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Study to Evaluate Efficacy and Safety of Certolizumab Pegol for Induction of Remission in Patients With Crohn's Disease

10. juli 2018 oppdatert av: UCB Pharma

Phase IIIb, Multinational, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Certolizumab Pegol, a Pegylated Fab' Fragment of a Humanized Anti-Tumor Necrosis Factor(TNF)-Alpha Monoclonal Antibody, Administered in Subjects With Moderately to Severely Active Crohn's Disease.

The primary objective of the study is to evaluate efficacy of certolizumab pegol in inducing clinical remission in patients with moderate to severe Crohn's disease as compared with placebo based on Crohn's Disease Activity Index (CDAI) score at Week 6.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

439

Fase

  • Fase 3

Utvidet tilgang

Tilgjengelig utenfor den kliniske utprøvingen. Se utvidet tilgangspost.

Kontakter og plasseringer

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

Studiesteder

  • Australia
      • Adelaide, Australia
      • Bankstown, Australia
      • Clayton, Australia
      • Fitzroy, Australia
      • Fremantle, Australia
      • Garran, Australia
    • New South Wales
      • Concord, New South Wales, Australia
    • Victoria
      • Box Hill, Victoria, Australia
      • Footscray, Victoria, Australia
      • Parkville, Victoria, Australia
  • Belgia
      • Bonheiden, Belgia
      • Brussels, Belgia
      • Gent, Belgia
      • Leuven, Belgia
      • Liege, Belgia
      • Roeselare, Belgia
  • Brasil
      • Curitiba, Brasil
      • Goiania, Brasil
      • Porto Alegre, Brasil
      • Rio de Janeiro, Brasil
      • Santo-Andre, Brasil
      • Santos, Brasil
      • Sao Paulo, Brasil
    • MG
      • Belo-Horizonte, MG, Brasil
  • Canada
      • Calgary, Canada
    • Alberta
      • Edmonton, Alberta, Canada
    • British Columbia
      • Kelowna, British Columbia, Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada
    • Ontario
      • Hamilton, Ontario, Canada
      • Kingston, Ontario, Canada
      • London, Ontario, Canada
      • Toronto, Ontario, Canada
  • Chile
      • Santiago, Chile
      • Vina del Mar, Chile
  • Den russiske føderasjonen
      • Kazan, Den russiske føderasjonen
      • Moscow, Den russiske føderasjonen
      • St. Petersburg, Den russiske føderasjonen
  • Estland
      • Tallin, Estland
      • Tartu, Estland
  • Finland
      • Mikkeli, Finland
  • Forente stater
    • Alabama
      • Pell City, Alabama, Forente stater
    • Colorado
      • Colorado Springs, Colorado, Forente stater
      • Lakewood, Colorado, Forente stater
      • Littleton, Colorado, Forente stater
    • Florida
      • Hollywood, Florida, Forente stater
      • Jacksonville, Florida, Forente stater
      • New Port Richey, Florida, Forente stater
      • Winter Park, Florida, Forente stater
    • Illinois
      • Chicago, Illinois, Forente stater
    • Kentucky
      • Louisville, Kentucky, Forente stater
    • Louisiana
      • Metairie, Louisiana, Forente stater
      • Monroe, Louisiana, Forente stater
    • Maryland
      • Annapolis, Maryland, Forente stater
      • Towson, Maryland, Forente stater
    • Michigan
      • Chesterfield, Michigan, Forente stater
      • West Bloomfield, Michigan, Forente stater
    • Minnesota
      • Rochester, Minnesota, Forente stater
    • North Carolina
      • Raleigh, North Carolina, Forente stater
    • Ohio
      • Cincinnati, Ohio, Forente stater
      • Cleveland, Ohio, Forente stater
    • Pennsylvania
      • Lancaster, Pennsylvania, Forente stater
    • Tennessee
      • Germantown, Tennessee, Forente stater
    • Virginia
      • Norfolk, Virginia, Forente stater
    • Washington
      • Seattle, Washington, Forente stater
  • Israel
      • Beer Sheva, Israel
      • Haifa, Israel
      • Holon, Israel
      • Jerusalem, Israel
      • Kfar Saba, Israel
      • Petha Tikva, Israel
      • Rehovot, Israel
      • Tel Aviv, Israel
      • Zerifin, Israel
  • Italia
      • Bologna, Italia
      • Padova, Italia
      • Roma, Italia
  • Latvia
      • Riga, Latvia
      • Valmiera, Latvia
  • New Zealand
      • Auckland, New Zealand
      • Christchurch, New Zealand
      • Hamilton, New Zealand
    • Auckland
      • Milford, Auckland, New Zealand
    • Wellington
      • Newton, Wellington, New Zealand
  • Polen
      • Czestochowa, Polen
      • Lodz, Polen
      • Warszawa, Polen
      • Wroclaw, Polen
  • Romania
      • Bucharest, Romania
      • Cluj Napoca, Romania
      • Constanta, Romania
  • Tsjekkia
      • Hradec Kralove, Tsjekkia
      • Hradek Kralove, Tsjekkia
      • Praha 7, Tsjekkia
      • Usti Nad Orlici, Tsjekkia
      • Zlin, Tsjekkia
  • Tyskland
      • Berlin, Tyskland
      • Frankfurt, Tyskland
      • Freiburg, Tyskland
      • Homburg, Tyskland
      • Jena, Tyskland
      • Kiel, Tyskland
      • Munchen, Tyskland
      • Ulm, Tyskland
      • Wilhelmshaven, Tyskland
  • Ukraina
      • Dniepropetrovsk, Ukraina
      • Donetsk, Ukraina
      • Kiev, Ukraina
      • Kyiv, Ukraina
      • Lviv, Ukraina
      • Simferopol, Ukraina
  • Ungarn
      • Budapest, Ungarn
      • Gyor, Ungarn
      • Nagykanizsa, Ungarn
      • Szeged, Ungarn
      • Szombathely, Ungarn
  • Østerrike
      • Wien, 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 til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • male/female
  • 18 - 75 years inclusive
  • diagnosis of Crohn's disease confirmed
  • moderate to severe disease activity (Crohn's Disease Activity Index (CDAI) 225 - 450)
  • no previous treatment with anti-tumor necrosis factor (anti-TNF) medications

Exclusion Criteria:

  • previous participation in a certolizumab pegol study
  • general exclusion criteria as common for studies in this indication

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
Eksperimentell: Certolizumab pegol
Certolizumab pegol 400 mg for subcutaneous (sc) injection
Biologisk: certolizumab pegol (CDP870, CZP)
Certolizumab Pegol 400 mg CZP sc injection 2 x 1 mL CZP (200 mg/mL) at Week 0, 2, and 4
Andre navn:
  • CZP
  • CDP870
  • CIMZIA ®
Placebo komparator: Placebo
Placebo, saline solution for sc injection
Annen: Placebo
Saline 0.9% sc injection 2 x 1 mL Placebo at Week 0, 2 and 4

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of Subjects in Clinical Remission at Week 6
Tidsramme: Week 6
The percentage of subjects in clinical remission at Week 6 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Week 6

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of Subjects Achieving a Clinical Response at Week 6
Tidsramme: Week 0, Week 6
The percentage of subjects achieving a clinical response at Week 6 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Week 0, Week 6
Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 6
Tidsramme: Week 6
The percentage of subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 6 (IBDQ remission is defined as a total IBDQ score of 170 points or more). The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.
Week 6
Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 6
Tidsramme: Week 0 to Week 6
The change in total Crohn's Disease Activity Index (CDAI) score from Week 0 to Week 6. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Week 0 to Week 6
Change in Harvey Bradshaw Index (HBI) Score From Week 0 to Week 6
Tidsramme: Week 0 to Week 6
The change in Harvey Bradshaw Index (HBI) score from Week 0 to Week 6. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (score 1 per item). The first three items are scored for the previous day. Lower scores indicated better well being.
Week 0 to Week 6
Percentage of Subjects in Clinical Remission at Week 2
Tidsramme: Week 2
The percentage of subjects in clinical remission at Week 2 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Week 2
Percentage of Subjects in Clinical Remission at Week 4
Tidsramme: Week 4
The percentage of subjects in clinical remission at Week 4 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Week 4
Percentage of Subjects Achieving a Clinical Response at Week 2
Tidsramme: Week 0, Week 2
The percentage of subjects achieving a clinical response at Week 2 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Week 0, Week 2
Percentage of Subjects Achieving a Clinical Response at Week 4
Tidsramme: Week 0, Week 4
The percentage of subjects achieving a clinical response at Week 4 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Week 0, Week 4
Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 2
Tidsramme: Week 0 to Week 2
The change in total Crohn's Disease Activity Index (CDAI) score from Week 0 to Week 2. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Week 0 to Week 2
Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 4
Tidsramme: Week 0, Week 4
The change in total Crohn's Disease Activity Index (CDAI) score from Week 0 to Week 4. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Week 0, Week 4
Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 2
Tidsramme: Week 2
The percentage of subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 2 (IBDQ remission is defined as a total IBDQ score of 170 points or more). The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.
Week 2
Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 4
Tidsramme: Week 4
The percentage of subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 4 (IBDQ remission is defined as a total IBDQ score of 170 points or more). The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.
Week 4
Percentage of Subjects in Subgroup With Less Than 10 mg/L C-reactive Protein (CRP) at Entry Who Are in Clinical Remission at Week 6
Tidsramme: Week 6
The percentage of subjects in the subgroup with less than 10 mg/L of C-reactive Protein (CRP) at Entry who are in clinical remission at Week 6 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Week 6
Percentage of Subjects in Subgroup With 10 mg/L or Greater C-reactive Protein (CRP) at Entry Who Are in Clinical Remission at Week 6
Tidsramme: Week 6
The percentage of subjects in the subgroup with 10 mg/L or greater C-reactive Protein (CRP) at Entry in clinical remission at Week 6 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Week 6
Percentage of Subjects in Subgroup With Less Than 10 mg/L C-reactive Protein (CRP) at Entry Achieving a Clinical Response at Week 6
Tidsramme: Week 0, Week 6
The percentage of subjects in the subgroup with less than 10 mg/L C-reactive Protein (CRP) at Entry achieving a clinical response at Week 6 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Week 0, Week 6
Percentage of Subjects in Subgroup With 10 mg/L or Greater C-reactive Protein (CRP) at Entry Achieving a Clinical Response at Week 6
Tidsramme: Week 0, Week 6
The percentage of subjects in the subgroup with 10 mg/L or greater C-reactive Protein (CRP) at Entry achieving a clinical response at Week 6 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Week 0, Week 6

Samarbeidspartnere og etterforskere

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

Sponsor

UCB Pharma

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

Hjelpsomme linker

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. mars 2008

Primær fullføring (Faktiske)

1. oktober 2009

Studiet fullført (Faktiske)

1. november 2009

Datoer for studieregistrering

Først innsendt

18. oktober 2007

Først innsendt som oppfylte QC-kriteriene

31. oktober 2007

Først lagt ut (Anslag)

1. november 2007

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. august 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. juli 2018

Sist bekreftet

1. oktober 2011

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • C87085
  • 2007-001913-41 (EudraCT-nummer)

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. .

Kliniske studier på Crohns sykdom

Kliniske studier på certolizumab pegol (CDP870, CZP)

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