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
- Diseases
- Ulcerative colitis
- 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
Sites (17)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ulf Eriksson Coordinator of this site? Confirm its status | Alingsås | Sweden | Unknown status |
| Medicinkliniken, Södra Älvsborgs Sjukhus Borås, Brämhultsvägen 53 Coordinator of this site? Confirm its status | Borås | Sweden | Unknown status |
| Gävle Hospital Coordinator of this site? Confirm its status | Gävle | Sweden | Unknown status |
| SU/Sahlgrenska, Gastroenterologi & Hepatologi Coordinator of this site? Confirm its status | Gothenburg | Sweden | Unknown status |
| Medicinkliniken, Länssjukhuset Ryhov, Sjukhusgatan Coordinator of this site? Confirm its status | Jönköping | Sweden | Unknown status |
| Daniel Molin Coordinator of this site? Confirm its status | Kristianstad | Sweden | Unknown status |
| Shiprock Consulting AB, Coordinator of this site? Confirm its status | Lidingö | Sweden | Unknown status |
| Mag-Tarmmedicinska kliniken, Universitetssjukhuset i Linköping Coordinator of this site? Confirm its status | Linköping | Sweden | Unknown status |
| Region Skane Skanes Universitetssjukhus Coordinator of this site? Confirm its status | Malmo | Sweden | Unknown status |
| Medicinmottagning 4, Medicinska Kliniken, Universitetssjukhuset Örebro Coordinator of this site? Confirm its status | Örebro | Sweden | Unknown status |
| Ersta Sjukhus, Medicinkliniken, Fjällgatan 44 Coordinator of this site? Confirm its status | Stockholm | Sweden | Unknown status |
| Danderyds Hospital Coordinator of this site? Confirm its status | Stockholm | Sweden | Unknown status |
| Karolinska Universitetssjukhuset i Solna, Eugeniavägen 3, B4-09, Coordinator of this site? Confirm its status | Stockholm | Sweden | Unknown status |
| Stockholm Gastro Center Coordinator of this site? Confirm its status | Stockholm | Sweden | Unknown status |
| Medicinkliniken, Umeås Universitetssjukhus Coordinator of this site? Confirm its status | Umeå | Sweden | Unknown status |
| Specialmedicin, Akademiska Sjukhuset, Sjukhusvägen ing 40 Coordinator of this site? Confirm its status | Uppsala | Sweden | Unknown status |
| Medicinmottagningen gastroenterologi, Västmanlands sjukhus Coordinator of this site? Confirm its status | Västerås | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.