AuthorisedPhase II and Phase III (Integrated)Interventional

MAINRITSys : Rituximab vs placebo for maintenance in systemic sclerosis – interstitial lung disease

This clinical trial, called MAINRITSys, is investigating if follow-up treatment with a medication called rituximab can help manage lung disease in people with systemic sclerosis, also known as scleroderma. Systemic sclerosis can sometimes cause scarring in the lungs (interstitial lung disease, or ILD), which can make it hard to breathe. Patients taking part have stable lung disease after already receiving an initial course of rituximab. The study will compare whether continued rituximab treatment, given as an infusion, is more effective than a dummy treatment (placebo) in preventing further worsening of lung function over 18 months. Researchers will also look at safety, quality of life, and other important aspects of the disease.

At a glance

Status

Authorised

Phase

Phase II and Phase III (Integrated)

Sponsor

Assistance Publique Hopitaux De Paris

Enrolment target

120

Start

11 May 2026

Patient with stabilized SSc-ILD (as defined by a decline of FVC ≤ 5%) following RTX induction treatment

What is this study about?

This study, known as MAINRITSys, is looking into how best to manage a lung condition called interstitial lung disease (ILD) that can affect people with systemic sclerosis. Systemic sclerosis, or scleroderma, is a condition where the body's immune system attacks healthy tissues, leading to symptoms like skin thickening and, in some cases, scarring in the lungs. This scarring can make breathing difficult.

Some people with lung scarring due to systemic sclerosis have already had treatment with a medication called rituximab. This trial wants to find out if continuing to give rituximab regularly as a 'maintenance' treatment, after the initial course, can help keep the lung condition stable. They will compare this to giving a 'dummy' treatment, called a placebo, to see if there's a difference in how well patients' lungs function over time. The main thing they will measure is how patients' lung capacity (FVC) changes over 18 months.

This study is important because researchers want to find the best ways to prevent lung scarring from getting worse and improve the lives of people with systemic sclerosis and lung disease. By carefully comparing rituximab to a placebo, they hope to understand if this regular treatment can offer long-term benefits.

Key takeaways

The study investigates if regular rituximab infusions help manage systemic sclerosis lung disease.
It compares rituximab to a dummy treatment (placebo) after initial therapy.
The main goal is to see how lung function (FVC) changes over 18 months.
Participants will have stable lung disease and be aged 18 or over.
Regular hospital visits and health checks will be part of taking part.
The study aims to improve long-term outcomes for patients with this condition.

Who may be eligible?

To be considered for this study, you need to be an adult, aged 18 or older. Both men and women are welcome to take part.

You must have been diagnosed with systemic sclerosis that has affected your lungs, specifically causing interstitial lung disease (ILD). Importantly, your lung disease needs to have been stable or not significantly worsened after you've already had an initial treatment with rituximab.

The study defines 'stable' as your lung capacity (FVC) not having dropped by more than 5% since your initial treatment. This means that the treatment you had before has helped to stabilise your lung condition.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with systemic sclerosis that affects your lungs (ILD)?
Have you already received an initial treatment with rituximab for your lung disease?
Is your lung function (FVC) currently stable (not declined by more than 5%) after your previous rituximab treatment?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive regular treatments over 18 months. Half of the participants will receive the active study drug, Truxima (Rituximab), and the other half will receive a dummy treatment (placebo). Both are given through an infusion, which means the medicine goes directly into your bloodstream over a period of time, usually in a clinic setting.

Throughout the study, you'll have regular hospital visits. During these visits, doctors and nurses will check your general health, measure your lung function (like how much air you can breathe out, called FVC), and assess how you are feeling. They will also collect information about your quality of life, your walking ability, and may take some scans of your lungs to see any changes. The total commitment to follow-up for this study is 18 months.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from receiving the active drug, which could help stabilise your lung condition, or you might contribute valuable information that helps others in the future. However, there's no guarantee that the treatment will work for you, and like all medicines, rituximab can have side effects. These will be fully explained by the study team. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
France

Common questions

What is systemic sclerosis and ILD?

Systemic sclerosis (often called scleroderma) is a condition where your immune system attacks your own body. ILD (interstitial lung disease) happens when this affects your lungs, causing scarring which can make breathing difficult.

What is rituximab?

Rituximab is a medication given as a drip (infusion) that works by affecting certain parts of your immune system. It's used in some conditions where the immune system is overactive.

What is a placebo?

A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active drug. It helps researchers see if the real drug is truly effective compared to no treatment.

How long will the study last for me?

If you join the study, you'll be involved for 18 months from the point of being assigned to either the active drug or the placebo group.

Will I know if I'm getting the real drug or the placebo?

No, this is a 'blinded' study, meaning neither you nor your study doctor will know if you're receiving rituximab or the placebo. This ensures fair and accurate results.