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Study on Abatacept for Rheumatoid Arthritis in Patients Responding to Initial TNF Inhibitor Treatment

Verified siteRegistered drugNo placebo
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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 the effectiveness of a treatment strategy for Rheumatoid Arthritis, a condition that causes pain and swelling in the joints. The study will use a medication called abatacept, which is administered as a solution for injection. The purpose of the study is to compare how well patients achieve remission, meaning a reduction in disease activity, when treated with abatacept compared to continuing with a routine treatment using TNF inhibitors, which are another type of medication used to manage rheumatoid arthritis.

Participants in the study will be randomly assigned to receive either abatacept or continue with their current TNF inhibitor treatment. The study will last for 36 weeks, during which time the effectiveness of the treatments will be assessed. The goal is to see which treatment helps more patients reach remission, defined by a specific score that measures disease activity. This score is known as DAS28-CRP, which stands for Disease Activity Score in 28 joints with C-reactive protein, a marker of inflammation in the body.

Throughout the study, participants will have regular check-ups to monitor their health and the progress of their rheumatoid arthritis. The study will also look at other factors, such as the frequency of flare-ups, which are periods when symptoms worsen, and the overall safety of the treatments. By the end of the study, researchers hope to determine which treatment strategy is more effective in helping patients manage their rheumatoid arthritis and improve their quality of life.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit and randomization

    Upon joining the study, the patient will attend an initial visit. During this visit, eligibility will be confirmed based on specific criteria, such as age and medical history related to rheumatoid arthritis.

    The patient will be randomly assigned to one of two treatment groups. This process is called randomization and ensures that each participant has an equal chance of receiving either the new treatment or the standard treatment.

  2. Step 2

    Treatment administration

    If assigned to the new treatment group, the patient will receive abatacept, which is administered as a subcutaneous injection. The dosage is 125 mg, and it is given once a week.

    The treatment will continue for a total of 36 weeks. The patient will be monitored regularly to assess the effectiveness and safety of the treatment.

  3. Step 3

    Regular follow-up visits

    Throughout the trial, the patient will attend regular follow-up visits. These visits are scheduled at 12, 24, and 36 weeks after the start of the treatment.

    During these visits, the patient's health and response to the treatment will be evaluated. This includes checking for any side effects and measuring the disease activity using specific criteria.

  4. Step 4

    Completion of treatment

    At the end of the 36-week treatment period, the patient will have a final assessment. This will include a comprehensive evaluation of the treatment's effectiveness and any changes in the patient's condition.

    The patient will be informed about the results and any further steps that may be necessary for their ongoing care.

Who can join the trial?

8 criteria

  • Aged 18 years or above
  • Diagnosed with Rheumatoid Arthritis according to the ACR-EULAR 2010 guidelines
  • ACPA positive (this means having certain antibodies in the blood that are often found in people with rheumatoid arthritis)
  • Currently taking methotrexate or leflunomide for at least 3 months (these are medications used to treat rheumatoid arthritis)
  • DAS28-CRP score greater than 3.2 while on methotrexate or leflunomide, calculated with a CRP test done less than 7 days from the start of the study (DAS28-CRP is a measure of rheumatoid arthritis activity, and CRP is a blood test that measures inflammation)
  • Experienced an increase in inflammation markers like CRP (greater than 5 mg/L) or ESR (for men: greater than age in years divided by 2; for women: greater than age plus 10 divided by 2) within the last 6 months before starting the study (CRP and ESR are blood tests that measure inflammation)
  • Have not previously used targeted DMARDs (these are specific types of medications used to treat rheumatoid arthritis)
  • Have a medical reason to start a TNF inhibitor (a type of medication used to reduce inflammation in 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 pregnant or breastfeeding.
  • Patients who have had a recent infection that required treatment with antibiotics.
  • Patients who have a history of allergic reactions to the study medications.
  • Patients who have been treated with another experimental drug within the last 30 days.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have been diagnosed with cancer in the past five years, except for certain types of skin cancer.
  • Patients who have a history of certain blood disorders.
  • Patients who have received a live vaccine within the last four weeks.
  • Patients who have a history of tuberculosis (TB) or have been in close contact with someone with TB.
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Investigated drugs

  • Abatacept

    is a medication used in this trial to treat rheumatoid arthritis. It works by interfering with the immune system's activity, which is responsible for causing inflammation and joint damage in rheumatoid arthritis. By doing so, abatacept helps reduce symptoms like pain and swelling, and it aims to achieve remission, meaning the disease becomes less active or inactive.

  • TNF inhibitors

    are a group of medications that are also used to treat rheumatoid arthritis. They work by blocking a specific protein in the body called tumor necrosis factor (TNF), which plays a key role in causing inflammation and joint damage. By inhibiting this protein, TNF inhibitors help reduce inflammation, relieve symptoms, and prevent further joint damage. In this trial, the effectiveness of continuing TNF inhibitors is being compared to switching to abatacept.

What is already known about the treatment

Abatacept – Abatacept is administered through an injection, either under the skin or directly into a vein. It is currently used in medicine to treat rheumatoid arthritis, a condition where the immune system mistakenly attacks the joints. The main therapeutic indication for abatacept is to help reduce the symptoms of rheumatoid arthritis and improve physical function. At the molecular level, abatacept works by interfering with the activation of T-cells, a type of immune cell, which helps to reduce inflammation and prevent joint damage. It is classified as a selective co-stimulation modulator in pharmacology.

Investigated diseases

Rheumatoid Arthritis – Rheumatoid Arthritis is a chronic inflammatory disorder that primarily affects the joints. It typically begins with inflammation in the small joints of the hands and feet, leading to pain, swelling, and stiffness. As the disease progresses, it can cause joint damage and deformities, affecting larger joints such as the knees, hips, and shoulders. The inflammation can also spread to other parts of the body, including the skin, eyes, lungs, and blood vessels. Over time, the persistent inflammation can lead to the destruction of cartilage and bone within the joint, resulting in reduced mobility and function. The disease often progresses in a pattern of flares and remissions, where symptoms worsen and then improve.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-500234-29-00Protocol codeRECHMPL21_0568Estimated enrolment220 patientsSponsorCentre Hospitalier Universitaire De Montpellier

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