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Study Comparing Abatacept and Adalimumab for Adults with Early Rheumatoid Arthritis Not Responding to Methotrexate

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 two treatments for Rheumatoid Arthritis (RA), a condition that causes pain and swelling in the joints. The treatments being compared are Abatacept and Adalimumab, both of which are given as injections under the skin. These medications are used alongside another drug called methotrexate, which is commonly prescribed for RA. The study aims to determine which treatment is more effective in improving the symptoms of RA in patients who have not responded well to methotrexate alone.

Participants in the study will receive either Abatacept or Adalimumab, in addition to their regular methotrexate treatment. The study will last for several months, during which time the participants' response to the treatment will be monitored. The main goal is to see if one of the treatments leads to a better improvement in joint symptoms by the end of the study period. The study is designed to be single-blind, meaning that the participants will not know which treatment they are receiving, but the researchers will.

This trial is particularly focused on individuals with early-stage RA who have specific genetic markers known as "shared epitope" HLA Class II risk alleles. These markers are associated with a higher risk of developing RA. The study will assess the effectiveness of the treatments in achieving a significant reduction in RA symptoms, as measured by a standard clinical response called ACR50, which indicates a 50% improvement in symptoms. The results will help determine the best treatment option for patients with this type of RA.

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, the patient is randomly assigned to receive either abatacept or adalimumab. Both medications are administered as a solution for injection under the skin (subcutaneous use).

  2. Step 2

    Medication administration

    The patient receives the assigned medication, either abatacept or adalimumab, in addition to continuing their current methotrexate (MTX) treatment. The specific dosage and frequency of the injections are determined by the study protocol.

  3. Step 3

    Treatment duration

    The treatment period lasts for 24 weeks. During this time, the patient continues to receive the assigned medication along with methotrexate.

  4. Step 4

    Monitoring and assessments

    Throughout the study, the patient's response to the treatment is monitored. This includes regular assessments of joint tenderness and swelling, as well as blood tests to measure specific markers of rheumatoid arthritis activity.

  5. Step 5

    End of treatment evaluation

    At the end of the 24-week treatment period, the patient's response to the medication is evaluated. The primary goal is to determine if the patient has achieved a significant improvement in their condition, as measured by specific clinical criteria.

Who can join the trial?

7 criteria

  • Have **early rheumatoid arthritis (RA)**, which means symptoms started 12 months or less before the screening.
  • Have never used any targeted treatments for RA, including both biologic and nonbiologic drugs, except for **methotrexate (MTX)**.
  • Have been treated with **methotrexate (MTX)** for at least 12 weeks, with a stable dose for at least 4 weeks before joining the study.
  • Have a positive **Anti-CCP-2 test**, which is a blood test for RA, showing levels more than 3 times the normal limit, and also test positive for **rheumatoid factor (RF)**.
  • Have a **Disease Activity Score (DAS28-CRP)** of 3.2 or higher, which measures RA activity, at the time of screening.
  • Have at least 3 tender and 3 swollen joints at both the screening and when joining the study.
  • Both men and women can participate.

Who cannot join the trial?

8 criteria

  • Patients who do not have Rheumatoid Arthritis cannot participate. This is a condition where the body's immune system mistakenly attacks the joints, causing pain and swelling.
  • Patients who are not in the early stages of Rheumatoid Arthritis cannot participate. Early stage means the condition has not been present for a long time.
  • Patients who are not seropositive cannot participate. Seropositive means having certain antibodies in the blood that are often found in people with Rheumatoid Arthritis.
  • Patients who do not have the SE HLA Class II risk alleles cannot participate. These are specific genetic markers that can increase the risk of developing Rheumatoid Arthritis.
  • Patients who are not taking MTX (methotrexate) cannot participate. MTX is a medication commonly used to treat Rheumatoid Arthritis.
  • Patients who are not between the ages of 18 and 64 cannot participate.
  • Both male and female patients can participate, but those who do not meet other criteria cannot.
  • Patients who are considered part of a vulnerable population cannot participate. Vulnerable populations include groups who may have difficulty giving informed consent or are at higher risk of harm.
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Investigated drugs

  • Abatacept

    is a medication used in this study to treat adults with early rheumatoid arthritis. It is given as an injection under the skin. The goal of using abatacept is to help reduce the symptoms of rheumatoid arthritis by interfering with the activity of certain immune cells that contribute to the inflammation and joint damage seen in this condition.

  • Adalimumab

    is another medication used in the study for treating rheumatoid arthritis. It is also administered as an injection under the skin. Adalimumab works by blocking a specific protein in the body that causes inflammation, helping to decrease pain and swelling in the joints.

  • Methotrexate

    is a medication that is used as a background treatment in this study. It is commonly used to treat rheumatoid arthritis and works by slowing down the immune system to help reduce inflammation and prevent joint damage. Methotrexate is taken alongside the other medications to enhance their effectiveness in managing the symptoms of rheumatoid arthritis.

What is already known about the treatment

  • Abatacept

    Abatacept is administered as a subcutaneous injection and is currently used in the treatment of rheumatoid arthritis, particularly in patients who have not responded adequately to methotrexate. It is well-documented in medical literature as an effective option for managing this condition. The medication works by interfering with the activation of T-cells, a type of immune cell, thereby reducing inflammation and joint damage. Abatacept is classified as a selective co-stimulation modulator, which helps to modulate the immune response in autoimmune diseases.

  • Adalimumab

    Adalimumab is also administered via subcutaneous injection and is widely recognized in medical literature for its role in treating rheumatoid arthritis, among other inflammatory conditions. It is used when patients have not achieved sufficient relief from methotrexate alone. The drug functions by blocking tumor necrosis factor (TNF), a substance in the body that causes inflammation in the joints. Adalimumab is classified as a TNF inhibitor, which helps to reduce inflammation and prevent joint damage in autoimmune diseases.

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 hands and feet. Over time, the inflammation can lead to joint damage and deformities. The disease can also affect other parts of the body, including the skin, eyes, lungs, and blood vessels. It progresses in a pattern of flare-ups and remissions, where symptoms can worsen and then improve. 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 ID2023-506450-20-00Protocol codeIM101-863Estimated enrolment400 patientsSponsorBristol-Myers Squibb Services Unlimited Company

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