RecruitingNCT04338204

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)


Sponsor

Pfizer

Enrollment

120 participants

Start Date

Sep 14, 2020

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is an observational study in Sweden tracking how well tofacitinib (a JAK inhibitor pill) works in real-world clinical practice for people with ulcerative colitis — a chronic inflammatory bowel condition. Researchers want to understand how effective the drug is outside of clinical trials and how consistently patients take it as prescribed. **You may be eligible if...** - You are 18 years or older - You have active ulcerative colitis (confirmed by stool test or colonoscopy within 4 weeks of starting tofacitinib) - Your doctor has decided to prescribe tofacitinib as part of your normal care - You consent to having your health data collected from Sweden's IBD registry (SWIBREG) **You may NOT be eligible if...** - You are enrolled in another interventional (treatment-based) clinical trial for ulcerative colitis - You do not consent to data collection - Your doctor's treatment decision was influenced by this study (must be standard clinical practice) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGtofacitinib

Observational study


Locations(17)

Ulf Eriksson

Alingsås, Sweden

Medicinkliniken, Södra Älvsborgs Sjukhus Borås, Brämhultsvägen 53

Borås, Sweden

Gävle Hospital

Gävle, Sweden

SU/Sahlgrenska, Gastroenterologi & Hepatologi

Gothenburg, Sweden

Medicinkliniken, Länssjukhuset Ryhov, Sjukhusgatan

Jönköping, Sweden

Daniel Molin

Kristianstad, Sweden

Shiprock Consulting AB,

Lidingö, Sweden

Mag-Tarmmedicinska kliniken, Universitetssjukhuset i Linköping

Linköping, Sweden

Region skåne, Skånes Universitetssjukhus

Malmö, Sweden

Medicinmottagning 4, Medicinska Kliniken, Universitetssjukhuset Örebro

Örebro, Sweden

Stockholm Gastro Center

Stockholm, Sweden

Ersta Sjukhus, Medicinkliniken, Fjällgatan 44

Stockholm, Sweden

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

Stockholm, Sweden

Danderyds Hospital

Stockholm, Sweden

Medicinkliniken, Umeås Universitetssjukhus

Umeå, Sweden

Specialmedicin, Akademiska Sjukhuset, Sjukhusvägen ing 40

Uppsala, Sweden

Medicinmottagningen gastroenterologi, Västmanlands sjukhus

Västerås, Sweden

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NCT04338204


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