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Safety and efficacy of stopping versus maintenance dose of filgotinib, tofacitinib and upadacitinib in adult ulcerative colitis patients in deep remission

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

The study focuses on adults with ulcerative colitis who have achieved a stable, steroid‑free state for at least six months while taking a daily oral JAK inhibitor. The medications involved are the tablets filgotinib, tofacitinib and upadacitinib, each taken by mouth at a fixed dose.

The purpose of the trial is to find out whether a planned stopping strategy is safer, works better and leads to higher satisfaction compared with continuing the usual maintenance dose of the JAK inhibitor.

Participants who meet the remission criteria will be randomly assigned to either stop the medication (receiving a placebo) or keep taking the same dose for a period of about one year, with optional follow‑up for a second year. During this time they will have regular check‑ups to monitor any return of symptoms, side effects, and overall well‑being, using simple questionnaires and routine examinations.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Baseline assessment
Upon joining the trial you will attend a baseline visit where your ulcerative colitis status is confirmed. this includes a physical exam, endoscopic examination, and laboratory tests to document deep remission and steroid‑free status.
Your current medication will be recorded. the trial uses oral jak inhibitors such as jyseleca 200 mg (filgotinib), xeljanZ 40 mg (tofacitinib), or rinvoq 45 mg (upadacitinib). the dose you are taking at this time will be noted.
Step 2
Randomization
After the baseline assessment you will be randomly assigned to one of two groups: the stopping strategy group or the classical maintenance dose group. the assignment is done by the study system and you will be informed of your group without influence on the process.
Step 3
Medication phase – maintenance group
If you are assigned to the maintenance group you will continue taking your jak inhibitor at the same dose you were using at baseline. the tablet is taken orally once daily.
The medication schedule is:
- if you use jyseleca, take one 200 mg tablet each day.
- if you use xeljanZ, take one 40 mg tablet each day.
- if you use rinvoq, take one 45 mg tablet each day.
This regimen continues for at least 52 weeks, the primary observation period of the trial.
Step 4
Medication phase – stopping group
If you are assigned to the stopping strategy group you will discontinue the jak inhibitor after randomization. no further doses of the study medication are taken for the duration of the 52‑week primary period.
You will be instructed to stop the tablet completely and not to restart it unless directed by the study team because of a relapse.
Step 5
Regular follow‑up visits
Throughout the first 52 weeks you will attend scheduled clinic visits. typical visits occur at weeks 4, 12, 24, 36 and 52, but the exact timing follows the study calendar.
At each visit you will undergo:
- clinical evaluation of ulcerative colitis symptoms (partial mayo score)
- laboratory tests to monitor safety (including infection markers and blood chemistry)
- questionnaires that measure treatment satisfaction, quality of life and side‑effects (tsqm, sibdq, ibd‑di, sf‑36)
The study staff will record any adverse events such as infections, herpes zoster, cardiovascular problems, or other side effects.
Step 6
End‑of‑study assessments at week 52
At week 52 a comprehensive assessment is performed. this includes endoscopic examination, biological markers, and the same questionnaires used during follow‑up.
The primary outcome combines safety, efficacy and patient satisfaction for the first 52 weeks.
Step 7
Extended follow‑up to week 104
After the primary 52‑week period the study continues with optional follow‑up until week 104.
You will have additional visits, repeat endoscopy, laboratory tests and questionnaire assessments to evaluate longer‑term outcomes.

Who can join the trial?

14 criteria

Have a confirmed diagnosis of ulcerative colitis for at least 6 months, based on doctor‑examined symptoms, camera pictures of the colon (endoscopy), tissue tests (histology), or imaging scans.
Be 18 years of age or older.
Be currently treated with a JAK inhibitor medication (such as tofacitinib, upadacitinib, or filgotinib) for more than 12 months.
Be taking a stable dose of the JAK inhibitor for at least 6 months (tofacitinib 5 mg or 10 mg twice daily, upadacitinib 15 mg or 30 mg daily, or filgotinib 200 mg daily).
Be in steroid‑free clinical remission for at least 6 months, meaning a partial Mayo Score lower than 2, no individual score higher than 1, and no rectal bleeding.
Be in steroid‑free endoscopic remission at the start of the study, meaning a Mayo endoscopic subscore of 0 (the colon looks normal on camera).
Have a fecal calprotectin level of 150 µg/g or less, which indicates low inflammation in the gut.
Have no known risk factors for venous thromboembolism (VTE), which are conditions that increase the chance of blood clots forming in veins.
Have no known risk factors for major adverse cardiovascular events (MACE), which are serious heart problems such as heart attack or stroke.
Have no known risk factors for malignancy (cancer).
Women who could become pregnant and men with partners who could become pregnant must agree to use effective birth control during the study and for at least 4 weeks after it ends.
Be able to understand the study information and sign a written informed consent form.
Be covered by a social security or health insurance scheme.
Be in generally good health based on medical history and a physical exam.

Who cannot join the trial?

15 criteria

Use of steroids (anti‑inflammatory medicines) within the 6 months before joining the study.
Currently taking steroids, immunosuppressive drugs, or biologic medicines (special drugs that affect the immune system).
Being pregnant or planning to become pregnant at any time during the study.
Breastfeeding.
Unable or unwilling to follow the study rules and procedures.
Intolerance to JAK inhibitors (including any inactive ingredients) or having experienced a serious side effect from them.
Any medical reason that makes using a JAK inhibitor unsafe (including its inactive ingredients).
Having known risk factors for VTE (blood clots in veins such as deep‑vein thrombosis or pulmonary embolism).
Having known risk factors for MACE (major heart problems like heart attack or stroke).
Active cancer or a history of malignant tumours diagnosed less than 5 years ago.
Participating in another interventional clinical trial (except for specific RIPH3 studies).
Severe liver disease (hepatic insufficiency) that limits the liver’s ability to work.
Severe or end‑stage kidney disease (renal insufficiency) that limits the kidneys’ ability to work.
Active tuberculosis, serious infections such as blood infection (septicemia) or infections that occur when the immune system is weakened.
Refusing or being unable to give informed consent (the signed agreement to take part in the study).

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Assistance Publique Hopitaux De Marseille
Verified
Marseille, France
Besancon University Hospital Center
Verified
Besançon, France
CHRU De Nancy
Responsive
Vandoeuvre Les Nancy, France

Trial locations

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Investigated drugs

Jyseleca
is an oral tablet that belongs to a group of medicines called JAK inhibitors. It works by blocking specific enzymes that help control inflammation in the body. In this study, patients with ulcerative colitis who have been taking Jyseleca for more than a year and are in deep remission are either asked to stop the medication or to keep taking it at the usual maintenance dose. The goal is to see if stopping the drug can be safe and still keep the disease under control while reducing overall exposure to the medication.
XELJANZ
is another oral JAK inhibitor tablet used to treat ulcerative colitis. It reduces inflammation by interfering with the same enzymes that cause the immune system to become over‑active. For participants in the trial, those who have been on XELJANZ for at least 12 months and have achieved stable remission are randomly assigned to either stop the medication or continue with their regular maintenance dose. Researchers are looking at whether stopping the drug maintains safety and effectiveness compared with continuing it.
RINVOQ
is an oral prolonged‑release tablet that also belongs to the JAK inhibitor family. It helps keep ulcerative colitis in remission by limiting the activity of enzymes that drive inflammation. In the study, patients who have been using RINVOQ for more than a year and are in deep, steroid‑free remission are either asked to discontinue the medication or to stay on the standard maintenance dose. The trial aims to determine if stopping RINVOQ provides similar disease control with fewer side effects and lower overall drug exposure.

What is already known about the treatment

Jyseleca
This medication comes as a 200 mg film‑coated tablet taken by mouth. Filgotinib is an approved drug that is well documented in medical research for treating ulcerative colitis and rheumatoid arthritis. It works by blocking Janus kinase enzymes, which lowers the signals that cause inflammation. It belongs to the class of oral JAK inhibitors, a type of disease‑modifying therapy.
XELJANZ
XELJANZ is provided as a 5 mg film‑coated tablet for oral use. Tofacitinib is a widely approved and studied medicine used for ulcerative colitis, rheumatoid arthritis, and psoriatic arthritis. It reduces inflammation by inhibiting Janus kinase enzymes, interrupting the pathway that leads to immune activation. It is classified as an oral JAK inhibitor.
RINVOQ
RINVOQ is supplied as a 45 mg prolonged‑release tablet taken by mouth. Upadacitinib is an approved and extensively researched treatment for ulcerative colitis and rheumatoid arthritis. It acts by selectively blocking Janus kinase enzymes, which decreases inflammatory signals in the body. It is part of the oral JAK inhibitor drug class.

Investigated diseases

Ulcerative colitis - Ulcerative colitis is a long‑lasting inflammation of the lining of the large intestine. It begins in the rectum and can extend upward to involve more of the colon. The inflammation creates small sores that cause frequent loose stools, often with blood. Symptoms may appear suddenly, improve for a time, and then return in episodes called flares. Over time, the affected area can become larger, leading to more frequent or severe symptoms. The disease typically follows a pattern of periods of activity and periods of relative calm.