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

10 juli 2018 uppdaterad av: 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

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

539

Fas

  • Fas 3

Utökad åtkomst

Tillgängligt utanför den kliniska prövningen. Se utökad åtkomstpost.

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Belgien
      • Bonheiden, Belgien
      • Brussels, Belgien
      • Genk, Belgien
      • Gent, Belgien
      • Kortrijk, Belgien
      • Leuven, Belgien
      • Liege, Belgien
      • Roeselare, Belgien
  • Danmark
      • Aalborg, Danmark
      • Arhus, Danmark
      • Copenhagen, Danmark
      • Herlev, Danmark
  • Frankrike
      • Amiens, Frankrike
      • Clichy, Frankrike
      • Grenoble, Cedex 9, Frankrike
      • Lille, Frankrike
      • Montpellier, Cédex 5, Frankrike
      • Nice, Frankrike, Cedex 3
      • Paris, Frankrike
      • Pessac, Frankrike
      • Rouen, Frankrike
      • Toulouse, Cedex 9, Frankrike
  • Förenta staterna
    • California
      • San Francisco, California, Förenta staterna
    • Florida
      • Gainesville, Florida, Förenta staterna
    • Georgia
      • Atlanta, Georgia, Förenta staterna
    • Illinois
      • Chicago, Illinois, Förenta staterna
    • Indiana
      • Indianapolis, Indiana, Förenta staterna
    • Kentucky
      • Lexington, Kentucky, Förenta staterna
      • Louisville, Kentucky, Förenta staterna
    • Louisiana
      • Baton Rouge, Louisiana, Förenta staterna
    • Maryland
      • Baltimore, Maryland, Förenta staterna
    • Massachusetts
      • Boston, Massachusetts, Förenta staterna
    • Minnesota
      • Rochester, Minnesota, Förenta staterna
    • Nebraska
      • Lincoln, Nebraska, Förenta staterna
    • New York
      • Great Neck, New York, Förenta staterna
      • New York, New York, Förenta staterna
    • North Carolina
      • Chapel Hill, North Carolina, Förenta staterna
      • Charlotte, North Carolina, Förenta staterna
    • Ohio
      • Cincinnati, Ohio, Förenta staterna
      • Cleveland, Ohio, Förenta staterna
    • Oklahoma
      • Oklahoma City, Oklahoma, Förenta staterna
    • Oregon
      • Portland, Oregon, Förenta staterna
    • Pennsylvania
      • Philadelphia, Pennsylvania, Förenta staterna
      • Pittsburgh, Pennsylvania, Förenta staterna
    • South Carolina
      • Charleston, South Carolina, Förenta staterna
    • Tennessee
      • Germantown, Tennessee, Förenta staterna
      • Kingsport, Tennessee, Förenta staterna
      • Nashville, Tennessee, Förenta staterna
    • Texas
      • Dallas, Texas, Förenta staterna
      • Galveston, Texas, Förenta staterna
      • Houston, Texas, Förenta staterna
    • Washington
      • Seattle, Washington, Förenta staterna
    • Wisconsin
      • Milwaukee, Wisconsin, Förenta staterna
  • Italien
      • Bari, Italien
      • Bologna, Italien
      • Milano, Italien
      • Padova, Italien
      • Palermo, Italien
      • Roma, Italien
      • Torino, Italien
  • Kanada
      • Calgary, Kanada
    • Alberta
      • Edmonton, Alberta, Kanada
    • British Columbia
      • Vancouver, British Columbia, Kanada
    • Ontario
      • London, Ontario, Kanada
      • Richmond, Ontario, Kanada
      • Toronto, Ontario, Kanada
  • Nederländerna
      • Amsterdam, Nederländerna
      • Eindhoven, Nederländerna
      • Enschede, Nederländerna
      • Heerlen, Nederländerna
      • Leiden, Nederländerna
      • Terneuven, Nederländerna
      • Zwolle, Nederländerna
  • 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
  • Storbritannien
      • Bristol, Storbritannien
      • Cambridge, Storbritannien
      • Edinburgh, Storbritannien
      • London, Storbritannien
      • Nottingham, Storbritannien
      • Oxford, Storbritannien
      • Sheffield, Storbritannien
  • 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
  • Österrike
      • Innsbruck, Österrike
      • Oberpullendorf, Österrike
      • Wien, Österrike

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Active 1

Q4W regimen

- every 4 weeks: alternatively placebo and 400mg Certolizumab Pegol
Biologisk: Certolizumab pegol
400mg Certolizumab Pegol, Q4W, administered 4-weekly
Andra namn:
  • Cimzia
  • CDP870
Biologisk: Certolizumab pegol
400mg Certolizumab Pegol, Q2W, administered 2-weekly
Andra namn:
  • Cimzia
  • CDP870
Övrig: Placebo
placebo administered 4-weekly in Active 1
Experimentell: Active 2

Q2W regimen

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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Response Status With Response Defined as at Least 100 Point Decrease in CDAI Score From Baseline in the Randomized Maintenance Phase
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Time to Loss of Response (CDAI Score > 150 and Minimum Increase in CDAI of 70) After Week 6
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

UCB Pharma

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 april 2006

Primärt slutförande (Faktisk)

1 april 2008

Avslutad studie (Faktisk)

1 april 2008

Studieregistreringsdatum

Först inskickad

28 mars 2006

Först inskickad som uppfyllde QC-kriterierna

28 mars 2006

Första postat (Uppskatta)

29 mars 2006

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

7 augusti 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

10 juli 2018

Senast verifierad

1 april 2011

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • C87042
  • Eudract number: 2005-004104-37

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