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Um estudo para avaliar a eficácia, segurança e tolerabilidade a longo prazo da administração repetida de Upadacitinib (ABT-494) em participantes com doença de Crohn

10 de agosto de 2026 atualizado por: AbbVie

Estudo de Fase 2, Multicêntrico, de Extensão Aberta (OLE) para Observar a Eficácia, Segurança e Tolerabilidade a Longo Prazo da Administração Repetida de Upadacitinibe (ABT-494) em Indivíduos com Doença de Crohn

Este é um estudo de extensão aberta (OLE) projetado para avaliar a eficácia, segurança e tolerabilidade a longo prazo de Upadacitinib (ABT-494).

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

107

Estágio

  • Fase 2

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 75 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Descrição

Critério de inclusão:

  • O participante deve ter concluído o Estudo M13-740 até a Semana 52.
  • Se for do sexo feminino, a participante deve estar na pós-menopausa, ser cirurgicamente estéril ou usar um método anticoncepcional.

Critério de exclusão:

  • Por qualquer motivo, o participante é considerado pelo investigador como um candidato inadequado
  • Participante do sexo feminino com teste de gravidez positivo na linha de base ou que está pensando em engravidar durante o estudo.
  • O participante não está em conformidade com os requisitos e procedimentos de medicação prévia e concomitante ao longo do Estudo M13-740.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Não randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Upadacitinibe (ABT-494) Dose A
Dose de rótulo aberto A uma vez ao dia (QD)
Medicamento: ABT-494
Comprimido: Oral
Outros nomes:
  • RINVOQ
  • Upadacitinibe
Experimental: Upadacitinibe (ABT-494) Dose B
Dose de rótulo aberto B QD
Medicamento: ABT-494
Comprimido: Oral
Outros nomes:
  • RINVOQ
  • Upadacitinibe

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Percentage of Participants Achieving Endoscopic Remission at Month 12
Prazo: 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
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Percentage of Participants Achieving Endoscopic Remission
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

AbbVie

Investigadores

  • Diretor de estudo: ABBVIE INC., AbbVie

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

18 de maio de 2016

Conclusão Primária (Real)

18 de julho de 2025

Conclusão do estudo (Real)

18 de julho de 2025

Datas de inscrição no estudo

Enviado pela primeira vez

23 de maio de 2016

Enviado pela primeira vez que atendeu aos critérios de CQ

23 de maio de 2016

Primeira postagem (Estimado)

25 de maio de 2016

Atualizações de registro de estudo

Última Atualização Postada (Real)

13 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

10 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

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

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

A AbbVie está comprometida com o compartilhamento responsável de dados sobre os ensaios clínicos que patrocinamos. Isso inclui acesso a dados anônimos, individuais e de nível de ensaio (conjuntos de dados de análise), bem como outras informações (por exemplo, protocolos, planos de análise, relatórios de estudos clínicos), desde que os ensaios não façam parte de um processo regulatório em andamento ou planejado submissão. Isso inclui solicitações de dados de ensaios clínicos para indicações e produtos não licenciados.

Prazo de Compartilhamento de IPD

Para obter detalhes sobre quando os estudos estão disponíveis para compartilhamento, visite https://vivli.org/ourmember/abbvie/

Critérios de acesso de compartilhamento IPD

O acesso a esses dados de ensaios clínicos pode ser solicitado por qualquer pesquisador qualificado que se envolva em pesquisa científica independente rigorosa e será fornecido após a revisão e aprovação de uma proposta de pesquisa e plano de análise estatística e execução de uma declaração de compartilhamento de dados. As solicitações de dados podem ser enviadas a qualquer momento após a aprovação nos EUA e/ou UE e um manuscrito primário é aceito para publicação. Para obter mais informações sobre o processo ou para enviar uma solicitação, visite o seguinte link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA
  • ANALYTIC_CODE

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Não

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