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

• Conditions: Cryopyrin Associated Periodic Syndrome; MedDRA version: 19.0Level: PTClassification code 10068850Term: Cryopyrin associated periodic syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2015-003491-69-Outside-EU/EEA
• Lead Sponsor: ovartis Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-14
• Last Update Posted: 18 April 2016

Recruitment & Eligibility

• Status: A
• Sex: Female
• Target Recruitment: 4

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)

Other protocol-defined inclusion/exclusion criteria may apply
Are the trial subjects under 18? yes
Number of subjects for this age range: 2
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified