GA28951: An Open-Label Extension and Safety Monitoring Study of Moderate to Severe Ulcerative Colitis Patients Previously Enrolled in Etrolizumab Phase II/III Studies
September 15, 2014
Gastroenterology - Stomach
Principal Investigator: Nirmal Kaur, MD
This is an open-label extension (OLE) and safety-monitoring (SM) study. The purpose of this research study is divided into two parts:
- Part 1 (OLE) will assess the long-term safety and efficacy of continued etrolizumab subcutaneous injections (under the skin) in patients with moderate to severe ulcerative colitis and is open to patients who were previously enrolled in an Etrolizumab PhII/III study and meet eligibility criteria.
- Part 2 (SM) will assess the long-term safety of etrolizumab. Patients will not receive etrolizumab. This part of the study is open to patients who were previously enrolled in an etrolizumab PhII/III study and patients who transfer from Part 1 (OLE).
Please contact us for a full list of criteria.