Fact CheckerSign in

NCT04338204Completed

Observational Study To Assess The Effectiveness and Treatment Adherence Of Tofacitinib of Ulcerative Colitis In Clinical Practice In Sweden

OBSERVATIONAL STUDY OF TOFACITINIB IN ULCERATIVE COLITIS IN SWEDEN (ODEN)

Source: ClinicalTrials.gov · Last updated 3 Jun 2026

Brief summary (registry, in English)

This is a prospective observational study using data from an existing, ongoing National Swedish registry (SWIBREG). This study is designed to assess the effectiveness and treatment adherence of tofacitinib on clinical disease activity parameters in patients with ulcerative colitis in Swedish clinical practice. The study will also assess treatment adherence of tofacitinib using the Swedish Prescribed Drug Register.

Status (registry)
Completed
Study type
Observational
Enrollment
102 (actual)
First submitted
4 Apr 2020
Start date
14 Sept 2020
Primary completion date
30 Sept 2025
Lead sponsor
Pfizer
NCT number
NCT04338204

What you commit to

  • Study type: Observational
  • Participants enrolled: 102
  • From 14 Sept 2020 to the primary completion date, 30 Sept 2025
  • 17 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (17)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ulf Eriksson
Coordinator of this site? Confirm its status
AlingsåsSwedenUnknown status
Medicinkliniken, Södra Älvsborgs Sjukhus Borås, Brämhultsvägen 53
Coordinator of this site? Confirm its status
BoråsSwedenUnknown status
Gävle Hospital
Coordinator of this site? Confirm its status
GävleSwedenUnknown status
SU/Sahlgrenska, Gastroenterologi & Hepatologi
Coordinator of this site? Confirm its status
GothenburgSwedenUnknown status
Medicinkliniken, Länssjukhuset Ryhov, Sjukhusgatan
Coordinator of this site? Confirm its status
JönköpingSwedenUnknown status
Daniel Molin
Coordinator of this site? Confirm its status
KristianstadSwedenUnknown status
Shiprock Consulting AB,
Coordinator of this site? Confirm its status
LidingöSwedenUnknown status
Mag-Tarmmedicinska kliniken, Universitetssjukhuset i Linköping
Coordinator of this site? Confirm its status
LinköpingSwedenUnknown status
Region Skane Skanes Universitetssjukhus
Coordinator of this site? Confirm its status
MalmoSwedenUnknown status
Medicinmottagning 4, Medicinska Kliniken, Universitetssjukhuset Örebro
Coordinator of this site? Confirm its status
ÖrebroSwedenUnknown status
Ersta Sjukhus, Medicinkliniken, Fjällgatan 44
Coordinator of this site? Confirm its status
StockholmSwedenUnknown status
Danderyds Hospital
Coordinator of this site? Confirm its status
StockholmSwedenUnknown status
Karolinska Universitetssjukhuset i Solna, Eugeniavägen 3, B4-09,
Coordinator of this site? Confirm its status
StockholmSwedenUnknown status
Stockholm Gastro Center
Coordinator of this site? Confirm its status
StockholmSwedenUnknown status
Medicinkliniken, Umeås Universitetssjukhus
Coordinator of this site? Confirm its status
UmeåSwedenUnknown status
Specialmedicin, Akademiska Sjukhuset, Sjukhusvägen ing 40
Coordinator of this site? Confirm its status
UppsalaSwedenUnknown status
Medicinmottagningen gastroenterologi, Västmanlands sjukhus
Coordinator of this site? Confirm its status
VästeråsSwedenUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.