NL-OMON34354招募中2 期
Efficacy and safety of canakinumab in Schnitzler syndrome - Canakinumab in Schnitzler syndrome
niversitair Medisch Centrum Sint Radboud0 个研究点目标入组 10 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Patients with a diagnosis of Schnitzler syndrome as fulfilling the criteria (see table 1).
- •2. Patients with Schnitzler syndrome who have been treated with the biological agent Anakinra must have demonstrated a partial or complete clinical response with an associated decrease in their biomarkers of inflammation (CRP and SAA) below 10mg/L.
- •3. Active Schnitzler syndrome (if applicable after stop of current treatment) at time of start of study treatment.
- •4. Male and female patients at least 18 years of age at the time of the screening visit.
- •5. Patient*s informed consent prior to the study
- •6. 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.
- •7. Adequate contraception in premenopausal women
排除标准
- •1. Pregnant or nursing (lactating) women
- •2. History of being immunocompromised, including a positive HIV at screening (ELISA and Western blot).
- •3. Live vaccinations within 3 months prior to the start of the trial, during the trial, and up to 3 months following the last dose
- •4. History of significant medical conditions, which in the Investigator*s opinion would exclude the patient from participating in this trial
- •5. History of recurrent and/or evidence of active bacterial, fungal, or viral infection(s)
- •6. Use of any other medication to control the symptoms of active Schnitzler syndrome.
- •7. Corticosteroids > 0.1 mg/kg/day in the 1 week prior to the baseline visit
- •8. Use of the following therapies:
- •Anakinra within 24 hours prior to Baseline visit
- •Rilonacept within 1 week prior to Baseline visit
- •Toclizumab within 3 weeks prior to Baseline visit
- •Etanercept within 4 weeks prior to Baseline visit
- •Adalimumab within 8 weeks prior to the Baseline visit
- •Infliximab within 12 weeks prior to the Baseline visit
- •Rituximab within 26 weeks prior to the Baseline visit
- •Leflunomide within 4 weeks prior to the Baseline visit. Documentation of a completion of a full cholestyramine elimination treatment after most recent leflunomide use will be required.
- •Thalidomide within 4 weeks prior to the Baseline visit
- •Cyclosporine within 4 weeks prior to the Baseline visit
- •Intravenous immunoglobulin (i.v. Ig) within 8 weeks prior to the Baseline visit
- •6-Merceptopurine, azathioprine, cyclophosphamide, or chlorambucil within 12 weeks prior to the Baseline visit
- •Dapsone, mycophenolate mofetil within 3 weeks prior to the Baseline visit
- •Growth hormone within 4 weeks prior to the 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
- •9. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
- •10. Severe co-morbidity (as judged by investigator).
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