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

Sponsor
University College Dublin
Study ID
NCT02687724
Phase
PHASE4
Status
Unknown

Conditions

  • Colitis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Golimumab (GLM) — DRUG
    GLM is a human IgG1κ monoclonal antibody produced by a murine hybridoma cell line with recombinant DNA technology

Study Details

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.

Key Dates

Start date
Jun 30, 2016
Status verified
Jul 2018
Primary completion
Feb 29, 2020
Completion
Feb 29, 2020

Study Design

Enrollment
136 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard treatment as per SmPC
    Patients will receive standard loading dose of GLM of 200/100 mgs at WKS 0 \& 2. They will then receive 100mgs/ 50mgs depending on their weight as per SmPC. Patients will report their modified partial mayo score and SHS score every 4 weeks (PRO) and provide it to the investigator site via a web based application.
  • Experimental: Intervention Arm
    Patients will receive standard loading dose of GLM of 200/100 mgs at WKS 0 \& 2. As with Group 1, Patients will report their modified partial mayo and SHS score every four weeks ( the window for this will be +/- one week) and provide it to the investigator site via a web based application. In addition FCP, GLM DL and ADA shall be measured every four weeks.

Primary Outcome Measure

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

Central Contacts

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