Generate Real World Data On Tofacitinib Induction Therapy and Changes In Clinical and Patient Reported Outcomes.
Reason given: Study was terminated due to difficulty in enrolling targeted number of participants. There were no safety and/or efficacy concerns in the decision to stop enrollment.
Key facts
- Where
- Basel, Bern, Fribourg, Liestal, and Sankt Gallen, SwitzerlandSee the 5 sites
Where in Switzerland
- Clarunis, UniversitätsspitalBasel, SwitzerlandNo longer taking part
- Verein IBD Study GroupBern, SwitzerlandNo longer taking part
- Centre Fribourgeois de GastroenterologieFribourg, SwitzerlandNo longer taking part
- Kantonsspital BasellandLiestal, SwitzerlandNo longer taking part
- Kantonsspital St. GallenSankt Gallen, SwitzerlandNo longer taking part
Trial details
- Who runs it
- Pfizer
- Trial code
- NCT05069259
- Record updated
- 19 December 2025
- Original description
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.Read full original descriptionShow less
A LOW-INTERVENTIONAL, PROSPECTIVE, MULTI-CENTER STUDY TO EVALUATE REAL-WORLD CLINICAL, BIOCHEMICAL AND PATIENT-REPORTED RESPONSES TO TOFACITINIB INDUCTION THERAPY IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS IN 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.
Inclusion: 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: 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; Presence of clinical findings suggestive of Crohn's disease; 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.