Evaluation of Efficacy and Safety of Rituximab With Mycophenolate Mofetil in Patients With Interstitial Lung Diseases
NCT ID: NCT02990286
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
122 participants
INTERVENTIONAL
2017-01-20
2020-02-17
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Rituximab with Mycophenolate Mofetil
Rituximab
Rituximab 500mg concentrate for solution for infusion. One course of IV rituximab consisting of a first infusion of 1000 mg (500 ml solution) rituximab (day 1 infusion), and a second infusion of 1000 mg (500 ml solution) rituximab two weeks later (day 15 infusion)
Mycophenolate Mofetil
Mycophenolate Mofetil 500mg film-coated tablets
1 gram twice daily on oral route of MMF (= 2 grams daily) for 6 months.
Placebo of rituximab with Mycophenolate Mofetil
Placebo of Rituximab
500 ml of saline (0.9% sodium chloride) for infusion One course of intravenous placebo of rituximab consisting of a first infusion of 500 ml of saline (0.9% sodium chloride) infusion (day 1 infusion), and a second infusion of 500 ml of saline infusion two weeks later (day 15 infusion)
Mycophenolate Mofetil
Mycophenolate Mofetil 500mg film-coated tablets
1 gram twice daily on oral route of MMF (= 2 grams daily) for 6 months.
Interventions
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Rituximab
Rituximab 500mg concentrate for solution for infusion. One course of IV rituximab consisting of a first infusion of 1000 mg (500 ml solution) rituximab (day 1 infusion), and a second infusion of 1000 mg (500 ml solution) rituximab two weeks later (day 15 infusion)
Placebo of Rituximab
500 ml of saline (0.9% sodium chloride) for infusion One course of intravenous placebo of rituximab consisting of a first infusion of 500 ml of saline (0.9% sodium chloride) infusion (day 1 infusion), and a second infusion of 500 ml of saline infusion two weeks later (day 15 infusion)
Mycophenolate Mofetil
Mycophenolate Mofetil 500mg film-coated tablets
1 gram twice daily on oral route of MMF (= 2 grams daily) for 6 months.
Eligibility Criteria
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Inclusion Criteria
2. A diagnosis of ILD:
* ILD associated with differentiated CTD or IPAF (based on internationally accepted criteria)
* OR idiopathic ILD
3. A diagnosis of NSIP based on:
* a histological pattern of NSIP
* OR 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
4. 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.
5. Subjects covered by or having the rights to French social security (including CMU),
6. 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.
7. Ability for subject to comply with the requirements of the study
Exclusion Criteria
2. 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.
3. HRCT pattern of typical usual interstitial pneumonia (UIP)
4. For patients with idiopathic ILD, HRCT pattern of possible UIP (no evocative of NSIP)
5. Histological pattern other than pattern of NSIP
6. A first line treatment with MMF or rituximab
7. Known hypersensitivity to MMF or rituximab or sulfonamide antibiotics
8. Treatment with immunosuppressive treatments other than corticosteroids:
* 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
9. Patients registered on a pulmonary transplantation list
10. Patients with known hypoxanthine-guanine phosphoribosyl-transferase (HGPRT) hereditary deficiency (such as Lesch-Nyhan and Kelley-Seegmiller syndrome)
11. 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.
12. 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
13. Current history of substance and/or alcohol abuse
14. Deprivation of liberty, under judicial protection
15. Participation in another biomedical research with experimental drug or medical device
18 Years
ALL
No
Sponsors
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University Hospital, Tours
OTHER
Responsible Party
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Principal Investigators
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TRACLET Julie
Role: PRINCIPAL_INVESTIGATOR
HC LYON
NUNES Hilario
Role: PRINCIPAL_INVESTIGATOR
AP-HP - Hôpital Avicenne
CRESTANI Bruno
Role: PRINCIPAL_INVESTIGATOR
AP-HP - Hôpital Bichat
ISRAEL BIET Dominique
Role: PRINCIPAL_INVESTIGATOR
AP-HP HEGP
NACCACHE Jean-Marc
Role: PRINCIPAL_INVESTIGATOR
AP-HP - Hôpital Tenon
WEMEAU Lidwine
Role: PRINCIPAL_INVESTIGATOR
CHRU LILLE
JOUNEAU Stéphane
Role: PRINCIPAL_INVESTIGATOR
CHU Rennes
PREVOT Grégoire
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Toulouse
REYNAUD-GAUBERT Martine
Role: PRINCIPAL_INVESTIGATOR
AP-HM Hôpital Nord
HIRSCHI SANTELMO Sandrine
Role: PRINCIPAL_INVESTIGATOR
CHRU Strasbourg
GONDOUIN Anne
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universitaire de Besancon
COURT-FORTUNE Isabelle
Role: PRINCIPAL_INVESTIGATOR
CHU ST-ETIENNE
BONNIAUD Philippe
Role: PRINCIPAL_INVESTIGATOR
CHU DIJON
QUETANT Sébastien
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Grenoble
GOMEZ Emmanuel
Role: PRINCIPAL_INVESTIGATOR
CHU NANCY
BLANC François-Xavier
Role: PRINCIPAL_INVESTIGATOR
Nantes University Hospital
MARQUETTE Charles-Hugo
Role: PRINCIPAL_INVESTIGATOR
CHU NICE
MARCHAND-ADAM Sylvain
Role: PRINCIPAL_INVESTIGATOR
CHRU TOURS
Locations
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Chu Besancon
Besançon, , France
Chu Dijon
Dijon, , France
AP-HM Hôpital NORD
Marseille, , France
Chu Rennes
Rennes, , France
CHRU Tours
Tours, , France
Countries
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References
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Mankikian J, Caille A, Reynaud-Gaubert M, Agier MS, Bermudez J, Bonniaud P, Borie R, Brillet PY, Cadranel J, Court-Fortune I, Crestani B, Debray MP, Gomez E, Gondouin A, Hirschi-Santelmo S, Israel-Biet D, Jouneau S, Juvin K, Leger J, Kerjouan M, Marquette CH, Naccache JM, Nunes H, Plantier L, Prevot G, Quetant S, Traclet J, Valentin V, Uzunhan Y, Wemeau-Stervinou L, Bejan-Angoulvant T, Cottin V, Marchand-Adam S; EVER-ILD investigators and the OrphaLung network. Rituximab and mycophenolate mofetil combination in patients with interstitial lung disease (EVER-ILD): a double-blind, randomised, placebo-controlled trial. Eur Respir J. 2023 Jun 8;61(6):2202071. doi: 10.1183/13993003.02071-2022. Print 2023 Jun.
Bejan-Angoulvant T, Naccache JM, Caille A, Borie R, Nunes H, Ferreira M, Cadranel J, Crestani B, Cottin V, Marchand-Adam S; OrphaLung. Evaluation of efficacy and safety of rituximab in combination with mycophenolate mofetil in patients with nonspecific interstitial pneumonia non-responding to a first-line immunosuppressive treatment (EVER-ILD): A double-blind placebo-controlled randomized trial. Respir Med Res. 2020 Nov;78:100770. doi: 10.1016/j.resmer.2020.100770. Epub 2020 May 23.
Other Identifiers
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PHRN15-SMA/EvER-ILD
Identifier Type: -
Identifier Source: org_study_id