Study of the Golimumab Exposure-Response Relationship Using Serum Trough Levels (GO-LEVEL)

Guy's and St Thomas' NHS Foundation Trust

Status and phase: Completed; Phase 4

Conditions: Ulcerative Colitis

Treatments: Drug: Golimumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03124121

2017-001374-42

Details and patient eligibility

About

The purpose of this study is to gain insight into the exposure-response relationship of golimumab in moderate-to-severe Ulcerative Colitis (UC).

Patients commencing induction therapy with golimumab will be enrolled into a prospective study and evaluated at three time-points (weeks 6, 10 and 14) for clinical and biochemical UC disease activity as well as serum golimumab concentrations and the presence of anti-golimumab antibodies. Patients already established on stable golimumab maintenance therapy will be enrolled into a cross-sectional study with the same evaluations taken at a single time point.

Full description

The study will involve two study groups designed to offer insights into the pharmacokinetics of golimumab during induction and maintenance therapy:

Cohort 1: Patients commencing golimumab induction therapy will be included in a prospective, observational study.

Cohort 2: Patients receiving golimumab maintenance therapy will be included in a cross-sectional, observational study.

Primary objective: To define a week 6 serum golimumab concentration that predicts response at week 14.

Secondary objective: To define serum golimumab concentrations at weeks 6, 10 and 14 that predict response at each time point, respectively and at week 14.

Exploratory objectives:

Correlations between serum golimumab concentrations and novel disease activity indices (PRO2), biochemical markers of disease activity (CRP, faecal calprotectin) and quality of life indices (IBD-Q and IBD-Control).

Correlations between the presence of anti-golimumab antibodies, serum golimumab concentrations and UC disease activity.

This study will also generate data that can be used to validate a commercially available golimumab assay as well as a novel patient reported outcome (PRO) assessment of clinical UC disease activity.

Enrollment: 112 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for cohort 1:

• Aged 18 years or over
• Moderate-to-severe UC, defined as:

SCCAI > 5 and, i. A raised fecal calprotectin (> 59 μg/g) or, ii. A raised CRP (> 5 mg/L) or, iii. Endoscopic disease activity Mayo 2 or above, Evaluated within 4 weeks of study enrollment

• Commencing golimumab treatment
• Written informed consent to participate
• Sufficient English language skills to understand the patient information sheet and consent form

Inclusion Criteria for cohort 2:

• Aged 18 years or over
• Receiving golimumab treatment for UC for over 18 weeks (6 injections)
• Written informed consent to participate
• Sufficient English language skills to understand the patient information sheet and consent form

Exclusion Criteria (cohort 1 only):

• Contra-indication to golimumab: tuberculosis or severe infections
• Imminent need for colectomy (i.e. colectomy is being planned)
• Previous primary non-response to anti-TNF therapy in the opinion of the investigator
• Previous treatment with more than one anti-TNF therapy (excluding golimumab)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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112 participants in 2 patient groups

Induction cohort

Other group

Description:

Golimumab induction therapy

Treatment:

Drug: Golimumab

Maintenance cohort

Other group

Description:

Golimumab maintenance therapy

Treatment:

Drug: Golimumab