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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

Primary Purpose

Cryopyrin Associated Periodic Syndrome

Status

Completed

Phase

Phase 3

Locations

Canada

Study Type

Interventional

Intervention

canakinumab (company code: ACZ885D)

About this trial

This is an interventional treatment trial for Cryopyrin Associated Periodic Syndrome focused on measuring 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)

Eligibility Criteria

4 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male and female patients at least 4 years of age at the time of the screening visit
Patient's informed consent for > or = 18 years of age before any assessment is performed
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.
Patients with a diagnosis of CAPS: FCAS/FCU, MWS, or NOMID/CINCA
Body weight > or = 15 kg
Able to communicate with the investigator and comply with the requirements of the study (for children the parent can assist when necessary)

Exclusion Criteria:

Patient is pregnant or breastfeeding. Women of childbearing potential must have a negative urine pregnancy test at baseline
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.
Participation in any clinical investigation within 4 weeks prior to dosing
Live vaccinations within 3 months prior to the start of the trial, during the trial and up to 3 months following the last dose.
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).
History of drug or alcohol abuse within 12 months prior to dosing
History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes

"Other protocol-defined inclusion/exclusion criteria may apply"

Sites / Locations

Alberta Children's Hospital, Department of Pediatrics
Queen Elizabeth II Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

canakinumab arm

Arm Description

Outcomes

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.

Secondary Outcome Measures

Change in long term maintenance of Health-Related Quality of Life and productivity measured from baseline to end of study.

Treatment adherence with canakinumab for the duration of the study.

Full Information

NCT ID

NCT01105507

First Posted

March 25, 2010

Last Updated

March 17, 2017

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01105507

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

August 2010 (undefined)

Primary Completion Date

May 12, 2012 (Actual)

Study Completion Date

May 12, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cryopyrin Associated Periodic Syndrome

Keywords

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)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

canakinumab arm

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

canakinumab (company code: ACZ885D)

Primary Outcome Measure Information:

Title

Time Frame

18 months

Secondary Outcome Measure Information:

Title

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

Title

Treatment adherence with canakinumab for the duration of the study.

Time Frame

18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male and female patients at least 4 years of age at the time of the screening visit Patient's informed consent for > or = 18 years of age before any assessment is performed 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. Patients with a diagnosis of CAPS: FCAS/FCU, MWS, or NOMID/CINCA Body weight > or = 15 kg Able to communicate with the investigator and comply with the requirements of the study (for children the parent can assist when necessary) Exclusion Criteria: Patient is pregnant or breastfeeding. Women of childbearing potential must have a negative urine pregnancy test at baseline 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. Participation in any clinical investigation within 4 weeks prior to dosing Live vaccinations within 3 months prior to the start of the trial, during the trial and up to 3 months following the last dose. 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). History of drug or alcohol abuse within 12 months prior to dosing History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes "Other protocol-defined inclusion/exclusion criteria may apply"

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Alberta Children's Hospital, Department of Pediatrics

City

Calgary

Country

Canada

Facility Name

Queen Elizabeth II Hospital

City

Halifax

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

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

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