Study on Filgotinib for Patients with Refractory Behcet’s Disease, Idiopathic Inflammatory Myopathies, and IgG4-Related Disease

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What is this study about?

This clinical trial is focused on studying the effects of a medication called filgotinib on certain rare diseases. The diseases being studied are Idiopathic Inflammatory Myopathies, Behçet’s Disease, and IgG4-related Disease. These are conditions where the immune system mistakenly attacks the body’s own tissues, leading to inflammation and other symptoms. The medication filgotinib is taken in the form of film-coated tablets and is known as a JAK-inhibitor, which means it works by blocking certain enzymes in the body that are involved in the immune response.

The purpose of this study is to see how filgotinib affects the quality of life, disease activity, and safety in patients who have these conditions and have not responded well to other treatments. Participants in the study will receive either filgotinib or a placebo, and their progress will be monitored over a period of time. The study will look at various aspects of the diseases, such as the number of oral ulcers, skin disease severity, and overall disease activity, to determine how well the treatment is working.

Throughout the study, participants will be asked to complete forms and assessments to help researchers understand the impact of the treatment on their symptoms and daily life. The study aims to provide valuable information on the potential benefits and safety of using filgotinib for these rare immune-mediated inflammatory diseases. The results could lead to improved treatment options for patients with these challenging conditions.

1 joining the study

Upon joining the study, you will be informed about the purpose and procedures of the clinical trial. This study aims to evaluate the effects of filgotinib on quality of life, disease activity, and safety in patients with certain rare inflammatory diseases.

You will be asked to provide consent to participate in the study, acknowledging that you understand the potential risks and benefits.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility. This includes reviewing your medical history and current health status.

Tests may be performed to ensure there is no active or latent tuberculosis infection, as this is a requirement for participation.

3 medication administration

You will be prescribed Jyseleca tablets, which contain the active substance filgotinib. The dosage will be either 200 mg or 100 mg, depending on your specific condition and doctor’s recommendation.

The tablets are to be taken orally, once daily, for the duration of the study.

4 regular monitoring

Throughout the study, regular monitoring will be conducted to assess your response to the medication. This includes completing forms such as the EuroQol 5D-5L and other disease-specific assessments.

You will be asked to report any side effects or changes in your condition to the study team.

5 follow-up visits

Scheduled follow-up visits will occur at intervals determined by the study protocol. These visits are essential for tracking your progress and making any necessary adjustments to your treatment plan.

During these visits, additional tests and assessments may be conducted to evaluate your health and the effectiveness of the treatment.

6 completion of the study

At the end of the study period, a final assessment will be conducted to gather comprehensive data on your health status and the impact of the treatment.

You will receive information about the study’s findings and any further steps regarding your treatment.

Who Can Join the Study?

Must be 18 years or older.
Must have a refractory disease, which means the disease continues to show symptoms even after trying corticoid therapy for 12 weeks and not responding to at least prednisone and one other medication like methotrexate (MTX), mycophenolate mofetil (MMF), azathioprine (AZA), or rituximab, or if you cannot tolerate standard treatments as determined by your doctor.
Must have no evidence of active or latent tuberculosis (TB). This means you need to have a negative result on both a QuantiFERON-TB Gold test and a Mantoux tuberculin skin test done within 3 months before screening. Also, a qualified doctor must confirm through a chest X-ray that there are no signs of active TB infection, and you should have no history of untreated or inadequately treated TB.
Must have one of the following conditions:
- Behçet’s disease with active symptoms but not life-threatening, and a BDCAF score greater than 2 (new BDCAF) or greater than 15 (old BDCAF), or active disease based on clinical judgment, such as needing new or additional medication.
- Idiopathic inflammatory myopathy with active disease, diagnosed according to specific guidelines. This includes dermatomyositis with a CDASI score of 5 or more, or abnormal levels of certain enzymes like creatine kinase, aldolase, lactate dehydrogenase (LDH), aspartate transaminase (AST), or alanine aminotransferase (ALT), or MRI showing active inflammation in muscles, or active disease based on clinical judgment, such as needing new or additional medication.
- IgG4-related disease with active disease, diagnosed according to 2019 guidelines, with a responder index greater than 10, or active disease based on clinical judgment, such as needing new or additional medication.

Who Cannot Join the Study?

Patients with active infections cannot participate. This means if you currently have an infection that is not being treated or is not under control, you cannot join the study.
Patients who have had a serious allergic reaction to similar medications in the past are not eligible. A serious allergic reaction is one that required medical treatment or caused severe symptoms.
Patients with severe heart problems are excluded. This includes conditions like heart failure or recent heart attacks.
Patients with uncontrolled high blood pressure cannot participate. This means if your blood pressure is not being managed with medication or lifestyle changes, you are not eligible.
Patients with liver disease that is not stable or controlled are excluded. This refers to ongoing liver problems that are not being effectively managed.
Patients with kidney disease that is not stable or controlled cannot join. This means if you have ongoing kidney issues that are not being managed, you are not eligible.
Patients who are pregnant or breastfeeding are not eligible to participate in the study.
Patients who have participated in another clinical trial within the last 30 days are excluded. This is to ensure that previous treatments do not affect the study results.
Patients with a history of cancer in the last 5 years, except for certain types of skin cancer, cannot participate. This is to ensure the safety of the participants.
Patients with mental health conditions that are not stable or controlled are excluded. This means if you have ongoing mental health issues that are not being managed, you are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Zuyderland Medisch Centrum Stichting	Geleen	The Netherlands

Other Sites

Site Name	City	Country
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Haga Hospital	Hague	The Netherlands
Apjghbeye Ulk	Amsterdam	The Netherlands
Sholnhqpj Rjlwlep Ufmooruwiw Mjiorfg Crccuq	Nijmegen	The Netherlands
Epyfiku Uslflckoihbz Mxnvtmg Cfhxdjt Rucvtbpsf (sfyciey Mhp	Rotterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	18.03.2024

Trial locations

Investigated drugs:

Filgotinib

Filgotinib is a medication that belongs to a group of drugs known as JAK inhibitors. It works by blocking certain enzymes in the body that are involved in the process of inflammation. This can help reduce symptoms such as pain and swelling in conditions where the immune system attacks the body’s own tissues, like in some rare inflammatory diseases. In this clinical trial, the goal is to see how well filgotinib can improve the quality of life and reduce disease activity in patients who have not responded well to other treatments for their conditions.

Investigated diseases:

Idiopathic Inflammatory Myopathies – These are a group of disorders characterized by muscle inflammation and weakness. The inflammation primarily affects the skeletal muscles, which are responsible for movement. Over time, individuals may experience increasing difficulty with physical activities such as walking, climbing stairs, or lifting objects. The progression can vary, with some experiencing gradual worsening of symptoms, while others may have periods of improvement and relapse. Muscle weakness often starts in the proximal muscles, such as those in the hips and shoulders. In some cases, other organs like the skin, lungs, or heart may also be involved.

Behçet’s Disease – This is a rare, chronic condition that causes inflammation of the blood vessels throughout the body. It often presents with recurrent mouth and genital ulcers, skin lesions, and eye inflammation. The disease can progress with periods of flare-ups and remissions, where symptoms may worsen and then improve. Joint pain and swelling, as well as gastrointestinal and neurological symptoms, can also occur. The severity and frequency of symptoms can vary widely among individuals. Over time, the inflammation can lead to complications in various organs.

IgG4-related Disease – This is a chronic inflammatory condition characterized by tissue infiltration with IgG4-positive plasma cells. It can affect multiple organs, including the pancreas, salivary glands, kidneys, and lymph nodes. The disease often progresses slowly, with the formation of masses or lesions in affected tissues. Symptoms depend on the organs involved and may include swelling, pain, or dysfunction of the affected area. Over time, the inflammation can lead to fibrosis, which is the thickening and scarring of connective tissue. The course of the disease can vary, with some individuals experiencing stable symptoms and others having progressive organ involvement.

Trial ID:

2022-502968-20-02

Protocol code:

2022-502968-20

NCT ID:

NCT06285539

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Filgotinib for Patients with Refractory Behcet’s Disease, Idiopathic Inflammatory Myopathies, and IgG4-Related Disease

What is this study about?

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