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クローン病の参加者におけるウパダシチニブ（ABT-494）の反復投与の長期有効性、安全性、および忍容性を評価するための研究

2026年8月10日 更新者：AbbVie

クローン病の被験者におけるウパダシチニブ（ABT-494）の反復投与の長期有効性、安全性、および忍容性を観察するための第2相、多施設、非盲検延長（OLE）試験

これは、ウパダシチニブ (ABT-494) の長期的な有効性、安全性、および忍容性を評価するために設計された非盲検延長 (OLE) 試験です。

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

107

段階

  • フェーズ2

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

  • アメリカ
    • California
      • La Jolla、California、アメリカ、92037
        • UC San Diego Health System /ID# 150041
      • San Francisco、California、アメリカ、94143-2204
        • Univ California, San Francisco /ID# 149987
    • Florida
      • Gainesville、Florida、アメリカ、32610
        • Duplicate_University of Florida - Archer /ID# 150033
      • Hollywood、Florida、アメリカ、33021
        • The Ctr for Gastro Disorders /ID# 150012
      • Inverness、Florida、アメリカ、34452-4717
        • Nature Coast Clinical Research - Inverness /ID# 149975
    • Georgia
      • Macon、Georgia、アメリカ、31201
        • Gastroenterology Associates of Central Georgia, LLC /ID# 149870
      • Marietta、Georgia、アメリカ、30060
        • GI Specialists of GA, PC /ID# 150015
    • Kansas
      • Topeka、Kansas、アメリカ、66606
        • Cotton O'Neil Clinical Research Center, Digestive Health /ID# 149900
    • Kentucky
      • Louisville、Kentucky、アメリカ、40202
        • Duplicate_University of Louisville /ID# 149884
    • Maryland
      • Annapolis、Maryland、アメリカ、21401
        • Investigative Clinical Research /ID# 149886
      • Towson、Maryland、アメリカ、21204
        • Charm City Research Group /ID# 150040
    • Michigan
      • Chesterfield、Michigan、アメリカ、48047
        • Clin Res Inst of Michigan, LLC /ID# 150008
    • Minnesota
      • Rochester、Minnesota、アメリカ、55905-0001
        • Mayo Clinic - Rochester /ID# 149894
    • Missouri
      • Kansas City、Missouri、アメリカ、64131
        • Kansas City Research Institute /ID# 149888
      • St Louis、Missouri、アメリカ、63110
        • Washington University-School of Medicine /ID# 149899
    • New York
      • Lake Success、New York、アメリカ、11042
        • NYU Langone Long Island Clinical Research Associates /ID# 149976
      • New York、New York、アメリカ、10021-4872
        • Weill Cornell Medicine/NYP /ID# 149895
    • North Carolina
      • Chapel Hill、North Carolina、アメリカ、27514-4220
        • Univ NC Chapel Hill /ID# 149982
    • Ohio
      • Cincinnati、Ohio、アメリカ、45219
        • University Of Cincinnati Medical Center /ID# 149977
    • Oklahoma
      • Tulsa、Oklahoma、アメリカ、74104
        • Options Health Research, LLC /ID# 150010
    • Texas
      • Southlake、Texas、アメリカ、76092
        • Texas Digestive Disease Consultants - Southlake /ID# 149869
      • Southlake、Texas、アメリカ、76092
        • Texas Digestive Disease Consultants - Southlake /ID# 149989
    • Utah
      • Orem、Utah、アメリカ、84058
        • Aspen Clinical Research /ID# 150020
    • Virginia
      • Charlottesville、Virginia、アメリカ、22908
        • University of Virginia /ID# 149881
    • Washington
      • Seattle、Washington、アメリカ、98109
        • University of Washington /ID# 149988
      • Seattle、Washington、アメリカ、98101
        • Virginia Mason Hospital & Medical Center /ID# 150042
    • Wisconsin
      • Milwaukee、Wisconsin、アメリカ、53215
        • Wisconsin Center for Advanced Research /ID# 149863
  • イギリス
    • Manchester
      • Manchester、Manchester、イギリス、M13 9WL
        • Duplicate_Manchester University NHS Foundation Trust /ID# 150006
    • Oxfordshire
      • Oxford、Oxfordshire、イギリス、OX3 9DU
        • Oxford University Hospitals NHS Foundation Trust /ID# 149963
  • イスラエル
      • Petah Tikva、イスラエル、4941492
        • Rabin Medical Center. /ID# 149942
    • Central District
      • Ẕerifin、Central District、イスラエル、70300
        • Yitzhak Shamir Medical Center /ID# 149943
    • Tel Aviv
      • Ramat Gan、Tel Aviv、イスラエル、5265601
        • The Chaim Sheba Medical Center /ID# 149945
  • イタリア
    • Calabria
      • Catanzaro、Calabria、イタリア、88100
        • University of Catanzaro /ID# 149927
    • Emilia-Romagna
      • Bologna、Emilia-Romagna、イタリア、40138
        • Duplicate_IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 149958
  • オランダ
    • North Holland
      • Amsterdam、North Holland、オランダ、1105 AZ
        • Amsterdam UMC, locatie AMC /ID# 149932
    • Utrecht
      • Utrecht、Utrecht、オランダ、3584 CX
        • Universitair Medisch Centrum Utrecht /ID# 149933
  • カナダ
    • Alberta
      • Edmonton、Alberta、カナダ、T6G 2B7
        • University of Alberta Hospital /ID# 149873
    • British Columbia
      • Vancouver、British Columbia、カナダ、V5Z 1M9
        • University of British Columbia (UBC) - Gordon and Leslie Diamond Health Care Ce /ID# 149876
      • Vancouver、British Columbia、カナダ、V6Z 2K5
        • Duplicate_(G.I.R.I.) GI Research Institute Foundation /ID# 149878
    • Ontario
      • Vaughan、Ontario、カナダ、L4L 4Y7
        • Toronto Digestive Disease Associates /ID# 149877
    • Quebec
      • Montreal、Quebec、カナダ、H4A 3J1
        • Disc_Royal Victoria Hospital / McGill University Health Centre /ID# 149871
  • スペイン
    • A Coruna
      • Ferrol、A Coruna、スペイン、15405
        • Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 149996
    • Madrid
      • Madrid、Madrid、スペイン、28046
        • Hospital Universitario La Paz /ID# 149997
  • スロバキア
    • Nitra Region
      • Nitra、Nitra Region、スロバキア、949 01
        • Duplicate_KM Management, spol. s.r.o. /ID# 149949
    • Presov
      • Prešov、Presov、スロバキア、080 01
        • Gastro I., s.r.o. /ID# 149948
  • チェコ
    • Hradec Kralove
      • Hradec Králové、Hradec Kralove、チェコ、500 12
        • Hepato-Gastroenterologie HK, s.r.o. /ID# 149882
  • デンマーク
    • Capital Region
      • Hvidovre、Capital Region、デンマーク、2650
        • Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 149890
    • Central Jutland
      • Aarhus N、Central Jutland、デンマーク、8200
        • Duplicate_Aarhus University Hospital /ID# 149919
  • ドイツ
      • Berlin、ドイツ、14050
        • DRK Kliniken Berlin Westend /ID# 149905
      • Münster、ドイツ、48155
        • Medizinisches Versorgungszentrum Portal 10 /ID# 149930
    • Schleswig-Holstein
      • Kiel、Schleswig-Holstein、ドイツ、24105
        • Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 149936
  • ニュージーランド
    • Otago
      • Otago、Otago、ニュージーランド、9016
        • Dunedin Hospital /ID# 149964
  • ノルウェー
    • Oslo
      • Oslo、Oslo、ノルウェー、0440
        • Lovisenberg Diakonale Sykehus /ID# 149967
  • ハンガリー
      • Budapest、ハンガリー、1124
        • Magyar Elhizastudomanyi Kozpont Kft. /ID# 149907
  • フランス
    • Meurthe-et-Moselle
      • Vandœuvre-lès-Nancy、Meurthe-et-Moselle、フランス、54500
        • Duplicate_CHRU Nancy - Hopitaux de Brabois /ID# 149896
    • Nord
      • Lille、Nord、フランス、59037
        • CHRU Lille - Hopital Claude Huriez /ID# 149897
    • Somme
      • Amiens、Somme、フランス、80054
        • Duplicate_CHU Amiens-Picardie Site Sud /ID# 149921
  • ベルギー
    • Liege
      • Liège、Liege、ベルギー、4000
        • Duplicate_CHU de Liege /ID# 149912
  • ポーランド
    • Masovian Voivodeship
      • Warsaw、Masovian Voivodeship、ポーランド、02-507
        • Panstwowy Instytut Medyczny MSWiA w Warszawie /ID# 149978
    • Łódź Voivodeship
      • Lodz、Łódź Voivodeship、ポーランド、90-302
        • Santa Sp. z o.o. Santa Familia Centrum Badan, Profilaktyki i Leczenia /ID# 149979
  • ルーマニア
      • Timișoara、ルーマニア、300002
        • Cabinet Particular Policlinic Algomed /ID# 149993

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～75年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

説明

包含基準:

  • 参加者は 52 週目まで M13-740 試験を完了している必要があります。
  • 女性の場合、参加者は閉経後、外科的に無菌であるか、避妊法を使用している必要があります。

除外基準:

  • 何らかの理由で、参加者は治験責任医師によって不適切な候補者であると見なされます
  • -ベースラインで妊娠検査が陽性の女性参加者、または研究中に妊娠することを検討している女性参加者。
  • -参加者は、研究M13-740全体で、以前および付随する投薬要件および手順を順守していません。

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

  • 主な目的：処理
  • 割り当て：非ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：ウパダシチニブ (ABT-494) 用量 A
オープンラベル用量 A 1 日 1 回 (QD)
薬：ABT-494
錠剤: 経口
他の名前：
  • リンヴォク
  • ウパダシチニブ
実験的：ウパダシチニブ (ABT-494) 用量 B
オープンラベル用量 B QD
薬：ABT-494
錠剤: 経口
他の名前：
  • リンヴォク
  • ウパダシチニブ

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
Percentage of Participants Achieving Endoscopic Remission at Month 12
時間枠：Month 12
Endoscopic remission was based on Simplified Endoscopic Score for Crohn's disease (SES-CD). The SES-CD assessed the size of mucosal ulcers, the ulcerated surface, the endoscopic extension and the presence of stenosis. SES-CD was based on endoscopic findings in 5 bowel segments (Ileum, right colon, transverse colon, left colon/sigmoid, and rectum). Each item was scored 0 to 3 per segment. The sum of the scores for each endoscopic variable ranged from 0 to 15, except for stenosis, where it varied between 0 and 11; total score ranged from 0 to 56. A lower score indicated better outcome. Endoscopic remission was defined as SES-CD ≤4 and at least two-point reduction versus Baseline of Study M13-740 and no subscore >1 in any individual variable.
Month 12
Percentage of Participants Achieving Clinical Remission at Month 12
時間枠：Month 12
Clinical remission was defined as average daily stool frequency ≤1.5 and not worse than Baseline and average daily abdominal pain score ≤1.0 and not worse than baseline in Study M13-740. Abdominal pain was assessed using the CDAI component "abdominal pain" rated as none [0], mild [1], moderate [2], and severe [3]) (cumulative total over the past 7 days) as per the CDAI to calculate abdominal pain score; total score range from 0 to 105.
Month 12

二次結果の測定

結果測定
メジャーの説明
時間枠
Percentage of Participants Achieving Endoscopic Remission
時間枠：Week 0 (Baseline), Months 24, 36, 48, 60, 72, 84, and 96
Endoscopic remission was based on SES-CD. The SES-CD assessed the size of mucosal ulcers, the ulcerated surface, the endoscopic extension and the presence of stenosis. SES-CD was based on endoscopic findings in 5 bowel segments (Ileum, right colon, transverse colon, left colon/sigmoid, and rectum). Each item was scored 0 to 3 per segment. The sum of the scores for each endoscopic variable ranged from 0 to 15, except for stenosis, where it varied between 0 and 11; total score ranged from 0 to 56. A lower score indicated better outcome. Endoscopic remission was defined as SES-CD ≤4 and at least two-point reduction versus Baseline of Study M13-740 and no subscore >1 in any individual variable. Week 52 visit of Study M13-740 was considered Week 0 (Baseline) of Study M14-327.
Week 0 (Baseline), Months 24, 36, 48, 60, 72, 84, and 96
Percentage of Participants Achieving Clinical Remission
時間枠：Week 0 (Baseline), Months 12, 24, 36, 48, 60, 72, 84, and 96
Clinical remission was defined as average daily stool frequency ≤1.5 and not worse than baseline and average daily abdominal pain score of ≤1.0 and not worse than baseline of Study M13-740. Abdominal pain was assessed using the CDAI component "abdominal pain" rated as none [0], mild [1], moderate [2], and severe [3]) (cumulative total over the past 7 days) and multiplied by a factor of 5 as per the CDAI to calculate abdominal pain score; total score range from 0 to 105.
Week 0 (Baseline), Months 12, 24, 36, 48, 60, 72, 84, and 96
Percentage of Participants Achieving Modified Clinical Remission
時間枠：Week 0 (Baseline), Months 12, 24, 36, 48, 60, 72, 84, and 96
Modified Clinical Remission was defined as average daily stool frequency ≤2.8 and not worse than baseline and average daily abdominal pain score of ≤1.0 and not worse than baseline of Study M13-740, among participants with stool frequency ≥4.0 or abdominal pain score ≥2.0 at Baseline of Study M13-740. Abdominal pain was assessed using the CDAI component "abdominal pain" rated as none [0], mild [1], moderate [2], and severe [3]) (cumulative total over the past 7 days) and multiplied by a factor of 5 as per the CDAI to calculate abdominal pain score; total score range from 0 to 105.
Week 0 (Baseline), Months 12, 24, 36, 48, 60, 72, 84, and 96
Percentage of Participants Achieving Remission
時間枠：Week 0 (Baseline), Months 12, 24, 36, 48, 60, 72, 84, and 96
Remission=clinical remission and endoscopic remission. Clinical remission was an average daily stool frequency ≤1.5 and not worse than baseline and average daily abdominal pain score of ≤1.0 and not worse than baseline of Study M13-740. Abdominal pain was assessed by CDAI component "abdominal pain"; rated as none [0], mild [1], moderate [2], severe [3]) cumulative total over the past 7 days and multiplied by a factor of 5 as per CDAI. Abdominal pain score range: 0 to 105. Endoscopic remission was based on SES-CD and assessed the size of mucosal ulcers, ulcerated surface, endoscopic extension and presence of stenosis. SES-CD was based on endoscopic findings in 5 bowel segments: Ileum, right colon, transverse colon, left colon/sigmoid, and rectum. Each item was scored 0 to 3 per segment. The sum of the scores for each endoscopic variable ranged from 0 to 15, except for stenosis, where it varied between 0 and 11; total score ranged from 0 to 56. A lower score indicated better outcome.
Week 0 (Baseline), Months 12, 24, 36, 48, 60, 72, 84, and 96
Percentage of Participants Achieving CDAI Remission
時間枠：Week 0 (Baseline), Months 12, 24, 36, 48, 60, 72, 84, and 96
CDAI is a measure of clinical response and remission that includes 8 variables encompassing both participant-reported (symptoms, general well-being) and objective (medication usage, laboratory variables, presence of abdominal mass or complications, and weight) variables. For symptoms scores, participants kept a diary card and the daily symptom scores were summed for the week. Each item in the CDAI was assigned a pre-specified factor to calculate the subtotals, and the subtotals of the items were totaled to produce the CDAI. Higher CDAI scores indicated greater disease activity, with a lower limit of 0 and no set upper limit. Total score range: 0 to 600. CDAI remission was defined as CDAI score <150.
Week 0 (Baseline), Months 12, 24, 36, 48, 60, 72, 84, and 96
Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission
時間枠：Week 0 (Baseline), Months 12, 24, 36, 48, 60, 72, 84, and 96
The IBDQ is a 32-item (ranged 1 to 7) self-report questionnaire for participants with inflammatory bowel disease to evaluate the participant-reported outcomes across 4 dimensions: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). IBDQ total score range: 32 to 224. A higher score indicating better outcome. IBDQ remission was defined as IBDQ score ≥170.
Week 0 (Baseline), Months 12, 24, 36, 48, 60, 72, 84, and 96
Percentage of Participants Achieving Endoscopic Improvement
時間枠：Week 0 (Baseline), Months 12, 24, 36, 48, 60, 72, 84, and 96
Endoscopic improvement was defined as SES-CD at least 50% reduction from Baseline or endoscopic remission. Endoscopic remission was based on SES-CD and assessed the size of mucosal ulcers, ulcerated surface, endoscopic extension and presence of stenosis. SES-CD was based on endoscopic findings in 5 bowel segments: Ileum, right colon, transverse colon, left colon/sigmoid, and rectum. Each item was scored 0 to 3 per segment. The sum of the scores for each endoscopic variable ranged from 0 to 15, except for stenosis, where it varied between 0 and 11; total score ranged from 0 to 56. A lower score indicated better outcome. Endoscopic remission was defined as SES-CD ≤4 and at least 2-point reduction versus baseline of Study M13-740 and no subscore >1 in any individual variable. Week 52 visit of Study M13-740 was considered Week 0 (Baseline) of Study M14-327.
Week 0 (Baseline), Months 12, 24, 36, 48, 60, 72, 84, and 96
Percentage of Participants Taking Steroids at Baseline (of Study M13-740) Who Are Steroid-Free at the Specified Timepoint in Study M14-327
時間枠：Months 12, 24, 36, 48, 60, 72, 84, and 96
Months 12, 24, 36, 48, 60, 72, 84, and 96
Percentage of Participants Achieving Remission and Normal C-Reactive Protein (CRP)
時間枠：Week 0 (Baseline), Months 12, 24, 36, 48, 60, 72, 84, and 96
Remission = clinical remission and endoscopic remission. Clinical remission was average daily stool frequency ≤1.5 and not worse than baseline and average daily abdominal pain score ≤1.0 and not worse than baseline of Study M13-740. Abdominal pain was assessed by CDAI component "abdominal pain" rated: none [0], mild [1], moderate [2], severe [3] cumulative total over the past 7 days and multiplied by a prespecified factor of 5; total score range from 0 to 105. Endoscopic remission was based on SES-CD and assessed size of mucosal ulcers, ulcerated surface, endoscopic extension and presence of stenosis. SES-CD was based on endoscopic findings in 5 bowel segments: Ileum, right colon, transverse colon, left colon/sigmoid, and rectum; scored 0 to 3 per segment. Sum of scores for each endoscopic variable ranged from 0 to 15, except for stenosis, where it varied between 0 and 11; total score ranged from 0 to 56. A lower score indicated better outcome. Normal CRP=high-sensitivity CRP <5 mg/L.
Week 0 (Baseline), Months 12, 24, 36, 48, 60, 72, 84, and 96
Percentage of Participants in Remission at Week 0 Who Maintained Remission
時間枠：Months 12, 24, 36, 48, 60, 72, 84, and 96
Remission=clinical remission and endoscopic remission. Clinical remission was an average daily stool frequency ≤1.5 and not worse than baseline and average daily abdominal pain score of ≤1.0 and not worse than baseline of Study M13-740. Abdominal pain was assessed by CDAI component "abdominal pain"; rated as none [0], mild [1], moderate [2], severe [3]) cumulative total over the past 7 days and multiplied by a factor of 5 as per CDAI. Abdominal pain score range: 0 to 105. Endoscopic remission was based on SES-CD and assessed the size of mucosal ulcers, ulcerated surface, endoscopic extension and presence of stenosis. SES-CD was based on endoscopic findings in 5 bowel segments: Ileum, right colon, transverse colon, left colon/sigmoid, and rectum. Each item was scored 0 to 3 per segment. The sum of the scores for each endoscopic variable ranged from 0 to 15, except for stenosis, where it varied between 0 and 11; total score ranged from 0 to 56. A lower score indicated better outcome.
Months 12, 24, 36, 48, 60, 72, 84, and 96
Percentage of Participants in Endoscopic Remission at Week 0 Who Maintained Endoscopic Remission
時間枠：Months 12, 24, 36, 48, 60, 72, 84, and 96
Endoscopic remission was based on SES-CD and assessed the size of mucosal ulcers, ulcerated surface, endoscopic extension and presence of stenosis. SES-CD was based on endoscopic findings in 5 bowel segments: Ileum, right colon, transverse colon, left colon/sigmoid, and rectum. Each item was scored 0 to 3 per segment. The sum of the scores for each endoscopic variable ranged from 0 to 15, except for stenosis, where it varied between 0 and 11; total score ranged from 0 to 56. A lower score indicated better outcome. Endoscopic remission was defined as SES-CD ≤4 and at least 2-point reduction versus baseline of Study M13-740 and no subscore >1 in any individual variable. Week 52 visit of Study M13-740 was considered Week 0 (Baseline) of Study M14-327.
Months 12, 24, 36, 48, 60, 72, 84, and 96
Percentage of Participants Achieving Response
時間枠：Week 0 (Baseline), Months 12, 24, 36, 48, 60, 72, 84, and 96
Response = clinical and endoscopic response. Clinical response was average daily stool frequency at least 30% reduction from baseline and average daily abdominal pain score not worse than baseline or average daily abdominal pain at least 30% reduction from baseline of Study M13-740 and average daily stool frequency not worse than baseline of Study M13-740. Abdominal pain based on CDAI component "abdominal pain" rated none [0], mild [1], moderate [2], severe [3] cumulative total over past 7 days and multiplied by prespecified factor of 5; total score range from 0-105. Endoscopic response was decrease ≥25% SES-CD from baseline of Study M13-740. SES-CD was based on endoscopic findings in 5 bowel segments (Ileum, right colon, transverse colon, left colon/sigmoid, rectum), scored 0 to 3 per each segment. Sum of the scores for each endoscopic variable ranged from 0-15, except for stenosis, where it varied between 0-11; total score ranged from 0-56. Lower score indicated better outcome.
Week 0 (Baseline), Months 12, 24, 36, 48, 60, 72, 84, and 96
Percentage of Participants Achieving Enhanced Clinical Response
時間枠：Week 0 (Baseline), Months 12, 24, 36, 48, 60, 72, 84, and 96
Enhanced Clinical Response was defined as average daily stool frequency at least 65% reduction from baseline and average daily abdominal pain score not worse than baseline or average daily abdominal pain score at least 35% reduction from baseline of Study M13-740 and average daily stool frequency not worse than baseline of Study M13-740.Abdominal pain was assessed by CDAI component "abdominal pain" rated none [0], mild [1], moderate [2], severe [3]; cumulative total over the past 7 days) and multiplied by prespecified factor of 5; total score range from 0 to 105.
Week 0 (Baseline), Months 12, 24, 36, 48, 60, 72, 84, and 96
Percentage of Participants Achieving Clinical Response
時間枠：Week 0 (Baseline), Months 12, 24, 36, 48, 60, 72, 84, and 96
Clinical response was defined as average daily stool frequency at least 30% reduction from Baseline and average daily abdominal pain score not worse than Baseline or average daily abdominal pain score at least 30% reduction from baseline of Study M13-740 and average daily stool frequency not worse than baseline of Study M13-740. Abdominal pain was assessed by CDAI component "abdominal pain" rated none [0], mild [1], moderate [2], severe [3]; cumulative total over the past 7 days) and multiplied by prespecified factor of 5; total score range from 0 to 105.
Week 0 (Baseline), Months 12, 24, 36, 48, 60, 72, 84, and 96
Percentage of Participants Achieving CDAI Response
時間枠：Week 0 (Baseline), Months 12, 24, 36, 48, 60, 72, 84, and 96
CDAI is a measure of clinical response and remission that includes 8 variables encompassing both participant-reported (symptoms, general well-being) and objective (medication usage, laboratory variables, presence of abdominal mass or complications, and weight) variables. For symptoms scores, participants kept a diary card and the daily symptom scores were summed for the week. Each item in the CDAI was assigned a prespecified factor to calculate the subtotals, and the subtotals of the items were totaled to produce the CDAI. Higher scores indicated greater disease activity, with a lower limit of 0 and no set upper limit. Total score range: 0 to 600. CDAI response was defined as a reduction in CDAI scores by ≥70 from baseline of Study M13-740.
Week 0 (Baseline), Months 12, 24, 36, 48, 60, 72, 84, and 96
Percentage of Participants Achieving Enhanced CDAI Response
時間枠：Week 0 (Baseline), Months 12, 24, 36, 48, 60, 72, 84, and 96
CDAI is a measure of clinical response and remission that includes 8 variables encompassing both participant-reported (symptoms, general well-being) and objective (medication usage, laboratory variables, presence of abdominal mass or complications, and weight) variables. For symptoms scores, participants kept a diary card and the daily symptom scores were summed for the week. Each item in the CDAI was assigned a prespecified factor to calculate the subtotals, and the subtotals of the items were totaled to produce the CDAI. Higher scores indicated greater disease activity, with a lower limit of 0 and no set upper limit. Total score range: 0 to 600. Enhanced CDAI response was defined as reduction in CDAI score by ≥100 from baseline of Study M13-740.
Week 0 (Baseline), Months 12, 24, 36, 48, 60, 72, 84, and 96
Percentage of Participants Achieving Endoscopic Response
時間枠：Week 0 (Baseline), Months 12, 24, 36, 48, 60, 72, 84, and 96
Endoscopic response was defined as decrease ≥ 25% SES-CD from Baseline of Study M13-740. SES-CD was based on endoscopic findings in 5 bowel segments (Ileum, right colon, transverse colon, left colon/sigmoid, and rectum). Each item was scored 0 to 3 per segment. The sum of the scores for each endoscopic variable ranged from 0 to 15, except for stenosis, where it varied between 0 and 11; total score ranged from 0 to 56. A lower score indicated better outcome.
Week 0 (Baseline), Months 12, 24, 36, 48, 60, 72, 84, and 96
Percentage of Participants Achieving IBDQ Response
時間枠：Week 0 (Baseline), Months 12, 24, 36, 48, 60, 72, 84, and 96
The IBDQ is a 32-item (ranged 1 to 7) self-report questionnaire for participants with inflammatory bowel disease to evaluate the participant-reported outcomes across 4 dimensions: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). IBDQ total Score range 32 to 224. A higher score indicated better outcome. IBDQ response was defined as an increase in IBDQ score ≥16 point from baseline of Study M13-740.
Week 0 (Baseline), Months 12, 24, 36, 48, 60, 72, 84, and 96
Percentage of Participants Taking Steroids at Baseline (of Study M13-740) Who Are Steroid-Free for At Least 90 Days and Achieve Remission
時間枠：Months 12, 24, 36, 48, 60, 72, 84, and 96
Remission = clinical remission and endoscopic remission. Clinical remission was average daily stool frequency ≤1.5, not worse than baseline, and average daily abdominal pain score ≤1.0 and not worse than baseline of Study M13-740. Abdominal pain was assessed using the CDAI component "abdominal pain" rated none [0], mild [1], moderate [2], severe [3] (cumulative total over the past 7 days) and multiplied by a factor of 5 as per the CDAI. Total score range 0 to 105. Endoscopic remission was defined as SES-CD ≤4 and at least 2- point reduction versus baseline of Study M13-740 and no subscore >1 in any individual variable. SES-CD was based on endoscopic findings in 5 segments (Ileum, right colon, transverse colon, left colon/sigmoid, and rectum). Each item was scored 0 to 3 per segment. The sum of the scores for each endoscopic variable ranged from 0 to 15, except for stenosis, where it varied between 0 and 11; total score ranged from 0 to 56. A lower score indicated better outcome
Months 12, 24, 36, 48, 60, 72, 84, and 96
Change From Baseline in Fecal Calprotectin Levels
時間枠：Week 0 (Baseline), Months 12, 24, 36, 48, 60, 72, 84, and 96
Stool samples were collected for analysis of fecal calprotectin levels.
Week 0 (Baseline), Months 12, 24, 36, 48, 60, 72, 84, and 96
Change From Baseline in Hs-CRP Levels
時間枠：Week 0 (Baseline), Months 12, 24, 36, 48, 60, 72, 84, and 96
Week 0 (Baseline), Months 12, 24, 36, 48, 60, 72, 84, and 96
Change From Baseline in IBDQ Total Score
時間枠：Week 0 (Baseline), Months 12, 24, 36, 48, 60, 72, 84, and 96
The IBDQ is a 32-item (ranged 1 to 7) self-report questionnaire for participants with inflammatory bowel disease to evaluate the participant-reported outcomes across 4 dimensions: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). IBDQ total score range from 32 to 224. A higher score indicated better outcome.
Week 0 (Baseline), Months 12, 24, 36, 48, 60, 72, 84, and 96
Change From Baseline in SES-CD
時間枠：Week 0 (Baseline), Months 12, 24, 36, 48, 60, 72, 84, and 96
The SES-CD assessed the size of mucosal ulcers, the ulcerated surface, the endoscopic extension and the presence of stenosis. SES-CD was based on endoscopic findings in 5 bowel segments (Ileum, right colon, transverse colon, left colon/sigmoid, and rectum). Each item was scored 0 to 3 per segment. The sum of the scores for each endoscopic variable ranged from 0 to 15, except for stenosis, where it varied between 0 and 11; total score ranged from 0 to 56. A lower score indicated better outcome. Endoscopic remission was defined as SES-CD ≤4 and at least two-point reduction versus Baseline of Study M13-740 and no subscore >1 in any individual variable.
Week 0 (Baseline), Months 12, 24, 36, 48, 60, 72, 84, and 96

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AbbVie

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  • スタディディレクター：ABBVIE INC.、AbbVie

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一般刊行物

便利なリンク

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)

2016年5月18日

一次修了 (実際)

2025年7月18日

研究の完了 (実際)

2025年7月18日

試験登録日

最初に提出

2016年5月23日

QC基準を満たした最初の提出物

2016年5月23日

最初の投稿 (推定)

2016年5月25日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月13日

QC基準を満たした最後の更新が送信されました

2026年8月10日

最終確認日

2026年8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

  • M14-327
  • 2015-003759-23 (EudraCT番号)

個々の参加者データ (IPD) の計画

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はい

IPD プランの説明

アッヴィは、スポンサーとなっている臨床試験に関する責任あるデータ共有に取り組んでいます。 これには、匿名化された個人および試験レベルのデータ（分析データセット）、およびその他の情報（プロトコル、分析計画、臨床研究レポートなど）へのアクセスが含まれます。提出。 これには、認可されていない製品および適応症の臨床試験データの要求が含まれます。

IPD 共有時間枠

いつ研究を共有できるかについての詳細は、https://vivli.org/ourmember/abbvie/ をご覧ください。

IPD 共有アクセス基準

この臨床試験データへのアクセスは、厳格な独立した科学研究に携わる資格のある研究者であれば誰でも要求でき、研究提案と統計分析計画のレビューと承認、およびデータ共有声明の実行後に提供されます。 データのリクエストは、米国および/または EU で承認された後、いつでも提出できます。 プロセスの詳細について、またはリクエストを送信するには、次のリンクにアクセスしてください https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

医薬品およびデバイス情報、研究文書

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はい

米国FDA規制機器製品の研究

いいえ

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いいえ

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