2026-525394-39-00招募中2 期
Efficacy of rituximab for remission maintenance in patients with primary angiitis of the central nervous system: an open-label, randomized, controlled trial comparing systematic rituximab infusions and azathioprine - MAINRIPAC
Groupe Hospitalier Universitaire Paris Psychiatrie Et Neuroscience22 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2026年9月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 74
- 试验地点
- 22
- 主要终点
- Time to relapse up to 24 months after initiation of maintenance therapy.
研究概览
简要总结
To determine the superiority of rituximab over azathioprine for maintenance therapy in patients with primary angiitis of central nervous system
研究设计
- 分配方式
- Randomized
- 主要目的
- Le Rituximab / L'azathioprine
- 盲法
- Double (Subject, Investigator)
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patient aged of 18 years or older
- •Patients who have documented PACNS diagnosis
- •Diagnosis of PACNS validated by the study committee
- •Patients in remission after induction therapy
- •Use of an effective method of contraception for female participants of childbearing age
- •Patient able to give written informed consent prior to participation in the study
- •Affiliation with a mode of social security
排除标准
- •Patients with other vasculitis
- •Patients with severe cardiac failure
- •Patients with acute or chronic active infections
- •Patients with active or recent cancer (< 5 years)
- •Pregnant women and lactation
- •Patients with hypersensitivity to a monoclonal antibody or biologic agent
- •Patients suspected not to be observant to the proposed treatments
- •Patients unable to give written informed consent prior to participation in the study
- •Patients under guardianship, conservatorship, or subject to a court-ordered restraint
研究组 & 干预措施
Azathioprine 25 mg tablets
Comparator
干预措施: Azathioprine 25 mg tablets (Drug)
Ruxience 500 mg concentrate for solution for infusion
Test
干预措施: Ruxience 500 mg concentrate for solution for infusion (Drug)
Azathioprine 50 mg film-coated tablets
Comparator
干预措施: Azathioprine 50 mg film-coated tablets (Drug)
结局指标
主要结局
Time to relapse up to 24 months after initiation of maintenance therapy.
Time to relapse up to 24 months after initiation of maintenance therapy.
次要结局
- Proportion of participants without relapse at 12 and 24 months (see definition in section 4.1.1 of Protocol)
- Proportion of participants without clinical relapse (i.e. reoccurrence or worsening of any neurological symptoms attributable to active PACNS) at 12 and 24 months (see definition in section 4.1.1 of Protocol)
- Proportion of participants without “radiological relapse” (i.e. worsening of existing or evidence of new abnormal neuroimaging findings on MRI consistent with PACNS activity) at 12 and 24 months (see definition in section 4.1.1 of Protocol)
- Proportion of participants without evidence of new stroke lesion at 12 and 24 months
- Proportion of participants without evidence of new contrast-enhanced lesions at 12 and 24 months
- Proportion of participants without evidence of new or progressive intracranial stenosis at 12 and 24 months
- Proportion of participants without evidence of progression ≥ 50% of preexisting intracranial stenosis at 12 and 24 months.
- Proportion of participants necessitating treatment change or escalation at 12 and 24 months
- Proportion of participants with favorable outcome defined as mRS < 3 at 12 and 24 months
- The SF-36 at 12 and 24 months
- Prednisone dosage at 12 and 24 months
- The number of adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) toxicity grading system at 12 and 24 months
- Proportion of death
研究者
Sylla
Scientific
Groupe Hospitalier Universitaire Paris Psychiatrie Et Neuroscience
研究点 (22)
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