Informations générales (source: ClinicalTrials.gov)
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 (EvER-ILD2)
Interventional
Phase 3
University Hospital, Tours (Voir sur ClinicalTrials)
janvier 2023
juillet 2026
25 juillet 2024
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL NOVO | BOITIAUX | 04/07/2024 11:04:58 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Chru Tours - Tours - France | Sylvain MARCHAND-ADAM | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
1. Patients ≥ 18 years old
2. Who meet at least one of the following criteria for worsening ILD within 24 months:
1. a relative decline in the FVC of >= 10% of the predicted value
2. 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.
3. worsening of respiratory symptoms AND an increased extent of ILD on
high-resolution CT
3. AND presence of an inflammatory component defined by
1. 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...)
2. OR a previous alveolar lymphocytosis >20% on Bronchoalveolar lavage fluid
(BALF)
4. Subjects covered by the French social security system
5. Written informed consent obtained from subject
6. Ability for subject to comply with the requirements of the study
1. Patients ≥ 18 years old
2. Who meet at least one of the following criteria for worsening ILD within 24 months:
1. a relative decline in the FVC of >= 10% of the predicted value
2. 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.
3. worsening of respiratory symptoms AND an increased extent of ILD on
high-resolution CT
3. AND presence of an inflammatory component defined by
1. 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...)
2. OR a previous alveolar lymphocytosis >20% on Bronchoalveolar lavage fluid
(BALF)
4. Subjects covered by the French social security system
5. Written informed consent obtained from subject
6. Ability for subject to comply with the requirements of the study
1. 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.
2. 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.
3. Patient who can not walk more than 100 meters at 6-minutes walk test
4. HRCT profile of typical usual interstitial pneumonia (UIP)
5. Histological model of typical NSIP or definitive UIP
6. Initiation of a new therapy or with interruption/modification of therapy dosage
within 6 weeks prior to visit 1
7. Patient who has already received a rituximab-based treatment line
8. Known hypersensitivity to rituximab, to murine proteins or other excipients or
sulfonamide antibiotics.
9. 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.
10. Patients on a lung transplant list
11. 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.
12. 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.
13. 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)
14. Patient under judicial protection, deprivation of liberty
15. Participation in other interventional research with an investigational drug or
medical device.