The Etro Studies
Addressing Needs. Qualified Participation.
In order to participate in one of the Etro Studies, individuals must meet the following criteria:
- 18-80 years of age, inclusive
- Moderately to severely active UC
- Moderately to severely active Crohn’s disease
- An inadequate response to immunosuppressant treatment, corticosteroids, and/or anti-TNF therapy. Some studies will evaluate etrolizumab in patients who are anti-TNF naïve, and others in patients who have had an inadequate response, loss of response, or intolerance to anti-TNF therapy.
- Background regimen for UC may include oral 5-ASA, oral corticosteroids, budenoside MMX, probiotics, AZA, 6-MP, or MTX if doses have been stable during the screening period
- Use of highly effective contraception as defined by the protocol
Patients with the following characteristics are not eligible:
- A history of or current conditions and diseases affecting the digestive tract, such as indeterminate colitis, fistulas or abdominal abscesses, colonic mucosal dysplasia, intestinal obstruction, toxic megacolon, or unremoved adenomatous colonic polyps
- History of moderate or severe allergic or anaphylactic/anaphylactoid reactions to chimeric, human, or humanized antibodies; fusion proteins, or murine proteins; hypersensitivity to etrolizumab or any of its excipients
- Prior or planned surgery for UC
- Past or present ileostomy or colostomy
- Have received non-permitted inflammatory bowel disease (IBD) therapies (including natalizumab and efalizumab) as stated in the protocol
- Chronic hepatitis B or C infection, HIV or tuberculosis (active or latent)