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

10. července 2018 aktualizováno: 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

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

539

Fáze

  • Fáze 3

Rozšířený přístup

Dostupný mimo klinické hodnocení. Viz rozšířený záznam o přístupu.

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Active 1

Q4W regimen

- every 4 weeks: alternatively placebo and 400mg Certolizumab Pegol
Biologický: Certolizumab pegol
400mg Certolizumab Pegol, Q4W, administered 4-weekly
Ostatní jména:
  • Cimzia
  • CDP870
Biologický: Certolizumab pegol
400mg Certolizumab Pegol, Q2W, administered 2-weekly
Ostatní jména:
  • Cimzia
  • CDP870
Jiný: Placebo
placebo administered 4-weekly in Active 1
Experimentální: Active 2

Q2W regimen

- every 2 weeks: 400 mg Certolizumab Pegol
Biologický: Certolizumab pegol
400mg Certolizumab Pegol, Q4W, administered 4-weekly
Ostatní jména:
  • Cimzia
  • CDP870
Biologický: Certolizumab pegol
400mg Certolizumab Pegol, Q2W, administered 2-weekly
Ostatní jména:
  • Cimzia
  • CDP870

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
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
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Response Status With Response Defined as at Least 100 Point Decrease in CDAI Score From Baseline in the Randomized Maintenance Phase
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Time to Loss of Response (CDAI Score > 150 and Minimum Increase in CDAI of 70) After Week 6
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

UCB Pharma

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. dubna 2006

Primární dokončení (Aktuální)

1. dubna 2008

Dokončení studie (Aktuální)

1. dubna 2008

Termíny zápisu do studia

První předloženo

28. března 2006

První předloženo, které splnilo kritéria kontroly kvality

28. března 2006

První zveřejněno (Odhad)

29. března 2006

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

7. srpna 2018

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

10. července 2018

Naposledy ověřeno

1. dubna 2011

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • C87042
  • Eudract number: 2005-004104-37

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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