Maintenance Study Including Re-induction Therapy for Patients Who Did Not Show a Clinical Effect in Study C87037 (NCT00291668)
27 de fevereiro de 2015 atualizado por: UCB Pharma
A Multi-center, Open-label Study to Investigate the Efficacy and Safety of CDP870 in Active Crohn's Disease Patients, Who Showed no Clinical Efficacy in a Remission Induction Study (Study C87037) But Showed Clinical Efficacy After Additional Remission Induction Therapy Was Applied, at Week 26 After Subcutaneous Administration of CDP870 400 mg From Week 8 Until Week 24 at 4-week Intervals
This 26-week extension study evaluates the efficacy and safety of certolizumab pegol administered subcutaneously every 4 weeks (dosed at Weeks 16, 20, 24, 28 and 32) in subjects with active Crohn's disease who had no clinical response at Week 6 to induction therapy in the 6-week double-blind main study, C87037 (NCT00291668), but subsequently showed clinical response at Week 14 to repeated induction therapy (dosed at Weeks 8, 10 and 12) in this extension study.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
This study is an open-label extension study which follows on from the 6-week double-blind main study C87037 (NCT00291668).
All 'Week' numbers quoted are relative to the start of the double-blind main study.
The first visit in this extension study is at Week 8, and the final efficacy assessment in this extension study, 26 weeks later, is at Week 34.
Tipo de estudo
Intervencional
Inscrição (Real)
46
Estágio
- Fase 2
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Fukuoka, Japão
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Kagoshima, Japão
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Nagasaki, Japão
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Niigata, Japão
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Osaka, Japão
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Aichi
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Aichi-Gun, Aichi, Japão
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Nagoya, Aichi, Japão
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Toyoake, Aichi, Japão
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Toyohashi, Aichi, Japão
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Chiba
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Kashiwa, Chiba, Japão
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Sakura, Chiba, Japão
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Fukuoka
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Chikusino, Fukuoka, Japão
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Hokkaido
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Asahikawa, Hokkaido, Japão
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Sapporo, Hokkaido, Japão
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Hyogo
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Nishinomiya, Hyogo, Japão
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Kanagawa
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Yokohama, Kanagawa, Japão
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Miyazaki
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Miyazaki-gun, Miyazaki, Japão
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Okayama
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Kurashiki, Okayama, Japão
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Okianawa
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Tyuto-gun, Okianawa, Japão
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Osaka
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Osaka Suita, Osaka, Japão
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Shiga
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Shiga Otsu, Shiga, Japão
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Tokyo
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Shinjyuku, Tokyo, Japão
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Shinjyuku/Tokyo, Tokyo, Japão
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
16 anos a 64 anos (Filho, Adulto)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Subjects who gave written informed consent and who did not show clinical efficacy at Week 6 of the double-blind main study (NCT00291668) [reduction in Crohn's Disease Activity Index (CDAI) score of ≥100 points from Week 0, or remission (CDAI ≤150)]
Exclusion Criteria:
- Subjects who experienced aggravation of Crohn's Disease during the double-blind main study (NCT00291668) and required treatment change
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: CZP 400 mg / Placebo
Certolizumabe pegol (CZP) 400 mg neste estudo de extensão / Placebo no estudo principal duplo-cego (NCT00291668)
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Certolizumab pegol (CZP) 400 mg administered subcutaneously in a liquid formulation at Weeks 8, 10, 12, 16, 20, 24, 28 and 32 relative to the start of the 6-week double-blind main study C87037 (NCT00291668) where subjects received Placebo at Weeks 0, 2 and 4.
Outros nomes:
Certolizumab pegol (CZP) 400 mg administered subcutaneously in a liquid formulation at Weeks 8, 10, 12, 16, 20, 24, 28 and 32 relative to the start of the 6-week double-blind main study C87037 (NCT00291668) where subjects received Certolizumab pegol (CZP) 200 mg at Weeks 0, 2 and 4.
Outros nomes:
Certolizumab pegol (CZP) 400 mg administered subcutaneously in a liquid formulation at Weeks 8, 10, 12, 16, 20, 24, 28 and 32 relative to the start of the 6-week double-blind main study C87037 (NCT00291668) where subjects received Certolizumab pegol (CZP) 400 mg at Weeks 0, 2 and 4.
Outros nomes:
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Experimental: CZP 400 mg / CZP 200 mg
Certolizumabe pegol (CZP) 400 mg neste estudo de extensão / Certolizumabe pegol (CZP) 200 mg no estudo principal duplo-cego (NCT00291668)
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Certolizumab pegol (CZP) 400 mg administered subcutaneously in a liquid formulation at Weeks 8, 10, 12, 16, 20, 24, 28 and 32 relative to the start of the 6-week double-blind main study C87037 (NCT00291668) where subjects received Placebo at Weeks 0, 2 and 4.
Outros nomes:
Certolizumab pegol (CZP) 400 mg administered subcutaneously in a liquid formulation at Weeks 8, 10, 12, 16, 20, 24, 28 and 32 relative to the start of the 6-week double-blind main study C87037 (NCT00291668) where subjects received Certolizumab pegol (CZP) 200 mg at Weeks 0, 2 and 4.
Outros nomes:
Certolizumab pegol (CZP) 400 mg administered subcutaneously in a liquid formulation at Weeks 8, 10, 12, 16, 20, 24, 28 and 32 relative to the start of the 6-week double-blind main study C87037 (NCT00291668) where subjects received Certolizumab pegol (CZP) 400 mg at Weeks 0, 2 and 4.
Outros nomes:
|
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Experimental: CZP 400 mg / CZP 400 mg
Certolizumabe pegol (CZP) 400 mg neste estudo de extensão / Certolizumabe pegol (CZP) 400 mg no estudo principal duplo-cego (NCT00291668)
|
Certolizumab pegol (CZP) 400 mg administered subcutaneously in a liquid formulation at Weeks 8, 10, 12, 16, 20, 24, 28 and 32 relative to the start of the 6-week double-blind main study C87037 (NCT00291668) where subjects received Placebo at Weeks 0, 2 and 4.
Outros nomes:
Certolizumab pegol (CZP) 400 mg administered subcutaneously in a liquid formulation at Weeks 8, 10, 12, 16, 20, 24, 28 and 32 relative to the start of the 6-week double-blind main study C87037 (NCT00291668) where subjects received Certolizumab pegol (CZP) 200 mg at Weeks 0, 2 and 4.
Outros nomes:
Certolizumab pegol (CZP) 400 mg administered subcutaneously in a liquid formulation at Weeks 8, 10, 12, 16, 20, 24, 28 and 32 relative to the start of the 6-week double-blind main study C87037 (NCT00291668) where subjects received Certolizumab pegol (CZP) 400 mg at Weeks 0, 2 and 4.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 34
Prazo: Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.
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Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150).
CDAI 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.
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Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 8
Prazo: Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.
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Crohn's disease activity index (CDAI) 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 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.
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Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 10
Prazo: Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.
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Crohn's disease activity index (CDAI) 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 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.
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Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 12
Prazo: Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.
|
Crohn's disease activity index (CDAI) 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 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.
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Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 14
Prazo: Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.
|
Crohn's disease activity index (CDAI) 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 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.
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Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 16
Prazo: Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.
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Crohn's disease activity index (CDAI) 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 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.
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Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 20
Prazo: Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.
|
Crohn's disease activity index (CDAI) 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 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.
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Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 24
Prazo: Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.
|
Crohn's disease activity index (CDAI) 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 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.
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Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 28
Prazo: Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.
|
Crohn's disease activity index (CDAI) 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 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.
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Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 32
Prazo: Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.
|
Crohn's disease activity index (CDAI) 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 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.
|
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Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 34
Prazo: Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.
|
Crohn's disease activity index (CDAI) 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 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.
|
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Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)
Prazo: Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.
|
Crohn's disease activity index (CDAI) 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 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.
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Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 8
Prazo: Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.
|
Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150).
CDAI 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.
|
Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.
|
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Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 10
Prazo: Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.
|
Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150).
CDAI 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.
|
Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.
|
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Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 12
Prazo: Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.
|
Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150).
CDAI 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.
|
Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.
|
|
Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 14
Prazo: Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.
|
Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150).
CDAI 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.
|
Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.
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Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 16
Prazo: Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.
|
Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150).
CDAI 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.
|
Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.
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Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 20
Prazo: Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.
|
Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150).
CDAI 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.
|
Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.
|
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Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 24
Prazo: Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.
|
Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150).
CDAI 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.
|
Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.
|
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Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 28
Prazo: Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.
|
Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150).
CDAI 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.
|
Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.
|
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Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 32
Prazo: Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.
|
Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150).
CDAI 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.
|
Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.
|
|
Percentage of Crohn's Disease Activity Index (CDAI) Responders at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)
Prazo: Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.
|
Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150).
CDAI 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.
|
Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.
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Percentage of Subjects Achieving Remission at Week 8
Prazo: Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.
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Crohn's disease activity index (CDAI) 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.
|
Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.
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Percentage of Subjects Achieving Remission at Week 10
Prazo: Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.
|
Crohn's disease activity index (CDAI) 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.
|
Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.
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Percentage of Subjects Achieving Remission at Week 12
Prazo: Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.
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Crohn's disease activity index (CDAI) 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.
|
Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.
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Percentage of Subjects Achieving Remission at Week 14
Prazo: Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.
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Crohn's disease activity index (CDAI) 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.
|
Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.
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Percentage of Subjects Achieving Remission at Week 16
Prazo: Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.
|
Crohn's disease activity index (CDAI) 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.
|
Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.
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Percentage of Subjects Achieving Remission at Week 20
Prazo: Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.
|
Crohn's disease activity index (CDAI) 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.
|
Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.
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Percentage of Subjects Achieving Remission at Week 24
Prazo: Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.
|
Crohn's disease activity index (CDAI) 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.
|
Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.
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Percentage of Subjects Achieving Remission at Week 28
Prazo: Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.
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Crohn's disease activity index (CDAI) 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.
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Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.
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Percentage of Subjects Achieving Remission at Week 32
Prazo: Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.
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Crohn's disease activity index (CDAI) 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.
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Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.
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Percentage of Subjects Achieving Remission at Week 34
Prazo: Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.
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Crohn's disease activity index (CDAI) 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.
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Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.
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Percentage of Subjects Achieving Remission at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)
Prazo: Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.
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Crohn's disease activity index (CDAI) 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.
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Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.
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Time to Disease Progression
Prazo: Week 14 to Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is the visit at which response to re-induction is assessed and 'Week 34' is 26 weeks after the first visit in this extension study.
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Time to disease progression is defined as the earliest of:
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Week 14 to Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is the visit at which response to re-induction is assessed and 'Week 34' is 26 weeks after the first visit in this extension study.
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Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 8
Prazo: Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.
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The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.
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Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.
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Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 10
Prazo: Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.
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The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.
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Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.
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Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 12
Prazo: Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.
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The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.
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Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.
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Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 14
Prazo: Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.
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The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.
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Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.
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Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 16
Prazo: Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.
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The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.
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Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.
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Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 20
Prazo: Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.
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The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.
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Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.
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Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 24
Prazo: Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.
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The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.
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Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.
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Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 28
Prazo: Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.
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The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.
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Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.
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Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 32
Prazo: Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.
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The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.
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Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.
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Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 34
Prazo: Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.
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The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.
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Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.
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Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)
Prazo: Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.
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The Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.
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Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.
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Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 8
Prazo: Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.
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The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
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Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.
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Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 10
Prazo: Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.
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The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
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Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.
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Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 12
Prazo: Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.
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The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
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Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.
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Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 14
Prazo: Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.
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The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
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Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.
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Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 16
Prazo: Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.
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The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
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Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.
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Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 20
Prazo: Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.
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The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
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Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.
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Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 24
Prazo: Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.
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The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
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Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.
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Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 28
Prazo: Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.
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The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
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Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.
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Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 32
Prazo: Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.
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The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
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Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.
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Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 34
Prazo: Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.
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The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
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Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.
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Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)
Prazo: Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.
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The Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
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Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.
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Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 8
Prazo: Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.
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The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
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Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.
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Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 10
Prazo: Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.
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The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
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Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.
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Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 12
Prazo: Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.
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The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
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Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.
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Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 14
Prazo: Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.
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The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
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Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.
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Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 16
Prazo: Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.
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The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
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Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.
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Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 20
Prazo: Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.
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The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
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Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.
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Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 24
Prazo: Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.
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The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
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Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.
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Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 28
Prazo: Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.
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The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
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Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.
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Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 32
Prazo: Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.
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The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
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Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.
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Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 34
Prazo: Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.
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The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
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Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.
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Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)
Prazo: Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.
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The Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
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Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.
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Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 8
Prazo: Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.
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The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
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Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.
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Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 10
Prazo: Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.
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The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
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Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.
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Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 12
Prazo: Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.
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The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
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Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.
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Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 14
Prazo: Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.
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The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
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Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.
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Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 16
Prazo: Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.
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The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
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Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.
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Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 20
Prazo: Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.
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The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
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Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.
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Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 24
Prazo: Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.
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The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
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Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.
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Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 28
Prazo: Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.
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The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
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Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.
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Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 32
Prazo: Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.
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The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
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Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.
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Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 34
Prazo: Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.
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The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
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Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.
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Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)
Prazo: Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.
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The Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
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Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.
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Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 8
Prazo: Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.
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The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
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Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.
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Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 10
Prazo: Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.
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The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
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Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.
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Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 12
Prazo: Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.
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The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
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Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.
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Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 14
Prazo: Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.
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The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
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Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.
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Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 16
Prazo: Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.
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The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
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Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.
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Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 20
Prazo: Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.
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The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
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Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.
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Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 24
Prazo: Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.
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The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
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Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.
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Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 28
Prazo: Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.
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The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
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Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.
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Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 32
Prazo: Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.
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The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
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Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.
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Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 34
Prazo: Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.
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The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
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Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.
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Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)
Prazo: Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.
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The Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
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Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.
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C-Reactive Protein (CRP) Level at Week 0
Prazo: Week 0 (relative to the start of the 6-week double-blind main study (N00291668)). 'Week 0' is the Baseline visit in the double-blind main study.
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Week 0 (relative to the start of the 6-week double-blind main study (N00291668)). 'Week 0' is the Baseline visit in the double-blind main study.
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Nível de Proteína C-Reativa (PCR) na Semana 8
Prazo: Semana 8 (em relação ao início do estudo principal duplo-cego de 6 semanas (NCT00291668)). 'Semana 8' é a primeira visita neste estudo de extensão.
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Semana 8 (em relação ao início do estudo principal duplo-cego de 6 semanas (NCT00291668)). 'Semana 8' é a primeira visita neste estudo de extensão.
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C-Reactive Protein (CRP) Level at Week 10
Prazo: Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.
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Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.
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Nível de Proteína C-Reativa (PCR) na Semana 12
Prazo: Semana 12 (em relação ao início do estudo principal duplo-cego de 6 semanas (NCT00291668)). 'Semana 12' é 4 semanas após a primeira visita neste estudo de extensão.
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Semana 12 (em relação ao início do estudo principal duplo-cego de 6 semanas (NCT00291668)). 'Semana 12' é 4 semanas após a primeira visita neste estudo de extensão.
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C-Reactive Protein (CRP) Level at Week 14
Prazo: Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.
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Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.
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Nível de Proteína C-Reativa (PCR) na Semana 16
Prazo: Semana 16 (em relação ao início do estudo principal duplo-cego de 6 semanas (NCT00291668)). 'Semana 16' é 8 semanas após a primeira visita neste estudo de extensão.
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Semana 16 (em relação ao início do estudo principal duplo-cego de 6 semanas (NCT00291668)). 'Semana 16' é 8 semanas após a primeira visita neste estudo de extensão.
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Nível de Proteína C-Reativa (PCR) na Semana 20
Prazo: Semana 20 (em relação ao início do estudo principal duplo-cego de 6 semanas (NCT00291668)). 'Semana 20' é 12 semanas após a primeira visita neste estudo de extensão.
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Semana 20 (em relação ao início do estudo principal duplo-cego de 6 semanas (NCT00291668)). 'Semana 20' é 12 semanas após a primeira visita neste estudo de extensão.
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Nível de Proteína C-Reativa (PCR) na Semana 24
Prazo: Semana 24 (em relação ao início do estudo principal duplo-cego de 6 semanas (NCT00291668)). 'Semana 24' é 16 semanas após a primeira visita neste estudo de extensão.
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Semana 24 (em relação ao início do estudo principal duplo-cego de 6 semanas (NCT00291668)). 'Semana 24' é 16 semanas após a primeira visita neste estudo de extensão.
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C-Reactive Protein (CRP) Level at Week 28
Prazo: Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.
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Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.
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C-Reactive Protein (CRP) Level at Week 32
Prazo: Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.
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Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.
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C-Reactive Protein (CRP) Level at Week 34
Prazo: Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.
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Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.
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C-Reactive Protein (CRP) Level at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)
Prazo: Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.
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Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.
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Ratio of C-Reactive Protein (CRP) Level at Week 8 to CRP Level at Week 0
Prazo: Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.
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The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 8 divided by the CRP Level at Week 0
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Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.
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Ratio of C-Reactive Protein (CRP) Level at Week 10 to CRP Level at Week 0
Prazo: Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.
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The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 10 divided by the CRP Level at Week 0
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Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.
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Ratio of C-Reactive Protein (CRP) Level at Week 12 to CRP Level at Week 0
Prazo: Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.
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The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 12 divided by the CRP Level at Week 0
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Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.
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Ratio of C-Reactive Protein (CRP) Level at Week 14 to CRP Level at Week 0
Prazo: Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.
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The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 14 divided by the CRP Level at Week 0
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Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.
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Ratio of C-Reactive Protein (CRP) Level at Week 16 to CRP Level at Week 0
Prazo: Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.
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The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 16 divided by the CRP Level at Week 0
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Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.
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Ratio of C-Reactive Protein (CRP) Level at Week 20 to CRP Level at Week 0
Prazo: Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.
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The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 20 divided by the CRP Level at Week 0
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Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.
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Ratio of C-Reactive Protein (CRP) Level at Week 24 to CRP Level at Week 0
Prazo: Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.
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The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 24 divided by the CRP Level at Week 0
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Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.
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Ratio of C-Reactive Protein (CRP) Level at Week 28 to CRP Level at Week 0
Prazo: Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.
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The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 28 divided by the CRP Level at Week 0
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Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.
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Ratio of C-Reactive Protein (CRP) Level at Week 32 to CRP Level at Week 0
Prazo: Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.
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The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 32 divided by the CRP Level at Week 0
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Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.
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Ratio of C-Reactive Protein (CRP) Level at Week 34 to CRP Level at Week 0
Prazo: Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.
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The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 34 divided by the CRP Level at Week 0
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Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.
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Ratio of C-Reactive Protein (CRP) Level at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) to CRP Level at Week 0
Prazo: Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.
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The ratio is calculated as the C-Reactive Protein (CRP) Level at Last Visit (Week 34 for completers or the Withdrawal Visit for premature withdrawals)divided by the CRP Level at Week 0
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Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.
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Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 8
Prazo: Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.
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70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI 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.
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Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.
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Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 10
Prazo: Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.
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70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI 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.
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Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.
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Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 12
Prazo: Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.
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70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI 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.
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Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.
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Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 14
Prazo: Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.
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70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI 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.
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Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.
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Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 16
Prazo: Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.
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70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI 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.
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Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.
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Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 20
Prazo: Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.
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70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI 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.
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Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.
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Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 24
Prazo: Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.
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70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI 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.
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Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.
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Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 28
Prazo: Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.
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70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI 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.
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Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.
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Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 32
Prazo: Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.
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70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI 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.
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Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.
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Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 34
Prazo: Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.
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70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI 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.
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Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.
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Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)
Prazo: Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.
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70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI 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.
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Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Links úteis
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de maio de 2006
Conclusão Primária (Real)
1 de maio de 2008
Conclusão do estudo (Real)
1 de maio de 2008
Datas de inscrição no estudo
Enviado pela primeira vez
22 de maio de 2006
Enviado pela primeira vez que atendeu aos critérios de CQ
22 de maio de 2006
Primeira postagem (Estimativa)
24 de maio de 2006
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
18 de março de 2015
Última atualização enviada que atendeu aos critérios de controle de qualidade
27 de fevereiro de 2015
Última verificação
1 de fevereiro de 2015
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- C87048
- 2014-004400-30 (Número EudraCT)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .