- Maladie : pneumopathie interstitielle non spécifique (PINS)
- Catégorie : étude académique
- Promoteur : CHRU Tours
- Objectif principal : Evaluer l’ efficacité sur la fonction respiratoire à 6 mois de l¹association rituximab + MMF comparativement à l¹association placebo + MMF chez les patients atteints de PID non répondeurs à une première ligne de traitement immunosuppresseur
- Date de début de l’étude : 2017-01-16
- Date de fin de l’étude : 2020-01-15
- Autorisation : NCT02990286
- Investigateur-coordinateur : Pr MARCHAND (ADAM )
- Investigateurs : TRACLET Julie, HC Lyon– NUNES Hilario, AP-HP – Hôpital Avicenne – CRESTANI Bruno, AP-HP – Hôpital Bichat– ISRAEL BIET Dominique, AP-HP HEGP– NACCACHE Jean-Marc, AP-HP – Hôpital Tenon– WEMEAU Lidwine CHRU, Lille
JOUNEAU Stéphane – CHU, Rennes – PREVOT Grégoire CHU, Toulouse – REYNAUD-GAUBERT Martine, AP-HM Hôpital Nord Marseille – HIRSCHI SANTELMO Sandrine, CHRU Strasbourg– GONDOUIN Anne, Centre Hospitalier Universitaire de Besancon – COURT-FORTUNE Isabelle, CHU ST-Étienne – BONNIAUD Philippe, CHU Dijon – QUETANT Sébastien, University Hospital, Grenoble – GOMEZ Emmanuel, CHU Nancy – BLANC François-Xavier CHU Nantes – MARQUETTE Charles-Hugo CHU Nice, MARCHAND-ADAM Sylvain, CHRU Tours - Principaux critères d’inclusion: Age 18 years
A diagnosis of ILD: ILD associated with differentiated CTD or IPAF (based on internationally accepted criteria)OR idiopathic ILDA diagnosis of NSIP based on: a histological pattern of NSIPOR HRCT findings suggestive of NSIP defined as basal predominant reticular abnormalities with traction bronchiectasis, peri-bronchovascular extension and subpleural sparing, frequently associated with ground-glass attenuation
Patients who did not respond or relapsed or were not able to continue at least one first-line immunosuppressive treatment of ILD: corticosteroids, azathioprine, cyclophosphamide or other immunosuppressants. For the assessment of clinical response, the absence of response was defined as: either a decrease or an increase, but <10% in % predicted FVC.
Subjects covered by or having the rights to French social security (including CMU),
Written informed consent obtained from subject, with a specific check box on the Consent form of the study, understanding the risk for
men and women treated with mycophenolate mofetil. And additional written consent from subject on the care and contraception agreement form for women of childbearing potential treated with mycophenolate.
Ability for subject to comply with the requirements of the study
• Principaux critères d’exclusion: Exclusion Criteria:
Known diagnosis of significant respiratory disorders (asthma, tuberculosis, sarcoidosis, aspergillosis, or cystic fibrosis) other than CTD-NSIP, IPAF-NSIP and iNSIP
Evidence of any clinically significant, severe or unstable, acute or chronically progressive cardiac (severe heart failure New York Heart
Association Class IV or severe uncontrolled cardiac disease), other medical disease (other than NSIP) or surgical disorder, or any condition that may affect patient safety in the judgment of the investigator.
HRCT pattern of typical usual interstitial pneumonia (UIP)
For patients with idiopathic ILD, HRCT pattern of possible UIP (no evocative of NSIP)
Histological pattern other than pattern of NSIP
A first line treatment with MMF or rituximab
Known hypersensitivity to MMF or rituximab or sulfonamide antibiotics
Treatment with immunosuppressive treatments other thancorticosteroids: azathioprine, cyclophosphamide, methotrexate, cyclosporine,
tacrolimus, leflunomide within 2 weeks (5 half-lives <= 2 weeks) prior to inclusion intravenous immunoglobulins, hydroxychloroquine or other monoclonal antibody therapies (such as but not limited to etanercept, adalimumab, efalizumab, infliximab, golimumab, certolizumab) within 6 months (5 half-lives <= 6 months) prior to inclusion
Patients registered on a pulmonary transplantation list
Patients with known hypoxanthine-guanine phosphoribosyl-transferase (HGPRT) hereditary deficiency (such as Lesch-Nyhan and Kelley-Seegmiller syndrome)
Pregnant or breastfeeding women, or women of child-bearing potential not using two reliable contraceptive methods (including
female partners of sexually active men treated with mycophenolate) and men not using a contraceptive method (condom), or women and men having a pregnancy project during the year following randomization.
Patients at significant risk for infectious complications: HIV positive, other known immunodeficiency syndromes, untreated tuberculosis, hepatitis B and C or other known viral infection, infection requiring anti-infectious treatment in the preceding 4 weeks
Current history of substance and/or alcohol abuse
Deprivation of liberty, under judicial protection
Participation in another biomedical research with experimental drug or medical device
• Nombre de patients prévus : 122
• Nombre de patients inclus : 61
