Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

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

22 janvier 2021 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Rectocolite hémorragique

Type d'étude

Observationnel

Inscription (Réel)

100

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Modèles d'observation: Cohorte
Perspectives temporelles: Éventuel

Nombre de groupes / cohortes

Cohortes et interventions

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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
Change from baseline in depressive symptoms at Week 52 Délai: 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

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
Change from baseline in depressive symptoms at Week 8 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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, Délai: 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 Délai: 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) Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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) Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

AbbVie

Collaborateurs

Cato Research

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

clinical study report synopsis

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

18 août 2015

Achèvement primaire (Réel)

10 février 2020

Achèvement de l'étude (Réel)

10 février 2020

Dates d'inscription aux études

Première soumission

26 juin 2015

Première soumission répondant aux critères de contrôle qualité

21 juillet 2015

Première publication (Estimation)

23 juillet 2015

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

25 janvier 2021

Dernière mise à jour soumise répondant aux critères de contrôle qualité

22 janvier 2021

Dernière vérification

1 janvier 2021

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

P15-325

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

Indécis

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .