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
Inclusion Criteria3
- 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.
Exclusion Criteria3
- 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.
Interventions
DRUGtofacitinib
Observational study
Locations(17)
View Full Details on ClinicalTrials.gov
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NCT04338204
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