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Real-World study checks how well tofacitinib controls ulcerative colitis

NCT ID NCT04338204

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 completed observational study looked at how well the drug tofacitinib works for people with ulcerative colitis in everyday Swedish clinics. Researchers used a national registry to track disease remission and whether patients stayed on the medication. The study included 102 patients and focused on real-world effectiveness rather than a controlled experiment.

What this could mean

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

Active substance
tofacitinib
What this could lead to
If successful, this study could confirm that tofacitinib works well in everyday clinical practice for ulcerative colitis patients, supporting its continued use.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by patient selection and real-world factors. It does not prove long-term safety or superiority over other treatments.

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

102 people

The number who actually took part.

Started

Sep 2020

Finished

Sep 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

Patients with a confirmed diagnosis of ulcerative colitis, ≥18years of age, with confirmed active disease (biomarker or endoscopy) initiating tofacitinib as per the Swedish 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: * The assignment of the patient to tofacitinib is not decided in advance by the protocol but falls within clinical practice and the prescription of the medicine is done according to the SmPC and is clearly separated from the decision to include the patient in the study. * The patient must sign the informed consent before enrollment in the study. The informed consent permits extraction of data from SWIBREG at baseline and during the duration of the study. For patients not registered in SWIBREG, they must complete all SWIBREG consents and registration at the time of treatment initiation. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. * Patients, male or female, must be 18 years old or above. * The patient must have active disease as confirmed by fecal calprotectin \>250 mg/kg or endoscopic assessment corresponding to a Mayo endoscopic subscore ≥2 not more than 4 weeks prior onset to the initiation of tofacitinib treatment. This inclusion criteria applies also to patients that have already been enrolled in the study. Exclusion Criteria: * The patient is enrolled in a clinical trial in which the treatment of ulcerative colitis is dictated by a study protocol. If the patient is participating in another ongoing observational study (non-interventional), the patient may be included in this observational study. * Patients that fulfill any of the contraindications according to the latest version of the SmPC. Any SmPC label updates will be communicated to all study sites. * For whatever reason the physician feels the patient unsuitable to participate in the study.

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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

  • Danderyds Hospital

    Stockholm, 18257, Sweden

  • Daniel Molin

    Kristianstad, 29185, Sweden

  • Ersta Sjukhus, Medicinkliniken, Fjällgatan 44

    Stockholm, 11691, Sweden

  • Gävle Hospital

    Gävle, 80324, Sweden

  • Karolinska Universitetssjukhuset i Solna, Eugeniavägen 3, B4-09,

    Stockholm, 17176, Sweden

  • Mag-Tarmmedicinska kliniken, Universitetssjukhuset i Linköping

    Linköping, 58185, Sweden

  • Medicinkliniken, Länssjukhuset Ryhov, Sjukhusgatan

    Jönköping, 55185, Sweden

  • Medicinkliniken, Södra Älvsborgs Sjukhus Borås, Brämhultsvägen 53

    Borås, Sweden

  • Medicinkliniken, Umeås Universitetssjukhus

    Umeå, 50985, Sweden

  • Medicinmottagning 4, Medicinska Kliniken, Universitetssjukhuset Örebro

    Örebro, 70185, Sweden

  • Medicinmottagningen gastroenterologi, Västmanlands sjukhus

    Västerås, 72189, Sweden

  • Region skåne, Skånes Universitetssjukhus

    Malmö, 20501, Sweden

  • SU/Sahlgrenska, Gastroenterologi & Hepatologi

    Gothenburg, Göteborg, Sweden

  • Shiprock Consulting AB,

    Lidingö, Sweden

  • Specialmedicin, Akademiska Sjukhuset, Sjukhusvägen ing 40

    Uppsala, 75185, Sweden

  • Stockholm Gastro Center

    Stockholm, 11486, Sweden

  • Ulf Eriksson

    Alingsås, SE-441 33, Sweden

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