Evaluate the Safety and Efficacy of Canakinumab in Pediatric Patients With Colchicine Intolerant or Colchicine Resistant Familial Mediterranean Fever (FMF)

Exclusion Criteria

• •1. Patients with end-organ dysfunction due to amyloidosis (e.g. existing biopsy proven amyloidosis or proteinuria \> 0.5 gram per day)
• •2. Subjects taking oral or IV steroids within 1 month prior to baseline. Subjects taking steroids for reasons other than FMF - may be enrolled into the study based on discussion with the investigator and sponsor.
• •3. Presence or history of any other inflammatory rheumatic disease
• •4. The subject has active non-infective GI disease (e.g., inflammatory bowel disease), a chronic or acute renal or hepatic disorder, or a significant coagulation defect.
• •5. The subject has an AST (SGOT), ALT (SGPT) or BUN \>2 x ULN or creatinine \>1.5 mg/dL, and any other laboratory abnormality considered by the examining physician to be clinically significant within 28 days before the Baseline visit.
• •6. Positive PPD test (according to local guidance) where a latent or active TB infection cannot be excluded via QuantiFERON (T-Spot or radiographic imaging if needed) or via Chest x-ray.
• •7. The subject has positive human immunodeficiency virus (HIV) status or current (acute or chronic) hepatitis B or C
• •8. Subjects who are pregnant or lactating
• •9. Presence of any active or chronic infection or any major episode of infection requiring hospitalization or treatment with i.v. antibiotics within 30 days or oral antibiotics within 14 days prior to screening
• •10. Malignancy, except for successfully excised squamous or basal cell carcinoma of the skin
• •11. The subject has received any investigational medication within 30 days before the first dose of study medication or is scheduled to receive an investigational drug, other than study medications described in this protocol, during the course of the study.
• •12. The subject has received a live virus vaccine within 3 months prior to the baseline visit.
• •13. Any concurrent medical condition which would, in the investigator's opinion, compromise the subject's ability to tolerate the study drug or would make the subject unable to follow with the protocol.
• •14. History of/or current psychiatric illness that would interfere with ability to comply with protocol requirements or provide informed consent.
• •15. Subject has a history of alcohol or drug abuse within the past 6 months that would interfere with ability to comply with protocol requirements.