Uveitis in chronic inflammatory conditions and ulcerative colitis-related pyoderma gangrenosum and axial spondylarthritis: an observational study of patients receiving advanced therapies in the United States

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/199002
• EU PAS number:
  EUPAS107604
• Study ID:
  199002
• Official title and acronym:
  Uveitis in chronic inflammatory conditions and ulcerative colitis-related pyoderma gangrenosum and axial spondylarthritis: an observational study of patients receiving advanced therapies in the United States
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  Tofacitinib is a Janus kinase (JAK) inhibitor approved for 5 indications in the US(United States): adults with moderately to severely active rheumatoid arthritis (RA), adults with active psoriatic arthritis (PsA), adults with moderately to severely active ulcerative colitis (UC), adults with active ankylosing spondylitis (also known as radiographic axSpA). Data on tofacitinib clinical efficacy in anterior uveitis (AU) from the clinical trial program across all the indications, and pyoderma gangrenosum (PG) and axial spondylarthritis (axSpA) in the UC clinical trial program, is very limited due to study design, inclusion criteria, and baseline characteristics of the different study populations, which would not allow to perform a post-hoc analysis for these outcomes. In the last years, however, several case reports and small observational studies have highlighted the potential beneficial use of JAK inhibitors (including tofacitinib) in treating uveitis as an extra-musculoskeletal or extra-intestinal manifestations, such as AU, PG, and axSpA. In addition, there is an ongoing phase 3 trial assessing the clinical effectiveness of another JAK inhibitor, baricitinib, in JIA-associated uveitis. This non-interventional study aims to provide data on the comparative clinical effectiveness of advanced therapies on incidence of AU among several chronic inflammatory conditions (UC, PsA and axSpA) as well as incidence of PG and axSpA in patients with UC. The results are intended to provide useful information to healthcare professionals and patients in real-world clinical decision making on treatment choice for patients with these conditions.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Pfizer

Komodo Health

Study timelines

Date when funding contract was signed

Actual: 11/11/2023

Study start date

Planned: 31/01/2024

Actual: 19/01/2024

Data analysis start date

Planned: 15/04/2024

Date of final study report

Planned: 01/06/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Study protocol

Initial protocol

A3921444_NIS_protocol_Cross_indication_uveitis__EIM_12Jan2024

Updated protocol

A3921444_NIS_Protocol_V2.0_31-May-2024.pdf

Regulatory

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