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Study of Janus kinase inhibitor dose reduction in patients with rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis who have achieved low disease activity

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 study focuses on patients with rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis who are currently taking medications called Janus Kinase inhibitors (JAKi). These medications include filgotinib (Jyseleca), tofacitinib (Xeljanz), upadacitinib (Rinvoq), and baricitinib (Olumiant), which are used to treat inflammatory conditions affecting joints and the spine.

The purpose of this research is to determine if gradually reducing the dose of these medications is as effective as continuing with the current dose in patients whose disease is well-controlled. The study will examine patients who have maintained low disease activity or whose symptoms have been in remission for at least 6 months while taking these medications.

During the 12-month study period, participants will be monitored for disease activity, quality of life, and any side effects. The study will track how well the joints function, any disease flare-ups, and other health-related factors. Researchers will also measure medication levels in the blood and examine immune system cells to better understand how these treatments work.

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

    Your disease activity will be evaluated using specific measurement tools depending on your condition: DAS28-CRP for rheumatoid arthritis, PASDAS for psoriatic arthritis, or ASDAS for axial spondyloarthritis.

    The assessment confirms that your condition has been stable with low disease activity or remission for at least 6 months while taking JAK inhibitor medication.

  2. Step 2

    Treatment assignment

    You will be assigned to either continue your current medication dose or follow a dose reduction strategy.

    The medications involved in this study include: Jyseleca (filgotinib), Xeljanz (tofacitinib), Rinvoq (upadacitinib), or Olumiant (baricitinib).

    All medications are taken orally in tablet form.

  3. Step 3

    6-month follow-up

    Your disease activity will be measured again using the same assessment tools as in the initial evaluation.

    The doctor will monitor any changes in your condition and document any side effects.

    Your use of additional medications will be recorded.

  4. Step 4

    12-month assessment

    A final evaluation of your disease activity will be conducted.

    The assessment will determine if your condition has remained stable with low disease activity.

    Any side effects or health events during the study period will be documented.

    Your quality of life and healthcare costs throughout the study will be evaluated.

  5. Step 5

    Study completion

    The study will evaluate whether reducing the medication dose was as effective as continuing the standard dose.

    The results will help determine the best long-term treatment approach for patients with similar conditions.

Who can join the trial?

11 criteria

  • You must be at least 16 years old
  • You must have been diagnosed with one of these conditions:
    • Rheumatoid arthritis (RA) - a condition that causes joint inflammation
    • Psoriatic arthritis (PsA) - joint inflammation related to psoriasis
    • Axial spondyloarthritis (axSpA) - inflammation affecting mainly the spine
    • You must be currently taking JAK inhibitor medication (a type of medication that helps reduce inflammation) either:
      • alone, or
      • in combination with other conventional medications for arthritis
      • at least half of the standard prescribed dose
      • Your disease must be well-controlled for at least 6 months, shown by:
        • For rheumatoid arthritis: low disease activity scores
        • For psoriatic arthritis: low disease activity and limited skin symptoms
        • For axial spondyloarthritis: low disease activity scores
        • Both men and women can participate in this study

Who cannot join the trial?

15 criteria

  • Age below 18 years old
  • Current pregnancy or breastfeeding
  • Active or chronic infection with hepatitis B or hepatitis C (viral liver infections)
  • History of tuberculosis that has not been properly treated
  • Severe or uncontrolled infections within the last 3 months
  • Current diagnosis of cancer or cancer treatment in the past 5 years
  • Severe heart, liver, or kidney problems
  • History of blood disorders that increase risk of blood clots
  • Recent major surgery (within last 8 weeks)
  • Current participation in other clinical trials
  • Inability to follow study procedures or attend scheduled visits
  • Known allergic reactions to JAK inhibitors (medications used to treat arthritis)
  • Unstable medical conditions that could interfere with the study
  • Use of prohibited medications that could interact with study treatment
  • History of substance abuse in the past 6 months
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Investigated drugs

JAK inhibitors (JAKi) are medications used to treat inflammatory rheumatic diseases such as rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis. These medications work by blocking specific proteins called Janus kinases that are involved in inflammation. They help reduce joint pain, swelling, and other symptoms of rheumatic conditions. JAK inhibitors are typically taken as oral tablets and are used when other treatments haven't worked well enough.

What is already known about the treatment

JAK inhibitors - A class of medications administered orally that work by blocking Janus kinase enzymes, which are involved in inflammation processes. These drugs are primarily used to treat rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis when patients haven't responded well to other treatments. JAK inhibitors work at the molecular level by interrupting signals that cause inflammation in the immune system, effectively reducing joint pain and swelling. They belong to a class of medications called targeted synthetic disease-modifying antirheumatic drugs (tsDMARDs) and are particularly notable for their ability to provide rapid symptom relief while potentially slowing disease progression. Note: Since the trial data doesn't specify individual JAK inhibitors, I've provided a general description of the drug class. Common JAK inhibitors include tofacitinib, baricitinib, and upadacitinib, but the specific medication(s) used in this trial isn't mentioned in the provided data.

Investigated diseases

  • Rheumatoid Arthritis

    A chronic inflammatory condition that primarily affects joints, causing swelling, stiffness, and pain. The immune system mistakenly attacks the joint lining, leading to gradual joint damage. The condition typically starts in smaller joints of hands and feet, often affecting both sides of the body symmetrically. Over time, it can spread to larger joints and may cause joint deformity.

  • Psoriatic Arthritis

    A form of arthritis that develops in some people with psoriasis, causing joint inflammation, stiffness, and swelling. It can affect any joint in the body and may develop before, after, or at the same time as skin psoriasis. The condition can vary from mild to severe, and symptoms may come and go. Joint problems often affect fingers and toes, causing them to become swollen and sausage-like.

  • Axial Spondyloarthritis

    A chronic inflammatory disease primarily affecting the spine and sacroiliac joints where the spine connects to the pelvis. The condition causes back pain and stiffness, typically starting in early adulthood. Pain and stiffness are usually worse in the morning or after periods of inactivity. The inflammation can lead to the growth of new bone, potentially causing some vertebrae to fuse over time.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-520757-36-00Protocol codeT1172Estimated enrolment200 patientsSponsorSint Maartenskliniek

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