Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Impact of Adalimumab on Patient-reported Outcomes in Ulcerative Colitis (UCanADA)

22. januar 2021 opdateret af: AbbVie

A Study of the Impact of Adalimumab on Patient-reported Outcomes (PROs) in Canadian Patients Suffering From Moderate-to-severe Ulcerative Colitis (UCanADA)

To evaluate the real-life effect after 1 year of adalimumab treatment on psychological distress/depression symptoms in moderate-to-severe Ulcerative Colitis (UC) patients.

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

100

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • University of Calgary /ID# 144032
      • Edmonton, Alberta, Canada, T6G 2X8
        • Zeidler Ledcor Centre /ID# 145973
    • British Columbia
      • New Westminster, British Columbia, Canada, V3L 3W5
        • Columbia Gastro Mgmnt Ltd /ID# 136820
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • GIRI Gastrointestinal Research Institute /ID# 141107
      • Victoria, British Columbia, Canada, V8T 5G4
        • Discovery Clinical Services /ID# 144102
      • Victoria, British Columbia, Canada, V8V 3M9
        • Percuro Clinical Research, Ltd /ID# 136533
    • New Brunswick
      • Fredericton, New Brunswick, Canada, E3B 5N5
        • Dr. Everett Chalmers Reg Hosp. /ID# 136534
      • St. John, New Brunswick, Canada, E2K 1J5
        • Dr Chadwick Ian Williams Professional Corporation /ID# 144802
    • Ontario
      • Brampton, Ontario, Canada, L6S 0C1
        • Bellini Medicine Professional /ID# 144241
      • Oshawa, Ontario, Canada, L1H 1B9
        • Oshawa Clinic /ID# 144364
      • Ottawa, Ontario, Canada, K1H 8L6
        • The Ottawa Hospital /ID# 139392
      • Toronto, Ontario, Canada, M53 TA9
        • Kensington Screening Clinic /ID# 141106
      • Toronto, Ontario, Canada, M5G 1X5
        • Mount Sinai Hosp.-Toronto /ID# 141108
      • Windsor, Ontario, Canada, N8W 1E6
        • Dr O Tarabain Medicine Prof Corp /ID# 144034
      • Windsor, Ontario, Canada, N8Y 4C9
        • Dr. Rahman Bacchus Med. Corp. /ID# 141780
    • Quebec
      • Levis, Quebec, Canada, G6V 3Z1
        • Hopital Hotel-Dieu de Levis /ID# 137099
      • Montreal, Quebec, Canada, H1T 2M4
        • Hospital Maisonneuve-Rosemont /ID# 137336
      • Montreal, Quebec, Canada, H2X 3J4
        • CHUM - Hopital Saint-Luc /ID# 139393
      • Montreal, Quebec, Canada, H3G 1A4
        • McGill Univ HC /ID# 136821
      • Montreal, Quebec, Canada, H3P 3E5
        • Clinique MEDI-CLE /ID# 153690
      • Quebec City, Quebec, Canada, G1R 2J6
        • CHU de Quebec-Universite Laval /ID# 147557
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • CHUS - Hopital Fleurimont /ID# 137840
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
        • Royal Univ. Hosp, Saskatoon,CA /ID# 137838

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Adult males and females with moderate to severe UC patients from Canada who meet the inclusion criteria and who do not meet any of the exclusion criteria will be eligible for enrollment into the study.

Beskrivelse

Inclusion Criteria:

  • Patient must voluntarily sign and date a patient authorization.
  • Patient must be ≥ 18 years of age.
  • Patient must have confirmed diagnosis of UC.

  • Patient must have:

    1. a Mayo endoscopic sub score of 2 or 3 from endoscopic investigation in the previous 3-months that is closest to the baseline visit or
    2. a Mayo rectal bleeding subscore ≥ 2 and a calprotectin value greater than 250 µg/gr.
  • Patient must have been prescribed adalimumab as part of his treatment by his treating physician.
  • If the patient was previously treated with vedolizumab or any anti-TNF agent (except adalimumab), an appropriate washout has taken place as per routine practice.

Exclusion Criteria:

  • Patient has previously received adalimumab.
  • Patient has previously used infliximab or any anti-TNF agent and have not clinically responded at any time ("primary non-responder") unless they experienced a treatment limiting reaction.
  • Patient with a history of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Kock pouch, or ileostomy for UC or planned bowel surgery.
  • Patient with a current diagnosis of indeterminate colitis, ulcerative proctitis only, or with a current diagnosis and/or have a history of Crohn's disease.
  • Patient with other tumor necrosis factor (TNF) immune-modulated disease.
  • Patient has a significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease that in the opinion of the investigator would adversely affect his/her participating in this study.
  • A female patient is pregnant or breast-feeding.
  • Patient is currently participating in another prospective study including controlled clinical trials and observational studies

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
Open-label cohort
Patients will be followed for 52 weeks post initiation of adalimumab (Week 0).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline in depressive symptoms at Week 52
Tidsramme: From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation
It is measured by the Patient Health Questionnaire - 9 Items (PHQ-9).
From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline in depressive symptoms at Week 8
Tidsramme: From Week 0 to Week 8, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
It is measured by the Patient Health Questionnaire - 9 Items (PHQ-9).
From Week 0 to Week 8, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Change from baseline in the proportion of patients with PHQ-9 >= 10
Tidsramme: From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation
The change from baseline in the proportion of patients with PHQ-9 >= 10 is assessed at week 8 and 52.
From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Change from baseline in Disability
Tidsramme: From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation
It is measured by the Inflammatory Bowel Disease (IBD) Disability Index at weeks 8 and 52.
From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Change from baseline in Overall quality of life
Tidsramme: From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
It is measured by the EuroQol 5-Dimensions, 5 Levels (EQ-5D-5L) and EQ5D VAS at weeks 8 and 52.
From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Change from baseline in Ulcerative Colitis (UC)-specific quality of life
Tidsramme: From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation
It is measured by the Short Quality of Life in Inflammatory Bowel Disease Questionnaire (SIBDQ) at weeks 8 and 52.
From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Change from baseline in Fatigue
Tidsramme: From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
It is measured by the Functional Assessment Chronic Illness Therapy-Fatigue (FACIT-F) at weeks 8 and 52.
From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Change from baseline in Sleep impairment,
Tidsramme: From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
It is measured by the Medical Outcomes Study Sleep scale (MOS Sleep) at weeks 8 and 52.
From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Change from baseline in Work productivity
Tidsramme: From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
The change from baseline in work productivity is assessed at week 8 and 52.
From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Assessing Simple Clinical Colitis Activity Index (SCCAI)
Tidsramme: Up to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
SCCAI is used to access response and remission rates.
Up to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Change from baseline in Fecal Calprotectin levels
Tidsramme: From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
The change from baseline in Fecal Calprotectin levels will be assessed.
From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Mayo endoscopic sub-score
Tidsramme: Up to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Mayo endoscopic sub-score will be assessed.
Up to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Proportion of patients with Complications including hospitalization and surgery
Tidsramme: At Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
The proportion of patients with complications including hospitalization and surgery will be assessed.
At Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Proportion of patients on steroids
Tidsramme: At Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
The proportion of patients on steroids will be assessed.
At Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Change from baseline in Physician's Global Assessment (PGA)
Tidsramme: From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation
The change from baseline in Physician's Global Assessment (PGA) will be assessed.
From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

AbbVie

Samarbejdspartnere

Cato Research

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

18. august 2015

Primær færdiggørelse (Faktiske)

10. februar 2020

Studieafslutning (Faktiske)

10. februar 2020

Datoer for studieregistrering

Først indsendt

26. juni 2015

Først indsendt, der opfyldte QC-kriterier

21. juli 2015

Først opslået (Skøn)

23. juli 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. januar 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. januar 2021

Sidst verificeret

1. januar 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • P15-325

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Uafklaret

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Colitis ulcerosa

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Cameroon

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner