Efficacy and safety of canakinumab in Schnitzler syndrome - Canakinumab in Schnitzler syndrome

Phase 1

• Conditions: Schnitzler syndrome is an acquired autoinflammatory syndrome characterized by urticaria and monoclonal gammopathy, accompanied by intermittent fever, arthralgia or arthritis, bone pain and lymphadenopathy. This chronic disease severely impedes the quality of life of the patients.

• Registration Number: EUCTR2010-021166-30-NL
• Lead Sponsor: Radboud University Nijmegen Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-10-01
• Last Update Posted: 21 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1.Patients with a diagnosis of Schnitzler syndrome as per criteria (see Table 1).
2.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).
3.Male and female patients at least 18 years of age at the time of the screening visit.
4.Patient’s informed consent.
5.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).
6.Adequate contraception in premenopausal females
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

1.Pregnant or nursing (lactating) women
2.History of being immunocompromised, including a positive HIV at screening (ELISA and Western blot).
3.Serologic evidence of hepatitis B or C infection
4.Live vaccinations within 3 months prior to the start of the trial, during the trial, and up to 3 months following the last dose
5.History of significant medical conditions, which in the Investigator’s opinion would exclude the patient from participating in this trial
6.History of recurrent and/or evidence of active bacterial, fungal, or viral infection(s)
7.Use of the following therapies:
•Anakinra within 24 hours prior to Baseline visit
•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
8.History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified