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An Efficacy and Safety Study of Golimumab in Participants With Ulcerative Colitis

29. april 2013 oppdatert av: Janssen Research & Development, LLC

A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects With Moderately to Severely Active Ulcerative Colitis

The purpose of this study is to assess the effects (good and bad) of golimumab (CNTO 148) therapy in participants with active ulcerative colitis (UC) (sores in the colon).

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This is a randomized (study medication assigned by chance), double-blind (neither the Physician nor the participant know about the study medication), placebo-controlled (an inactive substance; a pretend treatment [with no drug in it] that is compared in a clinical trial with a drug to test if the drug has a real effect), parallel-group (a medical research study comparing the response in 2 or more groups of participants receiving different interventions [treatments]) study to evaluate an appropriate intravenous (through a vein in the arm) golimumab induction dose and to demonstrate the safety and efficacy of intravenous induction dosing with golimumab in participants with moderately to severely active UC. At Week 6, participants will be asked to participate in an additional 1-year maintenance study. Participants not entering the 1-year golimumab maintenance study will be evaluated for safety at Week 16. The duration of study will be 6 weeks for participants who enter the 1-year golimumab maintenance study and 16 weeks for participant who do not enter the 1-year golimumab maintenance study.There are 2 parts in this study. Part 1 is Phase 2 "dose-ranging" portion of study. Participants enrolled in Part 1, will receive a single intravenous infusion of either matching placebo for golimumab or 1 milligram (mg) per kilogram(kg), 2 mg per kg or 4 mg per kg of golimumab. Part 2 of the study is called "dose-confirming" and newly enrolled participants will receive same doses studied in Part 1, until the doses for Part 2 are selected and Phase 3 begins. At the time that the final doses are selected, all newly enrolled participants will receive 1 of the selected doses or matching placebo; this is the start of the Phase 3 portion of the study. Participants will primarily be assessed using Mayo Score (it is a score developed for measuring disease activity). Participants' safety and quality of life will also be monitored throughout the study.

Studietype

Intervensjonell

Registrering (Faktiske)

291

Fase

  • Fase 2
  • Fase 3

Kontakter og plasseringer

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

Studiesteder

  • Australia
      • Adelaide, Australia
      • Brisbane, Australia
      • Malvern, Australia
  • Belgia
      • Bonheiden, Belgia
      • Leuven, Belgia
  • Bulgaria
      • Rousse, Bulgaria
      • Varna, Bulgaria
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
      • Victoria, British Columbia, Canada
    • Ontario
      • Hamilton, Ontario, Canada
      • Kingston, Ontario, Canada
      • London, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
  • Den russiske føderasjonen
      • Moscow, Den russiske føderasjonen
      • St.Petersburg, Den russiske føderasjonen
      • Yaroslavl, Den russiske føderasjonen
  • Forente stater
    • California
      • Orange, California, Forente stater
      • Roseville, California, Forente stater
    • Colorado
      • Littleton, Colorado, Forente stater
    • Connecticut
      • Bristol, Connecticut, Forente stater
    • Florida
      • Tampa, Florida, Forente stater
    • Iowa
      • Fort Dodge, Iowa, Forente stater
    • Kansas
      • Topeka, Kansas, Forente stater
    • Kentucky
      • Louisville, Kentucky, Forente stater
    • Maryland
      • Laurel, Maryland, Forente stater
    • Michigan
      • Dearborn, Michigan, Forente stater
      • Troy, Michigan, Forente stater
    • Missouri
      • Mexico, Missouri, Forente stater
      • St. Louis, Missouri, Forente stater
    • New Hampshire
      • Lebanon, New Hampshire, Forente stater
    • New York
      • Great Neck, New York, Forente stater
      • Huntington, New York, Forente stater
      • New York, New York, Forente stater
    • North Carolina
      • Charlotte, North Carolina, Forente stater
      • Kinston, North Carolina, Forente stater
    • Ohio
      • Cincinnati, Ohio, Forente stater
      • Cleveland, Ohio, Forente stater
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater
      • Tulsa, Oklahoma, Forente stater
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater
    • South Carolina
      • Charleston, South Carolina, Forente stater
      • Columbia, South Carolina, Forente stater
    • Tennessee
      • Germantown, Tennessee, Forente stater
      • Nashville, Tennessee, Forente stater
    • Texas
      • Austin, Texas, Forente stater
      • Galveston, Texas, Forente stater
    • Vermont
      • Burlington, Vermont, Forente stater
    • Virginia
      • Christiansburg, Virginia, Forente stater
      • Richmond, Virginia, Forente stater
    • Washington
      • Bellevue, Washington, Forente stater
    • Wisconsin
      • Madison, Wisconsin, Forente stater
      • Milwaukee, Wisconsin, Forente stater
  • Frankrike
      • Clichy, Frankrike
      • Lille Cedex, Frankrike
      • Nice Cedex 3, Frankrike
  • India
      • Hyderabad Andh Prad, India
      • Jaipur, India
      • Lucknow, India
      • Ludhiana, India
      • Pune, India
  • Israel
      • Afula, Israel
      • Hedera, Israel
      • Jerusalem, Israel
      • Kfar Sava, Israel
      • Tel-Aviv, Israel
  • Latvia
      • Daugavpils, Latvia
      • Riga, Latvia
  • Litauen
      • Klaipeda, Litauen
      • Siauliai, Litauen
      • Vilnius LT, Litauen
  • Nederland
      • Amsterdam, Nederland
      • Groningen, Nederland
      • Leiden, Nederland
      • Rotterdam, Nederland
  • New Zealand
      • Auckland, New Zealand
      • Hastings, New Zealand
  • Polen
      • Bialystok N/A, Polen
      • Czestochowa, Polen
      • Krakow, Polen
      • Krakow N/A, Polen
      • Lodz, Polen
      • Skierniewice, Polen
      • Sopot, Polen
  • Romania
      • Bucuresti, Romania
      • Timisoara, Romania
  • Serbia
      • Belgrade, Serbia
      • Beograd, Serbia
  • Slovakia
      • Bratislava, Slovakia
      • Nitra, Slovakia
      • Presov, Slovakia
  • Sverige
      • Göteborg, Sverige
  • Tyskland
      • Berlin, Tyskland
      • Herne, Tyskland
      • Magdeburg, Tyskland
    • HH
      • Hamburg, HH, Tyskland
  • Ukraina
      • Donetsk, Ukraina
      • Ivano, Ukraina
      • Kiev, Ukraina
      • Vynnytsya, Ukraina
  • Ungarn
      • Budapest N/A, Ungarn
      • Békéscsaba, Ungarn
      • Gyulai Ut 18, Ungarn
      • Gyõr, Ungarn
      • Miskolc, Ungarn
      • Miskolc N/A, Ungarn
      • Pécs, Ungarn
      • Szekesfehervar, Ungarn
      • Szombathely, Ungarn
  • Østerrike
      • Innsbruck N/A, Østerrike

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 og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Participants diagnosed with moderately to severely active ulcerative colitis (UC) defined by a Mayo score of 6 to 12 inclusive at Baseline (Week 0), including an endoscopic (examination of an internal part of the body with a lighted tube; looking at a part of the body with a lighted tube) subscore of greater than or equal to 2
  • Participants must have biopsy results (collected at the screening endoscopy (procedure or obtained within the last year) consistent with the diagnosis of UC
  • Participants either currently receiving treatment with, or have a history of failure to respond to, or tolerate, at least 1 of the following therapies: oral 5-aminosalicylate (5-ASAs), oral corticosteroids, 6-mercaptopurine (6-MP) and azathioprine (AZA)
  • Participants with current dependency or with a history of corticosteroid dependency (i.e. an inability to successfully taper corticosteroids without a return of the symptoms of UC) - Not have a diagnosis of active TB

Exclusion Criteria:

  • Participants with previous exposure to biologic anti-tumor necrosis factor (TNF) agents
  • Participants with severe extensive UC that is likely to require a colectomy (surgery to remove part or all of the colon) within 12 weeks of study entry
  • Participants having UC limited to the rectum only or to less than 20 centimeter (cm) of the colon
  • Presence of a stoma (an artificial permanent opening especially in the abdominal wall made in surgical procedures) or presence of a fistula
  • Participants with a history of extensive colonic resection

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: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: Placebo
Matching placebo for golimumab, intravenous (IV) (through a vein in the arm) infusion administered at Week 0
Annen: Placebo
Matching placebo for golimumab, intravenous infusion administered at Week 0
Eksperimentell: Golimumab 1 milligram (mg) per kilogram (kg)
Golimumab 1 mg per kg intravenous (IV) infusion administered at Week 0.
Legemiddel: Golimumab 1 mg per kg
Golimumab 1 mg per kg intravenous (IV) infusion administered at Week 0
Andre navn:
  • CNTO 148
Eksperimentell: Golimumab 2 mg per kg
Golimumab 2 mg per kg intravenous (IV) infusion administered at Week 0.
Legemiddel: Golimumab 2 mg per kg
Golimumab 2 mg per kg intravenous (IV) infusion administered at Week 0
Andre navn:
  • CNTO 148
Eksperimentell: Golimumab 4 mg per kg
Golimumab 4 mg per kg, intravenous (IV) infusion administered at Week 0.
Legemiddel: Golimumab 4 mg per kg
Golimumab 4 mg per kg intravenous (IV) infusion at Week 0

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Participants With Clinical Response
Tidsramme: Week 6
Clinical response is defined as decrease from baseline in Mayo score by greater than or equal to 30 percent and greater than or equal to 3, with either a decrease from baseline in rectal bleeding sub-score of greater than or equal to 1 or a rectal bleeding sub-score of 0 or 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and a physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12.
Week 6

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Participants With Clinical Remission
Tidsramme: Week 6
Clinical remission is defined as a Mayo score of less than or equal to 2, with no individual sub-score greater than 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and a physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12.
Week 6

Samarbeidspartnere og etterforskere

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

Sponsor

Janssen Research & Development, LLC

Samarbeidspartnere

Merck Sharp & Dohme LLC

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. august 2007

Primær fullføring (Faktiske)

1. mai 2009

Studiet fullført (Faktiske)

1. mai 2009

Datoer for studieregistrering

Først innsendt

18. juni 2007

Først innsendt som oppfylte QC-kriteriene

18. juni 2007

Først lagt ut (Anslag)

20. juni 2007

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

14. juni 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. april 2013

Sist bekreftet

1. april 2013

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CR014188
  • C0524T16 (Annen identifikator: Janssen Research & Development, LLC)
  • 2006-003397-94 (Annen identifikator: Janssen Research & Development, LLC)

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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Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

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Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

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