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Generate Real World Data On Tofacitinib Induction Therapy and Changes In Clinical and Patient Reported Outcomes.

TerminatedN/A

Sponsor: Pfizer

Conditions: Ulcerative Colitis

Interventions: Stool sample collection

Countries: Switzerland

This study is expected to contribute to the body of real-world data of tofacitinib's safety and efficacy profile in ulcerative colitis. Conventional clinical outcomes will give a better understanding of response and remission rates in a representative, post-marketing population. Regular patient questionnaires and measurement of a biomarker of gut inflammation will provide detail on how patients experience induction treatment and contextualise the efficacy data.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* Male or female participants 18 years of age or older at screening visit
* Participants with confirmed diagnosis of UC and who are prescribed tofacitinib (Xeljanz®) for moderately to severely active UC as per the Swiss label
* Participants who are willing and able to comply with all scheduled visits, treatment plan, study interventions, and other study procedures
* Capable of giving personally signed informed consent

Exclusion Criteria:

* Presence of clinical findings suggestive of Crohn's disease
* Any previous exposure to tofacitinib including participation in the tofacitinib clinical program
* Co-medication with any other advanced therapies for UC (biologics\*, azathioprine, mercaptopurine and methotrexate) or any other JAK inhibitor
* Any identified contra-indications for use of tofacitinib as per the Swiss label
* Not owning a handheld digital device compatible with the Sidekick Health App, not willing to have it installed on this device or not capable of using the App
* Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

Locations (5)

Sankt Gallen, Canton of St. Gallen, Switzerland
Basel, Switzerland
Bern, Switzerland
Fribourg, Switzerland
Liestal, Switzerland