Go-colitis
Research type
Research Study
Full title
Golimumab: A Phase 4, UK Open Label, Single arm Study on its Utilization and Impact in Ulcerative Colitis
IRAS ID
141896
Contact name
Chris Probert
Contact email
Sponsor organisation
MSD
Eudract number
2013-004583-56
Research summary
Ulcerative colitis (UC) is an inflammatory disease of the bowel. The symptoms can repeatedly flare and often present as bloody diarrhoea and abdominal pain. UC is diagnosed clinically and can be categorised in terms of the amount of the bowel involved and also the disease severity.
A key chemical messenger involved in promoting inflammation is called Tumour Necrosis Factor alpha (TNFα). The symptoms that are associated with UC are caused by inflammation and TNFα has a central role in this. The study drug, Golimumab, blocks TNFα, preventing it from binding to its receptors and activating a large immune reaction. The inhibition of TNFα can therefore help to reduce the symptoms associated with inflammation of the bowel.
Golimumab currently has licensed indications in the European Union (EU) for rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and UC.
This is a multi-site trial. This study aims to test how effective GLM is at treating patients with moderate-to-severe UC. All participants will receive the same interventional treatment (Golimumab) and will be aware of what medication they are taking.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
14/NW/0008
Date of REC Opinion
28 Jan 2014
REC opinion
Further Information Favourable Opinion