An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies

Phase 1

Conditions: lcerative colitis
MedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2013-004435-72-GB

Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 2625

Inclusion Criteria

Part 1 (Open-label Extension)
- Patients previously enrolled in 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)
- Patients who participated in one of the etrolizumab Phase II OLE study or 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2546
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 79

Exclusion Criteria

Part 1 (Open-label Extension)
- 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)
- No exclusion criteria

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: • Part 1 (OLE): to assess the long-term safety and efficacy of etrolizumab in eligible patients.<br>• Part 2 (SM): Progressive multifocal leukoencephalopathy (PML) safety monitoring.<br>;Secondary Objective: n.a.;Primary end point(s): 1) Long-term efficacy as determined by partial Mayo Clinic Score (pMCS)<br>2) To evaluate remission by MCS at Week 108 in Part 1 (OLE)<br>3) To evaluate endoscopic remission by MCS at Week 108 in Part 1 (OLE)<br>4) Incidence of adverse events;Timepoint(s) of evaluation of this end point: 1 and 4: Up to 7 years<br>2 and 3: at Week 108 in Part 1 (OLE)

Secondary Outcome Measures