Studie for å vurdere behandlingsmønstre og resultater med Upadcitinib hos voksne deltakere med inflammatorisk tarmsykdom i Belgia
Forstå lokale behandlingsmønstre og resultater med upAdacitinib hos IBD-pasienter i Belgia
Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. Ulcerative colitis (UC) is an idiopathic, chronic, inflammatory disease affecting the colon. This study will assess the (long-term) effectiveness and safety of upadacitinib in real-world clinical practice in adult participants with moderate to severe ulcerative colitis (UC) and crohn's disease (CD).
Upadacitinib is an approved drug for treating ulcerative colitis (UC) and Crohn's disease (CD). Approximately 280 participants who are prescribed Upadacitinib by their physician in accordance with local label will be enrolled in 8 sites across Belgium.
Participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 3 years.
There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice
Studieoversikt
Status
Forhold
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Liesbeth Ghys
- Telefonnummer: 844-663-3742
- E-post: liesbeth.ghys@abbvie.com
Studiesteder
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Liège, Belgia, 4000
- Rekruttering
- CHU de Liege /ID# 267209
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Antwerpen
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Bonheiden, Antwerpen, Belgia, 2820
- Rekruttering
- Imelda Ziekenhuis /ID# 268631
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Brussels Capital
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Anderlecht, Brussels Capital, Belgia, 1070
- Rekruttering
- Universite Libre de Bruxelles - Hopital Erasme /ID# 268632
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Hainaut
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Lodelinsart, Hainaut, Belgia, 6042
- Rekruttering
- Chu De Charleroi - Hopital Civil Marie Curie /ID# 284063
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Tournai, Hainaut, Belgia, 7500
- Rekruttering
- Centre Hospitalier De Wallonie Picarde - Site Notre Dame /ID# 284064
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Liege
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Liège, Liege, Belgia, 4000
- Rekruttering
- Groupe Sante CHC - Clinique du MontLegia /ID# 268662
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Limburg
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Genk, Limburg, Belgia, 3600
- Rekruttering
- Ziekenhuis Oost-Limburg, Campus St.-Jan /ID# 283334
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Oost-Vlaanderen
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Ghent, Oost-Vlaanderen, Belgia, 9000
- Rekruttering
- UZ Gent /ID# 268630
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Sint-Niklaas, Oost-Vlaanderen, Belgia, 9100
- Rekruttering
- Vitaz /Id# 268637
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West-Vlaanderen
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Kortrijk, West-Vlaanderen, Belgia, 8500
- Rekruttering
- AZ Groeninge /ID# 268638
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Roeselare, West-Vlaanderen, Belgia, 8800
- Rekruttering
- AZ-Delta. /ID# 283323
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Adult participants with ulcerative colitis or Crohn's Disease
Beskrivelse
Inclusion Criteria:
- Participants with a diagnosis of moderate to severe Crohn's disease or Ulcerative colitis, initiated with upadacitinib at least 12 months prior to inclusion, including participants that were initiated on upadacitinib, but later (i.e. at the moment of data collection) discontinued, or switched to another treatment.
- Participants initiating commercially available upadacitinib at the clinician's discretion as part of their routine clinical care; the decision to administer upadacitinib must be made prior to and independent of recruitment into the study
- Participants prescribed upadacitinib in accordance with the approved local label and treatment recommendations
Exclusion Criteria:
- Participants previously exposed to upadacitinib in a clinical trial or early access program
- Participants participating in interventional research (not including non-interventional
- Participants with stoma
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og intervensjoner
Gruppe / Kohort |
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Upadacitinib
Participants will receive upadacitinib as prescribed by their physician according to local label. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage of Participants Achieving Clinical Remission as per Partial Adapted Mayo Subscores for Ulcerative Colitis
Tidsramme: Up to approximately 52 weeks
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Clinical remission is defined as: stool frequency (SF) score < = 1 and not greater than baseline and Rectal bleeding (RB) score = 0 |
Up to approximately 52 weeks
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Percentage of Participants Achieving Clinical Remission as per Patient Reported Outcome (PRO2) for Crohn's Disease
Tidsramme: Up to approximately 52 weeks
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Clinical remission is defined as stool frequency (SF) score < =3 and not worse than baseline and Abdominal Pain (AP) score < =1 and not worse than baseline |
Up to approximately 52 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: ABBVIE INC., AbbVie
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- P24-960
Plan for individuelle deltakerdata (IPD)
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