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-DE
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-07-18
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 2100

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 1907
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 193

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