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

10. juli 2018 opdateret af: 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

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

539

Fase

  • Fase 3

Udvidet adgang

Ledig uden for det kliniske forsøg. Se udvidet adgangsregistrering.

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Active 1

Q4W regimen

- every 4 weeks: alternatively placebo and 400mg Certolizumab Pegol
Biologisk: Certolizumab pegol
400mg Certolizumab Pegol, Q4W, administered 4-weekly
Andre navne:
  • Cimzia
  • CDP870
Biologisk: Certolizumab pegol
400mg Certolizumab Pegol, Q2W, administered 2-weekly
Andre navne:
  • Cimzia
  • CDP870
Andet: Placebo
placebo administered 4-weekly in Active 1
Eksperimentel: Active 2

Q2W regimen

- every 2 weeks: 400 mg Certolizumab Pegol
Biologisk: Certolizumab pegol
400mg Certolizumab Pegol, Q4W, administered 4-weekly
Andre navne:
  • Cimzia
  • CDP870
Biologisk: Certolizumab pegol
400mg Certolizumab Pegol, Q2W, administered 2-weekly
Andre navne:
  • Cimzia
  • CDP870

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Response Status With Response Defined as at Least 100 Point Decrease in CDAI Score From Baseline in the Randomized Maintenance Phase
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to Loss of Response (CDAI Score > 150 and Minimum Increase in CDAI of 70) After Week 6
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

UCB Pharma

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2006

Primær færdiggørelse (Faktiske)

1. april 2008

Studieafslutning (Faktiske)

1. april 2008

Datoer for studieregistrering

Først indsendt

28. marts 2006

Først indsendt, der opfyldte QC-kriterier

28. marts 2006

Først opslået (Skøn)

29. marts 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. august 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. juli 2018

Sidst verificeret

1. april 2011

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • C87042
  • Eudract number: 2005-004104-37

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