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Study on the Long-Term Safety and Effectiveness of Filgotinib for Patients 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 Rheumatoid Arthritis, a condition that causes pain and swelling in the joints. The treatment being tested is a medication called Filgotinib, which is available in the form of film-coated tablets known as Jyseleca. The study involves two different dosages of this medication: 100 mg and 200 mg tablets. The purpose of the study is to evaluate the long-term safety and tolerability of Filgotinib in individuals who have previously participated in related studies.

Participants in this study will take the medication orally, meaning it is swallowed in tablet form. The study is designed to be open-label, which means that both the participants and the researchers know which treatment is being administered. This trial is a long-term extension study, which means it continues from previous research to gather more information over an extended period. The study will monitor participants for any side effects and assess how well the medication works in managing the symptoms of Rheumatoid Arthritis.

Throughout the study, participants will undergo regular check-ups to track their health and any changes in their condition. The study aims to ensure that Filgotinib is safe for long-term use and to understand its effects better. This research is important for developing effective treatments for Rheumatoid Arthritis and improving the quality of life for those affected by this condition.

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
Initial assessment
Upon joining the study, an initial assessment is conducted to ensure eligibility. This includes signing an informed consent form, which confirms understanding of the study requirements and agreement to comply with all visits and assessments.
A pregnancy test is required for females of childbearing potential before the first dose of the study drug. Lactating females must agree to stop nursing for the study's duration.
Step 2
Medication administration
The study involves taking filgotinib, which is available in two dosages: Jyseleca 200 mg and Jyseleca 100 mg. These are film-coated tablets taken orally.
The specific dosage and frequency will be determined by the study protocol and the investigator's judgment based on the participant's condition and previous study involvement.
Step 3
Ongoing monitoring
Throughout the study, regular monitoring is conducted to assess safety and effectiveness. This includes evaluating any adverse effects, conducting laboratory tests, and checking vital signs.
Participants are required to attend all scheduled visits and comply with the study's assessments.
Step 4
Completion of study
The study is estimated to conclude by May 28, 2025. Participants will continue to be monitored until the study's end date or until they complete their participation as per the study protocol.
Upon completion, final assessments will be conducted to evaluate the long-term safety and tolerability of filgotinib.

Who can join the trial?

7 criteria

Must be able and willing to sign a form that shows you understand the study and agree to participate. This form is called an informed consent form.
Must be a male or female who might benefit from the study drug, as decided by the study doctor, and have completed a previous study with the same drug for rheumatoid arthritis.
Women who can have children must have a negative pregnancy test before starting the study drug.
Women who are breastfeeding must agree to stop nursing from the start of the study until it ends.
Women who can have children and have heterosexual intercourse must agree to use specific birth control methods during the study and for 35 days after the last dose of the study drug.
If you are taking other medications for rheumatoid arthritis, your dose should not change for at least 7 days before starting the study drug.
If you need to stop the study drug for any reason at the start, you can still join the study but should wait to start the drug until it is safe to do so.

Who cannot join the trial?

3 criteria

Patients who have not completed one of the previous studies involving the medication **filgotinib** cannot participate. **Filgotinib** is a drug being studied for its effects on rheumatoid arthritis.
Patients who are not within the specified age range for the study cannot participate. The age range is determined by the study organizers.
Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.

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Verified sites

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

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Bacs-Kiskun Varmegyei Oktatokorhaz
Kecskemet, Hungary
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MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH
Hamburg, Germany
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University Multiprofile Hospital For Active Treatment Kaspela EOOD
Plovdiv, Bulgaria

Trial locations

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Investigated drugs

Filgotinib is a medication being studied for its long-term safety and effectiveness in treating rheumatoid arthritis. It is designed to help reduce inflammation and pain in the joints, which are common symptoms of rheumatoid arthritis. This study aims to understand how well patients tolerate the medication over an extended period.

Filgotinib

What is already known about the treatment

Filgotinib – Filgotinib is administered orally in the form of tablets. It is currently being studied in clinical trials for its long-term safety and effectiveness in treating rheumatoid arthritis. The main therapeutic indication for filgotinib is rheumatoid arthritis, a chronic inflammatory disorder affecting the joints. At the molecular level, filgotinib works by inhibiting Janus kinase 1 (JAK1), which plays a key role in the inflammatory process. It is classified pharmacologically as a JAK inhibitor, which helps reduce inflammation and alleviate symptoms associated with rheumatoid arthritis.

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 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. Rheumatoid arthritis can also affect other parts of the body, including the skin, eyes, and lungs.