patients Aged 4 Years or Older Diagnosed With Cryopyrin-associated Periodic Syndromes (CAPS) in Canada
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

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cryopyrin Associated Periodic Syndrome
Drug: canakinumab (company code: ACZ885D)
Experimental: canakinumab arm
Intervention: Drug: canakinumab (company code: ACZ885D)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4
Not Provided
May 2012   (final data collection date for primary outcome measure)

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"

Both
4 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01105507
CACZ885DCA01
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP