- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02506179
Impact of Adalimumab on Patient-reported Outcomes in Ulcerative Colitis (UCanADA)
22. Januar 2021 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Studientyp
Beobachtungs
Einschreibung (Tatsächlich)
100
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Alberta
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Calgary, Alberta, Kanada, T2N 4Z6
- University of Calgary /ID# 144032
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Edmonton, Alberta, Kanada, T6G 2X8
- Zeidler Ledcor Centre /ID# 145973
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British Columbia
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New Westminster, British Columbia, Kanada, V3L 3W5
- Columbia Gastro Mgmnt Ltd /ID# 136820
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Vancouver, British Columbia, Kanada, V6Z 2K5
- GIRI Gastrointestinal Research Institute /ID# 141107
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Victoria, British Columbia, Kanada, V8T 5G4
- Discovery Clinical Services /ID# 144102
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Victoria, British Columbia, Kanada, V8V 3M9
- Percuro Clinical Research, Ltd /ID# 136533
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New Brunswick
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Fredericton, New Brunswick, Kanada, E3B 5N5
- Dr. Everett Chalmers Reg Hosp. /ID# 136534
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St. John, New Brunswick, Kanada, E2K 1J5
- Dr Chadwick Ian Williams Professional Corporation /ID# 144802
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Ontario
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Brampton, Ontario, Kanada, L6S 0C1
- Bellini Medicine Professional /ID# 144241
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Oshawa, Ontario, Kanada, L1H 1B9
- Oshawa Clinic /ID# 144364
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Ottawa, Ontario, Kanada, K1H 8L6
- The Ottawa Hospital /ID# 139392
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Toronto, Ontario, Kanada, M53 TA9
- Kensington Screening Clinic /ID# 141106
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Toronto, Ontario, Kanada, M5G 1X5
- Mount Sinai Hosp.-Toronto /ID# 141108
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Windsor, Ontario, Kanada, N8W 1E6
- Dr O Tarabain Medicine Prof Corp /ID# 144034
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Windsor, Ontario, Kanada, N8Y 4C9
- Dr. Rahman Bacchus Med. Corp. /ID# 141780
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Quebec
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Levis, Quebec, Kanada, G6V 3Z1
- Hopital Hotel-Dieu de Levis /ID# 137099
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Montreal, Quebec, Kanada, H1T 2M4
- Hospital Maisonneuve-Rosemont /ID# 137336
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Montreal, Quebec, Kanada, H2X 3J4
- CHUM - Hopital Saint-Luc /ID# 139393
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Montreal, Quebec, Kanada, H3G 1A4
- McGill Univ HC /ID# 136821
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Montreal, Quebec, Kanada, H3P 3E5
- Clinique MEDI-CLE /ID# 153690
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Quebec City, Quebec, Kanada, G1R 2J6
- CHU de Quebec-Universite Laval /ID# 147557
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Sherbrooke, Quebec, Kanada, J1H 5N4
- CHUS - Hopital Fleurimont /ID# 137840
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Saskatchewan
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Saskatoon, Saskatchewan, Kanada, S7N 0W8
- Royal Univ. Hosp, Saskatoon,CA /ID# 137838
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
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.
Beschreibung
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:
- 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
- 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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: Kohorte
- Zeitperspektiven: Interessent
Kohorten und Interventionen
Gruppe / Kohorte |
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Open-label cohort
Patients will be followed for 52 weeks post initiation of adalimumab (Week 0).
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Change from baseline in depressive symptoms at Week 52
Zeitfenster: From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation
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It is measured by the Patient Health Questionnaire - 9 Items (PHQ-9).
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From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Change from baseline in depressive symptoms at Week 8
Zeitfenster: From Week 0 to Week 8, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
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It is measured by the Patient Health Questionnaire - 9 Items (PHQ-9).
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From Week 0 to Week 8, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
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Change from baseline in the proportion of patients with PHQ-9 >= 10
Zeitfenster: From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation
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The change from baseline in the proportion of patients with PHQ-9 >= 10 is assessed at week 8 and 52.
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From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation
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Change from baseline in Disability
Zeitfenster: From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation
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It is measured by the Inflammatory Bowel Disease (IBD) Disability Index at weeks 8 and 52.
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From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation
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Change from baseline in Overall quality of life
Zeitfenster: From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
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It is measured by the EuroQol 5-Dimensions, 5 Levels (EQ-5D-5L) and EQ5D VAS at weeks 8 and 52.
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From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
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Change from baseline in Ulcerative Colitis (UC)-specific quality of life
Zeitfenster: From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation
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It is measured by the Short Quality of Life in Inflammatory Bowel Disease Questionnaire (SIBDQ) at weeks 8 and 52.
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From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation
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Change from baseline in Fatigue
Zeitfenster: From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
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It is measured by the Functional Assessment Chronic Illness Therapy-Fatigue (FACIT-F) at weeks 8 and 52.
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From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
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Change from baseline in Sleep impairment,
Zeitfenster: From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
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It is measured by the Medical Outcomes Study Sleep scale (MOS Sleep) at weeks 8 and 52.
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From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
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Change from baseline in Work productivity
Zeitfenster: From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
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The change from baseline in work productivity is assessed at week 8 and 52.
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From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
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Assessing Simple Clinical Colitis Activity Index (SCCAI)
Zeitfenster: Up to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
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SCCAI is used to access response and remission rates.
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Up to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
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Change from baseline in Fecal Calprotectin levels
Zeitfenster: From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
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The change from baseline in Fecal Calprotectin levels will be assessed.
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From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
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Mayo endoscopic sub-score
Zeitfenster: Up to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
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Mayo endoscopic sub-score will be assessed.
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Up to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
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Proportion of patients with Complications including hospitalization and surgery
Zeitfenster: At Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
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The proportion of patients with complications including hospitalization and surgery will be assessed.
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At Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
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Proportion of patients on steroids
Zeitfenster: At Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
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The proportion of patients on steroids will be assessed.
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At Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
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Change from baseline in Physician's Global Assessment (PGA)
Zeitfenster: From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation
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The change from baseline in Physician's Global Assessment (PGA) will be assessed.
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From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Nützliche Links
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
18. August 2015
Primärer Abschluss (Tatsächlich)
10. Februar 2020
Studienabschluss (Tatsächlich)
10. Februar 2020
Studienanmeldedaten
Zuerst eingereicht
26. Juni 2015
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
21. Juli 2015
Zuerst gepostet (Schätzen)
23. Juli 2015
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
25. Januar 2021
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
22. Januar 2021
Zuletzt verifiziert
1. Januar 2021
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- P15-325
Plan für individuelle Teilnehmerdaten (IPD)
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Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Produkt, das in den USA hergestellt und aus den USA exportiert wird
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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