Systemic Sclerosis in AdultsPhase 2MAINRITSySNCT07827742
Rituximab vs Placebo for Maintenance in Systemic Sclerosis - Interstitial Lung Disease
A Phase 2 study testing Rituximab in people with Systemic Sclerosis in Adults, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Sclerosis in Adults
- What is being tested?
- Rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2026to Mar 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient (≥ 18 years old),
- Patient with a diagnosis of SSc, as defined by the ACR/EULAR 2013 criteria (cf. Table 2) (6)
- Patient with ILD identified on the basis of a HRCT, obtained within 12 months before screening, that showed fibrosis affecting at least 10% of the lungs,
- SSc-ILD induction with RTX, either twice 1000 mg two weeks apart, or 375 mg/m2 four times 4 weeks apart.
- The interval between the last induction dose and the first maintenance dose should be 6 months +/- 15 days.
- Patient with stabilized SSc-ILD following RTX induction treatment as defined by the absence of worsening respiratory symptoms, an absolute decline of FVC of < 5% of the predicted value, an absence of absolute decline of DLCO (corrected for hemoglobin) of < 10% related to SSc-ILD, and absence of radiological evidence of disease progression on HRCT(97)
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- All required vaccinations must have been carried out at least 4 weeks before D0. According to recommendations, prophylaxis against pneumocystis is recommended for scleroderma, but not mandatory.
- Woman of childbearing potential should have reliable contraception* for the 12 months' duration of the study's treatment and 12 months after last administration,
- Patient able to give written informed consent prior to participation in the study,
- Affiliation to a social security scheme (profit or being entitled). AME is not accepted.
Who cannot join
- Forced vital capacity < 40% of the predicted value
- Diffusion capacity of the lung for carbon monoxide (DLCO) (corrected for hemoglobin) < 30% of the predicted value.
- Contra-indication or anaphylaxis toward RTX
- Contra-indication to auxiliary medicinal products
- Cyclophosphamide, tacrolimus, ciclosporin, or voclosporin during the 2 months prior to screening or during screening
- Any biologic therapy (including other anti-CD20, anti-CD19, or anti-plasma cell) such as, but not limited to, belimumab, ustekinumab, anifrolumab, secukinumab, or atacicept during the 2 months prior to screening or during screening
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- Inhibitors of Janus-associated kinase (JAK), Bruton's tyrosine kinase (BTK), or tyrosine kinase 2 (TYK2), including baricitinib, tofacitinib, upadacitinib, filgotinib, ibrutinib, or fenebrutinib or any investigational agent during the 2 months prior to screening or during screening
- Any live vaccine during the 28 days prior to screening or during screening
- High risk for clinically significant bleeding or any condition requiring plasmapheresis, IV immunoglobulin, or acute blood product transfusions during the 28 days prior the screening
- Active infection with SARS-CoV-2 or absence of COVID-19 vaccination within the last six months (this criteria will be updated at the time of submission to European Agency to be in adequation with national recommendation at the time of submission).
- Significant or uncontrolled medical disease which, in the investigator's opinion, would preclude patient participation
- HIV infection : for participants with unknown HIV status (if the previous tests date more than 3 months), HIV testing will be performed locally at screening.
- Tuberculosis (TB) infection: Testing for latent TB will be performed locally at screening if required by local regulations or in accordance with local clinical practice. Latent TB after completion of appropriate treatment is not exclusionary
- Active infection of any kind, excluding fungal infection of the nail beds.
- History of serious recurrent or chronic infection
- History of progressive multifocal leukoencephalopathy (PML)
- History of cancer, including solid tumors, hematological malignancies, and carcinoma in situ, within the past 5 years. Participants with non-melanomatous carcinomas of the skin that have been treated or excised and have resolved are eligible.
- Major surgery requiring hospitalization during the 4 weeks prior to screening or during screening
- Current alcohol or drug abuse or history of alcohol or drug abuse within 12 months prior to screening or during screening
- History of severe allergic or anaphylactic reactions to monoclonal antibodies or known hypersensitivity to any component of the RTX infusion
- Any of the following laboratory parameters:
- AST or ALT above 2.5 upper limit normal range
- Neutrophils <1.5x103/mL
- Positive hepatitis B surface antigen (HBsAg)
- Positive hepatitis C serology Participants with positive hepatitis C antibody test result with no detectable hepatitis C virus (HCV) RNA for at least 6 months after completion of antiviral therapy are eligible but will require monthly HCV RNA monitoring until 12 months after the last dose of RTX or placebo.
- Pregnancy or breastfeeding
- Participation in another interventional study or being in the exclusion period at the end of a previous study.
- Participants under court supervision, guardianship, or conservatorship.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Cochin Hospital
Paris, Île-de-France Region, 75014
Benjamin CHAIGNE, MD, 01 58 41 41 17 ext. +33, benjamin.chaigne@aphp.fr
About this study
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.
Read the detailed description
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.
- Conditions
- Systemic Sclerosis in Adults
- Being tested
- Rituximab, Placebo
- Keywords
- Systemic sclerosis, Rituximab
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
500mg i.v at M0, M6 and M12
PlaceboDrug
500mg i.v at M0, M6 and M12
| Study group | Role | What they receive |
|---|---|---|
| Rituximab | Experimental | 500mg of i.v rituximab at M0, M6 and M12 Receives: Drug: Rituximab |
| Placebo | Placebo comparator | 500mg of i.v placebo at M0, M6 and M12 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in forced vital capacity (FVC) from baseline to Month 18 of randomisation.
PFTs: changes in forced vital capacity (FVC)
Measured: 18 months
Secondary outcomes (35)
Mortality up to 18 months
Measured: 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)
Measured: 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.
Measured: At 6, 12 and 18 months
Occurrence of AE of specific interest previously mentioned at 6, 12 and 18 months
Measured: At 6, 12 and 18 months
Change in gammaglobulin, lymphocytes and CD19 levels at 6, 12 and 18 months
Measured: At 6, 12 and 18 months
Change from baseline in DLCO over 6, 12, and 18 months
Measured: At 6, 12 and 18 months
Change from baseline in TLC over 6, 12, and 18 months
Measured: 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%)
Measured: At 6, 12 and 18 months
Change from in 6-min walk test distance over 6, 12 and 18 months
Measured: 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%)
Measured: 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
Measured: At 6, 12 and 18 months
Treatment failure (as determined by need for transplant or rescue therapy) at 6, 12 and 18 months
Measured: At 6, 12 and 18 months
INBUILD progression (as determined by the INBUILD criteria for ILD progression(73)) at 6, 12 and 18 months
Measured: At 6, 12 and 18 months
Change from baseline in capillary oxygen saturation (SpO2) at 6, 12 and 18 months
Measured: At 6, 12 and 18 months
Changes from baseline to 18 months in HRCT of chest images
Measured: 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
Measured: 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
Measured: 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
Measured: At 0, 6, 12, and 18 months
Changes in mRSS at 6, 12, and 18 months
Higher score mean worse outcome.
Measured: At 6, 12 and 18 months
Proportion of patients who improved mRSS at 6, 12 and 18 months after randomisation.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: At 0, 6, 12 and 18 months
Total corticosteroid requirement at 6, 12 and 18 months
Measured: 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.
Measured: At 6, 12 and 18 months
Presence of anti-RTX-antibody at months 6, 12 and 18.
Measured: At 6, 12 and 18 months
Dosage of plasma and serum residual concentration of RTX at months 6, 12 and 18
Measured: At 6, 12 and 18 months
Hospitalisation for respiratory cause over the duration of the trial
Measured: At 18 months
Time to first hospitalisation for respiratory cause
Measured: At 18 months
Time to death
Measured: At 18 months
Time to first acute ILD exacerbation
Measured: At 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionMay 2030 (estimated)
- Study completionMar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Sclerosis in AdultsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Luc MOUTHON, MD, PhD, Study chair, AP-HP - Hôpital Cochin 27 Rue du Faubourg Saint Jacques 75014 France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07827742
- Sponsor's protocol ID
- APHP240909
- Other IDs
- 2025-521331-36-00, 2025
- Acronym
- MAINRITSyS
- Status last verified
- Sep 2026
- First submitted
- 9 Jul 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rituximab vs Placebo for Maintenance in Systemic Sclerosis - Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT07827742
- Acronym / sponsor ID
- MAINRITSyS / APHP240909
- Conditions
- Systemic Sclerosis in Adults
- Keywords
- Systemic sclerosis, Rituximab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- Oct 2026 (estimated)
- Primary completion
- May 2030 (estimated)
- Study completion
- Mar 2031 (estimated)
- First posted
- 18 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rituximab | Experimental | Drug: Rituximab500mg of i.v rituximab at M0, M6 and M12 |
| Placebo | Placebo comparator | Drug: Placebo500mg of i.v placebo at M0, M6 and M12 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Adult patient (≥ 18 years old),
- Patient with a diagnosis of SSc, as defined by the ACR/EULAR 2013 criteria (cf. Table 2) (6)
- Patient with ILD identified on the basis of a HRCT, obtained within 12 months before screening, that showed fibrosis affecting at least 10% of the lungs,
- SSc-ILD induction with RTX, either twice 1000 mg two weeks apart, or 375 mg/m2 four times 4 weeks apart.
- The interval between the last induction dose and the first maintenance dose should be 6 months +/- 15 days.
Key exclusion criteria (28 listed)
- Forced vital capacity < 40% of the predicted value
- Diffusion capacity of the lung for carbon monoxide (DLCO) (corrected for hemoglobin) < 30% of the predicted value.
- Contra-indication or anaphylaxis toward RTX
- Contra-indication to auxiliary medicinal products
- Cyclophosphamide, tacrolimus, ciclosporin, or voclosporin during the 2 months prior to screening or during screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rituximab500mg i.v at M0, M6 and M12 | Drug | Rituximab |
| Placebo500mg i.v at M0, M6 and M12 | Drug | Placebo |
Primary outcome
changes in forced vital capacity (FVC) from baseline to Month 18 of randomisation.
Time frame: 18 months
PFTs: changes in forced vital capacity (FVC)
35 secondary outcomes
Mortality up to 18 months
Time frame: 18 months
Occurrence of Adverse Events
Time frame: At 6, 12 and 18 months
Occurrence of Adverse Events
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
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
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.
Time frame: at 0, 6, 12, 18 months
Changes in patients' visual analogue scales over 18 months.
Time frame: At 0, 6, 12, and 18 months
Changes in mRSS at 6, 12, and 18 months
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.
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.
Time frame: at 0, 6, 12, and 18 months
Short Form-36 (SF-36) health questionnaire
Time frame: At 0, 6, 12 and 18 months
EuroQol-5 Domain (EQ5D5L) health questionnaire
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Luc MOUTHON, MD, PhD study chair
AP-HP - Hôpital Cochin 27 Rue du Faubourg Saint Jacques 75014 France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rituximab in people with Systemic Sclerosis in Adults, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin CHAIGNE, MD (01 58 41 41 17 ext. +33, benjamin.chaigne@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in forced vital capacity (FVC) from baseline to Month 18 of randomisation. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.