Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-24 @ 2:53 PM
NCT ID:
NCT05069259
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05069259
Study Brief:
Protocol Section:
NCT05069259