This clinical trial is focused on studying the effects of a new treatment for Psoriatic Arthritis, a condition that causes joint pain and swelling in people who have psoriasis. The study will evaluate a medication known as JNJ-77242113, which is taken as a tablet. Participants in the study will be those who have not previously been treated with biologic medications, which are a type of advanced treatment for autoimmune diseases like psoriatic arthritis.
The purpose of the study is to assess how effective and safe JNJ-77242113 is in reducing the signs and symptoms of psoriatic arthritis. The study will compare the effects of this medication to a placebo, which is a substance with no active drug. Participants will receive either the medication or the placebo and will be monitored over a period of time to see how their symptoms change.
During the study, participants will receive the treatment for up to 100 weeks. The medication will be administered in different doses, and the effects will be evaluated at various points, including at 16 weeks. The study aims to provide valuable information on whether JNJ-77242113 can be a beneficial treatment option for those suffering from active psoriatic arthritis.
1initial visit and baseline assessment
Upon joining the study, you will attend an initial visit where a detailed assessment of your condition will be conducted. This includes checking the number of swollen and tender joints and measuring a protein in your blood called C-reactive protein (CRP).
You will also be asked about your medical history and any current medications you are taking. This information helps to ensure that you meet the study’s requirements.
2randomization and start of treatment
After the initial assessment, you will be randomly assigned to one of the treatment groups. This means you may receive either the study medication JNJ-77242113 or a placebo, which looks like the medication but does not contain the active ingredient.
The study medication is taken orally in the form of a tablet. You will receive either 200 mg or 400 mg of JNJ-77242113 or a placebo. The exact dosage and frequency will be determined by the study protocol.
3ongoing treatment and monitoring
Throughout the study, you will continue to take the assigned medication as directed. Regular follow-up visits will be scheduled to monitor your condition and any changes in symptoms.
During these visits, assessments similar to the initial visit will be conducted to track your progress. This includes checking joint swelling and tenderness, as well as measuring CRP levels.
4evaluation at week 16
At week 16, a key evaluation will take place to assess the effectiveness of the treatment. This involves measuring the reduction in signs and symptoms of psoriatic arthritis.
The primary goal is to determine if there is a significant improvement in your condition, as defined by a specific response criteria known as ACR 20.
5continuation and long-term follow-up
If you continue in the study beyond week 16, regular monitoring will persist to ensure ongoing safety and effectiveness of the treatment.
The study is expected to continue until November 2028, with periodic assessments to gather long-term data on the treatment’s impact.
Who Can Join the Study?
Must be at least 18 years old or the legal age of consent in your area.
Must have been diagnosed with Psoriatic Arthritis (PsA) for at least 3 months before starting the study. PsA is a type of arthritis that affects some people with the skin condition psoriasis.
Must have active PsA, which means having at least 3 swollen joints and 3 tender joints, and a C-reactive protein (CRP) level of 0.1 mg/dL or higher. CRP is a substance in the blood that indicates inflammation.
Must have at least one of the following PsA types: involvement of finger joints, arthritis without rheumatoid nodules, a severe form of arthritis called arthritis mutilans, asymmetric arthritis, or spine inflammation with peripheral arthritis.
Must have active plaque psoriasis, which means having at least one psoriatic plaque (a raised, red, scaly patch) that is 2 cm or larger, or nail changes due to psoriasis.
Must be considered suitable for treatment with a medication called ustekinumab and have no reasons that would prevent its use.
Must have active PsA despite current or previous treatment with non-biologic DMARDs (disease-modifying antirheumatic drugs) or a medication called apremilast. This means having tried these treatments for at least 12 weeks or being unable to tolerate them.
If currently using non-biologic DMARDs like methotrexate (MTX), sulfasalazine (SSZ), hydroxychloroquine (HCQ), or leflunomide (LEF), the treatment must have started at least 12 weeks ago, and the dose must be stable for at least 4 weeks before starting the study. If not using these medications, they should not have been taken for a certain period before the study.
If using apremilast, the dose must be stable for at least 12 weeks before starting the study. If not using apremilast, it should not have been taken within 4 weeks before the study.
If using NSAIDs (non-steroidal anti-inflammatory drugs) for PsA, the dose must be stable for at least 2 weeks before starting the study. If not using NSAIDs, they should not have been taken within 2 weeks before the study.
If using oral corticosteroids, the dose must be stable and equivalent to 10 mg or less of prednisone per day for at least 2 weeks before starting the study. If not using oral corticosteroids, they should not have been taken within 2 weeks before the study.
Who Cannot Join the Study?
Patients with any other active autoimmune disease, which means a condition where the immune system attacks the body, cannot participate.
Patients who have had a serious infection in the past 3 months, such as pneumonia, cannot participate.
Patients who have been diagnosed with cancer in the past 5 years, except for skin cancer that is not melanoma, cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have received any live vaccine within 4 weeks before the study starts cannot participate. A live vaccine is a type of vaccine that uses a weakened form of the germ that causes a disease.
Patients who have a history of drug or alcohol abuse in the past year cannot participate.
Patients who are currently participating in another clinical trial cannot participate.
Patients who have had a major surgery within 8 weeks before the study starts cannot participate.
Patients with a history of heart problems, such as heart attack or heart failure, cannot participate.
Patients with uncontrolled high blood pressure cannot participate.
JNJ-77242113 is a medication being studied for its potential to help people with active psoriatic arthritis, a condition that causes joint pain and swelling. This medication is designed to reduce the signs and symptoms of the disease, making it easier for patients to manage their daily activities. The study aims to see how effective and safe this medication is compared to not taking it at all. By participating in this trial, patients may experience relief from their symptoms and improve their quality of life.
Psoriatic Arthritis – Psoriatic Arthritis is a chronic inflammatory condition that affects the joints and is associated with psoriasis, a skin disease. It typically causes joint pain, stiffness, and swelling, which can vary in severity. The disease often progresses with periods of flare-ups and remissions. Over time, it can lead to joint damage and reduced function if not managed properly. The inflammation can also affect other parts of the body, including the eyes and the spine. The progression of symptoms can differ greatly among individuals, with some experiencing mild symptoms and others facing more severe joint involvement.
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