潰瘍性大腸炎の臨床試験-臨床試験登録-ICH GCP

調査の概要

状態

完了

条件

潰瘍性大腸炎

研究の種類

観察的

入学 (実際)

100

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

観測モデル：コホート
時間の展望：見込みのある

グループ/コホートの数

1

コホートと介入

グループ/コホート
Open-label cohort Patients will be followed for 52 weeks post initiation of adalimumab (Week 0).

この研究は何を測定していますか？

主要な結果の測定

結果測定	メジャーの説明	時間枠
Change from baseline in depressive symptoms at Week 52 時間枠：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

二次結果の測定

結果測定	メジャーの説明	時間枠
Change from baseline in depressive symptoms at Week 8 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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, 時間枠：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 時間枠：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) 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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) 時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

AbbVie

協力者

Cato Research

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

便利なリンク

clinical study report synopsis

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2015年8月18日

一次修了 (実際)

2020年2月10日

研究の完了 (実際)

2020年2月10日

試験登録日

最初に提出

2015年6月26日

QC基準を満たした最初の提出物

2015年7月21日

最初の投稿 (見積もり)

2015年7月23日

学習記録の更新

投稿された最後の更新 (実際)

2021年1月25日

QC基準を満たした最後の更新が送信されました

2021年1月22日

最終確認日

2021年1月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

P15-325

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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)