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

Colchicine Resistant/Intolerant Familial Mediterranean Fever Clinical Trial

Official title: A 6 Month Phase 2, Multi-Center, Open-label, Single Arm Study to Evaluate the Safety and Efficacy of Treatment With Canakinumab in Pediatric Patients With Colchicine Intolerant or Colchicine Resistant Familial Mediterranean Fever

Status Completed

Clinical Trial Summary

A study designed to evaluate the role of treatment with a biological agent - Canakinumab in pediatric (age 4-20) Familial Mediterranean Fever (FMF) patients that are intolerant or resistant for colchicine treatment.

The study hypothesis is that Canakinumab will reduce attack frequency and severity.

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brucellosis
• Colchicine Resistant/Intolerant Familial Mediterranean Fever
• Familial Mediterranean Fever
• Fever
• Hereditary Autoinflammatory Diseases

• NCT number: NCT01148797
• Study type: Interventional
• Source: Novartis
• Status: Completed
• Phase: Phase 2
• Start date: December 2010