NCT05596786招募中3 期
Evaluation de l'efficacité et de la sécurité du Rituximab Chez Les Patients Avec Une Pneumopathie Interstitielle Diffuse Progressive Avec Composante Inflammatoire : Essai Clinique randomisé Multicentrique en Double Insu Contre Placebo
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Forced vital capacity
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
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 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 relative decline in the FVC of >= 10% of the predicted value
- •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.
- •worsening of respiratory symptoms AND an increased extent of ILD on high-resolution CT
- •AND presence of an inflammatory component defined by
- •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...)
- •OR a previous alveolar lymphocytosis >20% on Bronchoalveolar lavage fluid (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, idiopathic pulmonary fibrosis (IPF), Connective Tissue Diseases-ILD, sarcoidosis, desquamative interstitial pneumonia, pulmonary hypertension (PAMp > 30mmHg))) or of significant severe heart failure.
- •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 cardiomyopathy or heart failure.
- •Patient who can not walk more than 100 meters at 6-minutes walk test
- •HRCT profile of typical usual interstitial pneumonia (UIP)
- •Histological model of typical NSIP or definitive 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) within 6 months (if 5 half-lives ≤ 6 months) prior to inclusion.
- •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), coronavirus disease (within 3 month) or other known viral infection, infection requiring anti-infective treatment within 4 weeks of inclusion.
- •Patients with incomplete anti-severe acute respiratory syndrome coronavirus 2 vaccine regimen (according to current recommendations) and in this case who has not receive a 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.
研究组 & 干预措施
Rituximab
Experimental
干预措施: Rituximab (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
Forced vital capacity
时间窗: 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
- Forced vital capacity(From baseline to 6 months)
- King's Brief Interstitial Lung Disease (K-BILD) questionnaire(From baseline to 6 months)
- Cumulative doses of corticosteroids(At 6 months)
- Diffusing capacity for carbon monoxide (DLCO)(From baseline to 6 months)
- Pharmacokinetic parameters of rituximab(Before and 2 hours after the end of each infusions, at 3 and 6 months after the first infusion)
- Adverse events(From baseline to 6 months)
- L-PF symptom questionnaire(From baseline to 6 months)
- 6 minutes walk test(From baseline to 6 months)
- High-resolution computed tomography (HRCT) of chest images(From baseline to 6 months)
- Progression free survival (PFS)(At 6 months)
- L-PF impact questionnaire(From baseline to 6 months)
- Accelerometer-assessed physical activity(From baseline to 6 months)
- Biological analyse on markers related to B-cell depletion(From baseline to 6 months)
- Environmental antigens(From baseline to 6 months)
- Severe Acute Respiratory Syndrome COronaVirus 2 (SARS COV 2) antibodies(From baseline to 6 months)
研究者
研究点 (1)
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