2022-501335-16-00招募中3 期
EvER-ILD 2: Evaluation of Efficacy and safety of Rituximab in patients with progressive Interstitial Lung Disease (ILD) with inflammatory component: a multicentre double-blind placebo-controlled randomized trial
Centre Hospitalier Regional Universitaire De Tours, Centre Hospitalier Regional Universitaire De Tours29 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2022年10月10日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 126
- 试验地点
- 29
- 主要终点
- The primary outcome is the change in Forced Vital Capacity (FVC) (in mL) from baseline to 6 months.
研究概览
简要总结
The main objective of the EvER-ILD2 study is to evaluate the efficacy on lung function at 6 months of one course rituximab (2 infusions) comparatively to one course of placebo (2 infusions) in a broad range of progressive ILD patients with inflammatory component.
研究设计
- 分配方式
- Randomized
- 主要目的
- M6
- 盲法
- Double (Analyst, Investigator, Carer, Subject, Monitor)
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
- •Patients ≥ 18 years old
- •Who meet at least one of the following criteria for worsening ILD within 24 months: a) a relative decline in the FVC of >= 10% of the predicted value b) a relative decrease in the FVC of >=5 to 10% of the predicted value AND i) worsening respiratory symptoms OR ii) an increased extent of ILD on high-resolution CT OR iii) a relative decrease in the DLCO of >= 15% of the predicted value. c) worsening of respiratory symptoms AND an increased extent of ILD on high-resolution CT
- •AND presence of an inflammatory component defined by: a) a previous histological pattern with lymphocyte infiltrations distant from pulmonary fibrosis to suggest an inflammatory component on pulmonary sample (for example: interstitial lymphoid aggregates with germinal centers, diffuse lympho-plasmocytic infiltrations, granulomas, giant cells or centrilobular inflammation…) b) OR a previous alveolar lymphocytosis > 20% on BALF
- •Subjects covered by the French social security system
- •Written informed consent obtained from subject
- •Ability for subject to comply with the requirements of the study.
排除标准
- •Known diagnosis of significant respiratory disorders (asthma, tuberculosis, aspergillosis, cystic fibrosis, IPF, CTD-ILD, sarcoidosis, desquamative interstitial pneumonia, pulmonary hypertension (PAMp > 30mmHg)) or a significant severe heart failure
- •Patients on a lung transplant list
- •Pregnant or breastfeeding women, or women of childbearing age not using a reliable method of contraception during the study and for 12 months following the end of the study treatment
- •Patients at high risk of infectious complications: Human Immunodeficiency Virus (HIV) positive or other known immunodeficiency syndromes, hepatitis B and C (HBV, HCV), COVID (within 3 month) or other known viral infection, infection requiring anti-infective treatment within 4 weeks of inclusion
- •Patients with incomplete anti-SarsCoV2 vaccine regimen (according to current recommendations) or patient who has not receive treatment with therapeutic antibodies anti-SARSCov2 (ex: tixagévimab/cilgavimab)
- •Patient under judicial protection, deprivation of liberty
- •Participation in other interventional research with an investigational drug or medical device.
- •Concomitant medical or surgical disease, clinically significant as considered by the investigator, serious or unstable, acute or chronically progressive, or any condition that could affect the safety of the patient, in the opinion of the investigator, including severe cardiomyopathy or severe heart failure
- •Patient who cannot walk more than 100 meters at 6-minutes walk test
- •HRCT profile of definite usual interstitial pneumonia (UIP)
- •Histological model of definite UIP
- •Initiation of a new therapy or with interruption/modification of therapy dosage within 6 weeks prior to visit 1
- •Patient who has already received a rituximab-based treatment line
- •Known hypersensitivity to rituximab, to murine proteins or other excipients or sulfonamide antibiotics
- •Treatment with monoclonal antibodies (such as, but not limited to, etanercept, adalimumab, efalizumab, infliximab, golimumab, certolizumab, tocilizumab) within 6 months (if 5 half-lives ≤ 6 months) prior to inclusion
结局指标
主要结局
The primary outcome is the change in Forced Vital Capacity (FVC) (in mL) from baseline to 6 months.
The primary outcome is the change in Forced Vital Capacity (FVC) (in mL) from baseline to 6 months.
次要结局
- Change from baseline in FVC (in % of predicted) to 6 months
- Progression free survival (PFS) at 6 months, defined as the time to (first event considered): a) a first acute exacerbation, or b) a relative decline in the FVC of ≥ 10% of the predicted value, or c) the need for new immunosuppressive therapy or/and anti-fibrotic therapies (excluding corticosteroids), or d) inclusion on a lung transplant list, or e) death.
- Changes from baseline to 6 months in the King’s Brief Interstitial Lung Disease (K-BILD) questionnaire and L-PF symptom and impact questionnaire
- Difference in cumulative doses of corticosteroids at 6 months
- Changes from baseline to 6 months in % of predicted diffusing capacity for carbon monoxide (DLCO)
- Changes from baseline to 6 months in the 6-minute walk test
- Change from baseline to 6 months in accelerometer-assessed physical activity
- Changes from baseline to 6 months of biological markers related to B-cell depletion: CD19 lymphocytes and gammaglobulins,
- Changes from baseline to 6 months of serology by ELISA of 15 environmental antigens.
- Changes from baseline to 6 months in high-resolution computed tomography (HRCT) of chest images
- All adverse events, especially serious infectious adverse events, occurring during the six-month treatment period
- Pharmacokinetic parameters of rituximab: volume of distribution, rituximab clearance and half-life
- Change from baseline to 6 months of SARS COV 2 antibodies
研究者
Pr. MARCHAND ADAM
Scientific
Centre Hospitalier Regional Universitaire De Tours
研究点 (29)
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