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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ClinicalTrials.gov Identifier: NCT01105507 |
Recruitment Status :
Completed
First Posted : April 16, 2010
Last Update Posted : March 21, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cryopyrin Associated Periodic Syndrome | Drug: canakinumab (company code: ACZ885D) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 4 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 Start Date : | August 2010 |
Actual Primary Completion Date : | May 12, 2012 |
Actual Study Completion Date : | May 12, 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: canakinumab arm |
Drug: canakinumab (company code: ACZ885D) |
- 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 ]
- 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 ]
- Treatment adherence with canakinumab for the duration of the study. [ Time Frame: 18 months ]

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Ages Eligible for Study: | 4 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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"

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01105507
Canada | |
Alberta Children's Hospital, Department of Pediatrics | |
Calgary, Canada | |
Queen Elizabeth II Hospital | |
Halifax, Canada |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT01105507 |
Other Study ID Numbers: |
CACZ885DCA01 |
First Posted: | April 16, 2010 Key Record Dates |
Last Update Posted: | March 21, 2017 |
Last Verified: | March 2017 |
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) |
Cryopyrin-Associated Periodic Syndromes Syndrome Disease Pathologic Processes |
Hereditary Autoinflammatory Diseases Genetic Diseases, Inborn Skin Diseases, Genetic Skin Diseases |