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Study on the Effectiveness of Nintedanib and Tocilizumab for Patients with Systemic Sclerosis and Interstitial Lung Disease

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What is this study about?

This clinical trial is focused on studying the effects of a combination treatment for patients with systemic sclerosis and interstitial lung disease. Systemic sclerosis, also known as scleroderma, is a condition where the skin and connective tissues become tight and hard. Interstitial lung disease involves scarring of the lung tissue, which can make it difficult to breathe. The trial will use two medications: nintedanib, which is taken as a soft capsule, and tocilizumab, which is given as an injection. These medications will be compared to standard treatments like methotrexate and mycophenolate mofetil.

The purpose of the study is to evaluate the safety and effectiveness of the combination of nintedanib and tocilizumab over a period of 56 weeks. During the study, participants will receive either the combination treatment or the standard treatment. The study will involve regular check-ups and assessments, including imaging tests like computed tomography (CT) and other evaluations to monitor lung function and overall health. Some participants may also receive a placebo, which is a substance with no active medication, to help compare the effects of the treatments.

Throughout the study, researchers will closely monitor the participants’ health and any changes in their condition. The goal is to determine if the combination of nintedanib and tocilizumab can provide better outcomes for patients with systemic sclerosis and interstitial lung disease compared to the standard treatments. This research could lead to improved treatment options for people living with these challenging conditions.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, your eligibility for the trial will be confirmed. This includes reviewing your medical history and conducting necessary tests to ensure you meet the study criteria.

2 baseline assessment

A baseline assessment will be conducted to evaluate your current health status. This may involve tests such as high-resolution computed tomography (HRCT) to assess lung involvement and other evaluations to measure skin induration and lung function.

3 treatment initiation

You will begin the treatment phase, which involves taking the study medications. You will receive RoActemra 162 mg as a solution for injection, administered subcutaneously. Additionally, you will take Ofev capsules orally. The dosage of Ofev will be either 100 mg or 150 mg, as determined by the study protocol.

4 ongoing treatment and monitoring

Throughout the 56-week study period, you will continue to take the study medications as prescribed. Regular follow-up visits will be scheduled to monitor your health and assess the effectiveness and safety of the treatment. These visits may include physical examinations, blood tests, and imaging studies.

5 final assessment

At the end of the 56-week treatment period, a final assessment will be conducted. This will involve similar evaluations to the baseline assessment to determine any changes in your condition and to assess the overall impact of the treatment.

Who Can Join the Study?

  • Men or women aged 18-74 at the date of signing the informed consent.
  • Must provide written informed consent, which means agreeing to participate in the study after understanding all the details.
  • Must have a documented diagnosis of systemic sclerosis according to specific medical criteria.
  • Must have interstitial lung disease (ILD) confirmed by a special lung scan called high-resolution computed tomography (HRCT), showing at least 10% lung involvement.
  • Must have a skin condition measured by a special scale called the modified Rodnan skin score (mRSS), with a score between 10 and 45.
  • If taking certain medications like mycophenolate mofetil or methotrexate, doses should be stable for at least 8 weeks before starting the study.
  • Should not start new treatments or stop existing treatments within 8 weeks before the first screening visit.
  • If taking oral corticosteroids (a type of medication), the dose should be stable and not more than 10 mg/day of prednisone or equivalent for at least 8 weeks before starting the study.
  • Women who can become pregnant should agree to avoid sexual activity or use a highly effective method of birth control during the study and for at least 3 months after the last dose of study medication.

Who Cannot Join the Study?

  • Patients who have a different type of lung disease not related to systemic sclerosis (a condition that affects the skin and internal organs).
  • Patients who have had a recent infection that required treatment with antibiotics, antivirals, or antifungals.
  • Patients who have a history of severe allergic reactions to the study medications.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a history of cancer within the last 5 years, except for certain types of skin cancer.
  • Patients who have uncontrolled high blood pressure or heart disease.
  • Patients who have liver disease or abnormal liver function tests.
  • Patients who have kidney disease or abnormal kidney function tests.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of alcohol or drug abuse within the last 2 years.
  • Patients who have any other medical condition that the study doctors think would make it unsafe for them to participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher Warsaw Poland
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Ulbzmpstkow Magsswoc W Limlf Lodz Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Poland Poland
Not recruiting
31.03.2023

Trial locations

Investigated drugs:

Nintedanib is a medication used in this trial to help manage systemic sclerosis and interstitial lung disease. It works by slowing down the process of scarring in the lungs, which can help improve breathing and lung function. Patients in the trial are receiving this medication to see if it can effectively reduce lung damage and improve their overall condition.

Tocilizumab is another medication being tested in the trial. It is used to reduce inflammation in the body by blocking a specific protein that contributes to the inflammatory process. By reducing inflammation, tocilizumab may help alleviate symptoms and prevent further damage in patients with systemic sclerosis and interstitial lung disease.

Methotrexate is part of the standard treatment being compared in this trial. It is commonly used to treat autoimmune conditions by suppressing the immune system, which can help reduce inflammation and slow disease progression. In this study, it serves as a benchmark to evaluate the effectiveness of the new combination therapy.

Mycophenolate mofetil is another standard treatment option in the trial. It works by weakening the immune system to prevent it from attacking the body’s own tissues. This can help reduce inflammation and prevent further damage in patients with systemic sclerosis and interstitial lung disease. It is used as a comparison to assess the new treatment’s effectiveness.

Systemic Sclerosis – Systemic sclerosis is a chronic connective tissue disease characterized by the hardening and tightening of the skin and connective tissues. It primarily affects the skin but can also involve internal organs such as the lungs, heart, and kidneys. The disease progresses with the overproduction of collagen, leading to fibrosis and scarring. As it advances, systemic sclerosis can cause joint pain, digestive issues, and respiratory problems. The severity and progression rate can vary significantly among individuals. Over time, it may lead to reduced mobility and function of affected areas.

Interstitial Lung Disease – Interstitial lung disease (ILD) refers to a group of disorders that cause progressive scarring of lung tissue. This scarring affects the interstitium, the tissue and space around the air sacs of the lungs, leading to stiffness and reduced lung capacity. As ILD progresses, it can cause symptoms such as shortness of breath and a persistent dry cough. The disease can result from long-term exposure to hazardous materials, autoimmune diseases, or unknown causes. Over time, the scarring can worsen, making it increasingly difficult for the lungs to function properly. The progression rate and severity can vary depending on the underlying cause and individual factors.

Trial ID:
2024-517005-85-00
Protocol code:
NIGRIR_004NINTOC-TU
Trial Phase:
Therapeutic confirmatory (Phase III)

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