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Real-World tofacitinib study in ulcerative colitis ends early

NCT ID NCT05069259

Disease control Sponsor: Pfizer Source: ClinicalTrials.gov ↗

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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 looked at how well the drug tofacitinib (Xeljanz) works for people with moderate to severe ulcerative colitis in everyday medical practice in Switzerland. It measured symptom improvement and gut inflammation using stool samples. The study was small with 18 participants and was terminated early, so results are limited.

What this could mean

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

Active substance
tofacitinib (Xeljanz)
What this could lead to
If successful, this study could confirm that tofacitinib works well in everyday practice for people with ulcerative colitis, helping doctors make better treatment decisions.
What could go wrong
This was a small, terminated study with only 18 participants, so results may not be reliable or apply to everyone. Tofacitinib also carries risks like infections and blood clots.

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.

Participants

18 people

The number who actually took part.

Started

Mar 2022

Finished

Apr 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

60 adults both male and female who are prescribed tofacitinib for moderately to severely active UC will be enrolled in the study.

Ages

18 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: * Male or female participants 18 years of age or older at screening visit * Participants with confirmed diagnosis of UC and who are prescribed tofacitinib (Xeljanz®) for moderately to severely active UC as per the Swiss label * Participants who are willing and able to comply with all scheduled visits, treatment plan, study interventions, and other study procedures * Capable of giving personally signed informed consent Exclusion Criteria: * Presence of clinical findings suggestive of Crohn's disease * Any previous exposure to tofacitinib including participation in the tofacitinib clinical program * Co-medication with any other advanced therapies for UC (biologics\*, azathioprine, mercaptopurine and methotrexate) or any other JAK inhibitor * Any identified contra-indications for use of tofacitinib as per the Swiss label * Not owning a handheld digital device compatible with the Sidekick Health App, not willing to have it installed on this device or not capable of using the App * Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

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Conditions

The condition(s) this trial relates to.

ulcerative colitis

As listed by the trial registrant

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

Ulcerative colitis

Contacts and locations

Locations

  • Centre Fribourgeois de Gastroenterologie

    Fribourg, Switzerland

  • Clarunis, Universitätsspital

    Basel, Switzerland

  • Kantonsspital Baselland

    Liestal, Switzerland

  • Kantonsspital St, Gallen

    Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

  • Verein IBD Study Group

    Bern, CH - 3012, Switzerland

More trials for these conditions

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