Clinical Trial: Golimumab (GLM) Dose Optimisation to Adequate Levels to Achieve Response in Colitis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 G

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: University College Dublin

Current Primary Outcome: Patient Continuous Clinical Response (pCCR) [ Time Frame: Wk 14 through to Wk 46 ]

Absence of clinical flare, defined as an increase in modified partial Mayo score of 2 points value with accompanying requirement for treatment intervention


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Total Mayo Score [ Time Frame: Week 1, Week 46 ]
    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.
  • Partial Mayo Score [ Time Frame: Week 14 ]
    Partial Mayo score consists of three subscores including stool frequency, rectal bleeding and PGA, a total score ranges from 0 - 9.
  • Modified Partial Mayo Score [ Time Frame: Week 1 to Week 46 ]
    A modified partial Mayo score comprises of the two PRO sub-scores, rectal bleeding and stool frequency
  • Week 14 Clinical Response [ Time Frame: Week 14 ]
    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.
  • Clinical Remission [ Time Frame: Week 46 ]
    Clinical remission is defined as a Mayo score ≤2 points, with no individual sub-score >1.
  • Clinical Flare [ Time Frame: Week 14 to Week 46 ]
    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
  • Corticosteroid Free Remission [ Time Frame: Week 46 ]
    Clinical remission at WK 46 with no concomitant steroids
  • Mucosal healing [ Time Frame: Week 46 ]
    A Mayo endoscopic subscore of 0 or 1


Original Secondary Outcome: Same as current

Information By: University College Dublin

Dates:
Date Received: February 16, 2016
Date Started: June 2016
Date Completion: February 2018
Last Updated: April 5, 2017
Last Verified: April 2017