Status:
COMPLETED
Ilaris (Canakinumab) in the Schnitzler Syndrome
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Schnitzler Syndrome
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
Schnitzler syndrome: Schnitzler syndrome is a rare disabling autoinflammatory syndrome characterized by a chronic urticarial rash and monoclonal gammopathy, accompanied by intermittent fever, arthral...
Detailed Description
Description of the study: Objectives: * Primary objective: To evaluate if canakinumab 150mg every 8 weeks can induce and maintain clinical remission in patients with the Schnitzler syndrome. * Secon...
Eligibility Criteria
Inclusion
- Patients with active Schnitzler syndrome after withdrawal of anakinra or tapering of corticosteroids.
- Male and female patients at least 18 years of age at the time of screening visit.
- Signed patient 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 Belgium guidelines. Patients with a positive PPD test (=5 mm induration) at screeninig may be enrolled only if they have a negative chest x-ray or negative QuantiFERON test (QFT-TB G In-Tube).
- Adequate contraception in females of childbearing potential.
Exclusion
- Pregnant or nursing (lactating) women
- History of being immunocompromised, including a positive HIV at screening (ELISA and Western blot)
- Serologic evidence of active 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).
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01245127
Start Date
May 1 2011
End Date
May 1 2012
Last Update
July 5 2019
Active Locations (1)
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1
UZ Gasthuisberg
Leuven, Belgium, 3000