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

NCT05069259 | Terminated Results

• 2 other identifiers: A3921395KIC-START
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 5

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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Achieved Clinical Response at Week 8

  Clinical response was defined as a reduction in the partial Mayo score (PMS) from baseline of \>=2 points or achieving clinical remission. Clinical remission was defined as PMS of \<= 2 with no subscore \>1. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity.

  Week 8

Secondary Outcomes (46)

• Percentage of Participants Who Achieved Clinical Remission at Week 8

  Week 8

• Percentage of Participants Who Achieved Clinical Response at Week 16

  Week 16

• Percentage of Participants Who Achieved Clinical Remission at Week 16

  Week 16

• Percentage of Participants Who Achieved Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 8

  Week 8

• Percentage of Participants Who Achieved IBDQ Remission at Week 16

  Week 16

Study Arms (1)

Patients with active Ulcerative Colitis

Other: Stool sample collection

Interventions

Stool sample collection OTHER

collection for measuring calprotectin levels

Patients with active Ulcerative Colitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

60 adults both male and female who are prescribed tofacitinib for moderately to severely active UC will be enrolled in the study.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (5)

Kantonsspital St, Gallen

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

Location

Clarunis, Universitätsspital

Basel, Switzerland

Location

Verein IBD Study Group

Bern, CH - 3012, Switzerland

Location

Centre Fribourgeois de Gastroenterologie

Fribourg, Switzerland

Location

Kantonsspital Baselland

Liestal, Switzerland

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2021
• First Posted: October 6, 2021
• Study Start: March 28, 2022
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: December 19, 2025
• Results First Posted: April 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

CH (5)