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 test a medication known as JNJ-77242113, which is taken as a film-coated tablet. Participants in the study will either receive this medication or a placebo, which looks like the medication but does not contain the active ingredient.
The purpose of the study is to evaluate how well JNJ-77242113 works in reducing the signs and symptoms of psoriatic arthritis in people who have previously been treated with other biological medications. The study will last for several weeks, during which participants will take the medication and have regular check-ups to monitor their condition and any changes in their symptoms.
Participants will be randomly assigned to receive either the active medication or the placebo, and neither the participants nor the researchers will know who is receiving which treatment. This is known as a double-blind study, which helps ensure that the results are not biased. The main goal is to see if the medication can help improve the condition by Week 16, as measured by a standard response used in rheumatology studies.
1joining the study
Upon joining the study, participants will be randomly assigned to receive either the study medication, JNJ-77242113, or a placebo. A placebo is a tablet that looks like the medication but does not contain the active ingredient.
The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo.
2medication administration
Participants will take the study medication or placebo orally in the form of a film-coated tablet.
The dosage of JNJ-77242113 will be either 200 mg or 400 mg, taken as directed by the study protocol.
3duration and frequency
The medication or placebo will be administered over a period leading up to Week 16.
Participants will follow the prescribed dosage and frequency as instructed by the study team.
4monitoring and assessments
Throughout the study, participants will undergo regular assessments to monitor the reduction in signs and symptoms of psoriatic arthritis.
The primary goal is to evaluate the effectiveness of JNJ-77242113 compared to the placebo by Week 16.
5completion of the study
At the end of the study period, participants will have a final assessment to determine the overall response to the treatment.
The primary endpoint is achieving an American College of Rheumatology (ACR) 20 response, which measures improvement in the condition.
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. Psoriatic Arthritis is a type of arthritis that affects some people with psoriasis, a condition that features red patches of skin topped with silvery scales.
Must have active Psoriatic Arthritis, which means having at least 3 swollen joints and 3 tender joints, and a specific blood test result called C-reactive protein (CRP) of 0.1 mg/dL or higher. CRP is a substance produced by the liver in response to inflammation.
Must have at least one of the following PsA types: involvement of the joints closest to the nails, arthritis affecting many joints without rheumatoid nodules, a severe form of arthritis called arthritis mutilans, arthritis affecting different joints on each side of the body, or inflammation of the spine with peripheral arthritis.
Must have active plaque psoriasis, which means having at least one psoriatic plaque (a raised, red patch of skin) that is 2 cm or larger, or nail changes due to psoriasis.
Must have been treated with at least one biologic agent for PsA or psoriasis before, and the reason for stopping the treatment must be documented. Biologic agents are a type of medication that targets specific parts of the immune system.
If currently using non-biologic DMARDs (disease-modifying antirheumatic drugs) like MTX (methotrexate), SSZ (sulfasalazine), HCQ (hydroxychloroquine), or LEF (leflunomide), the treatment must have started at least 12 weeks before and the dose must be stable for at least 4 weeks before starting the study. If not using these medications, they must not have been taken for a certain period before starting 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 must not have been taken within 2 weeks before starting the study.
If using oral corticosteroids (a type of steroid medication taken by mouth), 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 must not have been taken within 2 weeks before starting the study.
Who Cannot Join the Study?
Having any other active autoimmune disease besides Psoriatic Arthritis. An autoimmune disease is when the body’s defense system attacks its own cells.
Having a serious infection that requires treatment with antibiotics, antivirals, or antifungals. This means an infection that needs strong medicine to get better.
Having a history of cancer within the last 5 years, except for some types of skin cancer. Cancer is when cells in the body grow uncontrollably.
Having liver disease or liver problems. The liver is an organ that helps clean the blood and digest food.
Having kidney disease or kidney problems. The kidneys are organs that help filter waste from the blood.
Being pregnant or planning to become pregnant during the study. Pregnancy is when a woman is expecting a baby.
Breastfeeding during the study. Breastfeeding is feeding a baby with milk from the breast.
Having a history of drug or alcohol abuse within the last year. This means using drugs or alcohol in a way that is harmful.
Having received any live vaccines within 4 weeks before the study. Live vaccines are shots that contain a small amount of the live virus to help the body build protection.
Participating in another clinical trial at the same time. A clinical trial is a research study to test new treatments.
JNJ-77242113 is a medication being studied for its potential to help people with psoriatic arthritis, a condition that causes joint pain and swelling. This medication is designed to reduce the symptoms of psoriatic arthritis, such as pain and inflammation, by targeting specific pathways in the body that are involved in the disease process. The goal of the study is to see if this medication can effectively improve the condition of people who have already tried other biological treatments but still have active symptoms. Participants in the trial will receive this medication to see if it can help reduce 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 begins with mild symptoms and can progress to more severe joint damage over time. Inflammation can affect any joint in the body, leading to reduced range of motion and potential joint deformity. Skin symptoms, such as red, scaly patches, often accompany joint issues. The progression of the disease can be unpredictable, with periods of increased activity and remission.
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