EUCTR2013-005535-24-GB进行中（未招募）1 期
Abatacept (CTLA4-Ig) for the treatment of relapsing, non-severe, granulomatosis with polyangiitis (Wegener's) - ABROGATE
niveristy of South Florida0 个研究点目标入组 150 人开始时间: 2015年12月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
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.Patients must have met at least 2 of the 5 modified ACR classification criteria for GPA. These do not need to be present at the time of study entry. The modified ACR criteria are:
- •a.Nasal or oral inflammation, defined as the development of painful or painless oral ulcers or purulent or bloody nasal discharge
- •b.Abnormal chest radiograph, defined as the presence of nodules, fixed infiltrates, or cavities
- •c.Active urinary sediment, defined as microscopic hematuria (> 5 red blood cells per high power field) or red blood cell casts
- •d.Granulomatous inflammation on biopsy, defined as histologic changes showing granulomatous inflammation within the wall of an artery or in the perivascular or extravascular area (artery or arteriole)
- •e.Positive anti-neutrophil cytoplasmic antibody (ANCA) test specific for proteinase-3 measured by enzyme-linked immunoassay
- •2.Relapse of GPA within the 28 days prior to screening where the active disease features meet the following definition of non-severe disease:
- •a.No disease manifestations that would be scored as a major element in the BVAS/WG (49)
- •b.Absence of any disease feature that poses an immediate threat to either a critical individual organ or the patient’s life
- •3.Age of 15 years or older
- •4.Willing and able to comply with treatment and follow-up procedures
- •5.Both women and men must be willing to use an effective means of birth control while receiving treatment through this study. Effective contraception methods include abstinence, oral contraceptives (birth control pills), IUD, diaphragm, Norplant, approved hormone injections, condoms, or medical sterilization.
- •6.Willing and able to provide written informed consent with the written assent of those < 18 years of age.
- •Are the trial subjects under 18? yes
- •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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1.Presence of involvement that does not meet the criteria for non-severe disease
- •2.Treatment with CYC within 3 months prior to screening
- •3.Treatment with methylprednisolone 1000 mg within 28 days prior to enrollment
- •4.Treatment with prednisone > 30 mg/day for > 28 days immediately prior to study entry
- •5.Initiation or dose increase of the maintenance immunosuppressive agent (MTX, AZA, MA) within 3 months prior to screening
- •6.Evidence of active infection (includes chronic infection)
- •7.Patients who are pregnant or who are nursing infants
- •8.Known infection with human immunodeficiency virus (HIV), hepatitis C, or a positive hepatitis B surface antigen
- •9.Inability to comply with study guidelines
- •10.Cytopenia: platelet count < 100,000/mm3, white blood cell count (WBC) < 3,000/mm3 (3 x 109/L), absolute neutrophil count < 1500/mm3, hemoglobin (Hgb) < 8.5 g/dL
- •11.Chronic renal insufficiency defined by a creatinine clearance of less than or equal to 20 ml/min
- •12.Known current use of illegal drugs
- •13.Other uncontrolled disease (co-morbidity) that could prevent a patient from fulfilling the study requirements or that would substantially increase the risk of study procedures
- •14.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
- •15.Receipt of an investigational agent or device within 30 days prior to enrollment or 5 half lives of the investigational drug (whichever is longer)
- •16.A live vaccination fewer than 3 months before enrollment
- •17.Current clinical, radiographic, or laboratory evidence of active tuberculosis
- •18.A history of active tuberculosis within the past 3 years even if treated
- •19.A history of active tuberculosis greater than 3 years ago unless there is documentation of prior anti-tuberculosis treatment of appropriate duration and type
- •20.Latent tuberculosis unless there is documentation of prior anti-tuberculosis treatment of appropriate duration and type
- •21.Latent tuberculosis currently being treated with isoniazid (INH) or other therapy for latent tuberculosis given according to local health authority guidelines (e.g., Center for Disease Control) who have received such therapy for 4 weeks or less prior to randomization (Day 1). Subjects with a positive tuberculosis screening test indicative of latent tuberculosis will be eligible for the study if they have no evidence of current tuberculosis on chest x-ray at screening and they are actively being treated for tuberculosis with INH or other therapy for latent tuberculosis given according to local health authority guidelines (e.g., Center for Disease Control) that has been given for at least 4 weeks prior to randomization (Day 1). These subjects must complete treatment according to local health authority guidelines.
- •22.History of herpes zoster that resolved less than 2 months prior to enrollment
- •23.Treatment with rituximab or any other biologic B cell depleting agent within the past 6 months, or past treatment with rituximab or any other biologic B cell deleting agent where the B lymphocyte count remains < 60 cells/uL
- •24.Treatment with alemtuzumab or anti-thymocyte globulin within the last 12 months
- •25.Treatment with intravenous immunoglobulin or plasma exchange within the past 3 months
- •26.Treatment with infliximab, etanercept, adalimumab, tocilizumab, or any othe
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