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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Hopitaux Universitaires Pitie Salpetriere	Paris	France
Clinique De L’infirmerie Protestante De Lyon	Caluire Et Cuire	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Groupement Des Hopitaux De L’Institut Catholique De Lille	lomme	France
Ckixnd Htsfrbsjnbd Uoqlkmytpssrr Rtyal	Reims	France
Cmpytx Hicegxzpubs Rmuvagsv Ufxdrfpczcevc Dm Tmkcy	Tours	France
Iiyfkfka db Cyssmulvgkwt Hoxdmnpktwj Unfvglppbndzk dt Suysy Exebewm (rzocjhi	Saint Priest En Jarez	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.12.2024

Trial locations

Investigated drugs:

Adalimumab

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.

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 ID:

2024-514313-35-00

Protocol code:

24CH046

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?