A Phase 2 interventional study of Rituximab and Placebo in Systemic Sclerosis in Adults, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 2, Interventional, and Treatment
The purpose of this study is to determine whether Rituximab is safe and effective as a maintenance strategy in individuals with stabilized systemic sclerosis in adults.
Systemic sclerosis (SSc) is a rare autoimmune connective tissue-disease. Interstitial lung disease (ILD) is a common manifestation and a leading cause of death in SSc.
Rituximab (RTX) is commonly used in SSc-ILD induction treatment and recent trials have now fully demonstrated its safety and efficacy as an induction treatment. The DESIRES trial reported that RTX-induction was associated with a 24-week stabilization of FVC. As evaluated by the FVC at 24 weeks from baseline, 25 patients with SSc-ILD treated with RTX were significantly improved compared with 23 patients treated with placebo (0.09% vs -2.87%; [95%CI 0.08-5.84]; p \< 0.05). Recently, the RECITAL trial showed the absence of difference between induction treatment with cyclophosphamide (CYC) and RTX in ILD including SSc-ILD. Indeed, both RTX and CYC resulted in an improvement in FVC (97 ± 234mL and 99 ± 329mL respectively) at 24 weeks, without significant statistical difference in 101 subjects. Furthermore, the EVER-ILD study, also very recently presented, reported a beneficial of RTX in addition to mycophenolate mofetil (MMF) over RTX in CTD-ILD. Altogether with previous European database studies which analyzed the very common usage of RTX as induction therapy in SSc, these studies have confirmed its efficient and safe role as an induction treatment in SSc-ILD.
Still, the impact of re-treatment with RTX in maintaining ILD-stabilization has never been studied and deserve to be studied.
The hypothesis that drives the MAINRITSyS is that RTX maintains ILD stabilization in SSc-ILD.
610 studies on the registry are indexed under Scleroderma, Systemic; 218 are open to participants now.
This study's planned enrollment of 120 is above the median of 37 across 446 interventional studies indexed under Scleroderma, Systemic.
Browse Scleroderma, Systemic studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
The interval between the last induction dose and the first maintenance dose should be 6 months +/- 15 days.
Exclusion Criteria
Any of the following laboratory parameters:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
500mg of i.v rituximab at M0, M6 and M12
Drug: Rituximab
500mg of i.v placebo at M0, M6 and M12
Drug: Placebo
500mg i.v at M0, M6 and M12
500mg i.v at M0, M6 and M12
changes in forced vital capacity (FVC) from baseline to Month 18 of randomisation.
PFTs: changes in forced vital capacity (FVC)
Time frame: 18 months
Mortality up to 18 months
Time frame: 18 months
Occurrence of Adverse Events
Occurrence of adverse events, overall and occurring at time of perfusion (day 0, and 6, 12 and 18 months)
Time frame: At 6, 12 and 18 months
Occurrence of Adverse Events
The number of adverse events, expressed according to the Common Terminology Criteria for Adverse Events (CTCAE): CTCAE toxicity grading system per patient-year at month 6, 12, and 18, for the following adverse events combined: death (all causes), grade 2 or higher leukopenia or thrombocytopenia, grade 3 or higher infections, hospitalization resulting either from the disease or from a complication due to the study treatment.
Time frame: At 6, 12 and 18 months
Occurrence of AE of specific interest previously mentioned at 6, 12 and 18 months
Time frame: At 6, 12 and 18 months
Change in gammaglobulin, lymphocytes and CD19 levels at 6, 12 and 18 months
Time frame: At 6, 12 and 18 months
Change from baseline in DLCO over 6, 12, and 18 months
Time frame: At 6, 12 and 18 months
Change from baseline in TLC over 6, 12, and 18 months
Time frame: At 6, 12 and 18 months
Further analyses on TLC
Absolute categorical change of % TLC at 6, 12 and 18 months (decrease by \>5%, increase by \>5% and change within \<5%) Absolute categorical change of % TLC at 6, 12 and 18 months (decrease by \>10%, increase by \>10% and change within \<10%)
Time frame: At 6, 12 and 18 months
Change from in 6-min walk test distance over 6, 12 and 18 months
Time frame: At 6, 12 and 18 months
Further analyses on FVC
* Absolute categorical change of % FVC at 6, 12 and 18 months (decrease by \>5%, increase by \>5% and change within \<5%) * Absolute categorical change of % FVC at 6, 12 and 18 months (decrease by \>10%, increase by \>10% and change within \<10%)
Time frame: At 6, 12 and 18 months
Progression-free survival (composite endpoint of mortality, transplant, treatment failure or decline in FVC >10% compared to baseline) over 6, 12 and 18 months
Time frame: At 6, 12 and 18 months
Treatment failure (as determined by need for transplant or rescue therapy) at 6, 12 and 18 months
Time frame: At 6, 12 and 18 months
INBUILD progression (as determined by the INBUILD criteria for ILD progression(73)) at 6, 12 and 18 months
Time frame: At 6, 12 and 18 months
Change from baseline in capillary oxygen saturation (SpO2) at 6, 12 and 18 months
Time frame: At 6, 12 and 18 months
Changes from baseline to 18 months in HRCT of chest images
Time frame: At 18 months
Proportions of patients who achieved 20%, 30%, 40%, 50% ,60%, 70%, 80%, 90% and 100% response criteria according to revised CRISS at 6, 12 and 18 months
Time frame: At 6, 12 and 18 months
Changes in physicians visual analogue scales over 18 months.
These scales range from 0 (minimum) to ten (maximum) points and will be performed at day 0, at 6, 12, and 18 months. Higher score mean worse outcome
Time frame: at 0, 6, 12, 18 months
Changes in patients' visual analogue scales over 18 months.
These scales range from 0 (minimum) to ten (maximum) points and will be performed at day 0, at 6, 12, and 18 months. Higher score mean better outcome
Time frame: At 0, 6, 12, and 18 months
Changes in mRSS at 6, 12, and 18 months
Higher score mean worse outcome.
Time frame: At 6, 12 and 18 months
Proportion of patients who improved mRSS at 6, 12 and 18 months after randomisation.
Time frame: At 6, 12 and 18 months
Proportion of patients with an active disease according to the European scleroderma trials and research group (EUSTAR) SSc activity index at 6, 12 and 18 months after randomisation
Time frame: At 6, 12 and 18 months
Saint Georges Respiratory Hospital Questionnaire at day 0, and at 6, 12, and 18 months after randomisation.
These questionnaires are self-administered questionnaires assessing the perception of lung disease by the patients. These scales range from 0 (minimum) to one hundred (maximum) points. Higher score mean worse outcome
Time frame: At 0, 6, 12 and 18 months
King Brief's Interstitial Lung Disease questionnaire at day 0, and at 6, 12, and 18 months after randomisation.
These questionnaires are self-administered questionnaires assessing the perception of lung disease by the patients. These scales range from 0 (minimum) to 100 (maximum) points. Higher score mean better outcome
Time frame: at 0, 6, 12, and 18 months
Short Form-36 (SF-36) health questionnaire
SF36 : 0 à 100 - These scales range from 0 (minimum) to 100 (maximum) points. Higher score mean better outcome - to assess Quality of life
Time frame: At 0, 6, 12 and 18 months
EuroQol-5 Domain (EQ5D5L) health questionnaire
EQ5D5L : The EQ-5D-5L instrument comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on a five-point scale, from 1 (no problems) to 5 (extreme problems), with higher scores reflecting worse health status. To assess quality of life.
Time frame: At 0, 6, 12 and 18 months
Scleroderma skin patients reported outcome (SSPRO) at day 0, and at 6, 12 and 18 months after randomisation.
Time frame: At 0, 6, 12 and 18 months
HAQ-DI and SHAQ scales at day 0, and at 6, 12 and 18 months after randomisation. These scales range from 0 (minimum) to 3 (maximum) points. Higher score mean worse outcome
Time frame: At 0, 6, 12 and 18 months
Total corticosteroid requirement at 6, 12 and 18 months
Time frame: At 6, 12 and 18 months
Levels of prespecified biomarkers (KL-6, SP-D, MUC1, SFTPD, CCL18 and CXCL4) at months 6, 12 and 18 months.
Time frame: At 6, 12 and 18 months
Presence of anti-RTX-antibody at months 6, 12 and 18.
Time frame: At 6, 12 and 18 months
Dosage of plasma and serum residual concentration of RTX at months 6, 12 and 18
Time frame: At 6, 12 and 18 months
Hospitalisation for respiratory cause over the duration of the trial
Time frame: At 18 months
Time to first hospitalisation for respiratory cause
Time frame: At 18 months
Time to death
Time frame: At 18 months
Time to first acute ILD exacerbation
Time frame: At 18 months
Plan to share: No
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Studies of the drug tested here: Rituximab
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