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A study to compare the effectiveness of rituximab and a placebo in patients with interstitial lung disease associated with rheumatoid arthritis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on individuals living with rheumatoid arthritis-associated interstitial lung disease, a condition where chronic inflammation from rheumatoid arthritis causes scarring and damage to the lung tissues. The purpose of this study is to determine if rituximab is more effective than a placebo in maintaining lung function. Rituximab is a medication delivered through an infusion, which is a method of administering medicine directly into a vein.

During the trial, participants will be assigned to receive either rituximab or a placebo. The study will last for 48 weeks. While receiving the assigned treatment, the progress of the lung condition and the effectiveness of the medication will be monitored to see if it helps prevent the decline of the amount of air the lungs can hold.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Treatment assignment
Participation begins with the assignment to receive either the test medication or a placebo. a placebo is a substance that contains no active medicine, used here to compare against the test drug.
The assignment is randomized, meaning it is decided by chance, and double-blind, meaning neither the patient nor the medical staff knows which substance is being administered.
Step 2
Administration of medication
If assigned to the test medication, rituximab will be administered via infusion. the dosage is 1000 mg.
If assigned to the placebo group, a 0.9% sodium chloride solution without active medicine will be administered.
Step 3
Monitoring and evaluation
The trial continues for a total duration of 48 weeks.
At 24 weeks and 48 weeks, various assessments are performed to monitor lung function, such as forced vital capacity (the amount of air that can be forcibly exhaled from the lungs), and breathing capacity.
Assessments include measuring physical ability through a 6-minute walk test, evaluating disability levels, and checking symptoms related to breathlessness and chest health.
blood tests are conducted to measure inflammation and specific biomarkers (indicators in the blood that show how the disease is behaving).
imaging of the lungs, such as high-resolution computed tomography (HRCT), is used to observe any changes in the lung tissue.
disease activity related to rheumatoid arthritis is monitored through joint counts and other clinical scales.

Who can join the trial?

7 criteria

You must provide your written consent, which means you agree to take part in the study after being informed about it.
You must be an adult with rheumatoid arthritis (an autoimmune disease where the body's immune system attacks the joints) that is positive for certain markers in your blood called rheumatoid factor (RF) and/or anti-citrullinated protein antibodies (ACPA).
You must show signs of interstitial lung disease (ILD), which is scarring or inflammation in the lungs, on a special detailed X-ray called a high resolution computed tomography (HRCT) scan.
The scan must show specific patterns like ground glass opacities (hazy areas in the lungs), reticulations (net-like patterns), or honeycombing (small, cyst-like spaces in the lung tissue).
Your pulmonary function, which measures how well your lungs work, must meet specific levels for forced vital capacity (FVC) (the total amount of air you can breathe out) and diffusing capacity (DLCO) (how well oxygen moves from your lungs into your blood).
You must be on a stable dose of disease modifying anti-rheumatic drugs (DMARDs), which are medicines used to slow down the progression of rheumatoid arthritis, for at least 12 weeks.
You may be taking a low dose of prednisone, which is a type of steroid medicine used to reduce inflammation, as part of your regular treatment.

Who cannot join the trial?

19 criteria

People with other long-term rheumatic diseases (conditions that affect the joints, muscles, or bones), except for a specific condition called secondary Sjögrens syndrome.
People who have had malignancy (cancer) within the last 5 years, except for certain types of skin cancer or early-stage cervical cancer that were successfully treated and have not returned.
People with severe congestive heart failure (a condition where the heart cannot pump enough blood to meet the body's needs) or severe uncontrolled heart disease.
People with asthma or COPD (chronic obstructive pulmonary disease, a lung disease that makes it hard to breathe) who have low lung function scores.
People with any other significant comorbidity (another medical condition occurring at the same time) or health issues that make it unsafe to join the study.
People with factors that make it hard to follow the study rules, such as psychiatric disorders (mental health conditions), substance abuse (misuse of alcohol or drugs), or language barriers.
Women who are capable of becoming pregnant and are not willing or able to use highly effective birth control (methods to prevent pregnancy with a failure rate of less than 1%) during the study and for 6 months after it ends.
Women who are pregnant or lactating (breastfeeding) during the study or up to 6 months after it finishes.
People who are currently participating or have participated within the last 30 days in another clinical trial using an investigational product (a drug being tested).
People with a low absolute neutrophil count (a low level of white blood cells that help fight infection) below 1.5 x10^9/L.
People with a low absolute thrombocyte count (a low level of platelets, which are blood cells that help with clotting) below 75 x10^9/L.
People who have previously used anti-B cell targeted therapy (medicines that attack specific immune cells) for rheumatoid arthritis.
People with a hypersensitivity (an allergic reaction) to murine proteins (proteins from mice) or excipients (inactive ingredients used in medicines) found in the study drug.
People with an inborn error of immunity (a genetic condition where the immune system does not work correctly) or acquired severe immunodeficiency (a weakened immune system caused by other factors), including very low levels of immunoglobulin G (a type of protein in the blood that helps fight infection).
People with an active infection that required hospital stay or certain medicines in the weeks before the study begins.
People with a history of severe infections, such as repeated or widespread Herpes Simplex or Herpes Zoster (shingles).
People with chronic hepatitis B (a long-term liver infection) who are not taking the necessary preventive medicines or undergoing regular monitoring.
People with tuberculosis (a serious bacterial infection that usually affects the lungs) that is either active or latent (sleeping in the body but not yet causing illness).
People who have used biologic or targeted synthetic DMARDs (specialized drugs used to suppress an overactive immune system), anti-fibrotic therapy (medicines to slow lung scarring), or cyclophosphamide (a strong medicine used for immune issues) within the last 12 weeks.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Karolinska University Hospital
Solna, Sweden
Responsive
Region Oestergoetland
Linkoping, Sweden
Responsive
Region Vaesterbotten
Umea, Sweden

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Investigated drugs

Rituximab is a medication given through an infusion into a vein. It is used in this study to see if it can help protect lung function in people who have lung disease caused by rheumatoid arthritis.

Rituximab

What is already known about the treatment

Rituximab
This medication is administered through an intravenous infusion, meaning it is delivered directly into a vein. It is an established treatment used to manage various immune-related conditions, including certain types of lung disease related to rheumatoid arthritis. It works by targeting and attaching to specific proteins on the surface of B-cells, which are a type of white blood cell, to reduce their activity and prevent them from attacking the body's own tissues. This drug is classified as a monoclonal antibody.
0.9% Sodium Chloride
This substance is a sterile salt solution used as a placebo in this clinical trial and contains no active medication. It is administered through an infusion to mimic the process of receiving the test drug without providing any therapeutic effect. In medical studies, it serves as a control to help researchers determine if the effects seen in patients are truly caused by the medication being tested. It is pharmacologically classified as a saline solution.

Investigated diseases

Rheumatoid arthritis-associated interstitial lung disease - This condition occurs in individuals who already have rheumatoid arthritis, an autoimmune disease that primarily affects the joints. It involves inflammation and scarring within the lung tissue, which can lead to changes in how the lungs function. As the disease progresses, the lung tissue may become thickened or stiffened. This process can gradually decrease the amount of oxygen that moves into the bloodstream. The extent of the lung involvement can vary among different individuals.