ISRCTN16502655进行中（未招募）2 期
Biologics in refractory vasculitis (BIOVAS): a pragmatic, randomized, double-blind, placebo-controlled, modified-crossover trial of biologic therapy for refractory primary non-ANCA associated vasculitis in adults and children
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 140
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
- 性别
- All
入选标准
- •1. Aged at least 5 years
- •2. Have given, or their parent/legal guardian aged =16 years old has given, written informed consent
- •3. Diagnosis of NAAV
- •4. Refractory disease defined by:
- •4.1. Active disease, BVAS v3/ PVAS with = 1 severe (new/worse) or = 3 non-severe (new/worse) items despite 12 weeks of conventional therapy prior to screening visit OR
- •4.2. Inability to reduce prednisolone below 15 mg/day or (0.2 mg/kg/day in case of children) without relapse in the 12 weeks prior to screening visit
排除标准
- •1. Previous treatment failure/contraindication to =2 trial IMPs
- •2. Increase in the dose or frequency of background immunosuppressive (e.g. methotrexate) or anti-cytokine therapy within 30 days of screening visit
- •3. Use of intravenous immunoglobulins within 30 days, or cyclophosphamide or lymphocyte depleting biologic (e.g. rituximab) within 6 months of screening visit
- •4. Have an active systemic bacterial, viral or fungal infection, or tuberculosis
- •5. Hepatitis B (HB) core antibody (Ab) or HB surface antigen-positive or hepatitis C antibody positive or human immunodeficiency virus (HIV) antibody test positive
- •6. History of malignancy within five years prior to screening visit or any evidence of persistent malignancy, except fully excised basal cell or squamous cell carcinomas of the skin, or cervical carcinoma in situ which has been treated or excised in a curative procedure
- •7. Pregnant or breastfeeding (Section 11.9)
- •8. Severe disease, which in the opinion of the physician prevents randomization to placebo
- •9. Recent or upcoming major surgery within 45 days of screening visit
- •10. Leukocyte count < 3.5 x 109 cells/l, platelet count < 100 x 109 cells/l, neutrophil count of < 1 x 109 cells/l
- •11. ALT or ALP > 3 times the upper limit of normal
- •12. Symptomatic congestive heart failure (NYHA class III/IV) requiring prescription medication within 90 days of screening visit
- •13. Demyelinating disorders
- •14. History or presence of any medical condition or disease which, in the opinion of the Investigator, may place the participant at unacceptable risk because of trial participation
- •15. Administration of live or live-attenuated vaccines within 45 days of screening
- •16. Have received an investigational medicinal product (IMP) within 5 half-lives or 30 days prior to screening
- •17. Diagnosis of adenosine deaminase type 2 (DADA2)
- •18. Hypersensitivity to the active IMP substance or to any of the formulation excipients
研究者
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