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크론병 환자에서 우파다시티닙(ABT-494) 반복투여의 장기 유효성, 안전성 및 내약성을 평가하기 위한 연구

2026년 8월 10일 업데이트: AbbVie

크론병 환자에서 우파다시티닙(ABT-494) 반복 투여의 장기 효능, 안전성 및 내약성을 관찰하기 위한 2상, 다기관, 공개 확장(OLE) 연구

이는 우파다시티닙(ABT-494)의 장기 효능, 안전성 및 내약성을 평가하기 위해 설계된 공개 확장(OLE) 연구입니다.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

107

단계

  • 2 단계

연락처 및 위치

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

연구 장소

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

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 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

설명

포함 기준:

  • 참가자는 52주까지 연구 M13-740을 완료해야 합니다.
  • 여성인 경우 참가자는 폐경 후이거나 외과적으로 불임 상태이거나 피임 방법을 사용 중이어야 합니다.

제외 기준:

  • 어떤 이유로든 조사관은 참가자를 부적합한 후보로 간주합니다.
  • 기준선에서 양성 임신 테스트를 받았거나 연구 중에 임신을 고려하고 있는 여성 참가자.
  • 참가자는 연구 M13-740 전반에 걸쳐 이전 및 동시 약물 요구 사항 및 절차를 준수하지 않습니다.

공부 계획

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

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위화되지 않음
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 우파다시티닙(ABT-494) 용량 A
오픈 라벨 용량 A 1일 1회(QD)
의약품: ABT-494
정제: 구두
다른 이름들:
  • 린버크
  • 우파다시티닙
실험적: 우파다시티닙(ABT-494) 용량 B
오픈 라벨 용량 B QD
의약품: ABT-494
정제: 구두
다른 이름들:
  • 린버크
  • 우파다시티닙

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Percentage of Participants Achieving Endoscopic Remission at Month 12
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Percentage of Participants Achieving Endoscopic Remission
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

AbbVie

수사관

  • 연구 책임자: ABBVIE INC., AbbVie

간행물 및 유용한 링크

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

일반 간행물

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)

2016년 5월 18일

기본 완료 (실제)

2025년 7월 18일

연구 완료 (실제)

2025년 7월 18일

연구 등록 날짜

최초 제출

2016년 5월 23일

QC 기준을 충족하는 최초 제출

2016년 5월 23일

처음 게시됨 (추정된)

2016년 5월 25일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 13일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 10일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

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

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

AbbVie는 우리가 후원하는 임상 시험과 관련하여 책임 있는 데이터 공유를 약속합니다. 여기에는 임상시험이 진행 중이거나 계획된 규제의 일부가 아닌 한 익명화된 개인 및 시험 수준 데이터(분석 데이터 세트)와 기타 정보(예: 프로토콜, 분석 계획, 임상 연구 보고서)에 대한 액세스가 포함됩니다. 제출. 여기에는 허가되지 않은 제품 및 적응증에 대한 임상 시험 데이터 요청이 포함됩니다.

IPD 공유 기간

언제 연구를 공유할 수 있는지에 대한 자세한 내용은 https://vivli.org/ourmember/abbvie/를 방문하십시오.

IPD 공유 액세스 기준

이 임상 시험 데이터에 대한 액세스는 엄격하고 독립적인 과학 연구에 참여하는 모든 자격을 갖춘 연구원이 요청할 수 있으며 연구 제안 및 통계 분석 계획의 검토 및 승인과 데이터 공유 성명서의 실행 후에 제공됩니다. 데이터 요청은 미국 및/또는 EU에서 승인을 받은 후 언제든지 제출할 수 있으며 기본 원고의 출판이 승인됩니다. 프로세스에 대한 자세한 내용을 보거나 요청을 제출하려면 다음 링크를 방문하십시오 https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ANALYTIC_CODE

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

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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