Colitis Clinical Trial
Official title:
GLM Dose Optimisation to Adequate Levels to Achieve Response in Colitis (GOAL-ARC). A Nationwide Multi-centred Randomised Controlled Trial (RCT) Investigating the Use of GLM Dose Adjustment in Ulcerative Colitis (UC).
GLM dose Optimisation to Adequate Levels to Achieve Response in Colitis (GOAL-ARC). A nationwide multi-centred randomised controlled trial (RCT) investigating the use of GLM dose adjustment in ulcerative colitis (UC). The primary objective is to ascertain if dose adjustment of GLM based on GLM drug levels and FCP levels results in higher response and remission rates than standard SmPC dosing.
UC is a chronic inflammatory bowel disease (IBD) in which the lining of the large intestine
become inflamed. There is no official database which gives accurate figures but it is thought
that at least 20,000 people are living with IBD in Ireland. Males and females are affected
equally and patients can be diagnosed at any age, including babies and children. The peak age
of incidence is between the ages of 15 and 35, with a second (smaller) peak from the 50s to
70s.
GLM is a human IgG1κ monoclonal antibody produced by a murine hybridoma cell line with
recombinant DNA technology. It is part of the immunosuppressants pharmacotherapeutic group of
TNF-α inhibitors. It is licensed for use in several chronic inflammatory conditions including
UC, Psoriatic arthritis, axial spondylitis, rheumatoid arthritis.
The design of GOAL-ARC aims to address the impact of dose escalation of GLM immediately
following induction and during the subsequent maintenance phase in response to suboptimal
drugs levels or persisting inflammatory burden as represented by raised faecal calprotectin
(FCP). FCP has been shown to correlate closely to endoscopic disease activity6.
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