Xeljanz Special Investigation for Long-term Use in UC Patients

NCT03643211 | Completed Results

• 1 other identifier: A3921248
• Study Type: observational
• Target: 2,016
• Locations: 1 country
• Sites: 1

Brief Summary

Secondary data collection study: safety and effectiveness of Xeljanz in UC patients under Japanese medical practice

Conditions

Ulcerative Colitis

Keywords

Xeljanz; Ulcerative colitis; UC; Long-term

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Drug Reactions

  An adverse drug reaction (ADR) was any untoward medical occurrence attributed to XELJANZ in a participant who received XELJANZ. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to XELJANZ was assessed by the physician.

  60 weeks

Eligibility Criteria

• Age: 0 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

UC patients who were confirmed to have received Xeljanz after the approval date of dosage and administration of Xeljanz for UC patients

You may qualify if:

• Patients with ulcerative colitis treated with XELJANZ
• Patients naive to XELJANZ in the treatment of ulcerative colitis

You may not qualify if:

• \- None

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Local Country Office

Tokyo, Japan

Location

Related Publications (2)

• Matsuoka K, Motoya S, Shinzaki S, Mikami Y, Adachi C, Arai S, Endo Y, Sato K, Yuasa H, Mizuno Y, Hisamatsu T. Post-marketing Surveillance of Tofacitinib in Patients With Ulcerative Colitis in Japan: A Post Hoc Analysis of Safety and Effectiveness by Prior Biologic Status. Crohns Colitis 360. 2025 Nov 22;7(4):otaf065. doi: 10.1093/crocol/otaf065. eCollection 2025 Oct.

  PMID: 41425505 DERIVED

• Matsuoka K, Motoya S, Yamamoto T, Matsuura M, Fujii T, Shinzaki S, Mikami Y, Arai S, Oshima J, Endo Y, Yuasa H, Hoshi M, Sato K, Hisamatsu T. Post-marketing surveillance of tofacitinib in patients with ulcerative colitis in Japan: a final report of safety and effectiveness data. J Gastroenterol. 2025 Aug;60(8):979-989. doi: 10.1007/s00535-025-02249-5. Epub 2025 Apr 21.

  PMID: 40259041 DERIVED

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: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2018
• First Posted: August 22, 2018
• Study Start: June 8, 2018
• Primary Completion: November 10, 2022
• Study Completion: November 10, 2022
• Last Updated: October 8, 2024
• Results First Posted: October 8, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)