Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-26 @ 1:16 PM
Study NCT ID:
NCT05069259
Status:
TERMINATED
Last Update Posted:
2025-12-19
First Post:
2021-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Generate Real World Data On Tofacitinib Induction Therapy and Changes In Clinical and Patient Reported Outcomes.
Sponsor:
Pfizer
Organization:
Study Overview
Official Title:
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
Status:
TERMINATED
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
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.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KIC-START
Brief Summary:
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.
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.
Detailed 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).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| KIC-START | OTHER | Alias Study Number | View |