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

Sponsor
Guy's and St Thomas' NHS Foundation Trust
Study ID
NCT03124121
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Golimumab — DRUG
    A biologic agent which acts by antagonising the effects of tumour necrosis factor (TNF) alpha

Study Details

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.

Key Dates

Start date
Sep 5, 2017
Status verified
Jun 2021
Primary completion
Sep 30, 2019
Completion
Sep 30, 2019

Study Design

Enrollment
112 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Induction cohort
    Golimumab induction therapy
  • Other: Maintenance cohort
    Golimumab maintenance therapy

Primary Outcome Measure

Serum Golimumab Concentration (μg/ml) [ Time Frame: Week 6 during induction therapy and at the point of study entry during maintenance ]

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