This clinical trial is focused on studying the effects of a medication called filgotinib in adults with a condition known as axial spondyloarthritis. Axial spondyloarthritis is a type of arthritis that primarily affects the spine and the joints connecting the spine to the pelvis, causing inflammation and pain. The study will use Jyseleca tablets, which contain the active ingredient filgotinib, in doses of 100 mg and 200 mg. Some participants will receive a placebo, which looks like the filgotinib tablets but does not contain the active ingredient, to help compare the effects of the actual medication.
The purpose of the study is to evaluate how well filgotinib works in reducing the signs and symptoms of axial spondyloarthritis. Participants will be randomly assigned to receive either the filgotinib tablets or the placebo. The study will be conducted in a double-blind manner, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure that the results are not influenced by expectations about the treatment. The study will last for a period of time, during which participants will take the tablets orally and attend regular check-ups to monitor their condition and any changes in their symptoms.
Throughout the study, the effectiveness of filgotinib will be assessed by looking at various measures of disease activity and quality of life. These assessments will include changes in pain levels, physical function, and overall well-being. The study aims to provide valuable information about the potential benefits and safety of filgotinib for people living with axial spondyloarthritis. Participants will be closely monitored for any side effects or adverse reactions to ensure their safety during the trial.
Who Can Join the Study?
You must be a male or female who is 18 years of age or older at the time of signing the consent form.
You must have a confirmed diagnosis of axial spondyloarthritis, which is a type of long-term inflammatory arthritis that primarily affects the spine, by a specialist such as a rheumatologist (a doctor who specializes in joints, muscles, and bones).
For those in the first group of the study, you must have evidence of radiographic sacroiliitis, which means an X-ray shows inflammation or damage in the sacroiliac joints (the joints connecting the lower spine to the pelvis). This requires a history of back pain lasting at least 12 weeks that started before age 45, along with specific patterns of joint changes seen on an X-ray.
For those in the second group of the study, you must meet the criteria for non-radiographic axial spondyloarthritis, which means you have symptoms of the disease and inflammation visible on an MRI (a detailed imaging test using magnets), but the changes are not yet visible on a standard X-ray.
You must show signs of active disease, measured by a BASDAI score (a questionnaire used to measure how much the disease is affecting your daily life) of 4 or higher, and a spinal pain score of 4 or higher on a scale of 0 to 10.
You must have a history of not getting enough relief from at least two different NSAIDs (non-steroidal anti-inflammatory drugs, which are medicines used to reduce pain and swelling), or you must be unable to take these medicines due to side effects.
If you have used bDMARDs (biologic disease-modifying antirheumatic drugs, which are advanced medicines that target specific parts of the immune system), you must have used no more than two of them that were stopped because they did not work or caused problems.
If you are continuing to take csDMARDs (conventional synthetic disease-modifying antirheumatic drugs, which are standard medicines used to slow down disease progression), you may use a maximum of two types and must have taken them at a stable dose for at least 12 weeks before the study begins.
You cannot take methotrexate (a common medicine used for arthritis) and leflunomide (another medicine used for arthritis) at the same time during the study.
Who Cannot Join the Study?
You have previously used a Janus kinase inhibitor, which is a type of medicine that works by blocking specific proteins in the body to reduce inflammation.
You have had surgery to treat symptoms in your limbs, such as synovectomy (removal of the lining of a joint) or arthroplasty (replacement or repair of a joint), or any major surgery involving anesthesia (medicine used to make you sleep or numb pain) within the last 12 weeks, or if you have major surgery planned.
You have been diagnosed with other musculoskeletal disorders (conditions affecting muscles and bones) or systemic inflammatory conditions (diseases that cause inflammation throughout the whole body), such as osteoarthritis, gout, rheumatoid arthritis, psoriatic arthritis, lupus, scleroderma, fibromyalgia, or COVID-19 syndrome.
You have active Crohn’s disease or ulcerative colitis, which are types of inflammatory bowel disease (conditions that cause swelling and irritation in the digestive tract).
You have a history of malignancy (cancer) or myelo- or lymphoproliferative disorders (conditions where the body produces too many blood cells) within the last 5 years, including certain skin cancers or cervical cancer.
You have an active autoimmune disease (a condition where the immune system attacks the body’s own healthy cells) that could make the study unsafe or interfere with results, such as uveitis (inflammation in the eye), thyroiditis (inflammation of the thyroid gland), or peptic ulcer disease (sores in the stomach or intestine).
You have a history of opportunistic infections (infections that occur more often in people with weakened immune systems) or immunodeficiency syndrome (a condition where the immune system is not working properly).
The doctor believes that participating in the study is not in your best interest due to other health conditions, such as a high risk of cardiovascular problems (heart or blood vessel issues like a heart attack or stroke).
You have a current significant infection or a history of a serious infection that required hospital stay or strong antibiotics within the last 12 weeks.
You have a condition that prevents you from having an MRI (a medical imaging test that uses strong magnets to see inside the body).
You use opioid analgesics (strong pain medicines) at a high daily dose or have had changes in your pain medicine dose within the last 2 weeks.
You have used systemic immunomodulating therapies (medicines that change how the immune system works) within the last 4 weeks, such as azathioprine, cyclosporine, or antimalarials.
You have complete spinal ankylosis, which means your spine has become stiff and fused together due to bone growth.
Filgotinib is an oral medication being tested to see how well it works and how safe it is for adults with active axial spondyloarthritis. It is used to help manage the signs and symptoms of this condition.
Axial spondyloarthritis – This is a type of inflammatory disease that primarily affects the spine and the joints connecting the spine to the pelvis. It is characterized by ongoing inflammation in the axial skeleton. As the condition develops, it can lead to persistent pain and stiffness in the lower back and hips. Over time, the inflammation may cause the vertebrae to fuse together, which limits the movement of the spine. The progression often involves changes in the sacroiliac joints located at the base of the spine.
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