chronic bowel inflamation inflammatory bowel disease
Conditions
Interventions
Depending on the dose assignment in the Induction Phase,
patients receive either study drug in a 1-mL PFS containing 0.7 mL of
etrolizumab (105-mg
dose) or a 2.25-mL PFS containing 1.4 mL of etrolizu
inflammatory bowel disease
Sponsors
Hoffmann-La Roche
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Patients must meet the following criteria for study entry: - 18-80 years of age (inclusive) - Moderately to severely active Crohn's disease as determined by the Crohn's Disease Activity Index (CDAI), patient reported outcomes and endoscopically defined disease activity in the ileum and/or colon - Intolerance, loss of response or failure to respond to corticosteroids (CS) or, immunosuppressants (IS), or TNF inhibitors within the previous 5 years - Use of effective contraception as defined by the protocol, A complete list of inclusion criteria can be found in the protocol
Exclusion criteria
Exclusion criteria: - A history of, or current conditions affecting the digestive tract, such as ulcerative colitis, indeterminant colitis, abdominal or perianal abscess, adenomatous colonic polyps, colonic mucosal dysplasia, and short bowel syndrome - Sinus tract with evidence for infection (e.g., Fistula with purulent discharge) in the clinical judgment of the investigator. Fistulas related to Crohn's disease are not exclusionary - Planned surgery for CD - Ileostomy or colostomy - Has received non-permitted inflammatory bowel disease (IBD) therapies (including natalizumab, vedolizumab, and efalizumab, as stated in the protocol) - Chronic hepatitis B or C infection, HIV, active or latent tuberculosis (patients with prior history of BCG vaccination must pass protocoldefined screening criteria)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy objectives for ex-U.S. are: Induction Phase * Clinical remission at Week 14 * Endoscopic improvement at Week 14 Maintenance Phase, among patients who achieve CDAI-70 response at Week 14 * Clinical remission at Week 66 * Endoscopic improvement at Week 66 | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary efficacy outcome measures Induction Phase a, Clinical remission at Week 6 b, SES CD *4 (*2 for ileal patients), with no segment having a subcategory score that is >1, at Week 14 c, Change in CD signs and symptoms from baseline to Week 14 as assessed by the CD-PRO/SS measure Maintenance Phase a, Clinical remission at Week 66 among patients who achieved clinical remission at Week 14 b, Corticosteroid-free clinical remission at Week 66 among patients who were receiving corticosteroids at baseline c, Endoscopic improvement at Week 66 among patients who achieved endoscopic improvement at Week 14 d, SES CD *4 (*2 for ileal patients), with no segment having a subcategory score that is >1, at Week 66 e, Durable clinical remission f, Corticosteroid-free clinical remission for 24 weeks at Week 66 among patients who were receiving corticosteroids at baseline g, Change in CD signs and symptoms from baseline to Week 66 as assessed by the CD-PRO/SS measure | — |
Countries
The Netherlands
Outcome results
None listed