Open-Label Extension and Safety Study for Patients With Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144

  • Interventional
  • Recruiting
  • NCT02403323
Eligibility Details Visit Clinicaltrials.gov

AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN'S DISEASE PREVIOUSLY ENROLLED IN THE ETROLIZUMAB PHASE III PROTOCOL GA29144

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.

Gender
All

Age Group
18 Years and up

Accepting 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

At a Glance

National Government IDNCT02403323

IRB#IRB15-0720

Lead SponsorHoffmann-La Roche

Lead PhysicianDavid T. Rubin

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting