Schnitzler syndrome MedDRA version: 12.1 Level: LLT Classification code 10062908 Term: Schnitzler's syndrome
Conditions
Interventions
Trade Name: Ilaris
Product Name: canakinumab
Pharmaceutical Form: Powder and solvent for solution for injection
Sponsors
UZ Leuven
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: o Patients with active Schnitzler syndrome after withdrawal of anakinra or tapering of corticosteroids. o Male and female patients at least 18 years of age at the time of screening visit. o Signed patient informed consent o Negative QuantiFERON test or negative Purified Protein Derivative (PPD) test (=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: o Pregnant or nursing (lactating) women o History of being immunocompromised, including a positive HIV at screening (ELISA and Western blot) o Serologic evidence of active hepatitis B or C infection o Live vaccinations within 3 months prior to the start of the trial, during the trial, and up to 3 months following the last dose. o History of significant medical conditions, which in the investigator’s opinion would exclude the patient from participating in this trial. o History of recurrent and/or evidence of active bacterial, fungal or viral infection(s).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate if canakinumab 150mg every 8 weeks can induce and maintain clinical remission in patients with the Schnitzler syndrome.;Secondary Objective: o To test if canakinumab 150mg can induce a complete clinical response at Day 7. o To assess if addition canakinumab 150mg given at Day 7 for patients demonstrating only a partial response can induce a complete clinical response at Day 14. o To evaluate if canakinumab 300mg every 8 weeks can maintain clinical remission in those patients who required canakinumab 150 mg additional dose on Day 7 and achieved clinical remission at Day 14. o To evaluate the safety of canakinumab treatment in patients with the Schnitzler syndrome. o To assess the changes in C-reactive protein (CRP) levels during the treatment period. ;Primary end point(s): efficacy (body temperature, arthralgia, urticaria, fatigue, C-reactive protein) | — |
Countries
Belgium
Outcome results
None listed