2025-522049-23-00招募中4 期
PREP-ANCA - Comparison of a strategy based on clinic-biological surveillance versus pre-emptive treatment with rituximab in the event of ANCA (anti-neutrophil cytoplasm antibodies) repositivation in patients with granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA)
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 20
研究概览
简要总结
To evaluate the superiority of pre-emptive treatment with rituximab compared to clinic-biological monitoring every 3 months in the event of ANCA reactivation in patients with GPA and MPA who were previously treated with rituximab for 18 months and are in complete remission. The primary outcome is the maintenance of remission, defined by a Birmingham Vasculitis Activity Score (BVAS) of 0.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Diagnosis of GPA or MPA according to the ACR/EULAR 2022 classification criteria
- •Patients previously treated with rituximab as maintenance therapy, following the recommended regimen: an intravenous infusion of 500 mg on Day 1, possibly repeated on Day 15, then every 6 months for 18 months (4 to 5 infusions of 500 mg)
- •Complete remission (BVAS = 0) at randomization
- •Patients with ANCA repositivation on a specific antigenic test within 3 months prior to randomization
- •Ability to provide written informed consent before participating in the study
- •Affiliation with a social security system
排除标准
- •Diagnosis of another vasculitis
- •Suspicion of non-compliance with treatment and foreseeable inability or refusal to complete the follow-up exams required by the protocol
- •Inability to provide written informed consent before participating in the study
- •Pregnant women and breastfeeding mothers. Women of childbearing age must use reliable contraception throughout treatment and for 6 months after the last infusion.
- •Active vasculitis
- •Acute or chronic active infection requiring hospitalization or treatment with an intravenous anti-infective drug in the 4 weeks prior to study selection, or with an oral anti-infective drug in the 2 weeks prior to selection for the trial
- •History of deep tissue infection in the year prior to inclusion in the trial
- •History of severe chronic or recurrent infections, or any underlying disease predisposing to serious infections
- •Administration of a live vaccine within 4 weeks prior to enrolment in the trial
- •Evolving cancer or recent hematological malignancy (< 5 years), except localized prostate cancer and basal cell skin cancers
- •Patients with a systemic disease for which the treatments used in the trial could have unpredictable or inappropriate consequences
- •History of allergic reactions, severe anaphylaxis, or known hypersensitivity to humanized or murine monoclonal antibodies and/or corticosteroids
研究组 & 干预措施
Truxima 500 mg concentrate for solution for infusion
Test
干预措施: Truxima 500 mg concentrate for solution for infusion (Drug)
RITUXIMAB
Comparator
干预措施: RITUXIMAB (Drug)
研究者
Dr Florence DELESTRE
Scientific
Assistance Publique Hopitaux De Paris
研究点 (20)
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