Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study on Adjusting Adalimumab Dosage for Patients with Rheumatoid Arthritis in Remission

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 rheumatoid arthritis, a chronic inflammatory disorder that primarily affects the joints. The treatment being investigated is adalimumab, which is marketed under the name Humira. It is a medication given as an injection and is used to reduce inflammation and slow the progression of the disease. The purpose of the study is to evaluate a personalized approach to adjusting the dosage of adalimumab for patients who have been in remission, meaning their symptoms are under control, for at least six months.

Participants in the study will continue their current treatment with adalimumab and methotrexate (MTX), a common medication used to treat rheumatoid arthritis. The study will involve gradually spacing out the adalimumab injections based on regular assessments every three months. These assessments will help determine the lowest effective dose needed to maintain remission. The study aims to find the minimal necessary concentration of adalimumab in the blood to keep the disease in check.

Throughout the study, the presence of antibodies against adalimumab will be monitored, as these can affect how well the medication works. Participants will also be asked to report any infections they experience, as this information is important for understanding the safety of the treatment. The study is expected to continue until mid-2026, with recruitment starting in late 2024.

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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying that the patient is over 18 years old, has rheumatoid arthritis (RA) as per specific criteria, and has been in remission for at least 6 months.

    The patient must have been receiving adalimumab treatment (40 mg every other week) for at least 6 months. A negative pregnancy test is required for women who can become pregnant.

  2. Step 2

    Treatment continuation

    The patient continues with the current treatment regimen of adalimumab 40 mg administered every other week. This medication is provided as a solution for injection in a pre-filled syringe, intended for cutaneous use.

  3. Step 3

    Monitoring and evaluation

    Regular visits are scheduled to monitor the patient's condition. During these visits, the presence of anti-adalimumab antibodies is measured, and any infections are documented.

    The patient's tolerance to the treatment is assessed, with a focus on any infections. Patients are required to record every infection in a booklet to minimize memory-related errors.

  4. Step 4

    Data analysis

    The study aims to estimate the minimal necessary adalimumab concentration to maintain remission. This involves analyzing the relationship between the risk of RA flare-ups and adalimumab levels.

    A flare-up is defined as an increase in the DAS28 score above 2.6 for patients previously in remission, or an increase of 0.6 or greater for those with low disease activity.

  5. Step 5

    Study completion

    The study is expected to conclude by June 2026. Throughout the study, data collected will contribute to understanding the optimal adalimumab dosage for maintaining remission in RA patients.

Who can join the trial?

7 criteria

  • Patient must be over 18 years old.
  • Patient must have a diagnosis of **rheumatoid arthritis (RA)**, which is a condition that causes pain and swelling in the joints, according to specific criteria set by medical organizations (ACR/EULAR 2010).
  • Patient must be in **remission**, meaning their symptoms are under control, with a score of less than 2.6 on a test called **DAS28** for at least 6 months. DAS28 is a measure used to assess the activity of rheumatoid arthritis.
  • Patient must have been receiving **adalimumab** treatment, a medication used to reduce inflammation, at a dose of 40 mg every other week, for at least 6 months.
  • Patient must be affiliated with or a beneficiary of a social security scheme.
  • Patient must have signed an **informed consent**, which means they agree to participate in the study after being given all the necessary information.
  • For women who can have children, a negative result on a highly sensitive pregnancy test is required.

Who cannot join the trial?

4 criteria

  • Patients who have not been in remission from rheumatoid arthritis for at least 6 months. Remission means that the symptoms of the disease are reduced or not present.
  • Patients who are not being treated with both methotrexate (MTX) and adalimumab. These are medications used to manage rheumatoid arthritis.
  • Patients who are younger than 18 years old or older than 65 years old.
  • Patients who are part of a vulnerable population, 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.

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

  • Adalimumab

    is a medication used in this trial to help maintain remission in patients with rheumatoid arthritis (RA). It works by reducing inflammation and slowing down the progression of the disease. The trial aims to find the lowest effective concentration of adalimumab needed to keep patients in remission.

  • MTX

    , also known as methotrexate, is another medication used in combination with adalimumab in this trial. It is commonly used to treat rheumatoid arthritis by decreasing inflammation and suppressing the immune system to prevent joint damage.

What is already known about the treatment

Adalimumab – Adalimumab is administered via subcutaneous injection and is currently well-established in medical literature as a treatment for rheumatoid arthritis. It is primarily indicated for reducing inflammation and pain in patients with rheumatoid arthritis. At the molecular level, adalimumab works by blocking a protein called tumor necrosis factor (TNF), which plays a key role in causing inflammation. It is classified as a biologic disease-modifying antirheumatic drug (DMARD).

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 tissues, leading to inflammation. Over time, this inflammation can cause damage to the cartilage and bones within the joint. The disease often starts with minor joint pain and stiffness, which can progress to more severe symptoms. As it advances, it may lead to joint deformity and loss of function. The condition can also affect other parts of the body, including the skin, eyes, lungs, and blood vessels.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514313-35-00Protocol code24CH046Estimated enrolment60 patientsSponsorCentre Hospitalier Universitaire De Saint Etienne

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.