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An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis

14. januar 2014 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 Subcutaneously, 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 ulcerative colitis (UC).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a multi-center (conducted in more than one center), randomized (study medication assigned by chance), double-blind (neither the physician nor the participant know about the study medication), placebo-controlled (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial), parallel-group (a medical research study comparing the response in 2 or more groups of participants receiving different interventions) study to evaluate the safety and efficacy of golimumab in participants with moderately to severely active UC. There are 2 parts in this study. Part 1 is "Phase 2 dose-ranging" portion of study. Participants enrolled in Part 1, will receive subcutaneous (under the skin by way of a needle) injections of placebo, golimumab 100 milligram (mg), 200 mg, or 400 mg at Week 0, followed by subcutaneous injections of placebo, golimumab 50 mg, 100 mg, or 200 mg respectively at Week 2. Part 2 is "Phase 3 dose-confirming" portion of study and newly enrolled participants will receive same doses studied in Part 1, until the doses for Part 2 are selected. At the time that the final doses are selected, all newly enrolled participants will receive 1 of the selected doses or matching placebo. 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 16 weeks after last administration of study agent. The duration of study will be 6 weeks for participants who enter the 1-year golimumab maintenance study and 16 weeks after last administration of study agent for participants who do not enter the 1-year golimumab maintenance study. Efficacy of the participants will primarily be evaluated by clinical response at Week 6. Participants' safety will be monitored throughout the study.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1065

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
      • Bankstown, Australien
      • Box Hill, Australien
      • Fitzroy, Australien
      • Herston, Australien
      • Launceston, Australien
      • Parkville, Australien
      • Prahran, Australien
      • Westmead, Australien
  • Belgien
      • Brussels, Belgien
      • Gent, Belgien
      • Leuven, Belgien
      • Liege, Belgien
      • Roeselare, Belgien
  • Bulgarien
      • Pleven, Bulgarien
      • Rousse, Bulgarien
      • Sofia, Bulgarien
  • Canada
      • T2n, Canada
      • Windsor, Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
    • Ontario
      • Barrie, Ontario, Canada
      • Chatham, Ontario, Canada
      • London, Ontario, Canada
      • Toronto, Ontario, Canada
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
  • Danmark
      • Aalborg, Danmark
      • Aarhus C., Danmark
      • Hvidovre, Danmark
      • Odense C, Danmark
  • Den Russiske Føderation
      • Moscow, Den Russiske Føderation
      • Novosibirsk, Den Russiske Føderation
      • Omsk, Den Russiske Føderation
      • Saint Petersburg, Den Russiske Føderation
      • St Petersburg, Den Russiske Føderation
      • St-Petersburg, Den Russiske Føderation
      • Yaroslavl, Den Russiske Føderation
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater
    • Arkansas
      • Little Rock, Arkansas, Forenede Stater
    • California
      • Roseville, California, Forenede Stater
      • San Diego, California, Forenede Stater
    • Colorado
      • Golden, Colorado, Forenede Stater
    • Delaware
      • Newark, Delaware, Forenede Stater
    • Florida
      • Boca Raton, Florida, Forenede Stater
      • Gainesville, Florida, Forenede Stater
      • Hialeah, Florida, Forenede Stater
      • Naples, Florida, Forenede Stater
      • New Port Richey, Florida, Forenede Stater
      • Port Orange, Florida, Forenede Stater
      • Winter Park, Florida, Forenede Stater
      • Zephyrhills, Florida, Forenede Stater
    • Georgia
      • Atlanta, Georgia, Forenede Stater
      • Savannah, Georgia, Forenede Stater
    • Illinois
      • Arlington Heights, Illinois, Forenede Stater
      • Chicago, Illinois, Forenede Stater
    • Iowa
      • Clive, Iowa, Forenede Stater
    • Kansas
      • Pratt, Kansas, Forenede Stater
    • Kentucky
      • Lexington, Kentucky, Forenede Stater
    • Louisiana
      • Monroe, Louisiana, Forenede Stater
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater
      • Troy, Michigan, Forenede Stater
    • Minnesota
      • Rochester, Minnesota, Forenede Stater
    • Mississippi
      • Pascagoula, Mississippi, Forenede Stater
      • Tupelo, Mississippi, Forenede Stater
    • New Jersey
      • Egg Harbor Township, New Jersey, Forenede Stater
    • New York
      • New York, New York, Forenede Stater
      • Rochester, New York, Forenede Stater
    • North Carolina
      • Asheville, North Carolina, Forenede Stater
      • Charlotte, North Carolina, Forenede Stater
      • Morganton, North Carolina, Forenede Stater
      • New Bern, North Carolina, Forenede Stater
      • Raleigh, North Carolina, Forenede Stater
      • Wilmington, North Carolina, Forenede Stater
      • Winston Salem, North Carolina, Forenede Stater
    • North Dakota
      • Fargo, North Dakota, Forenede Stater
    • Ohio
      • Cincinnati, Ohio, Forenede Stater
      • Cleveland, Ohio, Forenede Stater
      • Colombus, Ohio, Forenede Stater
    • Oklahoma
      • Norman, Oklahoma, Forenede Stater
    • Oregon
      • Portland, Oregon, Forenede Stater
    • Pennsylvania
      • Limerick, Pennsylvania, Forenede Stater
    • South Carolina
      • Columbia, South Carolina, Forenede Stater
    • Tennessee
      • Germantown, Tennessee, Forenede Stater
      • Nashville, Tennessee, Forenede Stater
    • Texas
      • Houston, Texas, Forenede Stater
      • Sugar Land, Texas, Forenede Stater
    • Utah
      • Logan, Utah, Forenede Stater
      • Ogden, Utah, Forenede Stater
    • Virginia
      • Chesapeake, Virginia, Forenede Stater
      • Fairfax, Virginia, Forenede Stater
      • Richmond, Virginia, Forenede Stater
    • Washington
      • Spokane, Washington, Forenede Stater
      • Tacoma, Washington, Forenede Stater
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater
      • Milwaukee, Wisconsin, Forenede Stater
  • Frankrig
      • Amiens Cedex 1 80, Frankrig
      • Bordeaux 33, Frankrig
      • Lille Cedex, Frankrig
      • Nice Cedex 3, Frankrig
      • Paris, Frankrig
  • Holland
      • Amsterdam, Holland
      • Ede Gld, Holland
      • Groningen, Holland
      • Leiden, Holland
  • Indien
      • Bangalore, Indien
      • Chennai, Indien
      • Hyderabad, Indien
      • Hyderabad Andh Prad, Indien
      • Karnad, Indien
      • New Delhi, Indien
      • Pune, Indien
      • Vishakapatanam, Indien
  • Israel
      • Beer Sheva, Israel
      • Beer Yaakov, Israel
      • Haifa, Israel
      • Jerusalem, Israel
      • Kfar Saba, Israel
      • Nazareth, Israel
      • Petah-Tikv, Israel
      • Rechovot, Israel
      • Tel-Aviv, Israel
  • Japan
      • Bunkyo, Japan
      • Bunkyo-Ku, Japan
      • Chikushinoshi, Japan
      • Fukuoka, Japan
      • Hiroshima, Japan
      • Kagoshima, Japan
      • Kurashiki, Japan
      • Kurume, Japan
      • Nagoya, Japan
      • Nishinomiya, Japan
      • Okayama, Japan
      • Osaka, Japan
      • Sakura, Japan
      • Sapporo, Japan
      • Sapporo-Shi, Japan
      • Tokyo, Japan
      • Yokkaichi, Japan
  • Litauen
      • Kaunas, Litauen
      • Vilnius, Litauen
  • New Zealand
      • Christchurch, New Zealand
      • Dunedin, New Zealand
      • Hamilton, New Zealand
  • Polen
      • Bydgoszcz N/A, Polen
      • Czestochowa, Polen
      • Elblag, Polen
      • Gdansk, Polen
      • Krakow, Polen
      • Krakow N/A, Polen
      • Kraków N/A, Polen
      • Lodz, Polen
      • Lublin, Polen
      • Opole N/A, Polen
      • Sopot, Polen
      • Szczecin, Polen
      • Torun, Polen
      • Warszawa, Polen
      • Warszawa N/A, Polen
  • Rumænien
      • Bucuresti, Rumænien
      • Cluj-Napoca, Rumænien
      • Iasi, Rumænien
      • Targu Mures, Rumænien
      • Timisoara, Rumænien
  • Serbien
      • Belgrade, Serbien
      • Belgrado, Serbien
      • Nis, Serbien
      • Zemun, Serbien
  • Slovakiet
      • Bratislava, Slovakiet
      • Martin, Slovakiet
      • Nitra, Slovakiet
      • Nove Mesto Nad Vahom, Slovakiet
      • Presov, Slovakiet
  • Sverige
      • Stockholm, Sverige
  • Sydafrika
      • Cape Town, Sydafrika
      • Cape Town West Cape, Sydafrika
      • Marianhill Kz-Natal, Sydafrika
      • Pretoria Gauteng, Sydafrika
  • Tjekkiet
      • Hradec Kralove, Tjekkiet
      • Litomerice, Tjekkiet
      • Ostrava, Tjekkiet
      • Èeské Budìjovice 1, Tjekkiet
  • Tyskland
      • Berlin, Tyskland
      • Berlin Be, Tyskland
      • Bochum, Tyskland
      • Hamburg, Tyskland
      • Hannover, Tyskland
      • Haßloch, Tyskland
      • Kiel, Tyskland
      • Minden, Tyskland
      • Muenchen, Tyskland
      • Münster, Tyskland
      • Stade, Tyskland
  • Ukraine
      • Donetsk, Ukraine
      • Kharkiv, Ukraine
      • Kyiv, Ukraine
      • Simferopol, Ukraine
      • Vynnytsya, Ukraine
      • Zhaporozhia 69104, Ukraine
  • Ungarn
      • Balatonfured, Ungarn
      • Budapest, Ungarn
      • Debrecen, Ungarn
      • Dunaujvaros, Ungarn
      • Gyulai Ut 18, Ungarn
      • Mosonmagyarovar, Ungarn
      • Sopron, Ungarn
      • Szeged, Ungarn
      • Szekesfehervar, Ungarn
      • Szekszard, Ungarn
      • Veszprém, Ungarn
  • Østrig
      • Wien 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, oral corticosteroids, 6-mercaptopurine and azathioprine
  • 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 tuberculosis
  • Participants with negative stool test for enteric (by way of the intestines) pathogens

Exclusion Criteria:

  • Participants with prior 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 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: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo
Placebo subcutaneous injection (given under the skin by way of a needle) matching to golimumab administered at Week 0 and Week 2.
Biologisk: Placebo
Placebo subcutaneous injection (given under the skin by way of a needle) matching to golimumab administered at Week 0 and Week 2.
Eksperimentel: Golimumab 100 mg -> 50 mg
Golimumab 100 milligram (mg) subcutaneous injection administered at Week 0 and dose is decreased to 50 mg at Week 2.
Biologisk: Golimumab 100 mg
Golimumab 100 mg subcutaneous injection administered at Week 0 for Golimumab 100 mg -> 50 mg arm group and at Week 2 for Golimumab 200 mg -> 100 mg arm group.
Biologisk: Golimumab 50 mg
Golimumab 50 mg subcutaneous injection administered at Week 2 for Golimumab 100 mg -> 50 mg arm group.
Eksperimentel: Golimumab 200 mg -> 100 mg
Golimumab 200 mg subcutaneous injection administered at Week 0 and dose is decreased to 100 mg at Week 2.
Biologisk: Golimumab 100 mg
Golimumab 100 mg subcutaneous injection administered at Week 0 for Golimumab 100 mg -> 50 mg arm group and at Week 2 for Golimumab 200 mg -> 100 mg arm group.
Biologisk: Golimumab 200 mg
Golimumab 200 mg subcutaneous injection administered at Week 0 for Golimumab 200 mg -> 100 mg arm group and at Week 2 for Golimumab 400 mg -> 200 mg arm group.
Eksperimentel: Golimumab 400 mg -> 200 mg
Golimumab 400 mg subcutaneous injection administered at Week 0 and dose is decreased to 200 mg at Week 2.
Biologisk: Golimumab 200 mg
Golimumab 200 mg subcutaneous injection administered at Week 0 for Golimumab 200 mg -> 100 mg arm group and at Week 2 for Golimumab 400 mg -> 200 mg arm group.
Biologisk: Golimumab 400 mg
Golimumab 400 mg subcutaneous injection administered at Week 0 for Golimumab 400 mg -> 200 mg arm group.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Clinical Response at Week 6
Tidsramme: Baseline, 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 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.
Baseline, Week 6

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Clinical Remission at Week 6
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 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
Number of Participants With Mucosal Healing at Week 6
Tidsramme: Week 6
Mucosal healing is determined from the endoscopy sub-score of the Mayo score. Mucosal healing is defined as an endoscopy sub-score of 0 or 1. Higher score indicates higher severity of disease. Endoscopy sub-score ranges from 0 (normal or inactive disease) to 3 (severe disease; spontaneous bleeding and ulceration).
Week 6
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 6
Tidsramme: Baseline to Week 6
The IBDQ is used to measure disease specific quality of life on a 32 Likert-scaled items questionnaire. The IBDQ scale contains 4 component subscales: bowel symptoms, systemic symptoms, emotional function and social function with scores ranging from 10 to 70, 5 to 35, 12 to 84 and 5 to 35 respectively and the total score ranges from 32 to 224. Higher scores indicate better health related quality of life.
Baseline to 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. oktober 2010

Studieafslutning (Faktiske)

1. oktober 2010

Datoer for studieregistrering

Først indsendt

14. juni 2007

Først indsendt, der opfyldte QC-kriterier

14. juni 2007

Først opslået (Skøn)

18. juni 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

17. februar 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. januar 2014

Sidst verificeret

1. januar 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CR014176
  • C0524T17
  • 2006-003398-28 (EudraCT nummer)
  • NCT00487539 (Registry Identifier: ClinicalTrials.gov Identifier)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

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 .

Kliniske forsøg med Colitis, Ulcerativ

Kliniske forsøg med Placebo

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Tanzania

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner