EUCTR2017-003563-36-GB进行中（未招募）1 期
ACQUIVAS - Acquired immunodeficiency in ANCA associated vasculitis (AAV) - Acquired immunodeficiency in ANCA associated vasculitis
Cambridge University Hospital NHS Foundation Trust and University of Cambridge0 个研究点目标入组 124 人开始时间: 2018年4月23日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 124
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
入选标准
- •To be included in the trial all participants must:
- •Have given written informed consent to participate
- •Be aged 40 years and over
- •For patients in Group 1 only (rituximab treated):
- •Have a diagnosis of AAV [granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) or eosinophilic granulomatosis with polyangiitis (eGPA)]
- •Have current or historical PR3/MPO ANCA positivity by ELISA or histological confirmation of AAV
- •Have received = 2g rituximab
- •Have received their last dose of rituximab at least 12 months prior to enrolment
- •Be in stable remission with a prednisolone dose of = 5mg/day
- •For patients in Group 2 only (disease controls who have never received rituximab):
- •Have a diagnosis of AAV (GPA, MPA or eGPA)
- •Have current or historical PR3/MPO ANCA positivity by ELISA or histological confirmation of AAV
- •Have received cyclophosphamide (oral or IV) as initial induction therapy
- •Be on stable immunosuppression for the 6 months preceding screening including prednisolone = 5mg/day AND either azathioprine, methotrexate or mycophenolate mofetil (at stable or tapering dose)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 62
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 62
排除标准
- •The presence of any of the following will preclude participant inclusion:
- •Age < 40 years
- •History of severe allergic or anaphylactic reactions to pneumococcal vaccinations including excipients and diptheria toxoid.
- •Pneumococcal vaccination within 5 years prior to screening
- •Females who are pregnant, plan to become pregnant, or breast feeding
- •Medical, psychiatric, cognitive or other conditions that, in the investigator's opinion, compromise the patient's ability to understand the patient information, give informed consent, comply with the trial protocol, or to complete the study.
- •History of malignancy within the past five years 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.
- •Replacement immunoglobulin (IVIg) administered intravenously or subcutaneously in the 12 weeks prior to screening visit.
- •For patients in Groups 1 and 2 only (AAV patients):
- •Presence of another multisystem autoimmune rheumatic disease
- •The prior receipt of more than 36g of cumulative cyclophosphamide ever (either IV or oral)
- •For patients in group 1 only (rituximab group)
- •The receipt of any immune suppressing agent (azathioprine, methotrexate or mycophenolate mofetil) after rituximab
- •For patients in Group 2 only (disease controls):
- •A relapse of AAV within the 6 months prior to screening which has necessitated an increase in prednisolone or azathioprine, methotrexate or MMF dose.
- •Previous rituximab therapy at any time
- •For healthy controls:
- •Any history of any autoimmune condition
- •Any history of use of immune suppressing medication, including > 4 weeks of oral glucocorticoids, within the 5 years prior to screening.
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