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Efficacy and Safety of Canakinumab in Schnitzler Syndrome

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT01276522
First received: January 12, 2011
Last updated: May 23, 2012
Last verified: May 2012

January 12, 2011
May 23, 2012
January 2011
May 2011   (final data collection date for primary outcome measure)
Complete or clinical remission at Day 14. [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01276522 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Canakinumab in Schnitzler Syndrome
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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Schnitzler Syndrome
Drug: Canakinumab
Monthly subcutaneous injection with 150mg Canakinumab for 6 months
Other Name: Ilaris
Experimental: Canakinumab
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.
Intervention: Drug: Canakinumab

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
December 2011
May 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with a diagnosis of Schnitzler syndrome as per criteria (ref 1).
  • Patients that have been / are treated with Anakinra must have demonstrated a partial or complete clinical response with an associated normalization of their biomarkers of inflammation (CRP).
  • Male and female patients at least 18 years of age at the time of the screening visit.
  • Patient's informed consent.
  • Negative QuantiFERON test or negative Purified Protein Derivative (PPD) test (< 5 mm induration) at screening or within 1 month prior to the screening visit, according to the national guidelines. Patients with a positive PPD test (≥ 5 mm induration) at screening may be enrolled only if they have either a negative chest x-ray or a negative QuantiFERON test (QFT-TB G In-Tube).
  • Adequate contraception in premenopausal females

Exclusion Criteria:

  • Pregnant or nursing (lactating) women
  • History of being immunocompromised, including a positive HIV at screening (ELISA and Western blot).
  • Serologic evidence of hepatitis B or C infection
  • 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
  • History of recurrent and/or evidence of active bacterial, fungal, or viral infection(s)
  • Use of the following therapies:

    • Anakinra within 24 hours prior to Baseline visit XML File Identifier : tl8ybe8lI1o6DeawQocCBa8TF/w=
    • Corticosteroids (oral prednisone (or equivalent)) > 1.0 mg/kg/day (or greater than the maximum of 60 mg/day for children over 60 kg) within 3 days prior to the Baseline visit
    • Intra-articular, peri-articular or intramuscular corticosteroid injections within 4 weeks prior to the Baseline visit
    • Any other investigational biologics within 8 weeks prior to the Baseline visit
    • Any other investigational drugs, other than investigational biologic treatment, within 30 days (or 3 months for investigational monoclonal antibodies) or 5 half-lives prior to the Baseline visit, whichever is longer
  • History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01276522
2010-SS-Canakinumab
No
Radboud University
Radboud University
Novartis
Principal Investigator: Anna Simon, MD PhD Radboud University
Radboud University
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP