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Study on Guselkumab for Treating Psoriatic Arthritis in Patients New to Biologic Therapy

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called Guselkumab on individuals with a condition known as Psoriatic Arthritis, specifically targeting those with active axial disease. Psoriatic Arthritis is a type of arthritis that affects some people who have psoriasis, a condition that features red patches of skin topped with silvery scales. Axial disease refers to inflammation in the spine and the joints that connect the spine to the pelvis. The medication being tested, Guselkumab, is administered as an injection and is being compared to a placebo to evaluate its effectiveness and safety.

The purpose of this study is to assess how well Guselkumab can reduce symptoms related to the axial part of Psoriatic Arthritis. Participants in the study will receive either Guselkumab or a placebo through subcutaneous injections, which means the medication is injected under the skin. The study will follow participants over a period of time to observe changes in their symptoms and overall health. The main focus will be on the reduction of symptoms such as spinal pain and inflammation, which are common in individuals with this condition.

Throughout the study, participants will be monitored to ensure their safety and to gather data on the effectiveness of the treatment. The study aims to provide valuable information on whether Guselkumab can be a beneficial treatment option for those suffering from Psoriatic Arthritis with axial involvement. This research is important as it seeks to improve the quality of life for individuals affected by this chronic condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant is confirmed to meet the inclusion criteria, which include being at least 18 years old, having a diagnosis of psoriatic arthritis for at least 6 months, and having active psoriatic arthritis with specific symptoms and test results.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the participant's baseline condition. This includes measuring the number of swollen and tender joints, assessing spinal pain, and confirming psoriatic arthritis through imaging.

  3. Step 3

    Treatment administration

    Participants receive either guselkumab or a placebo. Guselkumab is administered as a solution for injection in a pre-filled syringe, with a dosage of 100 mg/mL, given subcutaneously (under the skin).

  4. Step 4

    Treatment duration

    The treatment is administered over a period leading up to Week 24. The specific schedule and frequency of administration are determined by the study protocol.

  5. Step 5

    Monitoring and follow-up

    Throughout the study, participants are monitored for changes in their condition, particularly focusing on the reduction of axial symptoms of psoriatic arthritis. This includes regular assessments of the BASDAI score, which measures disease activity.

  6. Step 6

    Completion of study

    At the end of the study period, a final assessment is conducted to evaluate the overall efficacy and safety of the treatment. The primary endpoint is the change in the BASDAI score from baseline to Week 24.

Who can join the trial?

9 criteria

  • Be at least 18 years old.
  • Have been diagnosed with Psoriatic Arthritis (PsA) for at least 6 months before starting the study. Psoriatic Arthritis is a type of arthritis that affects some people with the skin condition psoriasis.
  • Meet the CASPAR criteria for Psoriatic Arthritis at the time of screening. CASPAR criteria are a set of guidelines used to diagnose Psoriatic Arthritis.
  • Have active Psoriatic Arthritis, which means having at least 3 swollen joints and at least 3 tender joints at the time of screening and at the start of the study. Also, have a C-reactive protein level of 0.3 mg/dL or higher at screening. C-reactive protein is a substance in the blood that increases when there is inflammation in the body.
  • Have a BASDAI score of at least 4. BASDAI is a tool used to measure the severity of symptoms in people with certain types of arthritis.
  • Have Psoriatic Arthritis affecting the spine, confirmed by magnetic resonance imaging (MRI). MRI is a type of scan that uses magnets and radio waves to create detailed images of the inside of the body.
  • Have a spinal pain score of at least 4. This score measures the level of pain in the spine.
  • Have active plaque psoriasis, which means having at least one psoriatic plaque that is 2 cm or larger in diameter, or nail changes that are consistent with psoriasis. Plaque psoriasis is a skin condition that causes red, scaly patches on the skin.
  • Have active Psoriatic Arthritis despite previous treatment with non-biologic DMARDs, apremilast, and/or NSAIDs. DMARDs are drugs that slow down the progression of arthritis. Apremilast is a medication used to treat Psoriatic Arthritis. NSAIDs are non-steroidal anti-inflammatory drugs used to reduce pain and inflammation.

Who cannot join the trial?

4 criteria

  • Patients who do not have Psoriatic Arthritis cannot participate.
  • Patients who are not within the specified age range cannot participate. The age range is typically defined in the study details.
  • Patients who are not part of the specified clinical trial group cannot participate. This group is usually defined by specific characteristics or conditions.
  • Patients who are part of a vulnerable population, which may include groups like children, pregnant women, or those unable to give consent, cannot participate.
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Investigated drugs

Guselkumab is a medication used in this clinical trial to treat people with active psoriatic arthritis, specifically focusing on symptoms affecting the spine and pelvic area. It is administered through an injection under the skin. The goal of using guselkumab in this study is to see how well it can reduce the symptoms related to the axial part of the disease, which includes pain and inflammation in the spine and surrounding areas.

What is already known about the treatment

Guselkumab – Guselkumab is administered through subcutaneous injection and is currently being studied in clinical trials for its effectiveness in treating psoriatic arthritis, particularly in patients with active axial disease. It is an approved medication in the field of immunology and is well-documented in medical literature for its use in treating psoriasis and psoriatic arthritis. The main therapeutic indication for guselkumab is to reduce symptoms associated with psoriatic arthritis. At the molecular level, guselkumab works by targeting and inhibiting interleukin-23 (IL-23), a protein involved in inflammatory processes. It is classified pharmacologically as a monoclonal antibody.

Investigated diseases

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, often affecting fingers and toes. Over time, it may lead to joint damage and reduced range of motion. The condition can also affect the spine, leading to back pain and stiffness. Symptoms can vary in severity and may come and go in cycles.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504716-15-00Protocol codeCNTO1959PSA4002Estimated enrolment408 patientsSponsorJanssen Cilag International

sourced from the EU Clinical Trials Register and site verification

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