Study of the Golimumab Exposure-Response Relationship Using Serum Trough Levels (GO-LEVEL)
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.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 4
Kontakter och platser
Studieorter
-
-
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London, Storbritannien
- Guy's & St Thomas' NHS Foundation Trust
-
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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)
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Övrig: Induction cohort
Golimumab induction therapy
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A biologic agent which acts by antagonising the effects of tumour necrosis factor (TNF) alpha
Andra namn:
|
|
Övrig: Maintenance cohort
Golimumab maintenance therapy
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A biologic agent which acts by antagonising the effects of tumour necrosis factor (TNF) alpha
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Serum Golimumab Concentration (μg/ml)
Tidsram: Week 6 during induction therapy and at the point of study entry during maintenance
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Evaluated using an enzyme-linked immunosorbent assay (ELISA)
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Week 6 during induction therapy and at the point of study entry during maintenance
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of Patients in Clinical Remission
Tidsram: Week 14 during induction therapy and at the point of study entry during maintenance therapy
|
Evaluated using the Simple Clinical Colitis Activity Index (SCCAI).
Remission defined as SCCAI < 3.
|
Week 14 during induction therapy and at the point of study entry during maintenance therapy
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Faecal Calprotectin (μg/g)
Tidsram: Week 14 during induction therapy and at the point of study entry during maintenance
|
Faecal inflammatory marker with higher values suggestive of increasing biochemical disease activity
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Week 14 during induction therapy and at the point of study entry during maintenance
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Serum C-Reactive Protein (mg/L)
Tidsram: Week 14 during induction therapy and at the point of study entry during maintenance
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Serum inflammatory marker with higher values suggestive of increasing biochemical disease activity
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Week 14 during induction therapy and at the point of study entry during maintenance
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Serum Albumin (g/L)
Tidsram: Week 14 during induction therapy and at the point of study entry during maintenance
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Serum protein marker with higher values associated with increasing inflammatory activity and lower serum levels of anti-TNF agents (such as golimumab)
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Week 14 during induction therapy and at the point of study entry during maintenance
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Clinical UC Disease Activity
Tidsram: Week 14 during maintenance therapy and at the point of study entry during maintenance
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Evaluated using Patient Reported Outcome 2 (PRO2).
PRO2 ranges from 0-5 with higher scores denoting increasing clinical disease activity.
|
Week 14 during maintenance therapy and at the point of study entry during maintenance
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Quality of Life (IBD-Control)
Tidsram: Week 14 during induction therapy and at the point of study entry during maintenance therapy
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Evaluated using IBD-Control questionnaires.
IBD-Control scores range from 0-16 with higher scores denoting better quality of life.
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Week 14 during induction therapy and at the point of study entry during maintenance therapy
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Number of Patients With Detectable Anti-golimumab Antibodies
Tidsram: At any study time point during induction therapy (weeks 6, 10 or 14) and at the point if study entry during maintenance
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Evaluated using a drug-sensitive enzyme-linked immunosorbent assay (ELISA)
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At any study time point during induction therapy (weeks 6, 10 or 14) and at the point if study entry during maintenance
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Samarbetspartners och utredare
Samarbetspartners
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2017-001374-42
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