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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
136
GLM is a human IgG1κ monoclonal antibody produced by a murine hybridoma cell line with recombinant DNA technology
St Vincent's University Hospital
Dublin, Ireland
RECRUITINGPatient Continuous Clinical Response (pCCR)
Absence of clinical flare, defined as an increase in modified partial Mayo score of 2 points value with accompanying requirement for treatment intervention
Time frame: Wk 14 through to Wk 46
Total Mayo Score
The Total Mayo Score is a combined endoscopic and clinical scale used to assess the severity of UC. It is a composite of sub-scores from four categories, including stool frequency, rectal bleeding, findings at endoscopy and physician global assessment (PGA), with a total score ranging from 0 - 12.
Time frame: Week 1, Week 46
Partial Mayo Score
Partial Mayo score consists of three subscores including stool frequency, rectal bleeding and PGA, a total score ranges from 0 - 9.
Time frame: Week 14
Modified Partial Mayo Score
A modified partial Mayo score comprises of the two PRO sub-scores, rectal bleeding and stool frequency
Time frame: Week 1 to Week 46
Week 14 Clinical Response
A decrease from BL in partial Mayo score by ≥30% or a decrease of 3 points. or A decrease from BL in modified partial Mayo of 2 points or a decrease of ≥30% from baseline.
Time frame: Week 14
Clinical Remission
Clinical remission is defined as a Mayo score ≤2 points, with no individual sub-score \>1.
Time frame: Week 46
Clinical Flare
UC symptom recurrence as a defined by modified partial Mayo score increase of 2 points from week 14 value with accompanying requirement for treatment intervention
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Time frame: Week 14 to Week 46
Corticosteroid Free Remission
Clinical remission at WK 46 with no concomitant steroids
Time frame: Week 46
Mucosal healing
A Mayo endoscopic subscore of 0 or 1
Time frame: Week 46