A Long-Term, Observational Study within the Corrona Inflammatory Bowel Disease (IBD) Registry to Characterize the Safety of Tofacitinib in Patients with Ulcerative Colitis in the Post-Approval Setting

Study identification

• EU PAS number:
  EUPAS30314
• Study ID:
  34556
• Official title and acronym:
  A Long-Term, Observational Study within the Corrona Inflammatory Bowel Disease (IBD) Registry to Characterize the Safety of Tofacitinib in Patients with Ulcerative Colitis in the Post-Approval Setting
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The goal of the study is to characterize the safety of tofacitinib (all approved formulations) in ulcerative colitis (UC) patients in the post-approval setting. The primary outcome of interest is malignancy, excluding non-melanoma skin (NMSC).
• Study status:
  Ongoing

Research institutions and networks

Institutions

Pfizer

Study timelines

Date when funding contract was signed

Actual:07/03/2019

Study start date

Planned:30/06/2019

Actual:30/06/2019

Date of interim report, if expected

Planned:30/06/2024

Date of final study report

Planned:31/12/2027

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

A3921329