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

NCT ID: NCT01105507

Last Updated: 2017-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2012-05-12

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.

Conditions

Cryopyrin Associated Periodic Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

canakinumab arm

Group Type: EXPERIMENTAL

canakinumab (company code: ACZ885D)

Intervention Type: DRUG

Interventions

canakinumab (company code: ACZ885D)

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 4 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Alberta Children's Hospital, Department of Pediatrics

Calgary, , Canada

Queen Elizabeth II Hospital

Halifax, , Canada

Countries

Canada

Other Identifiers

CACZ885DCA01

Identifier Type: -

Identifier Source: org_study_id