A network meta-analysis of real-world studies comparing tofacitinib with other advanced therapies in the treatment of moderate-to-severe ulcerative colitis

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/199008
• EU PAS number:
  EUPAS108141
• Study ID:
  199008
• Official title and acronym:
  A network meta-analysis of real-world studies comparing tofacitinib with other advanced therapies in the treatment of moderate-to-severe ulcerative colitis
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The study is designed as a NMA (network meta-analysis) with the primary objective to compare the effectiveness of tofacitinib with other advanced therapies in real-world studies for the treatment of patients with moderate-to-severe UC (ulcerative colitis). ; The secondary objective of the study is to compare the safety outcomes as IR assessed through a meta-analysis of tofacitinib and other advanced therapies in real-world studies of patients with moderate-to-severe UC. ; These analyses will be performed on data collected from studies published in literature in the form of a systematic literature review (SLR) and no patient enrollment will be done.
• Study status:
  Finalised

Research institutions and networks

Institutions

Pfizer

ConnectHEOR Limited

Study timelines

Date when funding contract was signed

Actual: 06/11/2023

Study start date

Planned: 17/01/2024

Actual: 16/01/2024

Data analysis start date

Planned: 18/01/2024

Date of final study report

Planned: 15/03/2025

Actual: 11/03/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Study protocol

Initial protocol

A3921447_Non-Interventional Study Protocol V1.0_2Jan2024_FINAL -R

Updated protocol

A3921447_Protocol_V2.0_09Dec2024_R.pdf

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable