An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase III studies
- Conditions
- lcerative colitisMedDRA version: 17.0Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2013-004435-72-GR
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 2568
Part 1 (Open-label Extension)
- 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)
- 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.
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 2491
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 77
Part 1 (Open-label Extension)
- Any new, significant, uncontrolled condition
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) Incidence of adverse events;Timepoint(s) of evaluation of this end point: For 1 and 2: Up to 7 years<br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): n.a.;Timepoint(s) of evaluation of this end point: n.a.