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Badanie oceniające długoterminową skuteczność, bezpieczeństwo i tolerancję wielokrotnego podawania Upadacitinibu (ABT-494) uczestnikom z chorobą Leśniowskiego-Crohna

10 sierpnia 2026 zaktualizowane przez: AbbVie

Wieloośrodkowe, otwarte badanie fazy 2 (OLE), mające na celu obserwację długoterminowej skuteczności, bezpieczeństwa i tolerancji wielokrotnego podawania upadacytynibu (ABT-494) osobom z chorobą Leśniowskiego-Crohna

Jest to otwarte badanie rozszerzone (OLE) mające na celu ocenę długoterminowej skuteczności, bezpieczeństwa i tolerancji Upadacitinibu (ABT-494).

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

107

Faza

  • Faza 2

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 75 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Opis

Kryteria przyjęcia:

  • Uczestnik musi ukończyć badanie M13-740 do tygodnia 52.
  • W przypadku kobiet uczestnik musi być po menopauzie, być sterylny chirurgicznie lub stosować metodę antykoncepcji.

Kryteria wyłączenia:

  • Z jakiegokolwiek powodu uczestnik zostanie uznany przez badacza za nieodpowiedniego kandydata
  • Uczestniczka z pozytywnym wynikiem testu ciążowego na początku badania lub rozważająca zajście w ciążę podczas badania.
  • Uczestnik nie przestrzega wcześniejszych i towarzyszących wymagań dotyczących leków i procedur w całym badaniu M13-740.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nielosowe
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Upadacytynib (ABT-494) Dawka A
Dawka otwarta A raz na dobę (QD)
Lek: ABT-494
Tabletka: doustna
Inne nazwy:
  • RINVOQ
  • Upadacytynib
Eksperymentalny: Upadacytynib (ABT-494) Dawka B
Otwarta próba dawki B QD
Lek: ABT-494
Tabletka: doustna
Inne nazwy:
  • RINVOQ
  • Upadacytynib

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Percentage of Participants Achieving Endoscopic Remission at Month 12
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Percentage of Participants Achieving Endoscopic Remission
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

AbbVie

Śledczy

  • Dyrektor Studium: ABBVIE INC., AbbVie

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

18 maja 2016

Zakończenie podstawowe (Rzeczywisty)

18 lipca 2025

Ukończenie studiów (Rzeczywisty)

18 lipca 2025

Daty rejestracji na studia

Pierwszy przesłany

23 maja 2016

Pierwszy przesłany, który spełnia kryteria kontroli jakości

23 maja 2016

Pierwszy wysłany (Szacowany)

25 maja 2016

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

13 sierpnia 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

10 sierpnia 2026

Ostatnia weryfikacja

1 sierpnia 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

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

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

Firma AbbVie zobowiązuje się do odpowiedzialnego udostępniania danych dotyczących sponsorowanych przez nas badań klinicznych. Obejmuje to dostęp do zanonimizowanych danych indywidualnych i danych na poziomie badań (zestawów danych analitycznych), a także innych informacji (np. protokołów, planów analiz, raportów z badań klinicznych), o ile badania nie są częścią trwającej lub planowanej regulacji przedłożona praca. Obejmuje to prośby o dane z badań klinicznych dla nielicencjonowanych produktów i wskazań.

Ramy czasowe udostępniania IPD

Szczegółowe informacje na temat dostępności badań do udostępniania można znaleźć na stronie https://vivli.org/ourmember/abbvie/

Kryteria dostępu do udostępniania IPD

O dostęp do tych danych z badań klinicznych mogą wystąpić wszyscy wykwalifikowani badacze, którzy prowadzą rygorystyczne, niezależne badania naukowe, i zostanie on udzielony po przejrzeniu i zatwierdzeniu propozycji badań i planu analizy statystycznej oraz podpisaniu oświadczenia o udostępnianiu danych. Żądania danych można przesyłać w dowolnym momencie po zatwierdzeniu w USA i/lub UE, a pierwotny manuskrypt zostanie zaakceptowany do publikacji. Aby uzyskać więcej informacji na temat procesu lub złożyć wniosek, odwiedź następujący link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY
  • ANALITYCZNY_KOD

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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