Observational Study of Effectiveness and Safety of Recombinant Zoster Vaccine (Shingrix)® in Moderately-to-Severely Active Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) Patients Treated with Tofacitinib (Xeljanz)® in Real- World Clinical Care Settings

Study identification

• EU PAS number:
  EUPAS48998
• Study ID:
  199015
• Official title and acronym:
  Observational Study of Effectiveness and Safety of Recombinant Zoster Vaccine (Shingrix)® in Moderately-to-Severely Active Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) Patients Treated with Tofacitinib (Xeljanz)® in Real- World Clinical Care Settings
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This study plans to evaluate the effectiveness and safety of the RZV (“Shingrix ® vaccine”) in real-world patients with ulcerative colitis (UC) and rheumatoid artiritis (RA) treated with tofacitinib.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Pfizer

Optum

Germany

Study timelines

Date when funding contract was signed

Planned: 06/04/2022

Actual: 06/04/2022

Study start date

Planned: 02/01/2024

Actual: 01/03/2024

Date of final study report

Planned: 14/09/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer 100%

Regulatory

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

Other study registration identification numbers and links

A3921427