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Study on Reducing JAK Inhibitor Doses in Patients with Low Disease Activity in Rheumatoid Arthritis Using Tofacitinib and Drug Combination

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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 rheumatoid arthritis, a condition that causes pain and swelling in the joints. The study will explore a treatment approach using medications known as JAK inhibitors. These medications include Tofacitinib, Filgotinib, Upadacitinib, and Baricitinib. The purpose of the study is to compare a strategy of gradually reducing the dose of these medications with continuing the current therapy in patients who have low disease activity, meaning their symptoms are well-controlled.

Participants in the study will be randomly assigned to either continue their current dose of JAK inhibitors or to gradually reduce their dose over a period of 12 months. The study will monitor whether patients maintain their low disease activity or experience a return of symptoms, known as a flare. If symptoms worsen, a rescue therapy will be provided. The study will also track other aspects such as pain levels, quality of life, and any side effects experienced by the participants.

The trial aims to understand if reducing the dose of JAK inhibitors can help maintain low disease activity without increasing the risk of flares. This could potentially lead to fewer side effects and lower medication costs for patients. The study will last for about a year, and the results will help doctors make informed decisions about the best treatment strategies for managing rheumatoid arthritis.

The research process

The trial runs in 7 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, eligibility is confirmed based on specific criteria such as age, diagnosis of rheumatoid arthritis, and current treatment with a JAK inhibitor for at least six months.

    A negative pregnancy test is required for women of childbearing potential before starting the study.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to ensure the patient is in low disease activity, defined by a specific score (CDAI ≤ 10) for at least six months.

    Blood tests are performed to confirm a CRP level below the laboratory standard.

  3. Step 3

    Treatment phase

    Patients continue their current JAK inhibitor treatment, which may include medications such as tofacitinib, filgotinib, upadacitinib, or baricitinib, taken orally.

    The study aims to compare a dose-tapering strategy versus continuing the current therapy over a 12-month period.

  4. Step 4

    Monitoring and assessments

    Regular assessments are conducted to monitor disease activity using scores like CDAI, SDAI, and DAS28.

    Patient-reported outcomes are collected, including pain, function, fatigue, and quality of life.

  5. Step 5

    Evaluation of flare-ups

    The study evaluates the occurrence of flare-ups, defined by specific increases in disease activity scores.

    The delay between the initial visit and the first flare-up is recorded.

  6. Step 6

    Final assessment

    At the end of 12 months, the proportion of patients still in low disease activity is assessed.

    The possibility of reducing the JAK inhibitor dosage in the dose-tapering group is evaluated.

  7. Step 7

    Conclusion of the study

    The study concludes with a comprehensive analysis of the data collected over the 12-month period.

    The impact of socioeconomic factors on care costs and efficiency is also examined.

Who can join the trial?

7 criteria

  • Must be **18 years or older**.
  • Must have **rheumatoid arthritis**, which is a condition that causes joint pain and swelling, as defined by specific medical guidelines (ACR/EULAR criteria).
  • Must have been treated with a **JAK inhibitor** (a type of medication) at the full dose for at least **6 months**.
  • The JAK inhibitor should be prescribed either alone or with another medication called a **csDMARD** (a type of drug used to treat rheumatoid arthritis) at a stable dose for at least **3 months** before joining the study.
  • Must be in a state of **low disease activity** (LDA), which means the rheumatoid arthritis is not very active, for at least **6 months**. This is measured by a score called **CDAI** that should be **10 or less**.
  • Must have a **CRP level** (a blood test that measures inflammation) below the standard level set by the laboratory at the time of joining the study.
  • Women who can have children must have a **negative pregnancy test** before starting the study.

Who cannot join the trial?

5 criteria

  • Patients who do not have rheumatoid arthritis. This is a condition where the body's defense system attacks its own joints, causing pain and swelling.
  • Patients who are not in the age range specified for the study. The study is open to certain age groups only.
  • Patients who are not currently experiencing low disease activity. This means their rheumatoid arthritis symptoms are not mild or under control.
  • Patients who are not being treated with JAK inhibitors. These are medications that help reduce inflammation and pain in rheumatoid arthritis.
  • Patients who are part of a vulnerable population. This refers to groups of people who might need special protection or care.
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Investigated drugs

JAK Inhibitors are medications used to treat rheumatoid arthritis by reducing inflammation and slowing down the progression of the disease. They work by blocking certain enzymes known as Janus kinases, which play a role in the inflammatory process. In this clinical trial, JAK inhibitors are being studied to see if patients with low disease activity can maintain their condition with a reduced dose, compared to continuing the full therapy.

What is already known about the treatment

JAK Inhibitors – These medications are typically administered orally in the form of tablets. They are currently well-established in medical practice and literature, particularly for the treatment of rheumatoid arthritis. The main therapeutic indication for JAK inhibitors is to manage rheumatoid arthritis, especially in patients with low disease activity. At the molecular level, JAK inhibitors work by blocking the Janus kinase pathways, which are involved in the inflammatory process, thereby reducing inflammation and joint damage. They belong to the pharmacological class of targeted synthetic disease-modifying antirheumatic drugs (tsDMARDs).

Investigated diseases

Rheumatoid arthritis – Rheumatoid arthritis is a chronic inflammatory disorder that primarily affects the joints. It typically causes pain, swelling, and stiffness in the joints, often starting in the hands and feet. Over time, the inflammation can lead to joint damage and deformities. The disease can also affect other parts of the body, including the skin, eyes, lungs, and blood vessels. It progresses in a pattern of flares and remissions, where symptoms worsen and then improve. The exact cause is unknown, but it involves the immune system attacking the body's own tissues.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509788-25-00Protocol codeRC31/23/0373Estimated enrolment308 patientsSponsorCentre Hospitalier Universitaire De Toulouse

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