Generate Real World Data On Tofacitinib Induction Therapy and Changes In Clinical and Patient Reported Outcomes. (KIC-START)

Pfizer

Status and phase

Terminated

Phase 4

Conditions

Ulcerative Colitis

Treatments

Other: Stool sample collection

Study type

Observational

Funder types

Industry

Identifiers

NCT05069259

KIC-START (Other Identifier)

A3921395

Details and patient eligibility

About

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.

Full description

This is a low-interventional study in which the intervention under study is home fecal calprotectin testing which falls outside of normal standard of care in ulcerative colitis. Tofacitinib is prescribed and administered as per the Swiss prescribing information. Accordingly, this study is registered on ClinicalTrials.gov as an interventional study. Under Swiss law, this study is considered and approved as a non-interventional study (Category A, Human Research Ordinance, Swiss Confederation).

Enrollment

18 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.