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Study of Sarilumab for Patients with Rheumatoid Arthritis Not Responding to Anti-TNF Therapy

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What is this trial about?

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

This clinical trial focuses on studying the effects of a medication called Kevzara, which contains the active substance sarilumab, in patients with rheumatoid arthritis. Rheumatoid arthritis is a chronic inflammatory disorder that primarily affects the joints, causing pain and swelling. The study is designed for patients who have not responded well to a type of treatment known as anti-TNF therapy, which is commonly used to reduce inflammation and slow disease progression.

The purpose of the study is to evaluate how sarilumab affects the body, particularly looking at changes in joint inflammation and gene activity. Participants will receive Kevzara as a solution for injection under the skin. The study will last for 24 weeks, during which time participants will undergo various assessments, including MRI scans to monitor joint health and synovial tissue analysis, which involves examining the tissue lining the joints.

Throughout the study, researchers will collect data to understand the medication's impact on joint inflammation and overall disease activity. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of sarilumab. The study aims to provide insights into how sarilumab can benefit patients with rheumatoid arthritis who have not found relief with other treatments.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Participation begins after meeting specific criteria, including being at least 18 years old and having rheumatoid arthritis that is not responding to certain treatments.
Participants must have a certain level of disease activity and be on a stable dose of methotrexate (MTX) for at least three months.
Step 2
Treatment administration
The medication used in this study is sarilumab, administered as a solution for injection.
The injection is given subcutaneously, which means it is injected under the skin.
The specific product used is Kevzara 200 mg in a pre-filled syringe.
Step 3
Treatment duration
The study lasts for a total of 24 weeks.
During this period, the effects of the medication on clinical symptoms, MRI results, and synovial tissue will be evaluated.
Step 4
Evaluation and monitoring
Throughout the study, various assessments will be conducted to monitor the response to the treatment.
These assessments include studying gene expression profiles and examining synovial biopsies, which are small samples of tissue taken from the joints.
Step 5
Primary outcomes
The main goal is to understand changes in gene expression and tissue characteristics.
Responses will be measured at week 12 using specific criteria known as ACR 20, 50, and EULAR response.

Who can join the trial?

5 criteria

Participants must be **males or females** who are at least **18 years old**. Women who can have children must use **effective birth control** and should not be pregnant or nursing.
Participants must have a diagnosis of **rheumatoid arthritis** according to the **2010 EULAR/ACR criteria**. These are guidelines used by doctors to diagnose rheumatoid arthritis.
Participants must have **active disease**, which means having more than **4 tender joints** and more than **4 swollen joints** out of 68 joints, and a **DAS28-CRP score** greater than **3.7**. The DAS28-CRP is a measure used to assess the activity of rheumatoid arthritis.
Participants must have been treated with a **TNF BioDMARD** for at least **3 months**. A TNF BioDMARD is a type of medication used to treat rheumatoid arthritis, and it should be taken along with a stable dose of **MTX** (methotrexate), which is another medication.
Participants must not have used other types of **non-TNF BioDMARDs** such as **Abatacept, Tocilizumab, Rituximab**, or **JAK inhibitors**. These are different medications used to treat rheumatoid arthritis.

Who cannot join the trial?

10 criteria

Patients who have any other serious health conditions that could interfere with the study.
Patients who are currently participating in another clinical trial.
Patients who have had a recent infection or illness that could affect the study results.
Patients who are pregnant or breastfeeding.
Patients who have a history of drug or alcohol abuse.
Patients who are unable to provide informed consent, which means they cannot understand the study and agree to participate.
Patients who have had a recent surgery or are planning to have surgery during the study period.
Patients who have allergies to any of the study medications or treatments.
Patients who have a history of cancer, unless it has been in remission for a certain period.
Patients who have a history of heart disease or other significant heart problems.

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Responsive
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Belgium

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Investigated drugs

Sarilumab is a medication used in this clinical trial to help patients with active rheumatoid arthritis (RA) who have not responded well to TNF inhibitors. It works by blocking a specific protein in the body that causes inflammation, which can help reduce symptoms of RA such as pain and swelling. The trial aims to see how effective Sarilumab is in improving the condition of the joints and tissues in these patients.

Sarilumab

What is already known about the treatment

Sarilumab – Sarilumab is administered as an injection under the skin, typically in the form of a pre-filled syringe or auto-injector. It is currently recognized in medical literature as a treatment for rheumatoid arthritis, especially in patients who have not responded well to TNF inhibitors. The main therapeutic indication for Sarilumab is to reduce inflammation and slow the progression of rheumatoid arthritis. At the molecular level, Sarilumab works by blocking the interleukin-6 (IL-6) receptor, which plays a key role in the inflammatory process. It is classified pharmacologically as an interleukin inhibitor.

Investigated diseases

Rheumatoid arthritis – Rheumatoid arthritis is a chronic inflammatory disorder that primarily affects the joints. It occurs when the immune system mistakenly attacks the body's own tissues, leading to inflammation. Over time, this inflammation can cause damage to the joint tissues, resulting in pain, swelling, and stiffness. The disease often starts in smaller joints, such as those in the fingers and toes, and can progress to larger joints like the knees, hips, and shoulders. As the condition advances, it may lead to joint deformity and loss of function. Rheumatoid arthritis can also affect other parts of the body, including the skin, eyes, lungs, and blood vessels.