STEIG: Stelara Treatment Effectiveness in Irish Gastroenterology

STEIG: Stelara Treatment Effectiveness in Irish Gastroenterology

STEIG is a retrospective study of clinical outcomes of off licence treatment with Ustekinumab for Crohn’s Disease. Ustekinumab (Stelara) is a monoclonal antibody against the common p40 subunit of IL-12 and IL-23. It has been licenced as a treatment for psoriasis for several years and has thus been available in Ireland as an unlicenced therapy for IBD patients who have failed other licenced and approved IBD therapies.

The STEIG study invites gastroenterologists who are INITIative members to contribute data retrospectively for any patients they have treated with ustekinumab for Crohn’s Disease.

 

Data Collection

Data will be collected on;

  • age
  • gender
  • disease location and phenotype
  • disease duration
  • smoking status
  • prior and concurrent therapies
  • body weight/BMI
  • ustekinumab induction and maintenance dosing
  • duration of treatment
  • need for hospitalisation and/or surgery during follow-up

End-Points

The primary end-point will be treatment success, defined as maintenance therapy without need for hospitalisation due to disease flare or for surgical resection.
The secondary end-points will focus on loss of response and treatment related adverse events.

Multi-variate analysis of clinical factors determining treatment success and time to treatment failure will be performed.

 

Authorship

All gastroenterologists who contribute complete data on one or more patient will be listed as an investigator for the purposes of the study and will be included as an author on any published results.
Investigators who contribute data on five or more patients may also list a second investigator, i.e. a colleague, research nurse, coordinator or research registrar/fellow.

For more information or if you wish to participate, please contact Cathy Rowan at
c.rowan2@st-vincents.ie