This study is in progress, not accepting new patients

Study for Participants With Ulcerative Colitis Previously Enrolled in Etrolizumab Phase II/III Studies

a study on Inflammatory Bowel Disease Ulcerative Colitis

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Melvin Heyman
Headshot of Melvin Heyman
Melvin Heyman

Description

Summary

This two-part, part 1: open-label extension (OLE) and part 2: safety monitoring (SM) study will examine the efficacy and safety of continued etrolizumab treatment in moderate to severe ulcerative colitis (UC) participants previously enrolled in etrolizumab Phase II/III studies. Participants with moderate to severe UC who were enrolled in the Phase II OLE study (GA27927 [NCT01461317]) or the Phase III studies (GA28948 [NCT02163759], GA28949 [NCT02171429], GA28950 [NCT02100696], GA29102 [NCT02165215], and GA29103 [NCT02136069]) were included. Participants from the Phase II OLE study or the Phase III studies who are not eligible or willing to receive etrolizumab in the OLE-SM study, and who have completed the 12-week safety follow-up period will be enrolled in Part 2. Part 1 of OLE-SM will continue for up to 9 years after the first participant is enrolled into the study. Following Part 1, participants will enter Part 2 for a period of 92 weeks.

Official Title

An Open-Label Extension and Safety Monitoring Study of Moderate to Severe Ulcerative Colitis Patients Previously Enrolled in Etrolizumab Phase II/III Studies

Keywords

Ulcerative Colitis, Colitis, Ulcer, Etrolizumab, Open-label Extension, Safety Monitoring

Eligibility

You can join if…

Open to people ages 18 years and up

Part 1 (Open-label Extension)

  • Participants previously enrolled in the Phase II OLE study or Phase III controlled studies who meet the eligibility criteria for open-label etrolizumab for those studies as described in the protocol

Part 2 (Safety Monitoring)

  • Participants whose safety follow-up or PML follow-up is not completed within Study GA27927 and participants who had their last dose of etrolizumab in July 2016 in Study GA27927 and are not eligible or willing to enroll in Part 1 (OLE)
  • Participants who participated in one of the etrolizumab Phase III studies and are not eligible or willing to enter Part 1 (OLE)
  • Participants who transfer from Part 1 (OLE)
  • Completion of the 12-week safety follow-up prior to entering.

You CAN'T join if...

Part 1 (Open-label Extension)

  • Withdrawal of consent from and participant not compliant in the Phase II OLE study or any of the Phase III studies
  • Participant who discontinued etrolizumab/etrolizumab placebo prior to Week 10 or did not perform the Week 10 visit of the Phase III Studies GA28948, GA28949, GA29102, and GA29103
  • Participant who discontinued etrolizumab/etrolizumab placebo prior to Week 14 or did not perform the Week 14 visit of the Phase III Study GA28950
  • Any new, significant, uncontrolled condition

Locations

  • University of California at San Francisco
    San Francisco California 94115 United States
  • Ventura Clinical Trials
    Ventura California 93003 United States

Lead Scientist at UCSF

  • Melvin Heyman
    Professor, Pediatrics, School of Medicine. Authored (or co-authored) 321 research publications

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT02118584
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 1822 people participating
Last Updated