Study on Filgotinib and Triamcinolone for Newly Diagnosed Rheumatoid Arthritis Patients

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What is this study about?

This clinical trial is focused on studying the treatment of rheumatoid arthritis, a condition that causes pain and swelling in the joints. The study will compare two different treatments to see which is more effective in helping patients achieve remission, which means the symptoms of the disease are reduced or disappear. One group of patients will receive a medication called Filgotinib, taken as a 200 mg tablet once daily for three months. The other group will receive a single dose of a corticosteroid called triamcinolone acetonide, given as an injection.

The purpose of the study is to determine if the treatment with Filgotinib is not worse than, and possibly better than, the treatment with triamcinolone acetonide when both are used alongside standard therapies like methotrexate and hydroxychloroquine. Participants will be monitored over a period of time to assess their disease activity and overall health. The study will track how many patients achieve remission at three months and will also look at other factors such as patient satisfaction, side effects, and the overall use of medications during the study.

Throughout the study, participants will have regular check-ups to monitor their progress and any changes in their condition. The study aims to provide valuable information on the effectiveness of these treatments in managing rheumatoid arthritis, potentially leading to improved care for patients with this condition.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of rheumatoid arthritis by a rheumatologist, ensuring no prior use of disease-modifying antirheumatic drugs (DMARDs), and confirming age between 18 and 64 years.

The assessment also checks for a disease activity score (DAS28-CRP) greater than 2.6 and requires proficiency in Dutch. Informed consent must be signed.

2 randomization and treatment allocation

Participants are randomly assigned to one of two treatment groups. One group receives a JAK inhibitor called filgotinib at a dose of 200 mg taken orally once daily for three months.

The other group receives a single dose of 120 mg of triamcinolone acetonide administered via intramuscular injection.

3 concomitant therapy

Both groups begin treatment with methotrexate and hydroxychloroquine as part of their therapy for rheumatoid arthritis.

4 monitoring and follow-up

Participants are monitored for disease activity remission at three months, with the primary goal being a DAS28-CRP score of less than 2.6.

Secondary assessments occur at 6, 9, and 12 months, evaluating disease activity scores, changes in biomarkers such as CRP and ESR, and patient-reported outcomes.

5 evaluation of treatment adherence and satisfaction

Throughout the study, adherence to treatment and patient satisfaction are evaluated. Any adverse events, including side effects, are recorded to assess incidence and severity.

6 final assessment and study completion

The study concludes with a final assessment of disease activity remission and other secondary endpoints. The cumulative dosage of corticosteroids and usage of biological DMARDs (bDMARDs) over the study period are also evaluated.

Who Can Join the Study?

Must be a patient with a new diagnosis of rheumatoid arthritis confirmed by a specialist called a rheumatologist.
Should not have taken any DMARDs before. DMARDs are medicines used to slow down rheumatoid arthritis.
Must be between 18 and 64 years old.
Should have a DAS28-CRP score greater than 2.6 at the start of the study. This is a number that helps doctors understand how active the rheumatoid arthritis is.
Must be able to speak and understand Dutch.
Must have signed an informed consent form, which means agreeing to participate in the study after understanding what it involves.

Who Cannot Join the Study?

Patients who are pregnant or breastfeeding cannot participate.
Patients with a history of severe allergic reactions to any of the study medications cannot participate.
Patients with active infections, which means infections that are currently causing symptoms, cannot participate.
Patients with a history of cancer within the last 5 years cannot participate, except for certain types of skin cancer that have been treated.
Patients with serious heart problems, such as heart failure or recent heart attack, cannot participate.
Patients with liver disease, which affects how the liver works, cannot participate.
Patients with kidney disease, which affects how the kidneys work, cannot participate.
Patients who have used other experimental drugs within the last 30 days cannot participate.
Patients with a history of drug or alcohol abuse within the last year cannot participate.
Patients who are unable to follow the study procedures or attend study visits cannot participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Medisch Spectrum Twente	Enschede	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not yet recruiting	01.01.2025

Trial locations

Investigated drugs:

Filgotinib is a medication used in this trial as a JAK inhibitor. It is being tested to see if it can help achieve remission of disease activity in patients with newly diagnosed rheumatoid arthritis. The trial aims to determine if it is not inferior or potentially superior to other treatments in achieving this goal.

Triamcinolone is a type of corticosteroid used in this trial. It is administered as a single dose and is being compared to Filgotinib to see which is more effective in helping patients achieve remission of rheumatoid arthritis symptoms.

Methotrexate is a medication commonly used to treat rheumatoid arthritis. In this trial, it is part of the standard therapy that patients receive alongside the other treatments being tested. It helps reduce inflammation and slow the progression of the disease.

Hydroxychloroquine is another medication used in the treatment of rheumatoid arthritis. It is included in the trial as part of the standard therapy. It works by reducing inflammation and helping to control the symptoms of the disease.

Investigated diseases:

Rheumatoid arthritis

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 own tissues, leading to inflammation. Over time, this inflammation can cause damage to the joint tissues, resulting in pain, swelling, and stiffness. The disease often starts in smaller joints, such as those in the fingers and toes, and can progress to larger joints like the knees, hips, and shoulders. As the condition advances, it may lead to joint deformity and loss of function. In addition to joint issues, rheumatoid arthritis can also affect other parts of the body, including the skin, eyes, and lungs.

Trial ID:

2024-517112-30-00

Protocol code:

2024-517112-30-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Filgotinib and Triamcinolone for Newly Diagnosed Rheumatoid Arthritis Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?