Overview

Study of the Golimumab Exposure-Response Relationship Using Serum Trough Levels

Status:
Completed

Trial end date:
2019-09-30

Target enrollment:
0

Participant gender:
All

Summary

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Guy's and St Thomas' NHS Foundation Trust

Collaborator:

Merck Sharp & Dohme Corp.

Treatments:

Antibodies, Monoclonal
Golimumab

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)