Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Could older UC patients ditch risky meds for a simpler option?

NCT ID NCT07248644

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether older adults (60+) with ulcerative colitis who are in long-term remission can safely stop taking thiopurines (azathioprine or 6-mercaptopurine) and rely only on high-dose mesalazine. Thiopurines carry increased risks of infection and cancer with age, so switching may be safer. The trial will follow 304 participants for 24 months to compare relapse rates between those who stop thiopurines and those who continue.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
mesalazine (high-dose oral, ≥3 g/day) and thiopurines (azathioprine or 6-mercaptopurine)
What this could lead to
If successful, this could show that older patients with ulcerative colitis can safely switch to a simpler, lower-risk medication regimen without losing remission.
What could go wrong
This is a Phase 4 trial, so the drugs are already approved, but it is still possible that stopping thiopurines leads to more relapses. The study is also open-label, which may introduce bias.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 304 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male or female patients aged ≥60 years at screening. 2. Established diagnosis of ulcerative colitis according to ECCO criteria. 3. Clinical and endoscopic remission ≥12 months (Mayo score ≤2, subscore ≤1) according to clinical practice. 4. Treatment with a thiopurine (azathioprine 1-2.5 mg/kg/day or mercaptopurine 0.75-1.5 mg/kg/day) for ≥60 months. Treatment at stable doses (minimum effective dose without adverse events in the last 12 months. 5. In case of concomitant treatment with oral mesalazine, the dose must´ve been stable for ≥12 months. 6. Clinical remission (at the discretion of the investigator) for at least 3 years, without the need for treatment with oral or intravenous steroids or biological agents (topical rectal treatments are permitted as well as oral mesalazine if the dose has remained stable over the past 12 months). 7. Colonoscopy performed within 6 months prior to the start of the study in endoscopic remission (Mayo endoscopic index 0) according to clinical practice. 8. Two consecutive (centralised determinations in the period of one month) basal faecal calprotectin values \<150 mg/kg during screening. 9. Written informed consent. Exclusion Criteria: 1. Ulcerative proctitis (maximum observed extension \<25 cm throughout the course of the disease) 2. History of colectomy or imminent need for surgery. 3. Presence of ileoanal reservoir 4. History of complex perianal disease 5. Intolerance to oral 5-ASA treatment 6. Previous or concomitant biologic anti-TNF (vedolizumab, Ustekinumab) or JAK-inhibitor therapy for any condition. 7. Severe chronic renal insufficiency, defined as serum creatinine ≥ 2 mg/dL (estimated glomerular filtration rate ≤ 30 mL/min/1.73 m²). 8. Abnormal hepatic laboratory parameters, defined as AST, ALT, alkaline phosphatase, or GGT \> 2X the upper limit of normal (ULN) at screening. 9. Hematologic abnormalities at screening, defined as any of the following: absolute neutrophil count \< 1,500 cells/mm³, lymphocytes \< 500 cells/mm³, platelets \< 120,000 cells/mm³, or haemoglobin \< 12 g/dL (females) / \< 13 g/dL (males). 10. Any condition that in the investigator's opinion may compromise study participation.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Ulcerative colitis (UC) are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.