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Study on Monitoring Adalimumab for Maintaining Disease Control in Adults with Rheumatoid Arthritis

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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 effects of a treatment for rheumatoid arthritis, a condition that causes pain and swelling in the joints. The treatment being tested involves the use of a medication called adalimumab, which is a type of drug known as a tumor necrosis factor inhibitor. This medication is given as an injection under the skin. The study aims to determine if a method called proactive therapeutic drug monitoring can help maintain control of the disease without flare-ups better than the usual care.

Participants in the study will receive either the proactive monitoring or the standard care while continuing their treatment with adalimumab. The study will last for 18 months, during which time the participants' disease activity will be regularly checked. The goal is to see if the proactive approach helps in keeping the disease under control without any flare-ups, which are periods when symptoms get worse. The study will also look at how long the drug remains effective, any side effects, and the levels of the drug in the blood.

This trial is designed to provide valuable information on whether adjusting the treatment based on regular monitoring can improve outcomes for people with rheumatoid arthritis. The results could help in developing better strategies for managing this condition and improving the quality of life for those affected.

The research process

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

Step 1
Joining the study
Upon joining the study, the patient is confirmed to have a clinical diagnosis of rheumatoid arthritis and is between 18 and 75 years old.
The patient must have been on stable therapy with a standard dose of a subcutaneous tumor necrosis factor inhibitor (TNFi), specifically adalimumab, for at least 3 months and no more than 24 months.
The patient should be in low disease activity or remission, with a Disease Activity Score (DAS28-CRP) of less than 3.2, and have an indication for continuation of treatment as per the treating physician.
Step 2
Treatment administration
The patient receives adalimumab as a solution for injection, administered subcutaneously.
The medication is available in various forms, including pre-filled syringes and pens, each containing 40 mg of the solution.
The administration of the medication continues as per the standard care protocol.
Step 3
Monitoring and assessments
The study involves proactive therapeutic drug monitoring to assess the effectiveness of the treatment in maintaining disease control without flares.
Regular assessments of disease activity are conducted at 4, 8, 12, and 18 months.
The primary goal is to maintain sustained disease control over the 18-month follow-up period without experiencing a flare.
Step 4
Evaluation of outcomes
The primary outcome is defined as sustained disease control without flare, where a flare is identified by an increase in the DAS28-CRP score and the presence of swollen joints.
Secondary outcomes include the time to disease flare, the number and type of adverse events, drug survival, drug consumption, and serum drug levels.

Who can join the trial?

5 criteria

Have a clinical diagnosis of Rheumatoid Arthritis (RA), which is a condition that causes pain and swelling in the joints.
Be between 18 and 74 years old at the time of screening.
Have been on a stable treatment with a standard dose of a medication called adalimumab for at least 3 months but not more than 24 months. Adalimumab is a type of medication given as an injection under the skin to help reduce inflammation.
Have low disease activity or be in remission, which means the disease is not very active or is under control. This is measured by a score called DAS28-CRP, which should be less than 3.2. The doctor must also agree that continuing treatment is necessary.
Be able to understand and sign a form that gives permission to participate in the study, known as an informed consent form.

Who cannot join the trial?

10 criteria

Patients who are pregnant or breastfeeding cannot participate.
Individuals with a history of severe allergic reactions to medications used in the study are excluded.
Patients with other serious health conditions that could interfere with the study are not eligible.
Participants who have used certain medications recently that might affect the study results are excluded.
Individuals who are unable to follow the study procedures or attend required visits cannot participate.
Patients with a history of substance abuse that could affect their ability to participate are excluded.
Individuals who are currently participating in another clinical trial are not eligible.
Patients with certain infections that could interfere with the study are excluded.
Individuals who have had a recent surgery that might affect the study results cannot participate.
Patients with a history of cancer, except for some types of skin cancer, are excluded.

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Verified sites

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

Verified
Helse Bergen HF
Bergen, Norway
Responsive
Sykehuset Oestfold HF Kalnes
Graalum, Norway
Responsive
Universitetssykehuset Nord-Norge HF
Tromsø, Norway

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Investigated drugs

Tumor Necrosis Factor Inhibitor (TNFi) is a type of medication used in this trial to treat rheumatoid arthritis. It works by blocking a specific protein in the body that causes inflammation and is involved in the immune response. This helps reduce symptoms like pain and swelling in the joints. The medication is given as an injection under the skin.

Adalimumab

What is already known about the treatment

Tumor Necrosis Factor Inhibitor – This medication is administered subcutaneously, meaning it is injected under the skin. It is currently used in the treatment of rheumatoid arthritis, a chronic inflammatory disorder. The main therapeutic indication is to reduce inflammation and halt disease progression in rheumatoid arthritis patients. At the molecular level, it works by blocking the activity of tumor necrosis factor (TNF), a substance in the body that causes inflammation in the joints. It is classified pharmacologically 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 typically causes pain, swelling, and stiffness in the joints, often starting in the hands and feet. Over time, it can lead to joint damage and deformities. The disease progresses with periods of increased symptoms, known as flares, and times of remission when symptoms improve. It can also affect other parts of the body, including the skin, eyes, and lungs. The exact cause is unknown, but it involves the immune system attacking the body's own tissues.