Ignite Creation Date:
2024-05-05 @ 11:12 PM
Last Modification Date:
2024-10-26 @ 10:30 AM
Study NCT ID:
NCT01276522
Status:
COMPLETED
Last Update Posted:
2012-05-24
First Post:
2011-01-12
Brief Title:
Efficacy and Safety of Canakinumab in Schnitzler Syndrome
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
Efficacy and Safety of Canakinumab in Schnitzler Syndrome
Status:
COMPLETED
Status Verified Date:
2012-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Schnitzler syndrome is a disabling inflammatory disease characterized by chronic urticaria fever arthralgia bone pain and gammopathy which can so far only be effectively treated with anakinra an interleukin-1 receptor antagonist However this drug is not registered for use in Schnitzler syndrome and it needs to be injected daily which is uncomfortable and unpractical Therefore other treatments targeting IL-1 are needed Canakinumab is a long-acting monoclonal antibody against IL-1β that has been registered for bimonthly use in the rare autoinflammatory disease Cryopyrin-associated periodic syndrome CAPS We hypothesize that it will be effective in Schnitzler syndrome too in view of clinical similarities to CAPS and the targeting of IL-1B which is also blocked by anakinra which blocks both IL-1B and IL-1A
This is a 6-month open-label single treatment arm study of canakinumab 150 or 300 mg in case of insufficient response to 150 mg subcutaneous injection once per month in patients with active Schnitzler syndrome in which efficacy and safety will be assessed
This is a 6-month open-label single treatment arm study of canakinumab 150 or 300 mg in case of insufficient response to 150 mg subcutaneous injection once per month in patients with active Schnitzler syndrome in which efficacy and safety will be assessed
Detailed Description:
More on Canakinumab
Canakinumab is a high-affinity human monoclonal anti-human interleukin-1β IL-1βantibody of the IgG1k isotype developed for the treatment of IL-1β driven inflammatory diseases Canakinumab binds human IL-1β and functionally neutralizes the bioactivity of this pro-inflammatory cytokine IL-1β is produced mainly by mononuclear phagocytes in response to injury and infection and plays a dominant role in the pathobiology of autoinflammatory syndromes eg Cryopyrin associated periodic syndrome CAPS systemic Juvenile Idiopathic Arthritis and gout Canakinumab is expected to treat the signs and symptoms of inflammation and the underlying structural damage of disease Canakinumab has been administered in clinical trials as an intravenous iv infusion or as a subcutaneous sc injection and has been approved under the trade name ILARIS in the US for patients 4 years of age with CAPS and in the European Union and Switzerland for CAPS patients 4 years of age
Canakinumab is a high-affinity human monoclonal anti-human interleukin-1β IL-1βantibody of the IgG1k isotype developed for the treatment of IL-1β driven inflammatory diseases Canakinumab binds human IL-1β and functionally neutralizes the bioactivity of this pro-inflammatory cytokine IL-1β is produced mainly by mononuclear phagocytes in response to injury and infection and plays a dominant role in the pathobiology of autoinflammatory syndromes eg Cryopyrin associated periodic syndrome CAPS systemic Juvenile Idiopathic Arthritis and gout Canakinumab is expected to treat the signs and symptoms of inflammation and the underlying structural damage of disease Canakinumab has been administered in clinical trials as an intravenous iv infusion or as a subcutaneous sc injection and has been approved under the trade name ILARIS in the US for patients 4 years of age with CAPS and in the European Union and Switzerland for CAPS patients 4 years of age
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None