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Study on Morning vs. Evening Dosing of Tofacitinib for Patients with Rheumatoid or Psoriatic Arthritis

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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 tofacitinib, which is used to treat two types of arthritis: rheumatoid arthritis and psoriatic arthritis. These are conditions where the immune system mistakenly attacks the joints, causing pain and swelling. The medication being tested is a prolonged-release tablet known as XELJANZ 11 mg, which means it releases the active ingredient slowly over time.

The purpose of the study is to compare the effectiveness of taking tofacitinib either in the morning or in the evening. Participants will be randomly assigned to take the medication at one of these times. The study will last for about three months, during which participants will report on their disease activity, which refers to how active their arthritis symptoms are. The study will also look at other factors like morning stiffness, general health, fatigue, pain, sleep, and quality of life.

Researchers will also explore whether changes in certain genes related to the body's internal clock, known as circadian clock genes, and the composition of bacteria in the gut, called microbiota, are linked to how well the treatment works. This study aims to provide insights into the best time of day to take tofacitinib for managing symptoms of rheumatoid arthritis and psoriatic arthritis.

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

    Joining the study

    Upon joining the study, participation is confirmed based on specific criteria. These include having rheumatoid arthritis or psoriatic arthritis, being 18 years or older, and having active disease as defined by certain medical standards.

  2. Step 2

    Medication administration

    The medication used in this study is tofacitinib, provided in the form of XELJANZ 11 mg prolonged-release tablets. This medication is taken orally.

    Participants are randomly assigned to take the medication either in the morning or in the evening. This is to compare the effectiveness of different dosing times.

  3. Step 3

    Treatment duration

    The treatment with tofacitinib lasts for a period of 3 months. During this time, the main focus is on observing the difference in self-reported disease activity between morning and evening dosing.

  4. Step 4

    Assessment of outcomes

    The primary outcome measured is the difference in disease activity, which is self-reported by participants using a tool called the Routine Assessment of Patient Index Data 3 (RAPID-3).

    Secondary outcomes include assessments of morning stiffness, general health, fatigue, pain, sleep, functional ability, quality of life, work productivity, treatment satisfaction, and compliance.

  5. Step 5

    Additional investigations

    The study also investigates whether changes occur in the expression of circadian clock genes and the composition of microbiota over time, and if these changes correlate with the response to treatment.

Who can join the trial?

4 criteria

  • The patient must have either rheumatoid arthritis or psoriatic arthritis. These are types of joint diseases. The diagnosis should be according to specific criteria: the 2010 criteria for rheumatoid arthritis or the CASPAR criteria for psoriatic arthritis.
  • The patient must have active disease. This means the disease is currently causing symptoms. For rheumatoid arthritis, this is defined as a DAS score greater than 2.4. For psoriatic arthritis, this is defined as a DAPSA score greater than 14. These scores are ways to measure how active the disease is.
  • The patient must be at least 18 years old.
  • Both men and women can participate in the study.

Who cannot join the trial?

4 criteria

  • Patients who do not have rheumatoid arthritis or psoriatic arthritis as defined by specific medical criteria cannot participate. These are conditions that cause joint pain and swelling.
  • Patients who are not within the specified age range cannot participate. The age range is typically defined by the study.
  • Patients who belong to certain clinical trial groups that are not included in this study cannot participate. These groups are usually defined by the study based on specific characteristics.
  • Patients who are considered part of a vulnerable population cannot participate. This means people who might need special protection or care.
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Investigated drugs

Tofacitinib Extended-Release is a medication used in this trial to treat inflammatory arthritis. It works by reducing inflammation and pain in the joints. The trial is investigating whether taking this medication in the morning or evening is more effective in managing the symptoms of arthritis.

What is already known about the treatment

Tofacitinib – Tofacitinib is administered orally in an extended-release tablet form, designed for once-daily dosing. It is currently approved for use in treating rheumatoid arthritis and psoriatic arthritis, with ongoing research exploring the effects of dosing time on its efficacy. The medication works by inhibiting Janus kinases (JAKs), which are enzymes that play a key role in the inflammatory process, thereby reducing inflammation and joint damage. Tofacitinib is classified as a Janus kinase inhibitor, a type of targeted synthetic disease-modifying antirheumatic drug (DMARD).

Investigated diseases

  • Rheumatoid Arthritis

    Rheumatoid arthritis is a chronic inflammatory disorder that primarily affects the joints. It occurs when the immune system mistakenly attacks the body's own tissues, leading to joint pain, swelling, and stiffness. Over time, it can cause joint damage and deformities. The disease often starts in smaller joints, such as those in the fingers and toes, and can progress to larger joints like the knees and hips. Symptoms may vary in severity and can come and go, with periods of increased disease activity known as flares. It can also affect other parts of the body, including the skin, eyes, lungs, and blood vessels.

  • Psoriatic Arthritis

    Psoriatic arthritis is a form of arthritis that affects some people who have psoriasis, a condition characterized by red patches of skin topped with silvery scales. It involves joint pain, stiffness, and swelling, which can affect any part of the body, including the fingertips and spine. The disease can range from mild to severe and can worsen over time. Symptoms may include swollen fingers and toes, foot pain, and lower back pain. Like psoriasis, psoriatic arthritis is a chronic disease that can have periods of remission and flare-ups. It is an autoimmune condition, meaning the immune system attacks healthy cells and tissues.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517865-17-01Protocol codeChronIA001Estimated enrolment84 patientsSponsorErasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

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