NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

TerminatedPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Ulcerative Colitis

Interventions: Etrolizumab

Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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 (411)

Birmingham, Alabama, United States
La Jolla, California, United States
Orange, California, United States
San Diego, California, United States
San Francisco, California, United States
Ventura, California, United States
Colorado Springs, Colorado, United States
Lafayette, Colorado, United States
Wheat Ridge, Colorado, United States
Aventura, Florida, United States
Clearwater, Florida, United States
Miami, Florida, United States
Miami Beach, Florida, United States
Miramar, Florida, United States
Naples, Florida, United States
New Port Richey, Florida, United States
Orlando, Florida, United States
Winter Park, Florida, United States
Atlanta, Georgia, United States
Macon, Georgia, United States
Marietta, Georgia, United States
Suwanee, Georgia, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Oak Lawn, Illinois, United States
New Albany, Indiana, United States
Topeka, Kansas, United States
Baton Rouge, Louisiana, United States
Shreveport, Louisiana, United States
Boston, Massachusetts, United States
+ 381 more on CT.gov