EUCTR2019-003964-30-GB进行中（未招募）1 期
Biologics in refractory vasculitis (BIOVAS): A pragmatic, randomised, double-blind, placebo-controlled, modified-crossover trial of biologic therapy for refractory primary non-ANCA associated vasculitis in adults and children - Biologics in refractory vasculitis (BIOVAS)
相关药物
试验速览
- 阶段
- 1 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 clinical trial of medicinal product
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:
- •- Active disease, BVAS v3 modified for BIOVAS (BVAS v3-BIOVAS)/ PVAS with = 1 severe (new/worse) or =3 non-severe (new/worse) items despite 12 weeks of conventional therapy prior to screening visit (OR)
- •- Inability to reduce prednisolone below 15mg/day or (0.2mg/kg/day in case of children) without relapse in the 12 weeks prior to screening visit
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 14
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 91
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 35
排除标准
- •1.Previous treatment failure/contraindication to = 2 active 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 plasma exchange or 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 active/latent 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
- •8.Severe disease, which in the opinion of the physician prevents randomisation to placebo
- •9.Recent or upcoming major surgery within 45 days of screening visit
- •10.Leukocyte count < 3.5 x 10^9, platelet count < 100 x 10^9 cells/l, neutrophil count of < 1 x 10^9 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. Participation in any clinical trial of an investigational medicinal product within 30 days prior to screening or within 5 half-lives after taking the last dose
- •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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