NCT02687724: GOAL-ARC

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).

Status unknown Phase 4 Last updated 18 July 2018

What this trial tests

Phase 4 trial testing Golimumab (GLM) in Colitis in 136 participants. Status unknown.

Timeline

1 June 2016

Primary endpoint
1 February 2020

1 February 2020

Quick facts

Lead sponsor	University College Dublin
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	136
Start date	1 June 2016
Primary completion	1 February 2020
Estimated completion	1 February 2020
Sites	1 location across Ireland

Drugs / interventions tested

• Golimumab (GLM) — full drug profile →

Conditions studied

• Colitis — all drugs for Colitis →

Sponsor

University College Dublin

Who can join

18 and older, any sex, with Colitis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.