Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A multicentre clinical trial evaluating the safety and efficacy of the combination of nintedanib and tocilizumab compared to standard treatment in patients with systemic sclerosis and interstitial lung disease. Analysis with theranostic approach and assessment of cytokine activity, markers of inflammation and pulmonary fibrosis using computed tomography, positron emission tomography, and metabolome and transcriptome studies in selected patients. NINTOC-TU study

This important study is for people in the UK who have systemic sclerosis, an illness affecting your immune system, and have developed a lung condition called interstitial lung disease (ILD). ILD causes scarring in the lungs, making it harder to breathe. The study is testing whether giving two existing medications, nintedanib (Ofev) and tocilizumab (RoActemra), together works better than standard care. Researchers want to see if this combination can improve lung function, measured by how much air you can breathe out, over 56 weeks. They also want to understand if these medicines can help with other aspects of the condition, like skin changes and overall quality of life. This is a Phase 3 study, meaning it's a key step to see if these treatments are safe and effective enough for wider use.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher

Enrolment target

Start

16 Oct 2024

systemic sclerosis with interstitial lung disease (ILD) in the course of the disease

What is this study about?

This clinical trial is designed to help people living with a condition called systemic sclerosis, which is sometimes known as scleroderma. Systemic sclerosis is an autoimmune disease, meaning your body’s immune system mistakenly attacks healthy tissues. One of the ways it can affect people is by causing a lung condition called interstitial lung disease (ILD). With ILD, the lung tissue becomes scarred and stiff, making it harder to breathe and get enough oxygen.

Currently, there are treatments for ILD, but doctors are always looking for better options. This study aims to find out if combining two existing medications, nintedanib (known by its brand name Ofev) and tocilizumab (known as RoActemra), can make a significant difference for people with systemic sclerosis-related ILD. Both medicines are already used for different conditions, and nintedanib specifically helps slow down lung scarring in some types of ILD. This trial is hoping to see if using them together can be more effective than what is currently considered standard treatment.

The main goal is to see if this new combination of medicines can improve your lung function, specifically how much air you can breathe out after a deep breath, over a period of 56 weeks (just over a year). The researchers will also be looking at many other things, like how the treatment affects your breathing ability, your symptoms, your daily activities, and how much scarring is visible in your lungs. This information will help doctors understand if this combination could be a new and better way to manage ILD in people with systemic sclerosis.

Key takeaways

This study evaluates a new combination of medicines for lung scarring (ILD) caused by systemic sclerosis.
It aims to improve breathing and overall health for people with this condition.
The study lasts for 56 weeks and involves regular health checks and tests.
It compares two medicines (Ofev and RoActemra) against standard treatment.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be considered for this study, you need to be an adult, aged 18 years or older, regardless of whether you are male or female. The study is specifically for people who have been diagnosed with systemic sclerosis and have also developed interstitial lung disease (ILD) as part of their condition. This means your doctors have confirmed scarring in your lungs due to your systemic sclerosis.

There might be specific details about your health, other medications you are taking, or certain test results that would determine if you fit all the study requirements. These details are important to make sure the study treatments are safe and suitable for you.

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?
Do you also have interstitial lung disease (ILD) as part of your systemic sclerosis?
Are you able to attend regular clinic appointments for over a year?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive either the new combination of medications (nintedanib and tocilizumab) or the standard treatment already available. You won't know which group you are in, and neither will your doctor, which helps ensure the results are fair. The medications will be given as soft capsules (nintedanib) and injections via a pre-filled syringe (tocilizumab).

Over the 56-week treatment period, you would have several clinic visits. During these visits, the study team would regularly check your health. This would involve breathing tests to measure your lung function (like how much air you can breathe out), blood tests, and possibly scans of your lungs (like CT scans) to see any changes in scarring. You might also be asked to complete questionnaires about your symptoms and how you feel, which helps understand your quality of life. After the 56 weeks, there will likely be follow-up appointments to continue monitoring your health.

Potential risks and benefits

Taking part in a clinical trial offers the chance to receive new treatments that aren't widely available yet, which might improve your condition. You will also get very close medical attention throughout the study. However, like all medicines, the treatments in this study may have side effects, which the study team will discuss and monitor carefully. There is no guarantee that the new treatment will work better for you than standard care, or that it will work at all. It's important to remember that participating is entirely voluntary, and you have the right to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (1)

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

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Unverified
Poland

Common questions

What is systemic sclerosis?

It's an illness where your body's immune system attacks healthy tissues, causing problems like skin hardening and sometimes affecting internal organs like the lungs.

What is interstitial lung disease (ILD)?

ILD is a condition where the tissue in your lungs becomes scarred and thick, making it harder for you to breathe and for your body to get oxygen.

What are Ofev and RoActemra?

Ofev (nintedanib) and RoActemra (tocilizumab) are medications already used to treat certain conditions, and this study is testing if they work well together for ILD linked to systemic sclerosis.

How long will the treatment last?

The main treatment period for the study is 56 weeks, which is just over one year.

Will I know if I'm getting the new treatment or standard care?

No, you won't know, and neither will your doctor. This is common in studies and helps ensure the results are accurate and unbiased.