Purpose

This two-part, open-label extension and safety monitoring study will examine the safety and efficacy of continued etrolizumab treatment in patients with moderate to severely active Crohn's disease who were previously enrolled in the etrolizumab Phase III Study GA29144.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

Part 1 Open-label Extension:

- Patients previously enrolled in etrolizumab Phase III study GA29144 who meet the eligibility criteria for open-label etrolizumab as described in the protocol

Part 2 Safety Monitoring:

- Patients who participated in etrolizumab Phase III study GA29144 and are not eligible or choose not to enter Part 1

- Patients who transfer from Part 1

- Completion of the 12-week safety follow-up period prior to entering

Exclusion Criteria

Part 1 Open-label Extension:

- Any new, significant, uncontrolled condition

Part 2 Safety Monitoring:

- No exclusion criteria

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part 1 Open-label Extension
  • Drug: etrolizumab
    105 mg etrolizumab subcutaneous administration every 4 weeks
No Intervention
Part 2 Safety Monitoring

Recruiting Locations

Vanderbilt University Medical Center
Nashville, Tennessee 37232

More Details

NCT ID
NCT02403323
Status
Recruiting
Sponsor
Hoffmann-La Roche

Study Contact

Reference Study ID Number: GA29145 www.roche.com/about_roche/roche_worldwide.htm
888-662-6728 (U.S. and Canada)
global-roche-genentech-trials@gene.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.