Status:
RECRUITING
Observational Study To Assess The Effectiveness and Treatment Adherence Of Tofacitinib of Ulcerative Colitis In Clinical Practice In Sweden
Lead Sponsor:
Pfizer
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Brief 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 tofaci...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 14 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 30 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04338204
Start Date
September 14 2020
End Date
March 30 2026
Last Update
November 24 2025
Active Locations (17)
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1
Ulf Eriksson
Alingsås, Sweden, SE-441 33
2
Medicinkliniken, Södra Älvsborgs Sjukhus Borås, Brämhultsvägen 53
Borås, Sweden
3
Gävle Hospital
Gävle, Sweden, 80324
4
SU/Sahlgrenska, Gastroenterologi & Hepatologi
Gothenburg, Sweden, Göteborg