This clinical trial is focused on studying the effects of a medication called deucravacitinib in individuals with Psoriatic Arthritis. Psoriatic Arthritis is a condition that causes joint pain and swelling, often accompanied by skin symptoms like psoriasis. The medication being tested, deucravacitinib, is taken as a film-coated tablet and is being compared to a placebo, which looks like the medication but does not contain the active ingredient.
The purpose of the study is to evaluate how effective and safe deucravacitinib is for people with active Psoriatic Arthritis who have not previously been treated with biologic disease-modifying anti-rheumatic drugs. Participants in the study will be randomly assigned to receive either deucravacitinib or a placebo. 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 during the trial.
Throughout the study, participants will take the medication or placebo for a period of time, and their health will be monitored to assess any changes in their condition. The main goal is to see if there is an improvement in joint symptoms and overall health after 16 weeks of treatment. The study will also look at other health measures to understand the full impact of the treatment. This research aims to provide valuable information about the potential benefits of deucravacitinib for people living with Psoriatic Arthritis.
1initial visit
Upon joining the study, you will attend an initial visit. During this visit, your eligibility will be confirmed based on specific criteria, such as having psoriatic arthritis for at least 3 months and meeting certain medical conditions.
You will undergo various assessments, including joint examinations and blood tests, to ensure you meet the study requirements.
2randomization
After confirming eligibility, you will be randomly assigned to one of two groups. One group will receive the active medication, deucravacitinib, and the other will receive a placebo, which looks like the medication but has no active ingredients.
This process is double-blind, meaning neither you nor the study team will know which group you are in.
3medication administration
If you are in the active medication group, you will take a deucravacitinib 6 mg tablet once daily by mouth. If you are in the placebo group, you will take a placebo tablet once daily by mouth.
The duration of this phase is 16 weeks, during which you will continue taking the assigned tablet daily.
4follow-up visits
Throughout the 16-week period, you will have regular follow-up visits. These visits are essential for monitoring your health and the effects of the treatment.
During these visits, you will undergo various assessments, including joint examinations, blood tests, and questionnaires about your health and symptoms.
5end of treatment evaluation
At the end of the 16-week treatment period, you will have a final evaluation. This will include a comprehensive assessment of your condition and any changes in your symptoms.
The study team will review the results to determine the effectiveness and safety of the treatment.
Who Can Join the Study?
Must have been diagnosed with psoriatic arthritis (PsA) for at least 3 months before joining the study.
Must meet the Classification Criteria for Psoriatic Arthritis (CASPAR) at the time of joining the study. This is a set of guidelines used to confirm the diagnosis of psoriatic arthritis.
Must have active plaque psoriatic skin lesions or a documented medical history of plaque psoriasis (PsO) at the time of joining the study. Plaque psoriasis is a skin condition that causes red, scaly patches.
Must have active arthritis with at least 3 swollen joints and 3 tender joints at the time of joining the study and on the first day of the study.
Must have a high sensitivity C-reactive protein (hsCRP) level of 3 mg/L or higher at the time of joining the study. hsCRP is a blood test marker for inflammation in the body.
Must have at least one PsA-related joint erosion in the hand or foot, confirmed by an X-ray during the screening period.
Both male and female participants are eligible.
Who Cannot Join the Study?
Having any other active autoimmune disease. This means your immune system is attacking your own body, causing other health problems.
Having a serious infection. This is an illness caused by bacteria, viruses, or other germs that can make you very sick.
Having a history of cancer within the last 5 years, except for some types of skin cancer. Cancer is a disease where cells in the body grow uncontrollably.
Being pregnant or breastfeeding. This means you are expecting a baby or feeding a baby with your milk.
Having liver disease. This is a condition where your liver is not working properly.
Having kidney disease. This is a condition where your kidneys are not working properly.
Having a history of heart attack or stroke. A heart attack is when blood flow to the heart is blocked, and a stroke is when blood flow to the brain is blocked.
Using certain medications that might interfere with the study. This means taking drugs that could affect the results of the trial.
Having a history of drug or alcohol abuse. This means using drugs or alcohol in a way that is harmful to your health.
Being unable to follow the study procedures. This means not being able to do what the study requires.
Deucravacitinib 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 works by targeting specific pathways in the immune system that are involved in inflammation. By doing so, it aims to reduce the symptoms of psoriatic arthritis, such as pain and swelling, and improve the overall quality of life for those affected by this condition. The study is focused on people who have not previously been treated with biologic drugs, which are a type of advanced therapy for autoimmune diseases.
Psoriatic Arthritis – Psoriatic Arthritis is a chronic inflammatory disease that affects the joints and areas where tendons and ligaments connect to bone. It often occurs in people who have psoriasis, a condition characterized by red patches of skin topped with silvery scales. The disease can cause joint pain, stiffness, and swelling, which may worsen over time. It typically affects the fingers and toes, but can also involve the spine and other joints. As the disease progresses, it can lead to joint damage and reduced range of motion. Enthesitis, dactylitis, and changes in nail appearance are also common features of this condition.
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