Efficacy and safety of canakinumab in patients with Schnitzler syndrome
- Conditions
- MedDRA version: 20.0Level: PTClassification code 10062908Term: Schnitzler's syndromeSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersSchnitzler syndromeTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2010-024156-28-DE
- Lead Sponsor
- Charité - University Hospital of Berlin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
Adults (18 years or older)
Informed consent signed and dated
Able to read, understand and willing to sign the informed consent form and abide with study procedures
SchS diagnosis based on diagnostic criteria defined in Appendix
Patients with symptomatic SchS (as defined by the physician’s global assessment with a minimum score of 8 and CRP >ULN)
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 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
Concurrent/ongoing treatment with anakinra (Kineret®) or recent treatment within 48 hours prior to day 0
Concurrent/ongoing treatment with other biologics or recent treatment (less than 5 half lives)
Concurrent/ongoing treatment with immunosuppressives (e.g. cyclosporine, methotrexate, dapsone or others) within 4 weeks or 5 half lives prior to day 0, whichever is longer
Concurrent/ongoing treatment with high doses of systemic steroids (>20mg prednisolone equivalent)
Evidence of recurrent or latent systemic infection such as tuberculosis
Significant medical condition rendering the patient immunocompromised or not suitable for a clinical trial
Treatment with a live (attenuated) virus vaccine during three months prior to day 0 and for 3 months after end of study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the effect of canakinumab on the clinical signs and symptoms of Schnitzler Syndrome (SchS);Secondary Objective: To assess the safety of canakinumab in subjects with SchS<br><br>To assess the change in biomarkers of inflammation (C-reactive protein, serum amyloid A, erythrocyte sedimentation rate) during the treatment period with canakinumab<br><br>To assess changes in patients’ quality of life during the treatment period with canakinumab<br>;Primary end point(s): Proportion of patients with complete response (based on physician’s global assessment on overall autoinflammatory disease activity) at day 7 in the canakinumab treated group as compared to the placebo group ;Timepoint(s) of evaluation of this end point: at the end of the study
- Secondary Outcome Measures
Name Time Method