EUCTR2018-000637-12-FR进行中（未招募）1 期
Efficacy and safety of rituximab in the treatment of good prognosis microscopic polyangiitis - RITUXGOPRO
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 106
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
- •1. Patient (male or female) aged 18 years old and over
- •2. Patient agreement to participate in the study and signed written informed consent
- •3. Patient with MPA according to the CHCC established in 2012
- •4. Absence of any poor prognosis factor (modified five factor score (FFS) 1996=0)
- •5. Patient with recent onset or relapse of the disease (<1 month) defined by BVAS=3, who did not receive any other treatment than glucocorticoids over the last month. One to 3 initial glucocorticoids pulse(s) are allowed.
- •6. Patient with anti-MPO antibody measured by ELISA
- •7. Negative pregnancy test (serum ß-hCG) for women of child-bearing potential and a willingness to use contraceptive measures adequate to prevent the subject or the subject’s partner from becoming pregnant during the study and 12 months after stopping therapy
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 65
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 35
排除标准
- •1. Small-sized vessels vasculitis not associated with anti-MPO antibody or associated with anti-PR3 positivity.
- •2. Patients with either GPA or EGPA vasculitis according to ACR criteria.
- •3. Patient with a modified FFS 1996 = 1.
- •4. Patient with alveolar haemorrhage requiring mechanical ventilation.
- •5. Patient with previous glucocorticoids treatment >1 month and >10mg/day either for vasculitis or for any other reason.
- •6. Patient already receiving immunosuppressant or biological agent.
- •Prior treatment with any of the following:
- •- azathioprine, methotrexate, mycophenolate mophetil, mycophenolic acid within 4 weeks before inclusion
- •- alkylant agent such as cyclophosphamide within 6 months before inclusion
- •- anti-TNF? inhibitors : infliximab within 8 weeks, adalimumab and etanercept within 2 weeks before inclusion
- •-anti-CD20 therapy within one year before inclusion.
- •7. Patient with a previous diagnosis of cancer < 5 years (except for in situ cervical cancer and skin carcinoma with R0 resection)
- •8. Patient with acute infections or chronic active infections (including HIV, hepatitis B or C).
- •9. Breast feeding woman or woman refusing the use of a contraceptive method for the 18 months’ duration of the study.
- •10. Contraindication to treatment (glucocorticoids or rituximab).
- •11. Unable to receive written informed consent of patient. Patient unable to understand the protocol.
- •12. Patient already in another therapeutic protocol.
- •13. Patient without social security.
- •14. Patient with severe cardiac failure defined as class IV according to New York Heart Association classification.
- •15. Patients with hypersensitivity to a monoclonal antibody or biological agent.
研究者
相似试验
已完成
不适用
A study of the efficacy and safety to rituximab in treating adult onset refractory nephrotic syndromeRefractory nephrotic syndromeJPRN-UMIN000021143Fujita Health University School of Medicine, Department of Nephrology10
已完成
不适用
Efficacy and safety of rituximab for patients with severe rheumatic diseaseChildhood-onset severe rheumatic disease (systemic lupus erhythematosus, dermatomyositis, poly myositis, systemic sclerosis , mixed connective tissue disease, Sjogren's syndrome, anti-phospholipid syndrome)JPRN-UMIN000018376Yokohama City University Hospital Department of Pediatrics20
招募中
不适用
Efficacy and safety of rituximab for intractable immunogenic neurological disorder in childreJPRN-UMIN000009421Department of Pediatrics, Kobe Universtiy Graduate School of Medicine10
未知
2 期
Clinical study for effectiveness of rituximab for acquired coagulopathyacquired coagulopathyJPRN-UMIN000024612Gunma University10
进行中（未招募）
不适用
Efficacy and safety of rituximab in patients with rheumatoid arthritis - FIRSTMedDRA version: 8.1Level: PTClassification code 10039073Term: Rheumatoid arthritisRheumatoid arthritisEUCTR2006-001000-37-DERoche Pharma AG300