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

Cryopyrin Associated Periodic Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01105507
• Other study ID #: CACZ885DCA01
• Status: Completed
• Phase: Phase 3
• First received: March 25, 2010
• Last updated: March 17, 2017
• Start date: August 2010
• Est. completion date: May 12, 2012

Study information

• Verified date: March 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: May 12, 2012
• Est. primary completion date: May 12, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years and older

Eligibility

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"

Related Conditions & MeSH terms

• Cryopyrin Associated Periodic Syndrome
• Cryopyrin-Associated Periodic Syndromes
• Syndrome

Intervention

Drug:
• canakinumab (company code: ACZ885D)

Locations

Country	Name	City	State
Canada	Alberta Children's Hospital, Department of Pediatrics	Calgary
Canada	Queen Elizabeth II Hospital	Halifax

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		18 months
Secondary	Change in long term maintenance of Health-Related Quality of Life and productivity measured from baseline to end of study.		Baseline, 18 months
Secondary	Treatment adherence with canakinumab for the duration of the study.		18 months

External Links

•   View CACZ885DCA01 Trial Results at Novartis Clinical Trials Website