- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00308581
Certolizumab in Crohn's Disease Patients With Loss of Response or Intolerance to Infliximab
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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Fase 3
Utvidet tilgang
Kontakter og plasseringer
Studiesteder
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Bonheiden, Belgia
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Brussels, Belgia
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Genk, Belgia
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Gent, Belgia
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Kortrijk, Belgia
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Leuven, Belgia
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Liege, Belgia
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Roeselare, Belgia
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Calgary, Canada
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Alberta
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Edmonton, Alberta, Canada
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British Columbia
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Vancouver, British Columbia, Canada
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Ontario
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London, Ontario, Canada
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Richmond, Ontario, Canada
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Toronto, Ontario, Canada
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Aalborg, Danmark
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Arhus, Danmark
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Copenhagen, Danmark
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Herlev, Danmark
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California
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San Francisco, California, Forente stater
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Florida
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Gainesville, Florida, Forente stater
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Georgia
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Atlanta, Georgia, Forente stater
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Illinois
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Chicago, Illinois, Forente stater
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Indiana
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Indianapolis, Indiana, Forente stater
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Kentucky
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Lexington, Kentucky, Forente stater
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Louisville, Kentucky, Forente stater
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Louisiana
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Baton Rouge, Louisiana, Forente stater
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Maryland
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Baltimore, Maryland, Forente stater
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Massachusetts
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Boston, Massachusetts, Forente stater
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Minnesota
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Rochester, Minnesota, Forente stater
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Nebraska
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Lincoln, Nebraska, Forente stater
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New York
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Great Neck, New York, Forente stater
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New York, New York, Forente stater
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North Carolina
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Chapel Hill, North Carolina, Forente stater
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Charlotte, North Carolina, Forente stater
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Ohio
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Cincinnati, Ohio, Forente stater
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Cleveland, Ohio, Forente stater
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Oklahoma
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Oklahoma City, Oklahoma, Forente stater
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Oregon
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Portland, Oregon, Forente stater
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater
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Pittsburgh, Pennsylvania, Forente stater
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South Carolina
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Charleston, South Carolina, Forente stater
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Tennessee
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Germantown, Tennessee, Forente stater
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Kingsport, Tennessee, Forente stater
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Nashville, Tennessee, Forente stater
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Texas
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Dallas, Texas, Forente stater
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Galveston, Texas, Forente stater
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Houston, Texas, Forente stater
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Washington
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Seattle, Washington, Forente stater
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Wisconsin
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Milwaukee, Wisconsin, Forente stater
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Amiens, Frankrike
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Clichy, Frankrike
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Grenoble, Cedex 9, Frankrike
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Lille, Frankrike
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Montpellier, Cédex 5, Frankrike
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Nice, Frankrike, Cedex 3
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Paris, Frankrike
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Pessac, Frankrike
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Rouen, Frankrike
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Toulouse, Cedex 9, Frankrike
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Bari, Italia
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Bologna, Italia
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Milano, Italia
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Padova, Italia
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Palermo, Italia
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Roma, Italia
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Torino, Italia
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Amsterdam, Nederland
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Eindhoven, Nederland
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Enschede, Nederland
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Heerlen, Nederland
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Leiden, Nederland
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Terneuven, Nederland
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Zwolle, Nederland
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Oslo, Norge
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Tromso, Norge
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Barcelona, Spania
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Madrid, Spania
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Oviedo, Spania
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Santiago De Compostela, Spania
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Sevilla, Spania
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Valencia, Spania
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Bristol, Storbritannia
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Cambridge, Storbritannia
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Edinburgh, Storbritannia
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London, Storbritannia
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Nottingham, Storbritannia
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Oxford, Storbritannia
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Sheffield, Storbritannia
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Basel, Sveits
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Bern, Sveits
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Lausanne, Sveits
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Goteborg, Sverige
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Malmo, Sverige
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Orebro, Sverige
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Stockholm, Sverige
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Berlin, Tyskland
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Hamburg, Tyskland
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Hannover, Tyskland
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Herne, Tyskland
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Kiel, Tyskland
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Leipzig, Tyskland
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Minden, Tyskland
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Munchen, Tyskland
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Munich, Tyskland
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Innsbruck, Østerrike
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Oberpullendorf, Østerrike
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Wien, Østerrike
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Active 1
Q4W regimen - every 4 weeks: alternatively placebo and 400mg Certolizumab Pegol |
400mg Certolizumab Pegol, Q4W, administered 4-weekly
Andre navn:
400mg Certolizumab Pegol, Q2W, administered 2-weekly
Andre navn:
placebo administered 4-weekly in Active 1
|
Eksperimentell: Active 2
Q2W regimen - every 2 weeks: 400 mg Certolizumab Pegol |
400mg Certolizumab Pegol, Q4W, administered 4-weekly
Andre navn:
400mg Certolizumab Pegol, Q2W, administered 2-weekly
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
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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
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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
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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.
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Week 26
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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.
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Week 2
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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.
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Week 6
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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.
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Week 8
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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.
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Week 10
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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.
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Week 12
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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.
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Week 14
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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.
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Week 16
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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.
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Week 18
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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.
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Week 20
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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.
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Week 22
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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.
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Week 24
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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.
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Week 26
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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.
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Baseline to Week 2
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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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Taylor P, Manger B, Alvaro-Gracia J, Johnstone R, Gomez-Reino J, Eberhardt E, Wolfe F, Schwartzman S, Furfaro N, Kavanaugh A. Patient perceptions concerning pain management in the treatment of rheumatoid arthritis. J Int Med Res. 2010 Jul-Aug;38(4):1213-24. doi: 10.1177/147323001003800402.
- Sandborn WJ, Abreu MT, D'Haens G, Colombel JF, Vermeire S, Mitchev K, Jamoul C, Fedorak RN, Spehlmann ME, Wolf DC, Lee S, Rutgeerts P. Certolizumab pegol in patients with moderate to severe Crohn's disease and secondary failure to infliximab. Clin Gastroenterol Hepatol. 2010 Aug;8(8):688-695.e2. doi: 10.1016/j.cgh.2010.04.021. Epub 2010 May 6.
- Feagan BG, Sandborn WJ, Wolf DC, Coteur G, Purcaru O, Brabant Y, Rutgeerts PJ. Randomised clinical trial: improvement in health outcomes with certolizumab pegol in patients with active Crohn's disease with prior loss of response to infliximab. Aliment Pharmacol Ther. 2011 Mar;33(5):541-50. doi: 10.1111/j.1365-2036.2010.04568.x. Epub 2011 Jan 12.
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- C87042
- Eudract number: 2005-004104-37
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