2024-516052-17-01招募中3 期
Evaluation of Glucocorticoids plus Rituximab Compared to Glucocorticoids Plus Placebo for the Treatment of Patients With Newly-Diagnosed or Relapsing IgA vasculitis: A Prospective, randomized, controlled, double-blind study
Hospital Foch33 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2024年11月28日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 33
- 主要终点
- The proportion of patients alive who achieve remission with a prednisone dose of 0 mg/day at both days 180 and 360.
研究概览
简要总结
To determine the efficacy of rituximab to induce remission in patients with newly-diagnosed or relapsing adult IgAV.
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
- •Biopsy-proven diagnosis of IgAV according to Chapel Hill Consensus Conference definitions
- •Patient aged of 18 years or older
- •Patients with newly-diagnosed disease or relapsing disease at the time of screening, with an active disease defined by active manifestations attributable to IgAV
- •Patients with severe involvement of at least one organ
- •Patients within the first 21 days following initiation/increase of corticosteroids at a dose ≤1 mg/kg/day (pulses of methylprednisolone before oral corticosteroids therapy are not mandatory by the protocol but are allowed according to the physician’s discretion )
- •Patients must have signed an informed consent form prior to any study related procedures
- •Patients must be affiliated to the national health insurance
排除标准
- •Patients with ANCA-associated vasculitis, or other vasculitis, defined by the ACR criteria and/or the Chapel Hill Consensus Conference
- •Patients with IgAV in remission of the disease
- •Patients with severe cardiac failure defined as class IV in New York Heart Association
- •Patients with severe, uncontrolled cardiac disease
- •Patients with acute infections or chronic active infections (including HIV, HBV or HCV)
- •Patients with active cancer or recent malignancy (<5 years), except basocellular carcinoma and prostatic cancer of low activity controlled by hormonal treatment
- •Pregnant women and breastfeeding. Patients with childbearing potential must use reliable contraceptive methods throughout the study and at least for 12 months after the last study drug administration
- •Patients with IgAV who have already been treated with rituximab within the previous 12 months
- •New onset of immunosuppressive therapy within the last 3 months
- •Patients unable to give written informed consent prior to participation in the study,
- •Being deprived of liberty or under guardianship.
- •Patients with hypersensitivity to human or chimeric monoclonal antibodies
- •Patients with contraindication to use rituximab
- •Patients treated with any concomitant drugs contraindicated for use with the rituximab according to its SmPC
- •Patients with contraindication to use routine care treatments (Glucocorticoids, Angiotensin-converting-enzyme (ACEis) or angiotensin receptor blockers (ARBs), dexchlorphéniramine)
- •Patients in a severely immunocompromised state
- •Patients with other uncontrolled diseases, including drug or alcohol abuse, severe psychiatric disorders, that could interfere with his/her compliance to the protocol requirements
- •Patients currently participating in another clinical study or 3 months prior to randomization
- •Patients suspected not to be observant to the proposed treatments
结局指标
主要结局
The proportion of patients alive who achieve remission with a prednisone dose of 0 mg/day at both days 180 and 360.
The proportion of patients alive who achieve remission with a prednisone dose of 0 mg/day at both days 180 and 360.
The primary assessment criterion of this trial is the proportion of patients alive who achieved remission with a prednisone dose of 0 mg/day at both days 180 and 360.
The primary assessment criterion of this trial is the proportion of patients alive who achieved remission with a prednisone dose of 0 mg/day at both days 180 and 360.
次要结局
- Time to first IgAV relapse
- Number of major and minor relapse at 12 months
- Cumulative incidence of relapse at 12 months
- Area under the curve for prednisone dose at days 180 and 360 in the two treatment groups
- Proportion of patients in remission at days 180
- Proportion of patients in remission at days 360
- Proportion of patients in remission both at days 180 and 360
- Proportion of patients achieving remission for ≥3 consecutive months over the 360 days study period
- Proportion of patients with BVAS=0 (or BVAS of ≤5 if all scores were due to persistent hematuria or proteinuria) and a prednisone dose ≤5 mg/day at days 180 and 360
- Mean total accrued duration in weeks in remission of the disease (as previously defined) over the 360 days study period
- Proportion of patients in complete renal and partial renal remission at days 180 and 360
- Renal parameters at days 180 and 360 compared with baseline: eGFR, daily proteinuria, hematuria, arterial hypertension, use of angiotensin converting enzyme inhibitor, occurrence of end-stage renal disease
- Prednisone dosage at days 180 and 360 in the two treatment groups
- Adverse events, expressed as adverse events according to the CTCAE toxicity grading system per patient-year at days 180 and 360 for the following adverse events combined: death (all causes), grade 2 or higher leukopenia or thrombocytopenia, grade 3 or higher infections, malignancies, venous thromboembolic events, hospitalization resulting either from the disease or from a complication due to the study treatment, infusion reactions (within 24 hours of infusion)
- The Vasculitis Damage Index at days 180 and 360 in the two treatment groups
- Quality of life as measured by the HAQ and SF-36 questionnaires at days 180 and 360
- The patient-reported outcomes (PRO) including patient-reported disease activity, anxiety and depression, burden of the disease and treatment and adherence to treatment, at days 180 and 360 after randomization in the two treatment groups, and during the long-term follow-up
- Patient survival
研究者
Marjolaine NGOLLO
Scientific
Hospital Foch
研究点 (33)
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