This study is an open-label extension (OLE) trial to evaluate the safety and tolerability of etrolizumab in participants with moderate to severe ulcerative colitis (UC) who were enrolled in the Phase II Study ABS4986g (NCT01336465) and meet the eligibility criteria for entry in the OLE study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
121
Participants will receive etrolizumab at a dose of 100 mg.
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
Time frame: Baseline up to approximately Week 246
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Etrolizumab
Time frame: Baseline up to approximately Week 246 (assessed at predose (Hour 0) at baseline, Weeks 4, 8, 12, and every 12 weeks thereafter up to Week 252, 12 weeks after last dose [up to approximately Week 246])
Serum Concentrations of Etrolizumab
Time frame: Predose (Hour 0) at baseline, Weeks 4, 8, 12, and every 12 weeks thereafter up to approximately Week 246; 12 weeks after last dose (up to approximately Week 246)
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