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.
Studieoversikt
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Fase 4
Kontakter og plasseringer
Studiesteder
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-
-
London, Storbritannia
- Guy's & St Thomas' NHS Foundation Trust
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Annen: Induction cohort
Golimumab induction therapy
|
A biologic agent which acts by antagonising the effects of tumour necrosis factor (TNF) alpha
Andre navn:
|
|
Annen: Maintenance cohort
Golimumab maintenance therapy
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A biologic agent which acts by antagonising the effects of tumour necrosis factor (TNF) alpha
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Serum Golimumab Concentration (μg/ml)
Tidsramme: 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)
|
Week 6 during induction therapy and at the point of study entry during maintenance
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Patients in Clinical Remission
Tidsramme: 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.
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Week 14 during induction therapy and at the point of study entry during maintenance therapy
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Faecal Calprotectin (μg/g)
Tidsramme: Week 14 during induction therapy and at the point of study entry during maintenance
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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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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.
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Week 14 during maintenance therapy and at the point of study entry during maintenance
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Quality of Life (IBD-Control)
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Samarbeidspartnere
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i fordøyelsessystemet
- Gastrointestinale sykdommer
- Gastroenteritt
- Kolonsykdommer
- Tarmsykdommer
- Inflammatoriske tarmsykdommer
- Kolitt
- Kolitt, ulcerøs
- Fysiologiske effekter av legemidler
- Anti-inflammatoriske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Tumornekrosefaktorhemmere
- Golimumab
Andre studie-ID-numre
- 2017-001374-42
Plan for individuelle deltakerdata (IPD)
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Legemiddel- og utstyrsinformasjon, studiedokumenter
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