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A Study of the Safety and Efficacy of Ustekinumab (CNTO 1275) in Participants With Crohn's Disease

20 gennaio 2014 aggiornato da: Centocor, Inc.

A Multicenter, Randomized, Phase 2a Study of Human Monoclonal Antibody to IL-12p40 (CNTO 1275) in Subjects With Moderately to Severely Active Crohn's Disease

The purpose of this study is to examine the safety and efficacy of CNTO 1275 in participants with active Crohn's Disease.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This is a multicenter, randomized study of IL-12p40 (CNTO 1275), hereafter referred to as ustekinumab, in 2 populations of participants with moderately to severely active Crohn's disease of at least 6 weeks duration. A total of approximately 120 volunteers will participate in this study in Canada, Belgium, and the United States. Two separate groups of participants (Population 1 and Population 2) will be evaluated. The primary population of participants (Population 1) will consist of approximately 100 participants with Crohn's disease despite treatment with standard Crohn's disease medications (includes agents to decrease intestinal inflammation such as 5-ASA medications such as PENTASA, ASACOL), corticosteroids such as prednisone and/or other drugs known to suppress the immune system called immunomodulators such as azathioprine, 6-mercaptopurine, methotrexate, infliximab or adalimumab [marketed under the trade name of HUMMIRA]). Participants in Population 1 will be randomly assigned (assigned by chance, like "flipping a coin") to double-blind treatment (participants and study staff will not know the identity of the treatments) with ustekinumab and placebo (inactive substance) in 1 of 4 treatment groups as follows: (1) 4 weeks of treatment with ustekinumab 90 mg followed by 4 weeks of treatment with placebo injected subcutaneously (SC, under the skin), (II) 4 weeks of placebo followed by 4 weeks of ustekinumab 90 mg injected SC, (III) 1 intravenous (IV, in the vein) infusion of ustekinumab 4.5 mg/kg followed by 1 IV infusion of placebo, and (IV) 1 IV infusion of placebo followed by 1 IV infusion of ustekinumab 4.5 mg/kg. Population 2 consists of approximately 20 participants who failed to respond to previous therapy with infliximab (trade name REMICADE), a type of antibody that decreases inflammation in patients with moderate to severe Crohn's disease). All participants in Population 2 will receive open-label (un-blinded) treatment with ustekinumab 4.5 mg/kg administered SC for 4 weeks or as one IV infusion. Placebo will not be given to participants in Population 2. The duration of the study for each participant is 28 weeks (not including a screening period of up to 2 weeks) with participants returning at Week 54 to have blood samples collected to assess the concentration of ustekinumab and antibodies to ustekinumab. Adverse events (side-effects) as a measure of safety and tolerability and results from routine laboratory tests will be monitored and reported throughout the study from the time that informed consent is documented up to 3 days after the final blood sample collection at Week 54. Note: doses of ustekinumab used in the study were adjusted by a factor of 0.9 to be consistent with the corrected absorptivity constant for ustekinumab. Therefore, ustekinumab doses of 100 mg and 5 mg/kg previously stated in the study protocol have been restated as 90 mg and 4.5 mg/kg, respectively. No change was made to the amount of ustekinumab given to participants in this study.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

131

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Belgio
      • Leuven, Belgio
  • Canada
      • Hamilton, Canada
      • London, Canada
    • Alberta
      • Edmonton, Alberta, Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada
    • Ontario
      • Toronto, Ontario, Canada
  • Stati Uniti
    • Arizona
      • Scottsdale, Arizona, Stati Uniti
    • California
      • Anaheim, California, Stati Uniti
      • Sacramento, California, Stati Uniti
      • San Francisco, California, Stati Uniti
    • Connecticut
      • Bristol, Connecticut, Stati Uniti
      • New Haven, Connecticut, Stati Uniti
    • Florida
      • Jacksonville, Florida, Stati Uniti
      • Miami, Florida, Stati Uniti
    • Indiana
      • Indianapolis, Indiana, Stati Uniti
    • Kansas
      • Topeka, Kansas, Stati Uniti
    • Kentucky
      • Lexington, Kentucky, Stati Uniti
      • Louisville, Kentucky, Stati Uniti
    • Louisiana
      • Baton Rouge, Louisiana, Stati Uniti
      • Metairie, Louisiana, Stati Uniti
      • New Orleans, Louisiana, Stati Uniti
    • Maryland
      • Laurel, Maryland, Stati Uniti
    • Michigan
      • Chesterfield, Michigan, Stati Uniti
      • Troy, Michigan, Stati Uniti
    • Minnesota
      • Rochester, Minnesota, Stati Uniti
    • Nebraska
      • Omaha, Nebraska, Stati Uniti
    • New York
      • Great Neck, New York, Stati Uniti
      • New York, New York, Stati Uniti
    • North Carolina
      • Chapel Hill, North Carolina, Stati Uniti
      • Charlotte, North Carolina, Stati Uniti
    • Ohio
      • Cincinnati, Ohio, Stati Uniti
      • Cleveland, Ohio, Stati Uniti
      • Columbus, Ohio, Stati Uniti
    • Oklahoma
      • Oklahoma City, Oklahoma, Stati Uniti
    • Oregon
      • Portland, Oregon, Stati Uniti
    • Pennsylvania
      • Beaver Falls, Pennsylvania, Stati Uniti
      • Pittsburgh, Pennsylvania, Stati Uniti
    • Rhode Island
      • Providence, Rhode Island, Stati Uniti
    • South Carolina
      • Columbia, South Carolina, Stati Uniti
    • Tennessee
      • Germantown, Tennessee, Stati Uniti
      • Knoxville, Tennessee, Stati Uniti
      • Memphis, Tennessee, Stati Uniti
      • Nashville, Tennessee, Stati Uniti
    • Texas
      • Austin, Texas, Stati Uniti
      • Dallas, Texas, Stati Uniti
      • Houston, Texas, Stati Uniti
    • Utah
      • Ogden, Utah, Stati Uniti
      • Salt Lake City, Utah, Stati Uniti
    • Virginia
      • Charlottesville, Virginia, Stati Uniti
      • Christiansburg, Virginia, Stati Uniti
      • Richmond, Virginia, Stati Uniti
    • Washington
      • Everett, Washington, Stati Uniti
      • Seattle, Washington, Stati Uniti
      • Tacoma, Washington, Stati Uniti
    • Wisconsin
      • Madison, Wisconsin, Stati Uniti
      • Milwaukee, Wisconsin, Stati Uniti

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Have moderately to severly active Crohn's disease or fistulizing Crohn's disease for at least 6 weeks' duration with a Crohn's disease activity index (CDAI) score of >=220 and <=450
  • In Population 1, participants must have had active disease despite treatment with 5-ASA compounds, antibiotics, corticosteroids, and/or immunomodulators, including anti-TNF agents. In Population 2, participants must have had active disease and have failed to respond to infliximab at the maximum approved dose and treatment regimen for Crohn's disease as defined in the US package insert.

Exclusion Criteria:

  • Have local manifestations of Crohn's disease such as strictures, abscesses, or other disease complications for which surgery might be indicated
  • Had intra-abdominal surgery within 6 months prior to entering the study
  • Have received treatment with parenteral nutrition (ie, introduction of nutrition into the body via a route other than the mouth) (total parenteral nutrition [TPN]) within 6 weeks of baseline

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Population 1: Placebo SC followed by ustekinumab SC
Placebo injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by ustekinumab 90 mg SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.
Droga: Ustekinumab 90 mg
one 90 mg SC injection each week for 4 weeks (Weeks 0-3 during Intervention Period 1 or Weeks 8-11 during Intervention Period 2 for Population 1 or Weeks 0-3 during Intervention Period 1 for Population 2)
Altri nomi:
  • CNT 1275
Droga: Placebo SC
one SC injection each week for 4 weeks (Weeks 0-3 in Intervention Period 1 or Weeks 8-11 in Intervention Period 2 for Population 1 or at Weeks 0-3 in Intervention Period 1 for Population 2)
Sperimentale: Population 1: Ustekinumab SC followed by Placebo SC:
Ustekinumab 90 mg injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by ustekinumab 90 mg SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.
Droga: Ustekinumab 90 mg
one 90 mg SC injection each week for 4 weeks (Weeks 0-3 during Intervention Period 1 or Weeks 8-11 during Intervention Period 2 for Population 1 or Weeks 0-3 during Intervention Period 1 for Population 2)
Altri nomi:
  • CNT 1275
Droga: Placebo SC
one SC injection each week for 4 weeks (Weeks 0-3 in Intervention Period 1 or Weeks 8-11 in Intervention Period 2 for Population 1 or at Weeks 0-3 in Intervention Period 1 for Population 2)
Sperimentale: Population 1: Placebo IV followed by ustekinumab IV
Placebo given as 1 intravenous (IV) infusion at Week 0 during Intervention Period 1 and ustekinumab 4.5 mg/kg given as one IV infusion at Week 8 during Intervention Period 2.
Droga: Ustekinumab 4.5 mg/kg
one IV infusion of 4.5 mg/kg over a period of not less than 2 hours at Week 0 in Intervention Period 1 or Week 8 in Intervention Period 2 for Population 1 or at Week 0 in Intervention Period 1 for Population 2
Altri nomi:
  • CNT 1275
Droga: Placebo IV
one IV infusion over a period of not less than 2 hours at Week 0 in Intervention Period 1 for Population 1 and Population 2 or at Week 8 in Intervention Period 2 for Population 1
Sperimentale: Population 1: Ustekinumab IV followed by Placebo IV:
Ustekinumab 4.5 mg/kg given as one intravenous(IV) infusion at Week 0 during Intervention Period 1 followed by placebo given as one IV infusion at Week 8 during Intervention Period 2.
Droga: Ustekinumab 4.5 mg/kg
one IV infusion of 4.5 mg/kg over a period of not less than 2 hours at Week 0 in Intervention Period 1 or Week 8 in Intervention Period 2 for Population 1 or at Week 0 in Intervention Period 1 for Population 2
Altri nomi:
  • CNT 1275
Droga: Placebo IV
one IV infusion over a period of not less than 2 hours at Week 0 in Intervention Period 1 for Population 1 and Population 2 or at Week 8 in Intervention Period 2 for Population 1
Sperimentale: Population 2: Ustekinumab SC
Ustekinumab 90 mg injected subcutaneously (SC) once a week at Weeks 0-3 during Intervention Period 1. No intervention given during Intervention Period 2.
Droga: Ustekinumab 90 mg
one 90 mg SC injection each week for 4 weeks (Weeks 0-3 during Intervention Period 1 or Weeks 8-11 during Intervention Period 2 for Population 1 or Weeks 0-3 during Intervention Period 1 for Population 2)
Altri nomi:
  • CNT 1275
Sperimentale: Population 2: Ustekinumab IV
Ustekinumab 4.5 mg given as one intravenous (IV) infusion at Week 0 during Intervention Period 1. No intervention given during Intervention Period 2.
Droga: Ustekinumab 4.5 mg/kg
one IV infusion of 4.5 mg/kg over a period of not less than 2 hours at Week 0 in Intervention Period 1 or Week 8 in Intervention Period 2 for Population 1 or at Week 0 in Intervention Period 1 for Population 2
Altri nomi:
  • CNT 1275

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants in Population 1 With a Clinical Response at Week 8
Lasso di tempo: Week 8
The table below provides the number of participants in Population 1 with a clinical response at Week 8 defined as a reduction from baseline in the CDAI (Crohn's disease activity index) score of >= 25% and >= 70 points at Week 8. A reduction in CDAI score correlates with improvement in the severity of illness. The CDAI is derived as a weighted sum of 8 different Crohn's disease related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools (or bags emptied for participants with a stoma), abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well being. The primary endpoint analysis was based on the comparison between the combined SC and IV Placebo and combined SC and IV ustekinumab treatment groups in Population 1.
Week 8

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants in Population 2 With a Clinical Response at Week 8
Lasso di tempo: Week 8
The table below provides the number of participants in Population 2 with a clinical response at Week 8 defined as a reduction from baseline in the CDAI (Crohn's disease activity index) score of >= 25% and >= 70 points at Week 8. A reduction in CDAI score correlates with improvement in the severity of illness. The CDAI is derived as a weighted sum of 8 different Crohn's disease related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools (or bags emptied for participants with a stoma), abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being.
Week 8
Number of Participants in Population 1 With Clinical Remission at Week 8
Lasso di tempo: Week 8
The table below shows the number of participants in Population 1 with clinical remission at Week 8 defined a CDAI (Crohn's disease activity index) score < 150 points at Week 8. A reduction in CDAI score correlates with improvement in the severity of illness. The CDAI is derived as a weighted sum of 8 different Crohn's disease related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools (or bags emptied for participants with a stoma), abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being.
Week 8

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Centocor, Inc.

Investigatori

  • Direttore dello studio: Centocor Clinical Trial, Centocor, Inc.

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 aprile 2004

Completamento primario (Effettivo)

1 novembre 2005

Completamento dello studio (Effettivo)

1 ottobre 2006

Date di iscrizione allo studio

Primo inviato

13 dicembre 2005

Primo inviato che soddisfa i criteri di controllo qualità

13 dicembre 2005

Primo Inserito (Stima)

14 dicembre 2005

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

13 febbraio 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

20 gennaio 2014

Ultimo verificato

1 gennaio 2014

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CR005287
  • C0379T07 (Altro identificatore: Centocor, Inc.)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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