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

19. juni 2014 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

416

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: Placebo
Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
Annen: Placebo
Placebo intravenøs infusjon
Eksperimentell: Vedolizumab
Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
Legemiddel: vedolizumab
Vedolizumab for intravenøs infusjon
Andre navn:
  • Entyvio
  • MLN0002
  • MLN02
  • LDP-02

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of Participants in Clinical Remission in the Tumor Necrosis Factor Alpha (TNFα) Antagonist Failure Subpopulation
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of Participants in Clinical Remission at Week 6 in the Overall Population
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Millennium Pharmaceuticals, Inc.

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. november 2010

Primær fullføring (Faktiske)

1. februar 2012

Studiet fullført (Faktiske)

1. april 2012

Datoer for studieregistrering

Først innsendt

18. oktober 2010

Først innsendt som oppfylte QC-kriteriene

18. oktober 2010

Først lagt ut (Anslag)

19. oktober 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

21. juli 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. juni 2014

Sist bekreftet

1. juni 2014

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • C13011
  • U1111-1158-2581 (Registeridentifikator: WHO)
  • 2009-016488-12 (EudraCT-nummer)
  • NL34356.078.10 (Registeridentifikator: CCMO)

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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