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Study on Sarilumab and Etanercept for Rheumatoid Arthritis in Patients Not Responding to csDMARD 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 is focused on studying Rheumatoid Arthritis, a condition that causes pain and swelling in the joints. The study will explore the effectiveness of two treatments: Kevzara (sarilumab) and Enbrel (etanercept). Both medications are solutions for injection and are used to help reduce inflammation and pain in the joints.

The purpose of the study is to see if certain markers in the body, called biomarkers, can help predict how well a patient will respond to these treatments. This is particularly for patients who have not had success with previous treatments known as csDMARDs. The study will involve taking a small sample of tissue from a joint, known as a biopsy, to look for these biomarkers. This biopsy is done before starting the new treatment.

Participants in the study will receive either Kevzara or Enbrel or a placebo. The study will last for about 12 weeks, during which time the participants will have regular check-ups to monitor their response to the treatment. The main goal is to determine if the treatment helps reduce the symptoms of Rheumatoid Arthritis and to see if the biomarkers can predict this improvement.

The research process

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

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria, including a diagnosis of rheumatoid arthritis and previous treatment with csDMARDs for at least three months.

    Informed consent is required before any procedures begin.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the condition, including the Disease Activity Score (DAS) and the number of swollen joints.

    A biopsy may be performed on a selected joint with synovial thickening.

  3. Step 3

    Treatment initiation

    Treatment begins with biologic therapy, which may include Kevzara (sarilumab) or Enbrel (etanercept).

    Kevzara is administered as a subcutaneous injection, available in 150 mg or 200 mg doses.

    Enbrel is administered as a subcutaneous injection, available in a 50 mg dose.

  4. Step 4

    Treatment duration

    The treatment continues for a period of 12 weeks.

    Regular monitoring and assessments are conducted to evaluate the response to the treatment.

  5. Step 5

    Evaluation of treatment response

    The primary endpoint is assessed at 12 weeks, determining if the treatment is effective using the American College of Rheumatology 50 (ACR-50) measure.

    Secondary endpoints include the percentage of patients achieving low disease activity and changes in health assessment scores.

Who can join the trial?

7 criteria

  • Must have a diagnosis of Rheumatoid Arthritis according to the 2010 ACR/EULAR classification criteria. These are guidelines used by doctors to diagnose Rheumatoid Arthritis.
  • Must have experienced csDMARD failure and be eligible for anti-TNF therapy according to EULAR recommendations. This means the patient has tried certain medications for at least 3 months without success and is now eligible for a different type of treatment.
  • Must have a DAS score greater than 5.1 and at least 3 swollen joints. DAS is a measure of how active the arthritis is. If undergoing a biopsy, the swollen joints should include the one selected for biopsy and two others.
  • The joint selected for biopsy must have at least grade 2 synovial thickening. This means the lining of the joint is thicker than normal, as checked during the biopsy visit.
  • Must be 18 years of age or older.
  • Must be capable of giving informed consent. This means the patient understands the study and agrees to participate before any screening procedures begin.
  • Must be willing and able to follow the scheduled visits, treatment plans, laboratory tests, and other study procedures.

Who cannot join the trial?

5 criteria

  • Patients who have not been diagnosed with Rheumatoid Arthritis cannot participate. Rheumatoid Arthritis is a condition where the body's immune system attacks its own joints, causing pain and swelling.
  • Patients who are not within the specified age range for the study cannot participate. The study includes certain age groups, so it's important to check if you fall within these groups.
  • Patients who are not starting on a biologic therapy after failing csDMARD therapy cannot participate. Biologic therapy is a type of treatment that uses substances made from living organisms to treat disease.
  • Patients who have not had a biopsy at presentation prior to any RA treatment cannot participate. A biopsy is a small sample of tissue taken from the body to be examined more closely.
  • Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups who may be at a higher risk of harm or exploitation.
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Investigated drugs

  • Anti-TNF

    is a type of biologic therapy used in the treatment of rheumatoid arthritis (RA). It works by blocking the tumor necrosis factor (TNF), a substance in the body that causes inflammation and is involved in the immune response. By inhibiting TNF, this medication helps reduce inflammation, pain, and joint damage in RA patients.

  • IL6 Inhibitor

    is another biologic therapy used for treating rheumatoid arthritis. It targets and blocks the interleukin-6 (IL-6) protein, which plays a role in the inflammation process. By reducing the activity of IL-6, this medication helps decrease inflammation and alleviate symptoms associated with RA, such as swelling and pain.

What is already known about the treatment

  • Anti-TNF Therapy

    This medication is administered through injection and is currently used in the treatment of rheumatoid arthritis. It is well-documented in medical literature as a biologic therapy that targets tumor necrosis factor (TNF), a substance in the body that causes inflammation in the joints. The main therapeutic indication is for patients with rheumatoid arthritis who have not responded to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs). At the molecular level, anti-TNF therapy works by blocking the activity of TNF, thereby reducing inflammation and preventing joint damage. It is classified as a biologic disease-modifying antirheumatic drug (bDMARD).

  • IL-6 Inhibitor

    This medication is administered via injection and is used in the treatment of rheumatoid arthritis. It is recognized in medical literature as a biologic therapy that targets interleukin-6 (IL-6), a cytokine involved in the inflammatory process. The primary therapeutic indication is for patients with rheumatoid arthritis who have not responded adequately to csDMARDs. The mechanism of action involves inhibiting the IL-6 receptor, which helps to decrease inflammation and slow the progression of joint damage. It is classified as a biologic disease-modifying antirheumatic drug (bDMARD).

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 in the joint lining. Over time, this inflammation can cause joint damage, 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 wrists, knees, and ankles. As it advances, rheumatoid arthritis can lead to joint deformity and loss of function. It may also affect other parts of the body, including the skin, eyes, lungs, and blood vessels.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502021-18-00Estimated enrolment255 patientsSponsorQueen Mary University Of London

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).