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

2. juli 2021 opdateret af: Guy's and St Thomas' NHS Foundation Trust

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

112

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Induction cohort
Golimumab induction therapy
Medicin: Golimumab
A biologic agent which acts by antagonising the effects of tumour necrosis factor (TNF) alpha
Andre navne:
  • Simponi
Andet: Maintenance cohort
Golimumab maintenance therapy
Medicin: Golimumab
A biologic agent which acts by antagonising the effects of tumour necrosis factor (TNF) alpha
Andre navne:
  • Simponi

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Serum Golimumab Concentration (μg/ml)
Tidsramme: Week 6 during induction therapy and at the point of study entry during maintenance
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
Foranstaltningsbeskrivelse
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.
Week 14 during induction therapy and at the point of study entry during maintenance therapy
Faecal Calprotectin (μg/g)
Tidsramme: 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
Week 14 during induction therapy and at the point of study entry during maintenance
Serum C-Reactive Protein (mg/L)
Tidsramme: Week 14 during induction therapy and at the point of study entry during maintenance
Serum inflammatory marker with higher values suggestive of increasing biochemical disease activity
Week 14 during induction therapy and at the point of study entry during maintenance
Serum Albumin (g/L)
Tidsramme: Week 14 during induction therapy and at the point of study entry during maintenance
Serum protein marker with higher values associated with increasing inflammatory activity and lower serum levels of anti-TNF agents (such as golimumab)
Week 14 during induction therapy and at the point of study entry during maintenance
Clinical UC Disease Activity
Tidsramme: Week 14 during maintenance therapy and at the point of study entry during maintenance
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
Quality of Life (IBD-Control)
Tidsramme: Week 14 during induction therapy and at the point of study entry during maintenance therapy
Evaluated using IBD-Control questionnaires. IBD-Control scores range from 0-16 with higher scores denoting better quality of life.
Week 14 during induction therapy and at the point of study entry during maintenance therapy
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
Evaluated using a drug-sensitive enzyme-linked immunosorbent assay (ELISA)
At any study time point during induction therapy (weeks 6, 10 or 14) and at the point if study entry during maintenance

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Samarbejdspartnere

Merck Sharp & Dohme LLC

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

5. september 2017

Primær færdiggørelse (Faktiske)

30. september 2019

Studieafslutning (Faktiske)

30. september 2019

Datoer for studieregistrering

Først indsendt

4. april 2017

Først indsendt, der opfyldte QC-kriterier

18. april 2017

Først opslået (Faktiske)

21. april 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. juli 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juli 2021

Sidst verificeret

1. juni 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2017-001374-42

Plan for individuelle deltagerdata (IPD)

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