- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07597577
Upadacitinib in Isolated Small Bowel Versus Non-Small Bowel Crohn's Disease
Comparable Efficacy of Upadacitinib in Isolated Small Bowel Versus Non-Small Bowel Crohn's Disease: A Retrospective Cohort Study
Background & Aims: Isolated small bowel Crohn's disease (CD) is defined by involvement of the ileum, jejunum, or extensive small intestinal segments in the absence of colonic disease. This phenotype presents a therapeutic challenge, as biologic agents demonstrate reduced efficacy in this subgroup. Data on the use of upadacitinib specifically for isolated small bowel CD remain limited. This study aimed to evaluate the efficacy of upadacitinib in patients with this phenotype using the International Bowel Ultrasound Segment Activity Score (IBUS-SAS).
Methods: A retrospective cohort study including individuals with active Crohn's disease (CD) who received 12-week induction therapy with upadacitinib (45 mg/day) was conducted. Based on whether the disease involved the small bowel, individuals were categorized into an isolated small bowel CD group and a non-small bowel CD group. The primary endpoint was the change in the International Bowel Ultrasound Segment Activity Score (IBUS-SAS) from baseline to week 12. Secondary endpoints at week 12 included radiographic response (defined as a>25% or>2.0 mm reduction in bowel wall thickness [BWT] from baseline, or a>1.0 mm reduction in BWT from baseline accompanied by a decreased Color Doppler Signal grade), change in clinical activity as measured by the Crohn's Disease Activity Index (CDAI) from baseline, and changes in laboratory parameters (C-reactive protein, erythrocyte sedimentation rate). Statistical analyses included between-group comparisons, within-group comparison and logistic regression to identify predictors of radiographic response.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Guangzhou
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Guangdong, Guangzhou, China, 510000
- The Sixth Affiliated Hospital of Sun Yat-sen University
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
- confirmed diagnosis of Crohn's disease (CD) based on the 2023 Chinese clinical practice guidelines (Guangzhou);
- initiated upadacitinib treatment (45 mg once daily) and completed at least 12 weeks of follow-up;
- underwent intestinal ultrasound examinations both before treatment initiation and at week 12
Exclusion Criteria:
- age <18 years;
- concomitant use of other CD medications during upadacitinib treatment, including glucocorticoids, mesalazine, immunosuppressants, or biologics;
- undergoing surgical intervention during the upadacitinib treatment period
- history of other gastrointestinal diseases (e.g., ulcerative colitis, intestinal tuberculosis);
- incomplete clinical data.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
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case group:isolated small bowel Crohn's disease group
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A retrospective cohort study including individuals with active Crohn's disease (CD) who received 12-week induction therapy with upadacitinib (45 mg/day) was conducted.
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control group:a non-small bowel Crohn's disease group
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A retrospective cohort study including individuals with active Crohn's disease (CD) who received 12-week induction therapy with upadacitinib (45 mg/day) was conducted.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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the change in the International Bowel Ultrasound Segment Activity Score (IBUS-SAS)
Zeitfenster: from baseline to week 12
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The maximum value of IBUS-SAS (International Bowel Ultrasound Segment Activity Score) is 100.
The theoretical minimum is 4, but the clinically effective minimum is 0. In general, the lower the score, the milder the intestinal inflammation.
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from baseline to week 12
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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radiographic response
Zeitfenster: at week 12
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defined as a>25% or>2.0 mm reduction in bowel wall thickness [BWT] from baseline, or a>1.0 mm reduction in BWT from baseline accompanied by a decreased Color Doppler Signal grade
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at week 12
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change in clinical activity as measured by the Crohn's Disease Activity Index (CDAI)
Zeitfenster: from baseline to week 12
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The Crohn's Disease Activity Index (CDAI) has a theoretical maximum of 1100 and a theoretical minimum of 0. Consistent with the definition of disease activity in this scoring system, the lower the score, the lower the disease activity and the better the clinical status.
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from baseline to week 12
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changes in laboratory parameters (C-reactive protein)
Zeitfenster: from baseline to week 12
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from baseline to week 12
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changes in laboratory parameters (Erythrocyte sedimentation rate)
Zeitfenster: from baseline to week 12
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from baseline to week 12
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Mitarbeiter und Ermittler
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Satsangi J, Silverberg MS, Vermeire S, Colombel JF. The Montreal classification of inflammatory bowel disease: controversies, consensus, and implications. Gut. 2006 Jun;55(6):749-53. doi: 10.1136/gut.2005.082909.
- Dolinger M, Torres J, Vermeire S. Crohn's disease. Lancet. 2024 Mar 23;403(10432):1177-1191. doi: 10.1016/S0140-6736(23)02586-2. Epub 2024 Mar 1.
- Dulai PS, Singh S, Vande Casteele N, Boland BS, Rivera-Nieves J, Ernst PB, Eckmann L, Barrett KE, Chang JT, Sandborn WJ. Should We Divide Crohn's Disease Into Ileum-Dominant and Isolated Colonic Diseases? Clin Gastroenterol Hepatol. 2019 Dec;17(13):2634-2643. doi: 10.1016/j.cgh.2019.04.040. Epub 2019 Apr 19.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
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
- 2026ZSLYEC-305
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