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

22 januari 2021 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Studietyp

Observationell

Inskrivning (Faktisk)

100

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: Kohort
  • Tidsperspektiv: Blivande

Kohorter och interventioner

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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change from baseline in depressive symptoms at Week 52
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change from baseline in depressive symptoms at Week 8
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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,
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

AbbVie

Samarbetspartners

Cato Research

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

18 augusti 2015

Primärt slutförande (Faktisk)

10 februari 2020

Avslutad studie (Faktisk)

10 februari 2020

Studieregistreringsdatum

Först inskickad

26 juni 2015

Först inskickad som uppfyllde QC-kriterierna

21 juli 2015

Första postat (Uppskatta)

23 juli 2015

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

25 januari 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

22 januari 2021

Senast verifierad

1 januari 2021

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • P15-325

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

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