Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study Comparing Abatacept and Tocilizumab for Adults with Rheumatoid Arthritis Not Responding to Previous Treatments

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 two medications, abatacept and tocilizumab, for treating rheumatoid arthritis. Rheumatoid arthritis is a chronic inflammatory disorder that primarily affects joints, causing pain and swelling. The study involves patients who have not responded adequately to one or two previous targeted treatments. The medications being tested are administered through injections under the skin.

The purpose of the study is to compare the effectiveness of tocilizumab and abatacept in patients who have not had sufficient improvement with previous treatments. Participants will receive either of the medications for a period of up to 12 months. During this time, their condition will be monitored to assess changes in disease activity and overall health. The study will also track any side effects experienced by participants.

Throughout the study, participants will have regular check-ups to evaluate their response to the treatment. These evaluations will include assessments of joint tenderness and swelling, as well as overall health and quality of life. The study aims to provide valuable information on which medication may be more effective for patients with rheumatoid arthritis who have not responded well to other treatments.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, diagnosis of rheumatoid arthritis, and previous treatment responses.

    The assessment ensures that the patient has an inadequate response to one or two targeted treatments, as defined by specific disease activity scores.

  2. Step 2

    Randomization and treatment assignment

    Patients are randomly assigned to receive either abatacept or tocilizumab. Both medications are administered via subcutaneous injection.

    The specific medication and dosage are determined by the study protocol: ORENCIA (abatacept) 125 mg or RoActemra (tocilizumab) 162 mg, both provided in pre-filled syringes.

  3. Step 3

    Treatment administration

    The assigned medication is administered according to the study schedule. The frequency and duration of administration are specified by the trial protocol.

    Patients receive their medication through subcutaneous injections, which are typically self-administered or administered by a healthcare professional.

  4. Step 4

    Follow-up assessments

    Regular follow-up assessments are conducted at 3, 6, and 12 months to monitor treatment response and side effects.

    These assessments include evaluations of disease activity, quality of life, and any side effects experienced.

  5. Step 5

    Primary outcome evaluation

    The primary outcome is evaluated at 6 months, focusing on changes in the Clinical Disease Activity Index (CDAI).

    This index measures disease activity based on joint counts and patient and evaluator assessments.

  6. Step 6

    Secondary outcome evaluation

    Secondary outcomes are assessed at 3, 6, and 12 months, including various disease activity scores and quality of life measures.

    Additional evaluations include the proportion of patients achieving specific therapeutic responses and the occurrence of side effects.

  7. Step 7

    Completion of trial participation

    Upon completion of the 12-month period, patients conclude their participation in the trial.

    Final assessments are conducted to gather comprehensive data on treatment efficacy and safety.

Who can join the trial?

6 criteria

  • Must be an adult, meaning you are over 18 years old.
  • Have a condition called rheumatoid arthritis as defined by specific criteria from medical organizations (ACR/EULAR 2010).
  • Have not responded well to one or two specific treatments, which means your disease activity is still moderate to high after at least 3 months of treatment. This is measured by scores called DAS28-ESR greater than 3.2 and CDAI greater than 10.
  • Be a member of the French National Health Insurance Fund.
  • Have signed a form that shows you understand the study and agree to participate.
  • If you are a woman who can have children, you must use effective birth control during the study and continue using it for 14 weeks after the last treatment.

Who cannot join the trial?

5 criteria

  • Patients who do not have rheumatoid arthritis. Rheumatoid arthritis is a condition where the body's defense system attacks the joints, causing pain and swelling.
  • Patients who have not tried at least one or two specific treatments for their rheumatoid arthritis.
  • Patients who are not adults. This means individuals under the age of 18 cannot participate.
  • Patients who are not able to receive injections under the skin, as the study involves medications given this way.
  • Patients who are part of a vulnerable group, which means they might need special protection or care.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

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

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Abatacept

    is a medication used to treat rheumatoid arthritis. It works by interfering with the immune system's activity, which helps reduce inflammation and slow down the progression of the disease. In this trial, abatacept is given through an injection under the skin to see how effective it is for patients who have not responded well to other treatments.

  • Tocilizumab

    is another medication used for rheumatoid arthritis. It targets specific proteins in the body that cause inflammation, helping to relieve symptoms and prevent joint damage. In this study, tocilizumab is also administered as an injection under the skin, and its effectiveness is being compared to that of abatacept in patients who have not had success with previous treatments.

What is already known about the treatment

  • Abatacept

    Abatacept is administered through subcutaneous injection and is currently used in the treatment of rheumatoid arthritis, particularly in patients who have not responded adequately to one or two targeted treatments. It is well-documented in medical literature as an effective option for managing this condition. Abatacept works by interfering with the activation of T-cells, a type of immune cell, thereby reducing inflammation and joint damage. It is classified as a selective co-stimulation modulator.

  • Tocilizumab

    Tocilizumab is also administered via subcutaneous injection and is used to treat rheumatoid arthritis in patients who have not had sufficient response to previous targeted therapies. It is recognized in medical literature for its role in managing this autoimmune condition. Tocilizumab functions by blocking the interleukin-6 receptor, which plays a key role in the inflammatory process. It is classified as an interleukin-6 receptor antagonist.

Investigated diseases

Rheumatoid Arthritis – Rheumatoid arthritis is a chronic inflammatory disorder that primarily affects the joints. It typically causes pain, swelling, and stiffness in the joints, often starting in the small joints of the hands and feet. Over time, it can lead to joint damage and deformities. The disease progresses through periods of flares and remissions, where symptoms can worsen or improve. It can also affect other parts of the body, including the skin, eyes, lungs, and blood vessels. The exact cause is unknown, but it involves the immune system attacking the body's own tissues.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515600-39-00Protocol codeRC-P0055Estimated enrolment224 patientsSponsorGroupement Des Hopitaux De L'Institut Catholique De Lille

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.