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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 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 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).

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

1065

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
      • Bankstown, Australia
      • Box Hill, Australia
      • Fitzroy, Australia
      • Herston, Australia
      • Launceston, Australia
      • Parkville, Australia
      • Prahran, Australia
      • Westmead, Australia
  • Belgia
      • Brussels, Belgia
      • Gent, Belgia
      • Leuven, Belgia
      • Liege, Belgia
      • Roeselare, Belgia
  • Bulgaria
      • Pleven, Bulgaria
      • Rousse, Bulgaria
      • Sofia, Bulgaria
  • 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 føderasjonen
      • Moscow, Den russiske føderasjonen
      • Novosibirsk, Den russiske føderasjonen
      • Omsk, Den russiske føderasjonen
      • Saint Petersburg, Den russiske føderasjonen
      • St Petersburg, Den russiske føderasjonen
      • St-Petersburg, Den russiske føderasjonen
      • Yaroslavl, Den russiske føderasjonen
  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater
    • Arkansas
      • Little Rock, Arkansas, Forente stater
    • California
      • Roseville, California, Forente stater
      • San Diego, California, Forente stater
    • Colorado
      • Golden, Colorado, Forente stater
    • Delaware
      • Newark, Delaware, Forente stater
    • Florida
      • Boca Raton, Florida, Forente stater
      • Gainesville, Florida, Forente stater
      • Hialeah, Florida, Forente stater
      • Naples, Florida, Forente stater
      • New Port Richey, Florida, Forente stater
      • Port Orange, Florida, Forente stater
      • Winter Park, Florida, Forente stater
      • Zephyrhills, Florida, Forente stater
    • Georgia
      • Atlanta, Georgia, Forente stater
      • Savannah, Georgia, Forente stater
    • Illinois
      • Arlington Heights, Illinois, Forente stater
      • Chicago, Illinois, Forente stater
    • Iowa
      • Clive, Iowa, Forente stater
    • Kansas
      • Pratt, Kansas, Forente stater
    • Kentucky
      • Lexington, Kentucky, Forente stater
    • Louisiana
      • Monroe, Louisiana, Forente stater
    • Michigan
      • Ann Arbor, Michigan, Forente stater
      • Troy, Michigan, Forente stater
    • Minnesota
      • Rochester, Minnesota, Forente stater
    • Mississippi
      • Pascagoula, Mississippi, Forente stater
      • Tupelo, Mississippi, Forente stater
    • New Jersey
      • Egg Harbor Township, New Jersey, Forente stater
    • New York
      • New York, New York, Forente stater
      • Rochester, New York, Forente stater
    • North Carolina
      • Asheville, North Carolina, Forente stater
      • Charlotte, North Carolina, Forente stater
      • Morganton, North Carolina, Forente stater
      • New Bern, North Carolina, Forente stater
      • Raleigh, North Carolina, Forente stater
      • Wilmington, North Carolina, Forente stater
      • Winston Salem, North Carolina, Forente stater
    • North Dakota
      • Fargo, North Dakota, Forente stater
    • Ohio
      • Cincinnati, Ohio, Forente stater
      • Cleveland, Ohio, Forente stater
      • Colombus, Ohio, Forente stater
    • Oklahoma
      • Norman, Oklahoma, Forente stater
    • Oregon
      • Portland, Oregon, Forente stater
    • Pennsylvania
      • Limerick, Pennsylvania, Forente stater
    • South Carolina
      • Columbia, South Carolina, Forente stater
    • Tennessee
      • Germantown, Tennessee, Forente stater
      • Nashville, Tennessee, Forente stater
    • Texas
      • Houston, Texas, Forente stater
      • Sugar Land, Texas, Forente stater
    • Utah
      • Logan, Utah, Forente stater
      • Ogden, Utah, Forente stater
    • Virginia
      • Chesapeake, Virginia, Forente stater
      • Fairfax, Virginia, Forente stater
      • Richmond, Virginia, Forente stater
    • Washington
      • Spokane, Washington, Forente stater
      • Tacoma, Washington, Forente stater
    • Wisconsin
      • Madison, Wisconsin, Forente stater
      • Milwaukee, Wisconsin, Forente stater
  • Frankrike
      • Amiens Cedex 1 80, Frankrike
      • Bordeaux 33, Frankrike
      • Lille Cedex, Frankrike
      • Nice Cedex 3, Frankrike
      • Paris, Frankrike
  • India
      • Bangalore, India
      • Chennai, India
      • Hyderabad, India
      • Hyderabad Andh Prad, India
      • Karnad, India
      • New Delhi, India
      • Pune, India
      • Vishakapatanam, India
  • 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
  • Nederland
      • Amsterdam, Nederland
      • Ede Gld, Nederland
      • Groningen, Nederland
      • Leiden, Nederland
  • 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
  • Romania
      • Bucuresti, Romania
      • Cluj-Napoca, Romania
      • Iasi, Romania
      • Targu Mures, Romania
      • Timisoara, Romania
  • Serbia
      • Belgrade, Serbia
      • Belgrado, Serbia
      • Nis, Serbia
      • Zemun, Serbia
  • Slovakia
      • Bratislava, Slovakia
      • Martin, Slovakia
      • Nitra, Slovakia
      • Nove Mesto Nad Vahom, Slovakia
      • Presov, Slovakia
  • Sverige
      • Stockholm, Sverige
  • Sør-Afrika
      • Cape Town, Sør-Afrika
      • Cape Town West Cape, Sør-Afrika
      • Marianhill Kz-Natal, Sør-Afrika
      • Pretoria Gauteng, Sør-Afrika
  • Tsjekkisk Republikk
      • Hradec Kralove, Tsjekkisk Republikk
      • Litomerice, Tsjekkisk Republikk
      • Ostrava, Tsjekkisk Republikk
      • Èeské Budìjovice 1, Tsjekkisk Republikk
  • Tyskland
      • Berlin, Tyskland
      • Berlin Be, Tyskland
      • Bochum, Tyskland
      • Hamburg, Tyskland
      • Hannover, Tyskland
      • Haßloch, Tyskland
      • Kiel, Tyskland
      • Minden, Tyskland
      • Muenchen, Tyskland
      • Münster, Tyskland
      • Stade, Tyskland
  • Ukraina
      • Donetsk, Ukraina
      • Kharkiv, Ukraina
      • Kyiv, Ukraina
      • Simferopol, Ukraina
      • Vynnytsya, Ukraina
      • Zhaporozhia 69104, Ukraina
  • 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
  • Østerrike
      • Wien 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, 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

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: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / 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.
Eksperimentell: 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.
Eksperimentell: 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.
Eksperimentell: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

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. oktober 2010

Studiet fullført (Faktiske)

1. oktober 2010

Datoer for studieregistrering

Først innsendt

14. juni 2007

Først innsendt som oppfylte QC-kriteriene

14. juni 2007

Først lagt ut (Anslag)

18. juni 2007

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

17. februar 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. januar 2014

Sist bekreftet

1. januar 2014

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

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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