Ilaris (Canakinumab) in the Schnitzler syndrome - canakinumab in Schnitzler

Conditions: Schnitzler syndrome
MedDRA version: 12.1Level: LLTClassification code 10062908Term: Schnitzler's syndrome

Registration Number: EUCTR2010-023603-10-BE

Lead Sponsor: Z Leuven

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 3

Inclusion Criteria

oPatients with active Schnitzler syndrome after withdrawal of anakinra or tapering of corticosteroids.
oMale and female patients at least 18 years of age at the time of screening visit.
oSigned patient informed consent
oNegative 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).
oAdequate contraception in females of childbearing potential.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

oPregnant or nursing (lactating) women
oHistory of being immunocompromised, including a positive HIV at screening (ELISA and Western blot)
oSerologic evidence of active hepatitis B or C infection
oLive vaccinations within 3 months prior to the start of the trial, during the trial, and up to 3 months following the last dose.
oHistory of significant medical conditions, which in the investigator’s opinion would exclude the patient from participating in this trial.
oHistory of recurrent and/or evidence of active bacterial, fungal or viral infection(s).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate if canakinumab 150mg every 8 weeks can induce and maintain clinical remission in patients with the Schnitzler syndrome.;Secondary Objective: oTo test if canakinumab 150mg can induce a complete clinical response at Day 7.<br>oTo 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.<br>oTo 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.<br>oTo evaluate the safety of canakinumab treatment in patients with the Schnitzler syndrome.<br>oTo assess the changes in C-reactive protein (CRP) levels during the treatment period.<br>;Primary end point(s): efficacy (body temperature, arthralgia, urticaria, fatigue, C-reactive protein)

Secondary Outcome Measures