GA29103 - PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS
Research type
Research Study
Full title
PHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS
IRAS ID
144103
Contact name
Ramesh Arasaradnam
Contact email
Sponsor organisation
F.Hoffmann-La Roche Ltd
Eudract number
2013-004282-14
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 6 months, 4 days
Research summary
The purpose of this study is to compare the effects of etrolizumab versus infliximab in patients with moderately to severely active ulcerative colitis (UC) and who are naive to tumour necrosis factor (TNF) inhibitors.
Infliximab works by blocking the action of a protein called “tumour necrosis factor alpha” (TNF ). Blocking this protein can reduce inflammation in the body. Infliximab is approved for use in ulcerative colitis.
The study design is doubleblind, doubledummy, so all patients will receive two study treatments. Patients will be randomised into one of two study groups in a 1:1 ratio of either active etrolizumab + infliximab dummy or active infliximab + etrolizumab dummy. Dummy means a substance containing no medication.
The study will be divided into:
• Screening period of up to 28 days
• Doubleblind treatment period of 54 weeks, composed of an Induction Phase (up to Week 10) and a Maintenance Phase (Week 10 to Week 54)
• Safety follow-up period of 12 weeks or 12 weeks in Part 1 Open-Label Extension-Safety Monitoring study (OLE-SM; Study GA28951) where they will receive open-label etrolizumab, if eligible, following on to Part 2, 92 weeks of extended
PML (progressive multifocal leukoencephalopathy) monitoring.The end of the study is defined as the last patient last safety follow-up
visit in this protocol, or last patient enrolled in the OLE-SM study, whichever is later.A total of approximately 720 patients will be enrolled in this study from approximately 200 sites
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
14/NE/1099
Date of REC Opinion
29 Sep 2014
REC opinion
Further Information Favourable Opinion