- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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
Studientyp
Einschreibung (Voraussichtlich)
Kontakte und Standorte
Studienkontakt
- Name: Timo Rath, MD
- Telefonnummer: +49 913185-35000
- E-Mail: timo.rath@uk-erlangen.de
Studienorte
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Erlangen, Deutschland, 91054
- Rekrutierung
- University Hospital Erlangen
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Kontakt:
- Timo Rath, M.D.
- Telefonnummer: 85 45041 49 9131
- E-Mail: timo.rath@uk-erlangen.de
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
---|---|
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.
|
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.
|
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.
|
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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Predictive value of endoscopic remission in ulcerative colitis
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Timo Rath, MD, University Hospital Erlangen, Department of Medicine 1
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- ERIca Study
Plan für individuelle Teilnehmerdaten (IPD)
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Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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