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Certolizumab in Crohn's Disease Patients With Loss of Response or Intolerance to Infliximab

10 de julio de 2018 actualizado por: UCB Pharma

Phase IIIb Open-label Induction and Double-blind Comparison of 2 Maintenance Schedules Evaluating Clinical Benefit and Tolerability of Certolizumab Pegol in Crohn's Disease Patients With Prior Loss of Response or Intolerance to Infliximab

To assess the clinical efficacy of subcutaneous (sc) certolizumab pegol administration over 26 weeks in patients suffering from Crohn's Disease (CD) and previously treated with infliximab

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

539

Fase

  • Fase 3

Acceso ampliado

Disponible fuera del ensayo clínico. Ver registro de acceso ampliado.

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Alemania
      • Berlin, Alemania
      • Hamburg, Alemania
      • Hannover, Alemania
      • Herne, Alemania
      • Kiel, Alemania
      • Leipzig, Alemania
      • Minden, Alemania
      • Munchen, Alemania
      • Munich, Alemania
  • Austria
      • Innsbruck, Austria
      • Oberpullendorf, Austria
      • Wien, Austria
  • Bélgica
      • Bonheiden, Bélgica
      • Brussels, Bélgica
      • Genk, Bélgica
      • Gent, Bélgica
      • Kortrijk, Bélgica
      • Leuven, Bélgica
      • Liege, Bélgica
      • Roeselare, Bélgica
  • Canadá
      • Calgary, Canadá
    • Alberta
      • Edmonton, Alberta, Canadá
    • British Columbia
      • Vancouver, British Columbia, Canadá
    • Ontario
      • London, Ontario, Canadá
      • Richmond, Ontario, Canadá
      • Toronto, Ontario, Canadá
  • Dinamarca
      • Aalborg, Dinamarca
      • Arhus, Dinamarca
      • Copenhagen, Dinamarca
      • Herlev, Dinamarca
  • España
      • Barcelona, España
      • Madrid, España
      • Oviedo, España
      • Santiago De Compostela, España
      • Sevilla, España
      • Valencia, España
  • Estados Unidos
    • California
      • San Francisco, California, Estados Unidos
    • Florida
      • Gainesville, Florida, Estados Unidos
    • Georgia
      • Atlanta, Georgia, Estados Unidos
    • Illinois
      • Chicago, Illinois, Estados Unidos
    • Indiana
      • Indianapolis, Indiana, Estados Unidos
    • Kentucky
      • Lexington, Kentucky, Estados Unidos
      • Louisville, Kentucky, Estados Unidos
    • Louisiana
      • Baton Rouge, Louisiana, Estados Unidos
    • Maryland
      • Baltimore, Maryland, Estados Unidos
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos
    • Minnesota
      • Rochester, Minnesota, Estados Unidos
    • Nebraska
      • Lincoln, Nebraska, Estados Unidos
    • New York
      • Great Neck, New York, Estados Unidos
      • New York, New York, Estados Unidos
    • North Carolina
      • Chapel Hill, North Carolina, Estados Unidos
      • Charlotte, North Carolina, Estados Unidos
    • Ohio
      • Cincinnati, Ohio, Estados Unidos
      • Cleveland, Ohio, Estados Unidos
    • Oklahoma
      • Oklahoma City, Oklahoma, Estados Unidos
    • Oregon
      • Portland, Oregon, Estados Unidos
    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos
      • Pittsburgh, Pennsylvania, Estados Unidos
    • South Carolina
      • Charleston, South Carolina, Estados Unidos
    • Tennessee
      • Germantown, Tennessee, Estados Unidos
      • Kingsport, Tennessee, Estados Unidos
      • Nashville, Tennessee, Estados Unidos
    • Texas
      • Dallas, Texas, Estados Unidos
      • Galveston, Texas, Estados Unidos
      • Houston, Texas, Estados Unidos
    • Washington
      • Seattle, Washington, Estados Unidos
    • Wisconsin
      • Milwaukee, Wisconsin, Estados Unidos
  • Francia
      • Amiens, Francia
      • Clichy, Francia
      • Grenoble, Cedex 9, Francia
      • Lille, Francia
      • Montpellier, Cédex 5, Francia
      • Nice, Francia, Cedex 3
      • Paris, Francia
      • Pessac, Francia
      • Rouen, Francia
      • Toulouse, Cedex 9, Francia
  • Italia
      • Bari, Italia
      • Bologna, Italia
      • Milano, Italia
      • Padova, Italia
      • Palermo, Italia
      • Roma, Italia
      • Torino, Italia
  • Noruega
      • Oslo, Noruega
      • Tromso, Noruega
  • Países Bajos
      • Amsterdam, Países Bajos
      • Eindhoven, Países Bajos
      • Enschede, Países Bajos
      • Heerlen, Países Bajos
      • Leiden, Países Bajos
      • Terneuven, Países Bajos
      • Zwolle, Países Bajos
  • Reino Unido
      • Bristol, Reino Unido
      • Cambridge, Reino Unido
      • Edinburgh, Reino Unido
      • London, Reino Unido
      • Nottingham, Reino Unido
      • Oxford, Reino Unido
      • Sheffield, Reino Unido
  • Suecia
      • Goteborg, Suecia
      • Malmo, Suecia
      • Orebro, Suecia
      • Stockholm, Suecia
  • Suiza
      • Basel, Suiza
      • Bern, Suiza
      • Lausanne, Suiza

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Subjects with Crohn's Disease
  • Previous treatment failure to Infliximab (intolerance and/or no response)

Exclusion Criteria:

  • Obstructive intestinal strictures
  • Recent bowel resection
  • Proctocolectomy or total colectomy
  • Current total parenteral nutrition
  • Short bowel syndrome
  • All concomitant diseases or pathological conditions that could interfere with Crohn's disease assessment or to be harmful for the well being of the patient
  • Previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trial

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Active 1

Q4W regimen

- every 4 weeks: alternatively placebo and 400mg Certolizumab Pegol
Biológico: Certolizumab pegol
400mg Certolizumab Pegol, Q4W, administered 4-weekly
Otros nombres:
  • Cimzia
  • CDP870
Biológico: Certolizumab pegol
400mg Certolizumab Pegol, Q2W, administered 2-weekly
Otros nombres:
  • Cimzia
  • CDP870
Otro: Placebo
placebo administered 4-weekly in Active 1
Experimental: Active 2

Q2W regimen

- every 2 weeks: 400 mg Certolizumab Pegol
Biológico: Certolizumab pegol
400mg Certolizumab Pegol, Q4W, administered 4-weekly
Otros nombres:
  • Cimzia
  • CDP870
Biológico: Certolizumab pegol
400mg Certolizumab Pegol, Q2W, administered 2-weekly
Otros nombres:
  • Cimzia
  • CDP870

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Response Status With Response Defined as at Least 100 Point Decrease in Crohn's Disease Activity Score (CDAI Score) From Baseline in the Induction Phase
Periodo de tiempo: Baseline to Week 6

Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score) from baseline, otherwise there is a non-response.

The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Baseline to Week 6

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Response Status With Response Defined as at Least 100 Point Decrease in CDAI Score From Baseline in the Randomized Maintenance Phase
Periodo de tiempo: Baseline to Week 26
Response is defined as at least 100 point decrease in CDAI score from baseline. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Baseline to Week 26
Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Induction Phase
Periodo de tiempo: Baseline to Week 6
Response is defined as at least 70 points reduction in CDAI score. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Baseline to Week 6
Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Randomized Maintenance Phase
Periodo de tiempo: Baseline to Week 26
Response is defined as at least 70 points reduction in CDAI score. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Baseline to Week 26
Remission Status With Remission Defined as CDAI Score ≤ 150 in the Induction Phase
Periodo de tiempo: Week 6
Remission is defined as CDAI score ≤ 150. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Week 6
Remission Status With Remission Defined as CDAI Score ≤ 150 in the Randomized Maintenance Phase
Periodo de tiempo: Week 26
Remission is defined as CDAI score ≤ 150. The CDAI score is used to quantify the symptoms with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Week 26
CDAI Score at Week 2 of the Induction Phase
Periodo de tiempo: Week 2
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Week 2
CDAI Score at Week 4 of the Induction Phase
Periodo de tiempo: Week 4
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Week 4
CDAI Score at Week 6 of the Induction Phase
Periodo de tiempo: Week 6
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Week 6
CDAI Score at Week 8 in the Randomized Maintenance Phase
Periodo de tiempo: Week 8
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Week 8
CDAI Score at Week 10 in the Randomized Maintenance Phase
Periodo de tiempo: Week 10
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Week 10
CDAI Score at Week 12 in the Randomized Maintenance Phase
Periodo de tiempo: Week 12
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Week 12
CDAI Score at Week 14 in the Randomized Maintenance Phase
Periodo de tiempo: Week 14
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Week 14
CDAI Score at Week 16 in the Randomized Maintenance Phase
Periodo de tiempo: Week 16
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Week 16
CDAI Score at Week 18 in the Randomized Maintenance Phase
Periodo de tiempo: Week 18
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Week 18
CDAI Score at Week 20 in the Randomized Maintenance Phase
Periodo de tiempo: Week 20
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Week 20
CDAI Score at Week 22 in the Randomized Maintenance Phase
Periodo de tiempo: Week 22
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Week 22
CDAI Score at Week 24 in the Randomized Maintenance Phase
Periodo de tiempo: Week 24
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Week 24
CDAI Score at Week 26 in the Randomized Maintenance Phase
Periodo de tiempo: Week 26
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Week 26
Change From Baseline in CDAI Score at Week 2 of the Induction Phase
Periodo de tiempo: Baseline to Week 2
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Baseline to Week 2
Change From Baseline in CDAI Score at Week 4 of the Induction Phase
Periodo de tiempo: Baseline to Week 4
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Baseline to Week 4
Change From Baseline in CDAI Score at Week 6 of the Induction Phase
Periodo de tiempo: Baseline to Week 6
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Baseline to Week 6
Change From Baseline in CDAI Score at Week 8 in the Randomized Maintenance Phase
Periodo de tiempo: Baseline to Week 8
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Baseline to Week 8
Change From Baseline in CDAI Score at Week 10 in the Randomized Maintenance Phase
Periodo de tiempo: Baseline to Week 10
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Baseline to Week 10
Change From Baseline in CDAI Score at Week 12 in the Randomized Maintenance Phase
Periodo de tiempo: Baseline to Week 12
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Baseline to Week 12
Change From Baseline in CDAI Score at Week 14 in the Randomized Maintenance Phase
Periodo de tiempo: Baseline to Week 14
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Baseline to Week 14
Change From Baseline in CDAI Score at Week 16 in the Randomized Maintenance Phase
Periodo de tiempo: Baseline to Week 16
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Baseline to Week 16
Change From Baseline in CDAI Score at Week 18 in the Randomized Maintenance Phase
Periodo de tiempo: Baseline to Week 18
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Baseline to Week 18
Change From Baseline in CDAI Score at Week 20 in the Randomized Maintenance Phase
Periodo de tiempo: Baseline to Week 20
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Baseline to Week 20
Change From Baseline in CDAI Score at Week 22 in the Randomized Maintenance Phase
Periodo de tiempo: Baseline to Week 22
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Baseline to Week 22
Change From Baseline in CDAI Score at Week 24 in the Randomized Maintenance Phase
Periodo de tiempo: Baseline to Week 24
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Baseline to Week 24
Change From Baseline in CDAI Score at Week 26 in the Randomized Maintenance Phase
Periodo de tiempo: Baseline to Week 26
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Baseline to Week 26
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 10 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Periodo de tiempo: Week 10
Remission is defined as CDAI score ≤ 150.
Week 10
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 12 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Periodo de tiempo: Week 12
Remission is defined as CDAI score ≤ 150.
Week 12
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 14 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Periodo de tiempo: Week 14
Remission is defined as CDAI score ≤ 150.
Week 14
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 16 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Periodo de tiempo: Week 16
Remission is defined as CDAI score ≤ 150.
Week 16
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 18 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Periodo de tiempo: Week 18
Remission is defined as CDAI score ≤ 150.
Week 18
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 20 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Periodo de tiempo: Week 20
Remission is defined as CDAI score ≤ 150.
Week 20
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 22 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Periodo de tiempo: Week 22
Remission is defined as CDAI score ≤ 150.
Week 22
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 24 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Periodo de tiempo: Week 24
Remission is defined as CDAI score ≤ 150.
Week 24
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 26 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Periodo de tiempo: Week 26
Remission is defined as CDAI score ≤ 150.
Week 26
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 10 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Periodo de tiempo: Week 10
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Week 10
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 12 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Periodo de tiempo: Week 12
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Week 12
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 14 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Periodo de tiempo: Week 14
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Week 14
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 16 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Periodo de tiempo: Week 16
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Week 16
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 18 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Periodo de tiempo: Week 18
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Week 18
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 20 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Periodo de tiempo: Week 20
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Week 20
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 22 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Periodo de tiempo: Week 22
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Week 22
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 24 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Periodo de tiempo: Week 24
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Week 24
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 26 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Periodo de tiempo: Week 26
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Week 26
C - Reactive Protein (CRP) Level at Baseline (Week 0) of the Induction Phase
Periodo de tiempo: Week 0
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Week 0
CRP Level at Week 2 of the Induction Phase
Periodo de tiempo: Week 2
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Week 2
CRP Level at Week 4 of the Induction Phase
Periodo de tiempo: Week 4
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Week 4
CRP Level at Week 6 of the Induction Phase
Periodo de tiempo: Week 6
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Week 6
CRP Level at Week 8 in the Randomized Maintenance Phase
Periodo de tiempo: Week 8
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Week 8
CRP Level at Week 10 in the Randomized Maintenance Phase
Periodo de tiempo: Week 10 (optional measurement)
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Week 10 (optional measurement)
CRP Level at Week 12 in the Randomized Maintenance Phase
Periodo de tiempo: Week 12
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Week 12
CRP Level at Week 14 in the Randomized Maintenance Phase
Periodo de tiempo: Week 14 (optional measurement)
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Week 14 (optional measurement)
CRP Level at Week 16 in the Randomized Maintenance Phase
Periodo de tiempo: Week 16
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Week 16
CRP Level at Week 18 in the Randomized Maintenance Phase
Periodo de tiempo: Week 18 (optional measurement)
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Week 18 (optional measurement)
CRP Level at Week 20 in the Randomized Maintenance Phase
Periodo de tiempo: Week 20
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Week 20
CRP Level at Week 22 in the Randomized Maintenance Phase
Periodo de tiempo: Week 22 (optional measurement)
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Week 22 (optional measurement)
CRP Level at Week 24 in the Randomized Maintenance Phase
Periodo de tiempo: Week 24
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Week 24
CRP Level at Week 26 in the Randomized Maintenance Phase
Periodo de tiempo: Week 26
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Week 26
CRP Level at Endpoint (Last Visit) in the Randomized Maintenance Phase
Periodo de tiempo: Last visit on or before Week 26
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L. Endpoint is the visit when the last observation was taken, either at week 26 or at a visit before in case of early dropout.
Last visit on or before Week 26

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Time to Loss of Response (CDAI Score > 150 and Minimum Increase in CDAI of 70) After Week 6
Periodo de tiempo: Week 6 to Week 26
Median time to loss of response in the maintenance period (from Kaplan-Meier analysis); range is time of first event to time of last event. Loss of response is defined as both a CDAI score > 150 points and a minimum increase in CDAI of 70 points versus Week 6 at two consecutive visits.
Week 6 to Week 26

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

UCB Pharma

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de abril de 2006

Finalización primaria (Actual)

1 de abril de 2008

Finalización del estudio (Actual)

1 de abril de 2008

Fechas de registro del estudio

Enviado por primera vez

28 de marzo de 2006

Primero enviado que cumplió con los criterios de control de calidad

28 de marzo de 2006

Publicado por primera vez (Estimar)

29 de marzo de 2006

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

7 de agosto de 2018

Última actualización enviada que cumplió con los criterios de control de calidad

10 de julio de 2018

Última verificación

1 de abril de 2011

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • C87042
  • Eudract number: 2005-004104-37

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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