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Uno studio per valutare l'efficacia, la sicurezza e la tollerabilità a lungo termine della somministrazione ripetuta di Upadacitinib (ABT-494) nei partecipanti con malattia di Crohn

10 agosto 2026 aggiornato da: AbbVie

Uno studio di fase 2, multicentrico, di estensione in aperto (OLE) per osservare l'efficacia, la sicurezza e la tollerabilità a lungo termine della somministrazione ripetuta di Upadacitinib (ABT-494) in soggetti con malattia di Crohn

Questo è uno studio di estensione in aperto (OLE) progettato per valutare l'efficacia, la sicurezza e la tollerabilità a lungo termine di Upadacitinib (ABT-494).

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

107

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 75 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Descrizione

Criterio di inclusione:

  • Il partecipante deve aver completato lo studio M13-740 fino alla settimana 52.
  • Se femmina, il partecipante deve essere in postmenopausa, chirurgicamente sterile o utilizzare un metodo di controllo delle nascite.

Criteri di esclusione:

  • Per qualsiasi motivo il partecipante è considerato dall'investigatore un candidato non idoneo
  • Partecipante di sesso femminile con un test di gravidanza positivo al basale o che sta valutando la possibilità di rimanere incinta durante lo studio.
  • Il partecipante non è conforme ai requisiti e alle procedure terapeutiche precedenti e concomitanti durante lo Studio M13-740.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Upadacitinib (ABT-494) Dose A
Dose in aperto A una volta al giorno (QD)
Droga: ABT-494
Compressa: Orale
Altri nomi:
  • RINVOQ
  • Upadacitinib
Sperimentale: Upadacitinib (ABT-494) Dose B
Etichetta aperta dose B QD
Droga: ABT-494
Compressa: Orale
Altri nomi:
  • RINVOQ
  • Upadacitinib

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants Achieving Endoscopic Remission at Month 12
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants Achieving Endoscopic Remission
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

AbbVie

Investigatori

  • Direttore dello studio: ABBVIE INC., AbbVie

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

18 maggio 2016

Completamento primario (Effettivo)

18 luglio 2025

Completamento dello studio (Effettivo)

18 luglio 2025

Date di iscrizione allo studio

Primo inviato

23 maggio 2016

Primo inviato che soddisfa i criteri di controllo qualità

23 maggio 2016

Primo Inserito (Stimato)

25 maggio 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

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

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

AbbVie si impegna a condividere in modo responsabile i dati riguardanti le sperimentazioni cliniche che sponsorizziamo. Ciò include l'accesso a dati anonimi, individuali e a livello di sperimentazione (set di dati di analisi), nonché altre informazioni (ad es. protocolli, piani di analisi, rapporti di studi clinici), a condizione che le sperimentazioni non facciano parte di un regolamento normativo in corso o pianificato sottomissione. Ciò include le richieste di dati di studi clinici per prodotti e indicazioni senza licenza.

Periodo di condivisione IPD

Per dettagli su quando gli studi sono disponibili per la condivisione, visita https://vivli.org/ourmember/abbvie/

Criteri di accesso alla condivisione IPD

L'accesso a questi dati della sperimentazione clinica può essere richiesto da qualsiasi ricercatore qualificato che si impegni in una rigorosa ricerca scientifica indipendente e sarà fornito dopo la revisione e l'approvazione di una proposta di ricerca e di un piano di analisi statistica e l'esecuzione di una dichiarazione di condivisione dei dati. Le richieste di dati possono essere presentate in qualsiasi momento dopo l'approvazione negli Stati Uniti e/o nell'UE e un manoscritto primario è accettato per la pubblicazione. Per ulteriori informazioni sul processo o per inviare una richiesta, visitare il seguente link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • CODICE_ANALITICO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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