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Study on Reducing Immunosuppressive Drugs in Adults with Psoriatic Arthritis: Methotrexate Disodium, Abatacept, and Certolizumab Pegol

Verified siteRegistered drugNo placebo
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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 psoriatic arthritis, a condition that causes joint pain and swelling in people who have psoriasis, a skin disease. The study aims to understand how reducing the use of certain medications can help maintain minimal disease activity, which means keeping the symptoms under control. The medications being studied include a variety of treatments that help manage the immune system, such as methotrexate disodium, abatacept (also known as Orencia), certolizumab pegol (known as Cimzia), secukinumab (known as Cosentyx), risankizumab (known as Skyrizi), tofacitinib (known as Xeljanz), upadacitinib (known as Rinvoq), apremilast (known as Otezla), ixekizumab (known as Taltz), guselkumab (known as Tremfya), ustekinumab (known as Stelara), golimumab (known as Simponi), etanercept, adalimumab, infliximab, leflunomide, sulfasalazine, and prednisolone. Some participants may receive a placebo, which is a substance with no active medication.

The purpose of the study is to evaluate how far these medications can be reduced without causing a return of symptoms. Participants will be randomly assigned to different treatment groups, and the study will last for up to 24 months. During this time, the participants' health will be closely monitored to ensure that their condition remains stable. The study will involve regular check-ups to assess the activity of the disease and the overall health and quality of life of the participants.

Throughout the study, participants will receive either the medication or a placebo, and their progress will be tracked to see if they can maintain minimal disease activity. The study will help determine the best approach to managing psoriatic arthritis with the least amount of medication necessary, aiming to improve the quality of life for those affected by this 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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the diagnosis of psoriatic arthritis and ensuring the disease is in a state of minimal activity for at least six months.

    The assessment checks for stable treatment with specific medications without changes in dosage or type for at least six months.

  2. Step 2

    Random assignment to treatment groups

    Participants are randomly assigned to different treatment groups. This process is unblinded, meaning both the participant and the study team know which treatment is being administered.

  3. Step 3

    Treatment phase

    During the treatment phase, the focus is on tapering systemic immunosuppressive therapy. The goal is to maintain minimal disease activity while reducing medication dosage.

    Medications involved may include methotrexate disodium, abatacept, certolizumab pegol, secukinumab, risankizumab, etanercept, sulfasalazine, tofacitinib, infliximab, upadacitinib, leflunomide, apremilast, adalimumab, guselkumab, ustekinumab, prednisolone, ixekizumab, and golimumab.

    Routes of administration include subcutaneous injections, oral tablets, and intravenous infusions.

  4. Step 4

    Monitoring and evaluation

    Participants are monitored regularly to evaluate the presence of minimal disease activity. This includes checking joint counts, pain levels, and overall disease activity.

    The primary endpoint is the maintenance of minimal disease activity 12 months after the baseline assessment.

  5. Step 5

    Follow-up assessments

    Follow-up assessments occur at various intervals to track disease activity and quality of life. These assessments include measures of joint and entheseal point counts, psoriasis activity, and quality of life indicators.

    Secondary endpoints include the time to loss of minimal disease activity and the time needed to restore it after therapy adjustments.

  6. Step 6

    End of trial

    The trial is estimated to conclude by December 31, 2026. At this point, a final assessment is conducted to evaluate the long-term impact of the treatment approach on disease activity and quality of life.

Who can join the trial?

6 criteria

  • The patient must provide written informed consent, which means they agree to participate after understanding the study details.
  • The patient must be an adult, either male or female, aged 18 or older.
  • The patient must have a diagnosis of **Psoriatic Arthritis (PsA)**, which is a type of arthritis that affects some people with psoriasis, according to specific criteria known as **CASPAR criteria**.
  • The patient's disease must be in a state called **Minimal Disease Activity (MDA)** for at least 6 months. MDA is defined by meeting 5 out of 7 specific health criteria, such as having a low number of tender or swollen joints, low pain levels, and low impact on daily activities.
  • The patient must have a disease status called **MDA+** at the time of screening and at the start of the study. This means they meet the MDA criteria, especially in areas related to joints and musculoskeletal health.
  • The patient should have been on a stable treatment plan without changes for at least 6 months. This treatment can include certain medications like **csDMARDs** (conventional synthetic disease-modifying antirheumatic drugs), **bDMARDs/tsDMARDs** (biologic or targeted synthetic DMARDs), or low-dose **glucocorticoids** (a type of steroid medication).

Who cannot join the trial?

1 criterion

  • No specific exclusion criteria were provided for this clinical trial.
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Investigated drugs

Systemic Immunosuppressive Therapy is used in this trial to help manage psoriatic arthritis by reducing the activity of the immune system. This therapy aims to maintain minimal disease activity in patients who have already achieved stability in their condition. The trial is investigating the effects of gradually reducing the dosage of this therapy to see if patients can maintain their improved condition with less medication.

What is already known about the treatment

Systemic Immunosuppressive Therapy – This medication is administered orally or through injection, depending on the specific drug used within this category. It is currently being studied in clinical trials for its effectiveness in managing psoriatic arthritis, particularly in maintaining minimal disease activity. The main therapeutic indication is for psoriatic arthritis, a condition characterized by joint inflammation and skin lesions. At the molecular level, these medications work by suppressing the immune system to reduce inflammation and prevent joint damage. They are classified pharmacologically as immunosuppressants, which help control the overactive immune response associated with autoimmune diseases.

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, which may lead to joint damage over time. Symptoms often vary in severity and can affect any joint in the body, including the spine. Some individuals may experience periods of remission, where symptoms improve or disappear, followed by flare-ups. The progression of the disease can be unpredictable, with some people experiencing mild symptoms and others facing more severe joint involvement.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508251-39-00Protocol codeUKER-ATTRACTOR-01Estimated enrolment370 patientsSponsorUniversitaetsklinikum Erlangen AöR

sourced from the EU Clinical Trials Register and site verification

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