This clinical trial is focused on studying the effects of a medication called guselkumab in people with a condition known as psoriatic arthritis. Psoriatic arthritis is a type of arthritis that affects some people who have the skin condition psoriasis. It causes joint pain, stiffness, and swelling. The medication being tested, guselkumab, is given as an injection under the skin and is designed to help reduce the symptoms of this condition.
The purpose of the study is to evaluate how effective guselkumab is in improving the signs and symptoms of psoriatic arthritis and to see if it can help slow down the damage to the joints that can be seen on X-rays. Participants in the study will receive either guselkumab or a placebo, which looks like the medication but does not contain the active ingredient. The study will follow participants over a period of time to monitor their response to the treatment.
Throughout the study, participants will receive regular injections and attend scheduled visits to check on their progress. The study aims to provide valuable information on whether guselkumab can be a safe and effective treatment option for people living with active psoriatic arthritis.
1initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the diagnosis of active psoriatic arthritis and ensuring that the participant meets specific criteria, such as having at least three swollen and tender joints and a certain level of inflammation in the blood.
2baseline evaluation
A baseline evaluation is performed to document the current state of the condition. This involves physical examinations, blood tests, and imaging of the joints to assess any damage.
3treatment administration
Participants receive the study medication, guselkumab, or a placebo. The medication is administered as a subcutaneous injection, which means it is injected under the skin. The dosage is 100 mg/mL, delivered through a pre-filled syringe.
4regular follow-up visits
Regular follow-up visits are scheduled to monitor the participant’s response to the treatment. These visits include physical examinations, blood tests, and assessments of joint health. The frequency of these visits is determined by the study protocol.
5evaluation of treatment efficacy
At Week 24, the primary endpoint is evaluated. This involves determining the proportion of participants who achieve a 20% improvement in symptoms, as defined by the American College of Rheumatology (ACR) criteria.
6long-term monitoring
Participants continue to be monitored for the duration of the study, which is estimated to end in March 2028. This long-term monitoring helps assess the safety and sustained efficacy of the treatment.
Who Can Join the Study?
Be at least 18 years old or the legal age of consent in the area where the study is happening.
If currently using non-biologic DMARDs (a type of medication for arthritis), you should have started treatment at least 3 months ago, and the dose must be stable for at least 4 weeks before starting the study treatment. You should not have serious side effects from these medications.
If not using certain non-biologic DMARDs like MTX, SSZ, or HCQ, you must not have taken them for at least 4 weeks before starting the study treatment. If not using LEF, you must not have taken it for at least 12 weeks before starting the study treatment.
If using MTX, the dose must be 25 mg or less per week. If using SSZ, the dose must be 3 grams or less per day. If using HCQ, the dose must be 400 mg or less per day. If using LEF, the dose must be 20 mg or less per day.
Have active plaque psoriasis, which means having at least one psoriatic plaque (a type of skin rash) that is 2 cm or larger, and/or nail changes that are typical of psoriasis.
If using NSAIDs (a type of pain reliever) or other pain medications for PsA at the start, you must be on a stable dose for at least 2 weeks before starting the study treatment. If not using these medications, you must not have taken them within 2 weeks before starting the study treatment.
If using oral corticosteroids (a type of medication) at the start, you must be on a stable dose equal to 10 mg or less of prednisone per day for at least 2 weeks before starting the study treatment. If not using these medications, you must not have taken them within 2 weeks before starting the study treatment.
Have active PsA (psoriatic arthritis) even after trying non-biologic DMARDs, apremilast, and/or NSAID therapy.
Have been diagnosed with PsA for at least 6 months before starting the study treatment and meet specific criteria for PsA at screening.
Have active PsA, which means having at least three swollen joints and three tender joints at screening and at the start of the study, and a CRP (a blood test for inflammation) level of 0.3 mg/dL or higher at screening.
Have at least two joints with erosions (damage) on X-rays of the hands and feet as determined by a central reading.
Have at least one of the following types of PsA: involvement of the joints near the fingertips, arthritis affecting many joints without rheumatoid nodules, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis.
Who Cannot Join the Study?
Patients who have any other serious health conditions that could interfere with the study.
Patients who are currently participating in another clinical trial.
Patients who have had a recent infection that required treatment with antibiotics.
Patients who have a history of allergic reactions to the study medication or similar medications.
Patients who are pregnant or breastfeeding.
Patients who have a history of drug or alcohol abuse.
Patients who have received certain treatments for psoriatic arthritis recently.
Patients who have a history of certain types of cancer.
Guselkumab is a medication used in this clinical trial to treat individuals with active psoriatic arthritis. It is administered through an injection under the skin. The purpose of using guselkumab in this study is to evaluate its effectiveness in reducing the signs and symptoms associated with psoriatic arthritis. Additionally, the trial aims to determine if guselkumab can help prevent the progression of joint damage as seen on X-rays.
Psoriatic Arthritis – Psoriatic arthritis is a chronic inflammatory condition that affects both the skin and joints. It is associated with psoriasis, a skin disease characterized by red, scaly patches. The disease can cause joint pain, stiffness, and swelling, which may worsen over time. It often affects the fingers and toes, leading to a sausage-like appearance known as dactylitis. In some cases, it can also affect the spine, causing back pain and stiffness. The progression of psoriatic arthritis can vary, with periods of increased symptoms followed by times of remission.
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