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.
Panoramica dello studio
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 4
Contatti e Sedi
Luoghi di studio
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London, Regno Unito
- Guy's & St Thomas' NHS Foundation Trust
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Altro: Induction cohort
Golimumab induction therapy
|
A biologic agent which acts by antagonising the effects of tumour necrosis factor (TNF) alpha
Altri nomi:
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Altro: Maintenance cohort
Golimumab maintenance therapy
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A biologic agent which acts by antagonising the effects of tumour necrosis factor (TNF) alpha
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Serum Golimumab Concentration (μg/ml)
Lasso di tempo: 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
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Number of Patients in Clinical Remission
Lasso di tempo: Week 14 during induction therapy and at the point of study entry during maintenance therapy
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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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Collaboratori
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie dell'apparato digerente
- Malattie gastrointestinali
- Gastroenterite
- Malattie del colon
- Malattie intestinali
- Malattie infiammatorie intestinali
- Colite
- Colite, ulcerosa
- Effetti fisiologici delle droghe
- Agenti antinfiammatori
- Agenti immunosoppressivi
- Fattori immunologici
- Inibitori del fattore di necrosi tumorale
- Golimumab
Altri numeri di identificazione dello studio
- 2017-001374-42
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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