Study Design

Focusing on Crohn’s. Evaluating Outcomes.

Read an overview of the Etro Studies in Crohn’s Disesase.1

Bergamot¹

NCT02394028

Bergamot Chart

Key Inclusion Criteria:

  • 18-80 years of age, inclusive
  • Moderately to severely active Crohn’s disease
  • Loss of response or failure to respond to treatment with at least one corticosteroid, immunosuppressant, or TNF-inhibitor within the previous 5 years
  • Use of highly effective contraception as defined by the protocol
Juniper²

NCT02403323

Key Inclusion Criteria:

Part 1 (Open-label Extension)

  • Patients previously enrolled in the Bergamot Phase III controlled study who meet the eligibility criteria for open-label etrolizumab for the study as described in the study protocols

Part 2 (Safety Monitoring)

  • Patients who participated in the Bergamot Phase III study and are not eligible to choose or enter Part 1 (OLE)
  • Patients who transfer from Part 1 (OLE)
  • Completion of the 12-week safety follow-up within the Bergamot Phase III trial prior to entering

Key Exclusion Criteria

Part 1 (Open-label Extension)

  • Any new, significant, uncontrolled condition

Part 2 (Safety Monitoring)

  • No exclusion criteria

Interesting in referring a patient to the Etro Studies? Learn how now.

 

References:
1. http://clinicaltrials.gov/show/NCT02394028
2. http://clinicaltrials.gov/show/NCT02403323

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