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Study of Vedolizumab in Patients With Moderate to Severe Crohn's Disease (GEMINI III)

19. června 2014 aktualizováno: Millennium Pharmaceuticals, Inc.

A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn's Disease

This study in patients with moderately to severely active Crohn's disease is designed to establish the efficacy and safety of vedolizumab for the induction of clinical response and remission.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

After completing the study, patients were eligible to enroll in a long term safety study with continued access to vedolizumab (study C13008; NCT00790933) if study drug was well tolerated, and no major surgical intervention for Crohn's disease occurred or was required.

Participants who did not enroll in Study C13008 were to complete the Final Safety visit (16 weeks after the last dose of study drug) for a maximum time on study of 22 weeks.

Typ studie

Intervenční

Zápis (Aktuální)

416

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Kanada
    • Alberta
      • Edmonton, Alberta, Kanada, T6G2X8
        • Zeidler Ledcor Center-Univerisity of Alberta
  • Spojené státy
    • Colorado
      • Lafayette, Colorado, Spojené státy, 80026
        • Gastroenterology of the Rockies
    • Connecticut
      • Hamden, Connecticut, Spojené státy, 65180
        • Gastroenterology Center of Connecticut P.C.
    • Florida
      • Gainesville, Florida, Spojené státy, 32610
        • University of Florida
      • Miami, Florida, Spojené státy, 33136
        • University of Miami Miller School of Medicine
      • Winter Park, Florida, Spojené státy, 32789
        • Shafran Gastroenterology Center
    • Georgia
      • Atlanta, Georgia, Spojené státy, 30342
        • Atlanta Gastroenterology Associates
      • Macon, Georgia, Spojené státy, 31201
        • Gastroenterology Associates of Central Georgia
      • Suwanee, Georgia, Spojené státy, 30024
        • Atlanta Gastroenterology Specialist PC
    • Illinois
      • Chicago, Illinois, Spojené státy, 60637
        • University of Chicago Medical Center
    • Kansas
      • Topeka, Kansas, Spojené státy, 66606
        • Cotton O'Neil Digestive Health Center
    • Kentucky
      • Lexington, Kentucky, Spojené státy, 40536
        • University of Kentucky Medical Center
      • Louisville, Kentucky, Spojené státy, 40402
        • University of Louisville
    • Louisiana
      • Baton Rouge, Louisiana, Spojené státy, 70809
        • Gastroenterology Associates
      • Hammond, Louisiana, Spojené státy, 70403
        • Gastroenterology Research Of New Orleans
    • Maryland
      • Chevy Chase, Maryland, Spojené státy, 20815
        • Metropolitan Gastroenterology Group P.C.
      • Hollywood, Maryland, Spojené státy, 20636
        • Mid-Atlantic Medical Research Center
    • Massachusetts
      • Boston, Massachusetts, Spojené státy, 02114
        • Massachusetts General Hospital Crohn's and Colitis Center
    • Michigan
      • Ann Arbor, Michigan, Spojené státy, 48109
        • University of Michigan
      • Troy, Michigan, Spojené státy, 48098
        • Center for Digestive Health
      • Ypsilanti, Michigan, Spojené státy, 48197
        • Huron Gastroenterology Associates
    • Minnesota
      • Plymouth, Minnesota, Spojené státy, 55446
        • Minnesota Gastroenterology P.A.
      • Rochester, Minnesota, Spojené státy, 55905
        • Mayo Clinic
    • Missouri
      • St. Louis, Missouri, Spojené státy, 63110
        • Washington University
    • New Hampshire
      • Lebanon, New Hampshire, Spojené státy, 03756
        • Dartmouth-Hitchcock Medical Center
    • New York
      • Great Neck, New York, Spojené státy, 11021
        • Long Island Clinical Research Associates
      • New York, New York, Spojené státy, 10021
        • New York Presbyterian Hospital
      • Rochester, New York, Spojené státy, 14642
        • University of Rochester
    • North Carolina
      • Chapel Hill, North Carolina, Spojené státy, 27599
        • University of North Carolina At Chapel Hill
      • Charlotte, North Carolina, Spojené státy, 28207
        • Charlotte Gastroenterology and Hepatology P.L.L.C
    • Ohio
      • Cincinnati, Ohio, Spojené státy, 45219
        • Consultants for Clinical Research Inc.
    • Oklahoma
      • Tulsa, Oklahoma, Spojené státy, 74104
        • Options Health Research
    • Oregon
      • Portland, Oregon, Spojené státy, 97225
        • The Oregon Clinic-West Hills Gastroenterology
    • South Carolina
      • Columbia, South Carolina, Spojené státy, 29203
        • Consultants in Gastroenterology
    • Tennessee
      • Germantown, Tennessee, Spojené státy, 38138
        • Gastroenterology Center of the MidSouth PC
    • Texas
      • San Antonio, Texas, Spojené státy, 78229
        • Gastroenterology Clinic of San Antonio
      • Tyler, Texas, Spojené státy, 75701
        • Digestive Health Specialists of Tyler
    • Virginia
      • Charlottesville, Virginia, Spojené státy, 22908
        • University of Virginia Health System
    • Washington
      • Seattle, Washington, Spojené státy, 98195
        • University of Washington School of Medicine
    • Wisconsin
      • Milwaukee, Wisconsin, Spojené státy, 53226
        • Medical College of Wisconsin
      • Milwaukee, Wisconsin, Spojené státy, 53215
        • Wisconsin Center for Advanced Research

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 80 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  • Age 18 to 80
  • Diagnosis of moderately to severely active Crohn's disease
  • Crohn's Disease involvement of the ileum and/or colon
  • Demonstrated, over the previous 5 year period, an inadequate response to, loss of response to, or intolerance of at least one conventional therapy as defined by the protocol
  • May be receiving a therapeutic dose of conventional therapies for inflammatory bowel disease (IBD) as defined by the protocol

Exclusion Criteria

  • Evidence of abdominal abscess at the initial screening visit
  • Extensive colonic resection, subtotal or total colectomy
  • History of >3 small bowel resections or diagnosis of short bowel syndrome
  • Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine
  • Have received non permitted therapies within either 30 or 60 days, depending on the medication, as stated in the protocol
  • Chronic hepatitis B or C infection; human immunodeficiency virus (HIV) infection
  • Active or latent tuberculosis

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Trojnásobný

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Komparátor placeba: Placebo
Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
Jiný: Placebo
Intravenózní infuze placeba
Experimentální: Vedolizumab
Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
Lék: vedolizumab
Vedolizumab pro intravenózní infuzi
Ostatní jména:
  • Entyvio
  • 0002 MLN
  • 02 MLN
  • LDP-02

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Percentage of Participants in Clinical Remission in the Tumor Necrosis Factor Alpha (TNFα) Antagonist Failure Subpopulation
Časové okno: Week 6

Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points.

The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:

  • Number of liquid or soft stools each day for 7 days;
  • Abdominal pain (graded from 0-3 on severity) each day for 7 days;
  • General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;
  • Presence of complications;
  • Taking Lomotil or opiates for diarrhea;
  • Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);
  • Hematocrit of < 0.47 in men and < 0.42 in women;
  • Percentage deviation from standard weight.

The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.

All participants who prematurely discontinued for any reason were considered as not achieving clinical remission.
Week 6

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Percentage of Participants in Clinical Remission at Week 6 in the Overall Population
Časové okno: Week 6

Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points.

The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:

  • Number of liquid or soft stools each day for 7 days;
  • Abdominal pain (graded from 0-3 on severity) each day for 7 days;
  • General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;
  • Presence of complications;
  • Taking Lomotil or opiates for diarrhea;
  • Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);
  • Hematocrit of < 0.47 in men and < 0.42 in women;
  • Percentage deviation from standard weight.

The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.

All participants who prematurely discontinued for any reason were considered as not achieving clinical remission.
Week 6
Percentage of Participants in Clinical Remission at Week 10 in the TNFα Antagonist Failure Subpopulation
Časové okno: Week 10

Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points.

The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:

  • Number of liquid or soft stools each day for 7 days;
  • Abdominal pain (graded from 0-3 on severity) each day for 7 days;
  • General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;
  • Presence of complications;
  • Taking Lomotil or opiates for diarrhea;
  • Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);
  • Hematocrit of < 0.47 in men and < 0.42 in women;
  • Percentage deviation from standard weight.

The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.

All participants who prematurely discontinued for any reason were considered as not achieving clinical remission.
Week 10
Percentage of Participants in Clinical Remission at Week 10 in the Overall Population
Časové okno: Week 10

Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points.

The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:

  • Number of liquid or soft stools each day for 7 days;
  • Abdominal pain (graded from 0-3 on severity) each day for 7 days;
  • General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;
  • Presence of complications;
  • Taking Lomotil or opiates for diarrhea;
  • Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);
  • Hematocrit of < 0.47 in men and < 0.42 in women;
  • Percentage deviation from standard weight.

The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.

All participants who prematurely discontinued for any reason were considered as not achieving clinical remission.
Week 10
Percentage of Participants With Sustained Clinical Remission in the TNFα Antagonist Failure Population
Časové okno: Week 6 and Week 10

Sustained clinical remission is defined as a CDAI score ≤ 150 points at both Week 6 and Week 10. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:

  • Number of liquid or soft stools each day for 7 days;
  • Abdominal pain (graded from 0-3 on severity) each day for 7 days;
  • General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;
  • Presence of complications;
  • Taking Lomotil or opiates for diarrhea;
  • Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);
  • Hematocrit of < 0.47 in men and < 0.42 in women;
  • Percentage deviation from standard weight.

The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.

All participants who prematurely discontinued for any reason were considered as not achieving sustained clinical remission.
Week 6 and Week 10
Percentage of Participants With Sustained Clinical Remission in the Overall Population
Časové okno: Week 6 and Week 10

Sustained clinical remission is defined as a CDAI score ≤ 150 points at both Week 6 and Week 10. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:

  • Number of liquid or soft stools each day for 7 days;
  • Abdominal pain (graded from 0-3 on severity) each day for 7 days;
  • General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;
  • Presence of complications;
  • Taking Lomotil or opiates for diarrhea;
  • Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);
  • Hematocrit of < 0.47 in men and < 0.42 in women;
  • Percentage deviation from standard weight.

The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.

All participants who prematurely discontinued for any reason were considered as not achieving sustained clinical remission.
Week 6 and Week 10
Percentage of Participants With Enhanced Clinical Response at Week 6 in the TNFα Antagonist Failure Subpopulation
Časové okno: Baseline and Week 6

Enhanced clinical response is defined as a ≥ 100-point decrease in CDAI score from Baseline.

The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:

  • Number of liquid or soft stools each day for 7 days;
  • Abdominal pain (graded from 0-3 on severity) each day for 7 days;
  • General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;
  • Presence of complications;
  • Taking Lomotil or opiates for diarrhea;
  • Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);
  • Hematocrit of < 0.47 in men and < 0.42 in women;
  • Percent deviation from standard weight.

The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.

All participants who prematurely discontinued for any reason were considered as not achieving enhanced clinical response.
Baseline and Week 6
Number of Participants With Adverse Events (AEs)
Časové okno: From the date of first study drug administration to Week 22, through the 14 March 2012 database lock date. At the time of this database lock, 7 patients had completed Week 10 or early termination assessments but not Week 22 assessments.

An AE was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, which did not necessarily have a causal relationship with the treatment. A serious adverse event (SAE) was any AE, occurring at any dose and regardless of causality that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was an important medical event based upon appropriate medical judgment that may have jeopardized the patient and may have required medical or surgical intervention to prevent 1 of the outcomes listed above, or any diagnosis of progressive multifocal leukoencephalopathy (PML).

Relationship to study drug administration was determined by the investigator responding yes or no to the question: Is there a reasonable possibility that the AE is associated with the study drug?
From the date of first study drug administration to Week 22, through the 14 March 2012 database lock date. At the time of this database lock, 7 patients had completed Week 10 or early termination assessments but not Week 22 assessments.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Millennium Pharmaceuticals, Inc.

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. listopadu 2010

Primární dokončení (Aktuální)

1. února 2012

Dokončení studie (Aktuální)

1. dubna 2012

Termíny zápisu do studia

První předloženo

18. října 2010

První předloženo, které splnilo kritéria kontroly kvality

18. října 2010

První zveřejněno (Odhad)

19. října 2010

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

21. července 2014

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

19. června 2014

Naposledy ověřeno

1. června 2014

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • C13011
  • U1111-1158-2581 (Identifikátor registru: WHO)
  • 2009-016488-12 (Číslo EudraCT)
  • NL34356.078.10 (Identifikátor registru: CCMO)

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

produkt vyrobený a vyvážený z USA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

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