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AuthorisedTherapeutic use (Phase IV)Interventional

STOP - Safety and efficacy of a STOPping strategy versus classical maintenance dose of JAK inhibitors in deep remission patients with ulcerative colitis: a randomized controlled trial

Ulcerative colitis is a long-term condition that causes inflammation and sores in the bowel. Many people take modern tablets called JAK inhibitors—such as Jyseleca, Xeljanz, or Rinvoq—to keep their illness under control. When these medicines work well, patients can enter 'deep remission', where symptoms disappear and the bowel lining heals. However, staying on these medicines indefinitely can bring side effects and increased risk of infections. This trial tests whether people in deep remission can safely pause their medication, or if it is better to keep taking standard maintenance doses. Participants will be placed into one of two groups: one will stop taking the tablets, while the other continues taking them as normal. Doctors will closely track bowel symptoms, general health, side effects, and overall wellbeing for up to two years to see which approach is safest and most effective.

At a glance

Status
Authorised
Phase
Therapeutic use (Phase IV)
Sponsor
Centre Hospitalier Regional De Marseille
Enrolment target
224
Start
17 Jun 2026

What is this study about?

Ulcerative colitis is a lifelong condition where the lining of the large bowel becomes swollen and inflamed. To help control flare-ups and calm the gut, many patients take a class of targeted medicines known as JAK inhibitors. These include medicines like filgotinib (Jyseleca), tofacitinib (Xeljanz), and upadacitinib (Rinvoq). For many, these tablets are very successful and bring about 'deep remission'—a state where symptoms vanish and camera checks show that the bowel lining has fully healed.

While continuing these tablets helps prevent future flare-ups, long-term use can sometimes lead to unwanted side effects, such as a higher chance of developing shingles, other infections, or blood vessel issues. Because of this, doctors want to know if it is strictly necessary to stay on these tablets forever once the bowel has completely healed.

The STOP trial aims to answer this question. Researchers are comparing two strategies: stopping the JAK inhibitor under close medical supervision versus continuing with standard daily doses. By studying both groups over two years, the researchers want to find out whether pausing treatment is safe, whether it reduces side effects, and how it impacts day-to-day happiness and health.

This research is important because it could spare many patients from taking unnecessary medications for years on end. At the same time, it will help doctors establish clear safety plans to restart treatment quickly if a patient's symptoms begin to return.

Key takeaways

  • The STOP trial explores whether people in deep remission with ulcerative colitis can safely pause their JAK inhibitor tablets.
  • Participants will either stop their medication or continue taking their normal maintenance dose for up to two years.
  • Doctors will closely check bowel health, symptom control, infection rates, and general quality of life.
  • If you pause treatment and symptoms return, care plans are in place to restart medication quickly.
  • Joining is completely voluntary, and you can withdraw at any time without changing your usual care.

Who may be eligible?

This study is open to adults aged 18 and older who have been diagnosed with ulcerative colitis and are currently being treated with an approved JAK inhibitor (such as Jyseleca, Xeljanz, or Rinvoq).

To be considered, your colitis must be in 'deep remission'. This means you are free from typical bowel symptoms like pain or frequent bloody diarrhoea, and recent medical checks show that the lining of your bowel has fully healed.

You may not be able to join if your colitis is currently active, if you are having a flare-up, or if you are taking other heavy immune-suppressing medications like high-dose steroids. Your trial doctor will check your medical history to make sure taking part is safe for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. I am aged 18 or older.
  2. I have a confirmed diagnosis of ulcerative colitis.
  3. I am currently taking a JAK inhibitor (such as Jyseleca, Xeljanz, or Rinvoq).
  4. My colitis is currently quiet and considered to be in 'deep remission'.
  5. I am willing to attend regular check-ups and undergo bowel camera tests over two years.
Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will be randomly assigned by a computer to one of two groups. One group will pause taking their JAK inhibitor tablets, while the other group will continue taking their regular maintenance dose. Neither you nor your doctor will get to choose your group.

You will be closely followed for up to 104 weeks (two years). During this time, you will have regular clinic visits and health checks. These will include blood and stool tests, symptom questionnaires, and checks of your blood pressure and heart health. You will also have bowel camera examinations (endoscopies) at roughly one year and two years to look directly at your bowel lining. If your symptoms flare up at any point, doctors have plans in place to restart your treatment promptly.

Potential risks and benefits

A potential benefit of joining is having very close, specialised medical monitoring of your condition. If you stop the medicine, you may also experience fewer side effects and lower infection risks. The main risk is that your colitis could flare up if you stop taking your medication, which might cause uncomfortable bowel symptoms. If you continue the medication, you remain exposed to typical side effects such as shingles or mild infections. Taking part is completely voluntary. You are free to leave the study at any point without it affecting your regular NHS medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • —
    Unverified
    France

Common questions

What does 'deep remission' mean?

Deep remission means not only that you feel well with no bowel symptoms, but also that visual camera tests show the lining of your bowel has fully healed.

What happens if my symptoms return after stopping the tablets?

You will be monitored very closely. If you show signs of a flare-up, the study team will step in quickly to restart your treatment or provide standard colitis care.

Can I choose whether I stop or continue my medicine?

No. A computer will randomly assign you to either stop or continue your medication. This ensures the study results are fair and scientifically reliable.

How long will the study last?

The study monitors your health and bowel condition for up to 104 weeks, which is about two years in total.

Will taking part cost me anything?

No. The trial medication, tests, and extra clinic appointments are provided free of charge, and some studies may help with travel expenses.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

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