CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 102 enrolled / 102 target
Drug / intervention
tofacitinibdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04338204
NCT04338204N/ACompletedOn Track (1.5/mo)Completion was 9mo ago

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

Pfizer·observational·Posted Apr 8, 2020·Updated Jun 3, 2026

In Brief

An observational study evaluating tofacitinib for Ulcerative Colitis. Completed, enrolled 102 participants across 17 sites.

Detailed Summary

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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesSweden
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedApr 8, 2020
Enrollment StartSep 14, 2020
Primary CompletionSep 30, 2025
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 6.2 years ago

Arms & Interventions

Patients prescribed tofacitinibother

Patients with a confirmed diagnosis of ulcerative colitis with confirmed active disease (biomarker or endoscopy) initiating tofacitinib as per the Swedish summary of product characteristics (SmPC).

Drug: tofacitinib

Interventions

tofacitinibdrug

Observational study