Learn about Research & Clinical Trials

Evaluation of Efficacy and Safety of Rituximab With Mycophenolate Mofetil in Patients With Interstitial Lung Diseases

Study Purpose

The purpose of the study is to evaluate the efficacy on lung function 6 months after one course of rituximab (2 infusions) and mycophénolate mofétil (MMF) treatment compared to one course of placebo and 6 months of MMF treatment in a broad range of patients with Interstitial Lung Diseases (ILD) non-responders to a first line immunosuppressive treatment.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Age ≥ 18 years. 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:

1. Known diagnosis of significant respiratory disorders (asthma, tuberculosis, sarcoidosis, aspergillosis, or cystic fibrosis) other than CTD-NSIP, IPAF-NSIP and iNSIP. 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02990286
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University Hospital, Tours
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

TRACLET JulieNUNES HilarioCRESTANI BrunoISRAEL BIET DominiqueNACCACHE Jean-MarcWEMEAU LidwineJOUNEAU StéphanePREVOT GrégoireREYNAUD-GAUBERT MartineHIRSCHI SANTELMO SandrineGONDOUIN AnneCOURT-FORTUNE IsabelleBONNIAUD PhilippeQUETANT SébastienGOMEZ EmmanuelBLANC François-XavierMARQUETTE Charles-HugoMARCHAND-ADAM Sylvain
Principal Investigator Affiliation HC LYONAP-HP - Hôpital AvicenneAP-HP - Hôpital BichatAP-HP HEGPAP-HP - Hôpital TenonCHRU LILLECHU RENNESCHU TOULOUSEAP-HM Hôpital NordCHRU StrasbourgCentre Hospitalier Universitaire de BesanconCHU ST-ETIENNECHU DIJONUniversity Hospital, GrenobleCHU NANCYCHU NantesCHU NICECHRU TOURS
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Lung Disease, Interstitial
Arms & Interventions

Arms

Experimental: Rituximab with Mycophenolate Mofetil

Placebo Comparator: Placebo of rituximab with Mycophenolate Mofetil

Interventions

Drug: - 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)

Drug: - 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)

Drug: - Mycophenolate Mofetil

Mycophenolate Mofetil 500mg film-coated tablets 1 gram twice daily on oral route of MMF (= 2 grams daily) for 6 months.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Chu Besancon, Besancon, France

Status

Recruiting

Address

Chu Besancon

Besancon, , 25030

Chu Dijon, Dijon, France

Status

Recruiting

Address

Chu Dijon

Dijon, , 21079

Site Contact

BONNIAUD Philippe

sylvain.marchand-adam@univ-tours.fr

2 47 47 98 34

AP-HM Hôpital NORD, Marseille, France

Status

Recruiting

Address

AP-HM Hôpital NORD

Marseille, , 13015

Site Contact

REYNAUD-GAUBERT Martine

sylvain.marchand-adam@univ-tours.fr

2 47 47 98 34

Chu Rennes, Rennes, France

Status

Recruiting

Address

Chu Rennes

Rennes, , 35033

Site Contact

JOUNEAU Stéphane

sylvain.marchand-adam@univ-tours.fr

2 47 47 98 34

CHRU Tours, Tours, France

Status

Recruiting

Address

CHRU Tours

Tours, , 37044

Site Contact

MARCHAND-ADAM Sylvain

sylvain.marchand-adam@univ-tours.fr

2 47 47 98 34