Klinisk prøve på Ulcerøs kolitt - Klinisk prøveregister

Studieoversikt

Status

Fullført

Forhold

Ulcerøs kolitt

Studietype

Observasjonsmessig

Registrering (Faktiske)

100

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Observasjonsmodeller: Kohort
Tidsperspektiver: Potensielle

Antall grupper / kohorter

1

Kohorter og intervensjoner

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

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	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	Tiltaksbeskrivelse	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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

AbbVie

Samarbeidspartnere

Cato Research

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

clinical study report synopsis

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

18. august 2015

Primær fullføring (Faktiske)

10. februar 2020

Studiet fullført (Faktiske)

10. februar 2020

Datoer for studieregistrering

Først innsendt

26. juni 2015

Først innsendt som oppfylte QC-kriteriene

21. juli 2015

Først lagt ut (Anslag)

23. juli 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

25. januar 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

22. januar 2021

Sist bekreftet

1. januar 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

P15-325

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Ubestemt

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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

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