An Active Surveillance, Post-Authorisation Study to Characterize the Safety of Tofacitinib in Patients with Moderately to Severely Active Ulcerative Colitis in the Real-World Setting Using Data from the Swedish Quality Register for Inflammatory Bowel Disease (SWIBREG)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/40825
• EU PAS number:
  EUPAS40131
• Study ID:
  40825
• Official title and acronym:
  An Active Surveillance, Post-Authorisation Study to Characterize the Safety of Tofacitinib in Patients with Moderately to Severely Active Ulcerative Colitis in the Real-World Setting Using Data from the Swedish Quality Register for Inflammatory Bowel Disease (SWIBREG)
• DARWIN EU® study:
  No
• Study countries:
  Sweden
• Study description:
  This is a 6-year active surveillance, secondary data collection study of adult UC patients aged ≥18 years using data in SWIBREG linked via unique patient identifiers to existing nationwide health registers in Sweden. Due to a one-year lag associated with linking SWIBREG to other Swedish national registers (essential for the assessment of safety events associated with UC therapy), and to allow for a minimum follow-up duration of 12 months, UC patients meeting the study entry criteria through 31 March 2024 will be included in the analysis, follow-up of patients for the study will end 31 March 2025, and end of data collection will be 31 March 2026 when the full dataset with completed linkages will be available for analysis. Incidence rates and associated 95% confidence intervals (CIs) of the safety events of interest will be calculated in all four cohorts. Data capture and follow up methods are the same for the tofacitinib treatment cohort and the 3 comparator treatment cohorts within the Swedish Registers. For both primary and secondary safety events of interest, comparative analyses will be conducted as feasible.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Pfizer

Study timelines

Date when funding contract was signed

Actual: 25/06/2019

Study start date

Planned: 31/03/2021

Actual: 31/03/2021

Data analysis start date

Planned: 31/03/2026

Date of interim report, if expected

Planned: 31/08/2022

Date of final study report

Planned: 31/03/2027

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Study protocol

Initial protocol

Final_A3921344_Amended Protocol_SWIBREG PASS__11.17.2020_clean_QC complete

Updated protocol

A3921344_PROTOCOL- SWIBREG PASS CLEAN QC COMPLETE_V5.0_09FEB2022

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)