GA28951 – Open-label extension & safety monitoring study
Research type
Research Study
Full title
AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE III STUDIES
IRAS ID
152481
Contact name
Ramesh Arasaradnam
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd
Eudract number
2013-004435-72
Clinicaltrials.gov Identifier
Duration of Study in the UK
9 years, 1 months, 12 days
Research summary
This is an open-label extension study and safety monitoring study open to eligible patients who were enrolled in studies GA28950 or GA29103. Patients can enter either or both parts of this study.
The study is divided in two parts. Part 1 (open-label extension; OLE) will assess the long term safety and efficacy of etrolizumab via subcutaneous injections (SC). Patients will receive etrolizumab every 4 weeks until the patient enters Safety monitoring (SM) (Part 2). As a substantial proportion of patients enrolling in this study may be receiving etrolizumab for the first time, all patients will be required to receive their first four doses (Week 0, 4, 8 and Week 12) of etrolizumab in the clinic setting and be monitored for 60 minutes following each dose. After this and if they are happy to do so, patients can continue to self administer the medication themselves at home.
Part 1 (OLE) will continue for up to 7 years after the first patient is enrolled into the study or until commercial availability, whichever is the earlier, or until the Sponsor’s decision to terminate the study. Patients who withdraw from Part 1 (OLE) should complete the 12-week safety follow-up and then enter Part 2 (SM) for PML monitoring.
Part 2 (safety monitoring- SM), will assess the long-term safety of etrolizumab. Patients will not receive etrolizumab and will be followed up until 2 years after their last dose of etrolizumab. Part 2 will consist of telephone calls from the study doctor or study personnel approximately every 6 months to assess patients for any signs or symptoms of PML.REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
14/NE/1100
Date of REC Opinion
24 Oct 2014
REC opinion
Further Information Favourable Opinion