AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE III STUDIES

Phase 3

Recruiting

Conditions: inflammatory bowel disease
Ulcerative colitis
10017969

Registration Number: NL-OMON53027

Lead Sponsor: Hoffmann-La Roche

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 33

Inclusion Criteria

Part 1 (Open-label Extension; OLE), - Patients previously enrolled in 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; SM),
- Patients who participated in one of the etrolizumab Phase III studies and are
not eligible or chose not to enter Part 1 (OLE)
- Patients who transfer from Part 1 (OLE)
- Completion of the 12-week safety follow-up prior to entering., A complete
list of inclusion criteria can be found in the protocol

Exclusion Criteria

Part 1 (Open-label Extension; OLE), - Any new, significant, uncontrolled
condition
- Receipt of the following since commencement of the Phase II OLE or
Phase III controlled studies: Use of anti-adhesion molecules, Part 2 (Safety
Monitoring; SM), - No exclusion criteria, A complete list of exclusion criteria
can be found in the protocol

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The efficacy outcome measure for this study is as follows:<br /><br>• To describe the long-term efficacy of etrolizumab (105 mg SC every 4 weeks)<br /><br>by pMCS for patients with UC in Part 1 (OLE)<br /><br>• To evaluate remission by MCS at Week 108 in Part 1 (OLE)<br /><br>• To evaluate endoscopic remission by MCS at Week 108 in Part 1 (OLE)<br /><br>• Incidence of adverse events</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The safety outcome measures for this study are as follows:<br /><br><br /><br>Part 1 (OLE)<br /><br>• Incidence and severity of adverse events<br /><br>• Incidence of serious adverse events<br /><br>• Incidence and severity of infection-related adverse events<br /><br>• Incidence of serious infection-related adverse events<br /><br>• Incidence and severity of injection-site reactions<br /><br>• Incidence of adverse events leading to etrolizumab discontinuation<br /><br>• Incidence of laboratory abnormalities<br /><br>• Incidence of malignancies<br /><br>• Incidence of anti-therapeutic antibodies (ATAs) to etrolizumab<br /><br>• Incidence and severity of hypersensitivity reaction events<br /><br><br /><br>Part 2 (SM)<br /><br>• Incidence of suspected or confirmed PML events</p><br>