- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT05157750
Endoscopic Remission, Histologic Remission and Barrier Healing for Predicting Disease Behaviour in IBD (ERIca)
Direct Comparison of Endoscopic and Histologic Remission and Barrier Healing for Predicting Long Term Disease Behaviour in Clinically Remittent IBD Patients: the Prospective ERIca Study
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Mucosal healing is a key therapeutic goal in the management of patients with inflammatory bowel diseases (IBD) that is associated with favorable long-term disease outcome. In addition, histologic remission is an emerging endpoint and first data suggest that functional assessment of the integrity of the intestinal barrier, i.e. barrier healing, by confocal laser endomicroscopy (CLE) correlates to clinical disease behavior and outcome.
Within this study, the investigators will prospectively include IBD patients in clinical remission and assess endoscopic remission, histologic remission and barrier healing during baseline ileocolonoscopy. Participants will then be closely followed up in the IBD outpatient department of the University Hospital Erlangen every 4 to 8 weeks for participants under biological therapy and every 8 weeks for participants under conventional therapy. At each visit, clinical disease activity using the Mayo Clinical Score (MCS) and the Crohn's disease activity Index (CDAI), respectively, routine laboratory parameters and current and past medications will be recorded. Further, at each visit, major clinical events (MCE), defined as (i) disease flare; (ii) IBD-related hospitalization, (iii) IBD-related surgery, (iv) necessity for initiation of systemic steroids, immunosuppressants or biologics; (v) necessity for escalation of an existing biological therapy, will be recorded. The primary endpoint of this study is to comparatively assess the predictive values of barrier healing, endoscopic remission and histologic remission for predicting occurrence of MCE in IBD patients in clinical remission
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Contatto studio
- Nome: Timo Rath, MD
- Numero di telefono: +49 913185-35000
- Email: timo.rath@uk-erlangen.de
Luoghi di studio
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Erlangen, Germania, 91054
- Reclutamento
- University Hospital Erlangen
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Contatto:
- Timo Rath, M.D.
- Numero di telefono: 85 45041 49 9131
- Email: timo.rath@uk-erlangen.de
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- patients with an established IBD diagnosis for at least 12 months duration
- IBD patients in clinical remission
Exclusion Criteria:
- patients with poor bowel preparation
- patients with total colectomy,
- patients with concomitant beta blocker therapy,
- patients with known allergy to fluorescein
- patients with a planned change in IBD-related pharmacotherapy
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
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IBD patients with endoscopic remission
No intervention will be administered.
All patients with endoscopic remission will be monitored for the future development of major clinical events.
Diagnostic performances of endoscopic remission for predicting major clinical events will be calculated.
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During follow-up, major clinical events, defined as (i) disease flare; (ii) IBD-related hospitalization, (iii) IBD-related surgery, (iv) necessity for initiation of systemic steroids, immunosuppressants or biologics; (v) necessity for escalation of an existing biological therapy, will be recorded.
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IBD patients with histologic remission
No intervention will be administered.
All patients with histologic remission will be monitored for the future development of major clinical events.
Diagnostic performances of histologic remission for predicting major clinical events will be calculated.
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During follow-up, major clinical events, defined as (i) disease flare; (ii) IBD-related hospitalization, (iii) IBD-related surgery, (iv) necessity for initiation of systemic steroids, immunosuppressants or biologics; (v) necessity for escalation of an existing biological therapy, will be recorded.
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IBD patients with barrier healing
No intervention will be administered.
All patients with barrier healing will be monitored for the future development of major clinical events.
Diagnostic performances of barrier healing for predicting major clinical events will be calculated.
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During follow-up, major clinical events, defined as (i) disease flare; (ii) IBD-related hospitalization, (iii) IBD-related surgery, (iv) necessity for initiation of systemic steroids, immunosuppressants or biologics; (v) necessity for escalation of an existing biological therapy, will be recorded.
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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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Predictive value of endoscopic remission in ulcerative colitis
Lasso di tempo: 2 years
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Endoscopic remission will be assessed using the Mayo Endoscopy Score in ulcerative colitis
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2 years
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Predictive value of endoscopic remission in Crohn's disease
Lasso di tempo: 2 years
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Endoscopic remission will be assessed using the simplified endoscopic index of severity (SES-CD) in Crohn's disease
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2 years
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Predictive value of histologic remission in ulcerative colitis
Lasso di tempo: 2 years
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Histologic remission will be assessed using the Robarts Histology Index and the Nancy Histology Index in ulcerative colitis
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2 years
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Predictive value of histologic remission in Crohn's disease
Lasso di tempo: 2 years
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Histologic remission will be assessed using a modified Riley Score in Crohn's disease
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2 years
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Predictive value of barrier healing
Lasso di tempo: 2 years
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Barrier healing will be assessed using the well-established Watson-Score as a semiquantitative grading system of the intestinal barrier function
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2 years
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Timo Rath, MD, University Hospital Erlangen, Department of Medicine 1
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
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
Altri numeri di identificazione dello studio
- ERIca Study
Piano per i dati dei singoli partecipanti (IPD)
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Prove cliniche su Recording of major clinical events
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University of Ljubljana, Faculty of MedicineUniversity Medical Centre Ljubljana; University Maribor; University Psychiatric...ReclutamentoAutolesionismo non suicidario | Autolesionismo | Disturbo di Personalità, Borderline | Differenza, Individuale | Disturbo epigenetico | Modifica; MentaleSlovenia