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Study on Guselkumab for Treating Active Psoriatic Arthritis in Patients with Inadequate Response to One Prior Anti-TNF Agent

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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 in individuals with Psoriatic Arthritis. Psoriatic Arthritis is a condition that causes joint pain and swelling, often occurring in people who have psoriasis, a skin condition. The study involves participants who have not responded well or cannot tolerate a previous treatment known as anti-Tumor Necrosis Factor (anti-TNF) therapy, which is used to reduce inflammation.

The purpose of this study is to evaluate how effective Guselkumab is in reducing the signs and symptoms of Psoriatic Arthritis. Participants will receive Guselkumab through an injection under the skin, using a pre-filled syringe. Some participants will receive a placebo, which looks like the medication but does not contain the active ingredient. The study will compare the effects of Guselkumab to the placebo to determine its effectiveness.

Throughout the study, participants will be monitored to assess their response to the treatment. The main goal is to see how many participants achieve a significant improvement in their condition by the 24th week of the study. This improvement is measured by a standard response called ACR 20, which indicates a 20% improvement in the number of tender and swollen joints, as well as other criteria related to Psoriatic Arthritis. The study aims to provide valuable information on the safety and benefits of using Guselkumab for treating this condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of psoriatic arthritis for at least six months and ensuring active symptoms, such as at least three swollen and three tender joints.

    A blood test is performed to measure C-reactive protein (CRP) levels, which should be 0.3 mg/dL or higher. This test may be repeated once if necessary.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either the study medication, guselkumab, or a placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.

  3. Step 3

    Treatment administration

    The study medication, guselkumab, is administered as a solution for injection using a pre-filled syringe. The dosage is 100 mg/mL, given subcutaneously (under the skin).

    The frequency and duration of administration are determined by the study protocol, which is not specified in the provided data.

  4. Step 4

    Monitoring and follow-up

    Participants are monitored regularly to assess the effectiveness and safety of the treatment. This includes evaluating the reduction in signs and symptoms of psoriatic arthritis.

    The primary goal is to determine the proportion of participants who achieve an ACR 20 response at Week 24, which indicates a 20% improvement in the number of tender and swollen joints, among other criteria.

  5. Step 5

    Study completion

    The study is estimated to conclude by October 26, 2026. Participants will be informed of their treatment group and the overall study results upon completion.

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 treatment. PsA is a type of arthritis that affects some people with the skin condition psoriasis.
  • Have active PsA, which means having at least 3 swollen joints and 3 tender joints at the start of the study. Also, have a CRP level of 0.3 mg/dL or higher. CRP is a blood test that shows inflammation in the body.
  • 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 arthritis, which means it affects different joints on each side of the body.
    • Spondylitis with peripheral arthritis, which involves the spine and other joints.
    • Have not responded well or cannot tolerate anti-TNFα therapy. Anti-TNFα therapy is a treatment for inflammation. This means:
      • Not having enough improvement after at least 12 weeks of certain medications like etanercept, adalimumab, golimumab, or certolizumab pegol, or 14 weeks of infliximab.
      • Having a bad reaction to one of these medications.

Who cannot join the trial?

10 criteria

  • Patients who have a known allergy or reaction to the study medication or its ingredients cannot participate.
  • Individuals with a history of certain serious infections, such as tuberculosis, are not eligible.
  • Patients with a weakened immune system, which means their body has a harder time fighting infections, are excluded.
  • Those who have received certain treatments for Psoriatic Arthritis recently may not be able to join.
  • Participants with other significant health conditions that could interfere with the study are not allowed.
  • Women who are pregnant or breastfeeding cannot take part in the study.
  • Individuals who are currently participating in another clinical trial are not eligible.
  • Patients who have a history of certain types of cancer may be excluded.
  • Anyone with a history of drug or alcohol abuse that could affect their ability to follow the study procedures is not eligible.
  • Individuals who have had a recent vaccination with a live vaccine may not be able to participate.
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Investigated drugs

Guselkumab is a medication used in this clinical trial to treat patients with active psoriatic arthritis. It is administered through an injection under the skin. The purpose of using guselkumab in this study is to see how well it works in reducing the signs and symptoms of psoriatic arthritis in patients who did not respond well or could not tolerate a previous treatment with another type of medication called an anti-TNF agent.

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 who have not responded well to previous anti-TNF treatments. It is an approved medication in the field of immunology and is well-documented in medical literature for its use in treating certain inflammatory conditions. The main therapeutic indication for guselkumab is psoriatic arthritis, a chronic inflammatory disease affecting the joints and skin. At the molecular level, guselkumab works by targeting and inhibiting interleukin-23 (IL-23), a protein involved in inflammatory processes, thereby reducing inflammation and symptoms associated with the condition. 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 that causes 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. The progression of the disease can vary, with periods of increased symptoms followed by times of remission. In some cases, it can lead to joint damage if not managed properly.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504715-33-00Protocol codeCNTO1959PSA3005Estimated enrolment407 patientsSponsorJanssen - Cilag International

sourced from the EU Clinical Trials Register and site verification

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