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Real-World study checks if tofacitinib tames ulcerative colitis

NCT ID NCT04424303

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study followed 152 adults with moderate to severe ulcerative colitis who were prescribed tofacitinib by their doctors in France. Researchers tracked how many patients felt better after one and two years of treatment, using symptom scores and noting if they needed other medications or surgery. The goal was to see how well the drug works outside of clinical trials, in everyday medical practice.

What this could mean

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

Active substance
Tofacitinib (a pill that calms the immune system)
What this could lead to
If results are positive, it could confirm that tofacitinib is a useful option for controlling ulcerative colitis in real-world settings.
What could go wrong
This is an observational study, not a controlled trial, so results may be less reliable. It also does not test a new treatment, just how well an existing one works outside of strict research conditions.

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

152 people

The number who actually took part.

Started

Dec 2020

Finished

Dec 2025

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

Adult patients with moderate to severe Ulcerative Colitis initiating tofacitinib treatment as per the French Summary of product characteristics (SmPC)

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: * Patients of 18 years old or above * Patients with confirmed diagnosis of moderate to severe ulcerative colitis * Patients for whom gastroenterologist decides to initiate treatment with tofacitinib as per the French SmPC * Patients informed about the study procedures and receiving an information letter signed by the investigator Exclusion Criteria: * Patients who have already received tofacitinib treatment before baseline * Patients that fulfill any of the contrindications according to the latest version of the SmPC

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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

  • Aphp - Hopital Beaujon

    Clichy, 92118, France

  • Aphp - Hopital Saint Louis

    Paris, 75466, France

  • CH Le Mans

    Le Mans, 72037, France

  • CHU LYON

    Pierre-Bénite, 69495, France

  • Centre Hospitalier de Cahors

    Cahors, 46005, France

  • Ch Annecy Genevois

    Pringy, 74374, France

  • Ch Bicetre

    Le Kremlin-Bicêtre, 94275, France

  • Ch Dunkerque

    Dunkirk, 59385, France

  • Ch Emile Roux

    Le Puy-en-Velay, 43012, France

  • Ch Intercommunal de Creteil

    Créteil, 94010, France

  • Ch Montfermeil

    Montfermeil, 93370, France

  • Ch Saint Joseph Saint Luc

    Lyon, 69365, France

  • Ch Valence

    Valence, 26953, France

  • Ch Valenciennes

    Valenciennes, 59322, France

  • Chu Bichat Claude Bernard

    Paris, 75877, France

  • Chu Nantes

    Nantes, 44004, France

  • Chu Rennes

    Rennes, 35033, France

  • Chu de Bordeaux - Hopital Haut Leveque

    Pessac, 33600, France

  • Clinique Beau Soleil

    Montpellier, 34070, France

  • Clinique Jules Verne

    Nantes, 44014, France

  • Clinique Pasteur

    Toulouse, 31076, France

  • Clinique de l Europe

    Amiens, 80090, France

  • Groupe Hospitalier Mutualiste Les Portes du Sud

    Vénissieux, 69694, France

  • Groupe Hospitalier Saint Joseph

    Paris, 75674, France

  • Hopital Albert Michallon

    La Tronche, 38700, France

  • Hopital Caremeau

    Nîmes, 30029, France

  • Hopital Claude Huriez

    Lille, 59037, France

  • Hopital D'Estaing

    Clermont-Ferrand, 63100, France

  • Hopital Europeen Georges Pompidou

    Paris, 75015, France

  • Hopital Jean Minjoz

    Besançon, 25003, France

  • Hopital Nord

    Saint-Priest-en-Jarez, 42277, France

  • Hopital Rangueil

    Toulouse, 31403, France

  • Hopital Saint Eloi

    Montpellier, 34295, France

  • Hopital Sud

    Amiens, 80480, France

  • Hopital Trousseau

    Chambray-lès-Tours, 37171, France

  • Hopital de L'Archet

    Nice, 06202, France

  • Hopital de La Cote de Nacre

    Caen, 14027, France

  • Infirmerie Protestante de Lyon

    Caluire-et-Cuire, 69300, France

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