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

2021년 1월 22일 업데이트: 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.

연구 개요

상태

완전한

정황

연구 유형

관찰

등록 (실제)

100

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 관찰 모델: 보병대
  • 시간 관점: 유망한

코호트 및 개입

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

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change from baseline in depressive symptoms at Week 52
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Change from baseline in depressive symptoms at Week 8
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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,
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

AbbVie

협력자

Cato Research

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2015년 8월 18일

기본 완료 (실제)

2020년 2월 10일

연구 완료 (실제)

2020년 2월 10일

연구 등록 날짜

최초 제출

2015년 6월 26일

QC 기준을 충족하는 최초 제출

2015년 7월 21일

처음 게시됨 (추정)

2015년 7월 23일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2021년 1월 25일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 1월 22일

마지막으로 확인됨

2021년 1월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • P15-325

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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