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

29. april 2013 opdateret af: 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).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

291

Fase

  • Fase 2
  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Australien
      • Adelaide, Australien
      • Brisbane, Australien
      • Malvern, Australien
  • Belgien
      • Bonheiden, Belgien
      • Leuven, Belgien
  • Bulgarien
      • Rousse, Bulgarien
      • Varna, Bulgarien
  • 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 Føderation
      • Moscow, Den Russiske Føderation
      • St.Petersburg, Den Russiske Føderation
      • Yaroslavl, Den Russiske Føderation
  • Forenede Stater
    • California
      • Orange, California, Forenede Stater
      • Roseville, California, Forenede Stater
    • Colorado
      • Littleton, Colorado, Forenede Stater
    • Connecticut
      • Bristol, Connecticut, Forenede Stater
    • Florida
      • Tampa, Florida, Forenede Stater
    • Iowa
      • Fort Dodge, Iowa, Forenede Stater
    • Kansas
      • Topeka, Kansas, Forenede Stater
    • Kentucky
      • Louisville, Kentucky, Forenede Stater
    • Maryland
      • Laurel, Maryland, Forenede Stater
    • Michigan
      • Dearborn, Michigan, Forenede Stater
      • Troy, Michigan, Forenede Stater
    • Missouri
      • Mexico, Missouri, Forenede Stater
      • St. Louis, Missouri, Forenede Stater
    • New Hampshire
      • Lebanon, New Hampshire, Forenede Stater
    • New York
      • Great Neck, New York, Forenede Stater
      • Huntington, New York, Forenede Stater
      • New York, New York, Forenede Stater
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater
      • Kinston, North Carolina, Forenede Stater
    • Ohio
      • Cincinnati, Ohio, Forenede Stater
      • Cleveland, Ohio, Forenede Stater
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater
      • Tulsa, Oklahoma, Forenede Stater
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater
    • South Carolina
      • Charleston, South Carolina, Forenede Stater
      • Columbia, South Carolina, Forenede Stater
    • Tennessee
      • Germantown, Tennessee, Forenede Stater
      • Nashville, Tennessee, Forenede Stater
    • Texas
      • Austin, Texas, Forenede Stater
      • Galveston, Texas, Forenede Stater
    • Vermont
      • Burlington, Vermont, Forenede Stater
    • Virginia
      • Christiansburg, Virginia, Forenede Stater
      • Richmond, Virginia, Forenede Stater
    • Washington
      • Bellevue, Washington, Forenede Stater
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater
      • Milwaukee, Wisconsin, Forenede Stater
  • Frankrig
      • Clichy, Frankrig
      • Lille Cedex, Frankrig
      • Nice Cedex 3, Frankrig
  • Holland
      • Amsterdam, Holland
      • Groningen, Holland
      • Leiden, Holland
      • Rotterdam, Holland
  • Indien
      • Hyderabad Andh Prad, Indien
      • Jaipur, Indien
      • Lucknow, Indien
      • Ludhiana, Indien
      • Pune, Indien
  • Israel
      • Afula, Israel
      • Hedera, Israel
      • Jerusalem, Israel
      • Kfar Sava, Israel
      • Tel-Aviv, Israel
  • Letland
      • Daugavpils, Letland
      • Riga, Letland
  • Litauen
      • Klaipeda, Litauen
      • Siauliai, Litauen
      • Vilnius LT, Litauen
  • 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
  • Rumænien
      • Bucuresti, Rumænien
      • Timisoara, Rumænien
  • Serbien
      • Belgrade, Serbien
      • Beograd, Serbien
  • Slovakiet
      • Bratislava, Slovakiet
      • Nitra, Slovakiet
      • Presov, Slovakiet
  • Sverige
      • Göteborg, Sverige
  • Tyskland
      • Berlin, Tyskland
      • Herne, Tyskland
      • Magdeburg, Tyskland
    • HH
      • Hamburg, HH, Tyskland
  • Ukraine
      • Donetsk, Ukraine
      • Ivano, Ukraine
      • Kiev, Ukraine
      • Vynnytsya, Ukraine
  • 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
  • Østrig
      • Innsbruck N/A, Østrig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo
Matching placebo for golimumab, intravenous (IV) (through a vein in the arm) infusion administered at Week 0
Andet: Placebo
Matching placebo for golimumab, intravenous infusion administered at Week 0
Eksperimentel: Golimumab 1 milligram (mg) per kilogram (kg)
Golimumab 1 mg per kg intravenous (IV) infusion administered at Week 0.
Medicin: Golimumab 1 mg per kg
Golimumab 1 mg per kg intravenous (IV) infusion administered at Week 0
Andre navne:
  • CNTO 148
Eksperimentel: Golimumab 2 mg per kg
Golimumab 2 mg per kg intravenous (IV) infusion administered at Week 0.
Medicin: Golimumab 2 mg per kg
Golimumab 2 mg per kg intravenous (IV) infusion administered at Week 0
Andre navne:
  • CNTO 148
Eksperimentel: Golimumab 4 mg per kg
Golimumab 4 mg per kg, intravenous (IV) infusion administered at Week 0.
Medicin: Golimumab 4 mg per kg
Golimumab 4 mg per kg intravenous (IV) infusion at Week 0

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Janssen Research & Development, LLC

Samarbejdspartnere

Merck Sharp & Dohme LLC

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2007

Primær færdiggørelse (Faktiske)

1. maj 2009

Studieafslutning (Faktiske)

1. maj 2009

Datoer for studieregistrering

Først indsendt

18. juni 2007

Først indsendt, der opfyldte QC-kriterier

18. juni 2007

Først opslået (Skøn)

20. juni 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

14. juni 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. april 2013

Sidst verificeret

1. april 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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