Efficacy and Safety of Canakinumab in Schnitzler Syndrome
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Efficacy and Safety of Canakinumab in Schnitzler Syndrome|
- Complete or clinical remission at Day 14. [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
- Complete or clinical remission at Day 3 and Day 7 [ Time Frame: Day 3 and day 7 ] [ Designated as safety issue: No ]
- The prevention of disease relapse in patients who demonstrated complete remission at Day 14 [ Time Frame: Day 15 until end ] [ Designated as safety issue: No ]
- The change in biomarkers (CRP and SAA) and clinical parameters (physician and patient global assessment of disease activity) during the treatment and follow-up periods [ Time Frame: Whole study ] [ Designated as safety issue: No ]
- Time to relapse after the last canakinumab dose [ Time Frame: Month 6 - 9 ] [ Designated as safety issue: No ]
- Safety and tolerability as well as PK/PD/IG properties of canakinumab in the treatment of patients with Schnitzler syndrome. [ Time Frame: Whole study ] [ Designated as safety issue: Yes ]
- Changes in patient quality of life by using: Medical Outcome Short Form (36) Health Survey (SF-36®). [ Time Frame: Whole study ] [ Designated as safety issue: No ]
- Optimal canakinumab dose and frequency in patients with Schnitzler syndrome [ Time Frame: Whole study ] [ Designated as safety issue: No ]
|Study Start Date:||January 2011|
|Study Completion Date:||December 2011|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
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.
Monthly subcutaneous injection with 150mg Canakinumab for 6 months
Other Name: Ilaris
More on Canakinumab:
Canakinumab is a high-affinity human monoclonal anti-human interleukin-1β (IL-1β)antibody of the IgG1/k 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 (e.g. 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 (i.v.) 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.
|Radboud University Nijmegen Medical Centre|
|Nijmegen, Netherlands, 6500 HB|
|Principal Investigator:||Anna Simon, MD PhD||Radboud University|