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

Sponsor
Pfizer
Study ID
NCT04338204
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Sep 14, 2020
Status verified
Jun 2026
Primary completion
Sep 30, 2025
Completion
Sep 30, 2025

Study Design

Enrollment
102 participants (actual)

Arms

  • Arm: Patients prescribed tofacitinib
    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).

Primary Outcome Measure

Proportion of Participants in Remission as Measured by Partial Mayo Score [ Time Frame: Week 52 ]

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