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

10 luglio 2018 aggiornato da: 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

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

539

Fase

  • Fase 3

Accesso esteso

A disposizione al di fuori della sperimentazione clinica. Vedi record di accesso esteso.

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

  • Austria
      • Innsbruck, Austria
      • Oberpullendorf, Austria
      • Wien, Austria
  • Belgio
      • Bonheiden, Belgio
      • Brussels, Belgio
      • Genk, Belgio
      • Gent, Belgio
      • Kortrijk, Belgio
      • Leuven, Belgio
      • Liege, Belgio
      • Roeselare, Belgio
  • Canada
      • Calgary, Canada
    • Alberta
      • Edmonton, Alberta, Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
    • Ontario
      • London, Ontario, Canada
      • Richmond, Ontario, Canada
      • Toronto, Ontario, Canada
  • Danimarca
      • Aalborg, Danimarca
      • Arhus, Danimarca
      • Copenhagen, Danimarca
      • Herlev, Danimarca
  • 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
  • Germania
      • Berlin, Germania
      • Hamburg, Germania
      • Hannover, Germania
      • Herne, Germania
      • Kiel, Germania
      • Leipzig, Germania
      • Minden, Germania
      • Munchen, Germania
      • Munich, Germania
  • Italia
      • Bari, Italia
      • Bologna, Italia
      • Milano, Italia
      • Padova, Italia
      • Palermo, Italia
      • Roma, Italia
      • Torino, Italia
  • Norvegia
      • Oslo, Norvegia
      • Tromso, Norvegia
  • Olanda
      • Amsterdam, Olanda
      • Eindhoven, Olanda
      • Enschede, Olanda
      • Heerlen, Olanda
      • Leiden, Olanda
      • Terneuven, Olanda
      • Zwolle, Olanda
  • Regno Unito
      • Bristol, Regno Unito
      • Cambridge, Regno Unito
      • Edinburgh, Regno Unito
      • London, Regno Unito
      • Nottingham, Regno Unito
      • Oxford, Regno Unito
      • Sheffield, Regno Unito
  • Spagna
      • Barcelona, Spagna
      • Madrid, Spagna
      • Oviedo, Spagna
      • Santiago De Compostela, Spagna
      • Sevilla, Spagna
      • Valencia, Spagna
  • Stati Uniti
    • California
      • San Francisco, California, Stati Uniti
    • Florida
      • Gainesville, Florida, Stati Uniti
    • Georgia
      • Atlanta, Georgia, Stati Uniti
    • Illinois
      • Chicago, Illinois, Stati Uniti
    • Indiana
      • Indianapolis, Indiana, Stati Uniti
    • Kentucky
      • Lexington, Kentucky, Stati Uniti
      • Louisville, Kentucky, Stati Uniti
    • Louisiana
      • Baton Rouge, Louisiana, Stati Uniti
    • Maryland
      • Baltimore, Maryland, Stati Uniti
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti
    • Minnesota
      • Rochester, Minnesota, Stati Uniti
    • Nebraska
      • Lincoln, 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
    • Oklahoma
      • Oklahoma City, Oklahoma, Stati Uniti
    • Oregon
      • Portland, Oregon, Stati Uniti
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stati Uniti
      • Pittsburgh, Pennsylvania, Stati Uniti
    • South Carolina
      • Charleston, South Carolina, Stati Uniti
    • Tennessee
      • Germantown, Tennessee, Stati Uniti
      • Kingsport, Tennessee, Stati Uniti
      • Nashville, Tennessee, Stati Uniti
    • Texas
      • Dallas, Texas, Stati Uniti
      • Galveston, Texas, Stati Uniti
      • Houston, Texas, Stati Uniti
    • Washington
      • Seattle, Washington, Stati Uniti
    • Wisconsin
      • Milwaukee, Wisconsin, Stati Uniti
  • Svezia
      • Goteborg, Svezia
      • Malmo, Svezia
      • Orebro, Svezia
      • Stockholm, Svezia
  • Svizzera
      • Basel, Svizzera
      • Bern, Svizzera
      • Lausanne, Svizzera

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:

  • 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

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: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Active 1

Q4W regimen

- every 4 weeks: alternatively placebo and 400mg Certolizumab Pegol
Biologico: Certolizumab pegol
400mg Certolizumab Pegol, Q4W, administered 4-weekly
Altri nomi:
  • Cimzia
  • CDP870
Biologico: Certolizumab pegol
400mg Certolizumab Pegol, Q2W, administered 2-weekly
Altri nomi:
  • Cimzia
  • CDP870
Altro: Placebo
placebo administered 4-weekly in Active 1
Sperimentale: Active 2

Q2W regimen

- every 2 weeks: 400 mg Certolizumab Pegol
Biologico: Certolizumab pegol
400mg Certolizumab Pegol, Q4W, administered 4-weekly
Altri nomi:
  • Cimzia
  • CDP870
Biologico: Certolizumab pegol
400mg Certolizumab Pegol, Q2W, administered 2-weekly
Altri nomi:
  • Cimzia
  • CDP870

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Response Status With Response Defined as at Least 100 Point Decrease in CDAI Score From Baseline in the Randomized Maintenance Phase
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Time to Loss of Response (CDAI Score > 150 and Minimum Increase in CDAI of 70) After Week 6
Lasso di tempo: 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

Collaboratori e investigatori

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

Sponsor

UCB Pharma

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

Collegamenti utili

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 2006

Completamento primario (Effettivo)

1 aprile 2008

Completamento dello studio (Effettivo)

1 aprile 2008

Date di iscrizione allo studio

Primo inviato

28 marzo 2006

Primo inviato che soddisfa i criteri di controllo qualità

28 marzo 2006

Primo Inserito (Stima)

29 marzo 2006

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

7 agosto 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 luglio 2018

Ultimo verificato

1 aprile 2011

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • C87042
  • Eudract number: 2005-004104-37

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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