Crohn's Disease
Conditions
Keywords
Crohn's Disease, CDP870, Certolizumab pegol, CZP
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALCertolizumab pegol
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.
Sponsors
UCB Pharma
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 34 | 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) 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 10 | 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) 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. |
| Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 12 | 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. |
| Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 14 | 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. |
| Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 16 | 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) 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. |
| Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 20 | 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. |
| Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 24 | 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. |
| Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 28 | 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. |
| Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 32 | 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. |
| Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 34 | 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. |
| 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) | 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. |
| Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 8 | 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. |
| Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 10 | 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. |
| Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 12 | 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. |
| Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 14 | 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. |
| Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 16 | 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. |
| Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 20 | 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. |
| Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 24 | 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. |
| Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 28 | 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. |
| Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 32 | 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. |
| Percentage of Crohn's Disease Activity Index (CDAI) Responders at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) | 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. |
| Percentage of Subjects Achieving Remission at Week 8 | 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) 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. |
| Percentage of Subjects Achieving Remission at Week 10 | 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. |
| Percentage of Subjects Achieving Remission at Week 12 | 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. |
| Percentage of Subjects Achieving Remission at Week 14 | 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. |
| Percentage of Subjects Achieving Remission at Week 16 | 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. |
| Percentage of Subjects Achieving Remission at Week 20 | 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. |
| Percentage of Subjects Achieving Remission at Week 24 | 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. |
| Percentage of Subjects Achieving Remission at Week 28 | 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. |
| Percentage of Subjects Achieving Remission at Week 32 | 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. |
| Percentage of Subjects Achieving Remission at Week 34 | 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. |
| Percentage of Subjects Achieving Remission at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) | 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. |
| Time to Disease Progression | 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. | Time to disease progression is defined as the earliest of: * time to an increase from Week 14 of ≥100 points in Crohn's Disease Activity Index (CDAI) score and CDAI\>175 points for at least 2 consecutive visits, * time to use of rescue therapy, or, * time to subject withdrawal from the study. |
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 8 | 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. | 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. |
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 10 | 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. | 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. |
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 12 | 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. | 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. |
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 14 | 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. | 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. |
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 16 | 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. | 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. |
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 20 | 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. | 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. |
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 24 | 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. | 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. |
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 28 | 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. | 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. |
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 32 | 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. | 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. |
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 34 | 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. | 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. |
| 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) | 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. | 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. |
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 8 | 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. | 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. |
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 10 | 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. | 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. |
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 12 | 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. | 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. |
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 14 | 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. | 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. |
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 16 | 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. | 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. |
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 20 | 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. | 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. |
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 24 | 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. | 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. |
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 28 | 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. | 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. |
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 32 | 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. | 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. |
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 34 | 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. | 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. |
| 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) | 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. | 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. |
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 8 | 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. | 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. |
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 10 | 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. | 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. |
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 12 | 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. | 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. |
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 14 | 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. | 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. |
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 16 | 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. | 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. |
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 20 | 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. | 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. |
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 24 | 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. | 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. |
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 28 | 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. | 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. |
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 32 | 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. | 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. |
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 34 | 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. | 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. |
| 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) | 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. | 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. |
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 8 | 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. | 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. |
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 10 | 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. | 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. |
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 12 | 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. | 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. |
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 14 | 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. | 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. |
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 16 | 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. | 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. |
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 20 | 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. | 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. |
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 24 | 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. | 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. |
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 28 | 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. | 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. |
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 32 | 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. | 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. |
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 34 | 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. | 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. |
| 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) | 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. | 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. |
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 8 | 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. | 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. |
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 10 | 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. | 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. |
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 12 | 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. | 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. |
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 14 | 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. | 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. |
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 16 | 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. | 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. |
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 20 | 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. | 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. |
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 24 | 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. | 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. |
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 28 | 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. | 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. |
| C-Reactive Protein (CRP) Level at Week 16 | 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. | — |
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 32 | 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. | 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. |
| Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 34 | 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. | 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. |
| 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) | 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. | 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. |
| C-Reactive Protein (CRP) Level at Week 0 | 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. | — |
| C-Reactive Protein (CRP) Level at Week 8 | 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. | — |
| C-Reactive Protein (CRP) Level at Week 10 | 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. | — |
| C-Reactive Protein (CRP) Level at Week 12 | 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. | — |
| C-Reactive Protein (CRP) Level at Week 14 | 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. | — |
| C-Reactive Protein (CRP) Level at Week 20 | 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. | — |
| C-Reactive Protein (CRP) Level at Week 24 | 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. | — |
| C-Reactive Protein (CRP) Level at Week 28 | 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. | — |
| C-Reactive Protein (CRP) Level at Week 32 | 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. | — |
| C-Reactive Protein (CRP) Level at Week 34 | 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. | — |
| C-Reactive Protein (CRP) Level at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) | 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. | — |
| Ratio of C-Reactive Protein (CRP) Level at Week 8 to CRP Level at Week 0 | 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. | The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 8 divided by the CRP Level at Week 0 |
| Ratio of C-Reactive Protein (CRP) Level at Week 10 to CRP Level at Week 0 | 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. | The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 10 divided by the CRP Level at Week 0 |
| Ratio of C-Reactive Protein (CRP) Level at Week 12 to CRP Level at Week 0 | 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. | The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 12 divided by the CRP Level at Week 0 |
| Ratio of C-Reactive Protein (CRP) Level at Week 14 to CRP Level at Week 0 | 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. | The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 14 divided by the CRP Level at Week 0 |
| Ratio of C-Reactive Protein (CRP) Level at Week 16 to CRP Level at Week 0 | 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. | The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 16 divided by the CRP Level at Week 0 |
| Ratio of C-Reactive Protein (CRP) Level at Week 20 to CRP Level at Week 0 | 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. | The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 20 divided by the CRP Level at Week 0 |
| Ratio of C-Reactive Protein (CRP) Level at Week 24 to CRP Level at Week 0 | 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. | The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 24 divided by the CRP Level at Week 0 |
| Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 8 | 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) 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. |
| Ratio of C-Reactive Protein (CRP) Level at Week 32 to CRP Level at Week 0 | 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. | The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 32 divided by the CRP Level at Week 0 |
| Ratio of C-Reactive Protein (CRP) Level at Week 34 to CRP Level at Week 0 | 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. | The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 34 divided by the CRP Level at Week 0 |
| 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 | 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. | 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 |
| Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 8 | 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. | 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. |
| Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 10 | 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. | 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. |
| Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 12 | 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. | 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. |
| Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 14 | 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. | 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. |
| Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 16 | 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. | 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. |
| Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 20 | 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. | 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. |
| Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 24 | 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. | 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. |
| Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 28 | 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. | 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. |
| Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 32 | 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. | 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. |
| Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 34 | 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. | 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. |
| 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) | 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. | 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. |
| Ratio of C-Reactive Protein (CRP) Level at Week 28 to CRP Level at Week 0 | 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. | The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 28 divided by the CRP Level at Week 0 |
Countries
Japan
Participant flow
Recruitment details
Non-responders at Week 6 of the double-blind main study, C87037 (NCT00291668) could enter this single-group open-label extension study, C87048 (NCT00329420). Recruitment into this extension study was between May 2006 and May 2008. Of the 26 hospitals in the main study (NCT00291668), 16 sites went on to enter subjects into this extension study.
Pre-assignment details
Subjects who responded to re-induction (Week 14 visit) in this extension study could enter the 4-weekly dosing phase. Efficacy data are based on these 26 subjects. However, adverse event data are based on all 46 subjects who entered this extension study. Data are presented by the three possible treatment sequences received across both studies.
Participants by arm
| Arm | Count |
|---|---|
| CZP 400 mg / Placebo Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | 18 |
| CZP 400 mg / CZP 200 mg Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | 13 |
| CZP 400 mg / CZP 400 mg Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | 15 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| 4-weekly Dosing Phase (Responders Only) | Adverse Event | 2 | 1 | 1 |
| 4-weekly Dosing Phase (Responders Only) | Lack of Efficacy | 1 | 1 | 0 |
| 4-weekly Dosing Phase (Responders Only) | Withdrawal of Consent | 1 | 0 | 0 |
| Re-induction Phase | Did not respond to re-induction | 6 | 5 | 7 |
| Re-induction Phase | Lack of Efficacy | 0 | 1 | 0 |
| Re-induction Phase | Withdrawal of Consent | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | CZP 400 mg / CZP 200 mg | CZP 400 mg / CZP 400 mg | CZP 400 mg / Placebo | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 15 Participants | 17 Participants | 45 Participants |
| Age, Continuous | 37.5 years STANDARD_DEVIATION 8.2 | 29.9 years STANDARD_DEVIATION 5.9 | 30.4 years STANDARD_DEVIATION 7.5 | 32.2 years STANDARD_DEVIATION 7.8 |
| Region of Enrollment Japan | 13 participants | 15 participants | 18 participants | 46 participants |
| Sex: Female, Male Female | 4 Participants | 3 Participants | 4 Participants | 11 Participants |
| Sex: Female, Male Male | 9 Participants | 12 Participants | 14 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 15 / 18 | 10 / 13 | 13 / 15 | 38 / 46 | 40 / 46 |
| serious Total, serious adverse events | 1 / 18 | 3 / 13 | 4 / 15 | 8 / 46 | 8 / 46 |
Outcome results
Primary
Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 34
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.
Time frame: 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.
Population: Non-responders at Week 6 of main study C87037 (NCT00291668) could enter this extension study, C87048 (NCT00329420). This summary is based on the 26 subjects in the Full Analysis Set (FAS) Population who responded to re-induction at Week 14. Subject withdrawal or use of rescue therapy is counted as non-response from that time onwards in that study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CZP 400 mg / Placebo | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 34 | Percentage of CDAI responders | 66.7 Percentage of subjects |
| CZP 400 mg / Placebo | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 34 | Percentage of CDAI non-responders | 33.3 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 34 | Percentage of CDAI responders | 28.6 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 34 | Percentage of CDAI non-responders | 71.4 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 34 | Percentage of CDAI responders | 42.9 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 34 | Percentage of CDAI non-responders | 57.1 Percentage of subjects |
Secondary
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)
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. All those in this subgroup with data are included in this summary.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | 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) | -112.0 score on a scale | Standard Deviation 75.6 |
| CZP 400 mg / CZP 200 mg | 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) | -61.0 score on a scale | Standard Deviation 93.7 |
| CZP 400 mg / CZP 400 mg | 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) | -132.7 score on a scale | Standard Deviation 89.7 |
Secondary
Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 10
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. All those in this subgroup with data are included in this summary.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 10 | -96.1 score on a scale | Standard Deviation 76.1 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 10 | -100.3 score on a scale | Standard Deviation 35.4 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 10 | -90.0 score on a scale | Standard Deviation 18.2 |
Secondary
Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 12
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. All those in this subgroup with data are included in this summary.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 12 | -101.3 score on a scale | Standard Deviation 56.6 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 12 | -100.5 score on a scale | Standard Deviation 49.3 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 12 | -109.9 score on a scale | Standard Deviation 36.7 |
Secondary
Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 14
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. All those in this subgroup with data are included in this summary.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 14 | -124.3 score on a scale | Standard Deviation 50.4 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 14 | -131.7 score on a scale | Standard Deviation 41.3 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 14 | -147.0 score on a scale | Standard Deviation 45.2 |
Secondary
Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 16
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. All those in this subgroup with data are included in this summary.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 16 | -121.0 score on a scale | Standard Deviation 57.7 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 16 | -70.4 score on a scale | Standard Deviation 84.1 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 16 | -136.2 score on a scale | Standard Deviation 32.2 |
Secondary
Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 20
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. All those in this subgroup with data are included in this summary.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 20 | -105.3 score on a scale | Standard Deviation 82.9 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 20 | -79.6 score on a scale | Standard Deviation 60.9 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 20 | -130.9 score on a scale | Standard Deviation 62.5 |
Secondary
Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 24
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. All those in this subgroup with data are included in this summary.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 24 | -89.8 score on a scale | Standard Deviation 79.8 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 24 | -70.6 score on a scale | Standard Deviation 91.3 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 24 | -150.2 score on a scale | Standard Deviation 48 |
Secondary
Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 28
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. All those in this subgroup with data are included in this summary.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 28 | -118.2 score on a scale | Standard Deviation 62.6 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 28 | -67.3 score on a scale | Standard Deviation 77.1 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 28 | -154.8 score on a scale | Standard Deviation 74.2 |
Secondary
Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 32
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. All those in this subgroup with data are included in this summary.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 32 | -89.0 score on a scale | Standard Deviation 88.3 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 32 | -77.3 score on a scale | Standard Deviation 70.9 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 32 | -128.3 score on a scale | Standard Deviation 75.3 |
Secondary
Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 34
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. All those in this subgroup with data are included in this summary.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 34 | -134.9 score on a scale | Standard Deviation 39.3 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 34 | -97.4 score on a scale | Standard Deviation 33.1 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 34 | -132.7 score on a scale | Standard Deviation 89.7 |
Secondary
Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 8
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. All those in this subgroup with data are included in this summary.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 8 | -20.5 score on a scale | Standard Deviation 81.6 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 8 | -53.1 score on a scale | Standard Deviation 38.1 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 8 | -63.8 score on a scale | Standard Deviation 26.4 |
Secondary
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)
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | 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) | 5.5 score on a scale | Standard Deviation 6.9 |
| CZP 400 mg / CZP 200 mg | 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) | 8.3 score on a scale | Standard Deviation 12.2 |
| CZP 400 mg / CZP 400 mg | 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) | 5.8 score on a scale | Standard Deviation 6.5 |
Secondary
Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 10
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 10 | 6.2 score on a scale | Standard Deviation 8.4 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 10 | 10.6 score on a scale | Standard Deviation 8.4 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 10 | 5.9 score on a scale | Standard Deviation 7.1 |
Secondary
Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 12
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 12 | 5.7 score on a scale | Standard Deviation 4.4 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 12 | 11.7 score on a scale | Standard Deviation 9.7 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 12 | 7.4 score on a scale | Standard Deviation 7.9 |
Secondary
Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 14
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 14 | 6.9 score on a scale | Standard Deviation 5.6 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 14 | 12.3 score on a scale | Standard Deviation 9.3 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 14 | 9.3 score on a scale | Standard Deviation 7 |
Secondary
Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 16
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 16 | 5.2 score on a scale | Standard Deviation 6.3 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 16 | 8.4 score on a scale | Standard Deviation 9.9 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 16 | 6.3 score on a scale | Standard Deviation 7.2 |
Secondary
Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 20
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 20 | 3.5 score on a scale | Standard Deviation 7.4 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 20 | 9.9 score on a scale | Standard Deviation 11.7 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 20 | 5.1 score on a scale | Standard Deviation 5.5 |
Secondary
Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 24
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 24 | 0.7 score on a scale | Standard Deviation 5.3 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 24 | 4.7 score on a scale | Standard Deviation 11 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 24 | 5.6 score on a scale | Standard Deviation 8.2 |
Secondary
Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 28
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 28 | 4.6 score on a scale | Standard Deviation 6 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 28 | 8.3 score on a scale | Standard Deviation 10 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 28 | 5.4 score on a scale | Standard Deviation 8.4 |
Secondary
Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 32
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 32 | 3.1 score on a scale | Standard Deviation 6.7 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 32 | 9.6 score on a scale | Standard Deviation 11 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 32 | 7.5 score on a scale | Standard Deviation 5.1 |
Secondary
Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 34
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 34 | 7.1 score on a scale | Standard Deviation 4.9 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 34 | 11.8 score on a scale | Standard Deviation 9.8 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 34 | 5.8 score on a scale | Standard Deviation 6.5 |
Secondary
Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 8
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 8 | 1.9 score on a scale | Standard Deviation 7.5 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 8 | 6.4 score on a scale | Standard Deviation 5.6 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 8 | 2.4 score on a scale | Standard Deviation 5.3 |
Secondary
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)
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | 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) | 3.5 score on a scale | Standard Deviation 7.1 |
| CZP 400 mg / CZP 200 mg | 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) | 0.7 score on a scale | Standard Deviation 7.9 |
| CZP 400 mg / CZP 400 mg | 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) | 6.4 score on a scale | Standard Deviation 10.9 |
Secondary
Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 10
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 10 | 3.3 score on a scale | Standard Deviation 4.7 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 10 | 4.4 score on a scale | Standard Deviation 9.7 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 10 | 4.3 score on a scale | Standard Deviation 5.9 |
Secondary
Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 12
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 12 | 2.5 score on a scale | Standard Deviation 5.5 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 12 | 7.0 score on a scale | Standard Deviation 13.8 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 12 | 5.3 score on a scale | Standard Deviation 6.5 |
Secondary
Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 14
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 14 | 3.8 score on a scale | Standard Deviation 4 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 14 | 7.1 score on a scale | Standard Deviation 10.3 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 14 | 6.7 score on a scale | Standard Deviation 8 |
Secondary
Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 16
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 16 | 2.5 score on a scale | Standard Deviation 5.8 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 16 | 3.0 score on a scale | Standard Deviation 6.2 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 16 | 6.0 score on a scale | Standard Deviation 8.1 |
Secondary
Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 20
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 20 | 1.9 score on a scale | Standard Deviation 6.5 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 20 | 3.4 score on a scale | Standard Deviation 10.7 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 20 | 3.6 score on a scale | Standard Deviation 6.9 |
Secondary
Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 24
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 24 | 2.1 score on a scale | Standard Deviation 5.9 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 24 | 1.6 score on a scale | Standard Deviation 5.7 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 24 | 6.1 score on a scale | Standard Deviation 7.4 |
Secondary
Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 28
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 28 | 4.3 score on a scale | Standard Deviation 5.8 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 28 | 1.1 score on a scale | Standard Deviation 8 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 28 | 3.6 score on a scale | Standard Deviation 7.4 |
Secondary
Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 32
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 32 | 2.9 score on a scale | Standard Deviation 5.7 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 32 | 1.8 score on a scale | Standard Deviation 6.1 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 32 | 7.7 score on a scale | Standard Deviation 9.5 |
Secondary
Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 34
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 34 | 5.6 score on a scale | Standard Deviation 6.7 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 34 | 0.0 score on a scale | Standard Deviation 8.6 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 34 | 6.4 score on a scale | Standard Deviation 10.9 |
Secondary
Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 8
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 8 | -0.3 score on a scale | Standard Deviation 6.1 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 8 | 2.1 score on a scale | Standard Deviation 2.3 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 8 | 0.4 score on a scale | Standard Deviation 6.7 |
Secondary
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)
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | 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) | 15.6 score on a scale | Standard Deviation 19.5 |
| CZP 400 mg / CZP 200 mg | 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) | 10.8 score on a scale | Standard Deviation 23.3 |
| CZP 400 mg / CZP 400 mg | 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) | 20.6 score on a scale | Standard Deviation 17.6 |
Secondary
Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 10
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 10 | 17.0 score on a scale | Standard Deviation 17.5 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 10 | 20.9 score on a scale | Standard Deviation 24.9 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 10 | 15.1 score on a scale | Standard Deviation 13.4 |
Secondary
Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 12
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 12 | 17.3 score on a scale | Standard Deviation 12 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 12 | 26.3 score on a scale | Standard Deviation 33.6 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 12 | 20.1 score on a scale | Standard Deviation 16.6 |
Secondary
Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 14
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 14 | 20.1 score on a scale | Standard Deviation 12.3 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 14 | 28.6 score on a scale | Standard Deviation 22.9 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 14 | 26.3 score on a scale | Standard Deviation 16.1 |
Secondary
Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 16
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 16 | 16.3 score on a scale | Standard Deviation 12.2 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 16 | 15.3 score on a scale | Standard Deviation 19.1 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 16 | 20.0 score on a scale | Standard Deviation 16.4 |
Secondary
Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 20
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 20 | 12.2 score on a scale | Standard Deviation 16 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 20 | 18.4 score on a scale | Standard Deviation 27.5 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 20 | 15.9 score on a scale | Standard Deviation 14.7 |
Secondary
Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 24
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 24 | 8.3 score on a scale | Standard Deviation 14.5 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 24 | 7.6 score on a scale | Standard Deviation 23.3 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 24 | 18.4 score on a scale | Standard Deviation 18 |
Secondary
Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 28
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 28 | 14.9 score on a scale | Standard Deviation 20 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 28 | 11.4 score on a scale | Standard Deviation 24.3 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 28 | 15.9 score on a scale | Standard Deviation 19.3 |
Secondary
Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 32
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 32 | 11.3 score on a scale | Standard Deviation 17.8 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 32 | 11.2 score on a scale | Standard Deviation 21.7 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 32 | 25.3 score on a scale | Standard Deviation 17 |
Secondary
Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 34
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 34 | 21.6 score on a scale | Standard Deviation 16.9 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 34 | 14.8 score on a scale | Standard Deviation 23.6 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 34 | 20.6 score on a scale | Standard Deviation 17.6 |
Secondary
Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 8
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 8 | 4.6 score on a scale | Standard Deviation 15.3 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 8 | 9.1 score on a scale | Standard Deviation 7.5 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 8 | 5.3 score on a scale | Standard Deviation 13.8 |
Secondary
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)
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | 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) | 1.7 score on a scale | Standard Deviation 3.4 |
| CZP 400 mg / CZP 200 mg | 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) | -1.3 score on a scale | Standard Deviation 4.5 |
| CZP 400 mg / CZP 400 mg | 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) | 3.0 score on a scale | Standard Deviation 3.1 |
Secondary
Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 10
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 10 | 2.5 score on a scale | Standard Deviation 3 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 10 | 2.1 score on a scale | Standard Deviation 4.7 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 10 | 1.1 score on a scale | Standard Deviation 3.4 |
Secondary
Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 12
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 12 | 3.0 score on a scale | Standard Deviation 3.1 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 12 | 2.6 score on a scale | Standard Deviation 5.1 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 12 | 2.3 score on a scale | Standard Deviation 4 |
Secondary
Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 14
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 14 | 2.8 score on a scale | Standard Deviation 2.6 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 14 | 2.7 score on a scale | Standard Deviation 3.4 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 14 | 4.0 score on a scale | Standard Deviation 2 |
Secondary
Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 16
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 16 | 2.5 score on a scale | Standard Deviation 2.1 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 16 | 0.0 score on a scale | Standard Deviation 3.9 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 16 | 2.4 score on a scale | Standard Deviation 2.1 |
Secondary
Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 20
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 20 | 2.8 score on a scale | Standard Deviation 2.3 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 20 | 1.6 score on a scale | Standard Deviation 3 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 20 | 3.6 score on a scale | Standard Deviation 2.3 |
Secondary
Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 24
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 24 | 1.8 score on a scale | Standard Deviation 2.7 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 24 | -0.9 score on a scale | Standard Deviation 4.9 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 24 | 2.6 score on a scale | Standard Deviation 2.1 |
Secondary
Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 28
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 28 | 2.1 score on a scale | Standard Deviation 2.7 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 28 | -1.0 score on a scale | Standard Deviation 4.6 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 28 | 2.4 score on a scale | Standard Deviation 3.1 |
Secondary
Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 32
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 32 | 1.3 score on a scale | Standard Deviation 3.4 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 32 | -0.6 score on a scale | Standard Deviation 2.9 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 32 | 3.3 score on a scale | Standard Deviation 2.4 |
Secondary
Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 34
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 34 | 3.0 score on a scale | Standard Deviation 3 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 34 | 0.0 score on a scale | Standard Deviation 3.4 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 34 | 3.0 score on a scale | Standard Deviation 3.1 |
Secondary
Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 8
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 8 | 1.3 score on a scale | Standard Deviation 3.6 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 8 | 0.0 score on a scale | Standard Deviation 2.4 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 8 | 0.7 score on a scale | Standard Deviation 3.7 |
Secondary
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)
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | 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) | 4.2 score on a scale | Standard Deviation 4.1 |
| CZP 400 mg / CZP 200 mg | 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) | 3.2 score on a scale | Standard Deviation 4.4 |
| CZP 400 mg / CZP 400 mg | 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) | 5.4 score on a scale | Standard Deviation 2.1 |
Secondary
Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 10
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 10 | 4.6 score on a scale | Standard Deviation 4.4 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 10 | 3.7 score on a scale | Standard Deviation 6.2 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 10 | 3.9 score on a scale | Standard Deviation 1.3 |
Secondary
Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 12
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 12 | 5.7 score on a scale | Standard Deviation 3.2 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 12 | 5.0 score on a scale | Standard Deviation 7.3 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 12 | 5.1 score on a scale | Standard Deviation 2.1 |
Secondary
Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 14
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 14 | 5.9 score on a scale | Standard Deviation 3 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 14 | 6.4 score on a scale | Standard Deviation 4.3 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 14 | 6.3 score on a scale | Standard Deviation 3.1 |
Secondary
Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 16
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 16 | 5.5 score on a scale | Standard Deviation 2.4 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 16 | 3.9 score on a scale | Standard Deviation 3.7 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 16 | 5.3 score on a scale | Standard Deviation 3.5 |
Secondary
Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 20
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 20 | 3.6 score on a scale | Standard Deviation 4 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 20 | 3.6 score on a scale | Standard Deviation 6.3 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 20 | 3.6 score on a scale | Standard Deviation 2.6 |
Secondary
Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 24
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 24 | 3.1 score on a scale | Standard Deviation 2.9 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 24 | 2.1 score on a scale | Standard Deviation 5.9 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 24 | 4.1 score on a scale | Standard Deviation 2.7 |
Secondary
Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 28
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 28 | 3.0 score on a scale | Standard Deviation 6.1 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 28 | 3.0 score on a scale | Standard Deviation 5.8 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 28 | 4.4 score on a scale | Standard Deviation 3.6 |
Secondary
Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 32
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 32 | 3.4 score on a scale | Standard Deviation 4.3 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 32 | 0.4 score on a scale | Standard Deviation 3.1 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 32 | 6.8 score on a scale | Standard Deviation 3.8 |
Secondary
Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 34
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 34 | 5.0 score on a scale | Standard Deviation 3.2 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 34 | 3.0 score on a scale | Standard Deviation 4.8 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 34 | 5.4 score on a scale | Standard Deviation 2.1 |
Secondary
Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 8
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 8 | 1.4 score on a scale | Standard Deviation 3.4 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 8 | 0.6 score on a scale | Standard Deviation 1.7 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 8 | 1.7 score on a scale | Standard Deviation 1.6 |
Secondary
C-Reactive Protein (CRP) Level at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| CZP 400 mg / Placebo | C-Reactive Protein (CRP) Level at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) | 11.25 mg/L |
| CZP 400 mg / CZP 200 mg | C-Reactive Protein (CRP) Level at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) | 8.46 mg/L |
| CZP 400 mg / CZP 400 mg | C-Reactive Protein (CRP) Level at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) | 23.52 mg/L |
Secondary
C-Reactive Protein (CRP) Level at Week 0
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| CZP 400 mg / Placebo | C-Reactive Protein (CRP) Level at Week 0 | 19.58 mg/L |
| CZP 400 mg / CZP 200 mg | C-Reactive Protein (CRP) Level at Week 0 | 14.97 mg/L |
| CZP 400 mg / CZP 400 mg | C-Reactive Protein (CRP) Level at Week 0 | 26.45 mg/L |
Secondary
C-Reactive Protein (CRP) Level at Week 10
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| CZP 400 mg / Placebo | C-Reactive Protein (CRP) Level at Week 10 | 7.76 mg/L |
| CZP 400 mg / CZP 200 mg | C-Reactive Protein (CRP) Level at Week 10 | 5.62 mg/L |
| CZP 400 mg / CZP 400 mg | C-Reactive Protein (CRP) Level at Week 10 | 12.01 mg/L |
Secondary
C-Reactive Protein (CRP) Level at Week 12
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| CZP 400 mg / Placebo | C-Reactive Protein (CRP) Level at Week 12 | 7.82 mg/L |
| CZP 400 mg / CZP 200 mg | C-Reactive Protein (CRP) Level at Week 12 | 7.06 mg/L |
| CZP 400 mg / CZP 400 mg | C-Reactive Protein (CRP) Level at Week 12 | 13.39 mg/L |
Secondary
C-Reactive Protein (CRP) Level at Week 14
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| CZP 400 mg / Placebo | C-Reactive Protein (CRP) Level at Week 14 | 9.57 mg/L |
| CZP 400 mg / CZP 200 mg | C-Reactive Protein (CRP) Level at Week 14 | 6.32 mg/L |
| CZP 400 mg / CZP 400 mg | C-Reactive Protein (CRP) Level at Week 14 | 15.30 mg/L |
Secondary
C-Reactive Protein (CRP) Level at Week 16
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| CZP 400 mg / Placebo | C-Reactive Protein (CRP) Level at Week 16 | 12.54 mg/L |
| CZP 400 mg / CZP 200 mg | C-Reactive Protein (CRP) Level at Week 16 | 12.23 mg/L |
| CZP 400 mg / CZP 400 mg | C-Reactive Protein (CRP) Level at Week 16 | 15.10 mg/L |
Secondary
C-Reactive Protein (CRP) Level at Week 20
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| CZP 400 mg / Placebo | C-Reactive Protein (CRP) Level at Week 20 | 12.27 mg/L |
| CZP 400 mg / CZP 200 mg | C-Reactive Protein (CRP) Level at Week 20 | 13.24 mg/L |
| CZP 400 mg / CZP 400 mg | C-Reactive Protein (CRP) Level at Week 20 | 14.99 mg/L |
Secondary
C-Reactive Protein (CRP) Level at Week 24
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| CZP 400 mg / Placebo | C-Reactive Protein (CRP) Level at Week 24 | 9.11 mg/L |
| CZP 400 mg / CZP 200 mg | C-Reactive Protein (CRP) Level at Week 24 | 14.16 mg/L |
| CZP 400 mg / CZP 400 mg | C-Reactive Protein (CRP) Level at Week 24 | 15.70 mg/L |
Secondary
C-Reactive Protein (CRP) Level at Week 28
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| CZP 400 mg / Placebo | C-Reactive Protein (CRP) Level at Week 28 | 8.79 mg/L |
| CZP 400 mg / CZP 200 mg | C-Reactive Protein (CRP) Level at Week 28 | 14.25 mg/L |
| CZP 400 mg / CZP 400 mg | C-Reactive Protein (CRP) Level at Week 28 | 26.81 mg/L |
Secondary
C-Reactive Protein (CRP) Level at Week 32
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| CZP 400 mg / Placebo | C-Reactive Protein (CRP) Level at Week 32 | 15.28 mg/L |
| CZP 400 mg / CZP 200 mg | C-Reactive Protein (CRP) Level at Week 32 | 10.27 mg/L |
| CZP 400 mg / CZP 400 mg | C-Reactive Protein (CRP) Level at Week 32 | 16.71 mg/L |
Secondary
C-Reactive Protein (CRP) Level at Week 34
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| CZP 400 mg / Placebo | C-Reactive Protein (CRP) Level at Week 34 | 9.19 mg/L |
| CZP 400 mg / CZP 200 mg | C-Reactive Protein (CRP) Level at Week 34 | 6.23 mg/L |
| CZP 400 mg / CZP 400 mg | C-Reactive Protein (CRP) Level at Week 34 | 23.52 mg/L |
Secondary
C-Reactive Protein (CRP) Level at Week 8
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| CZP 400 mg / Placebo | C-Reactive Protein (CRP) Level at Week 8 | 22.06 mg/L |
| CZP 400 mg / CZP 200 mg | C-Reactive Protein (CRP) Level at Week 8 | 11.91 mg/L |
| CZP 400 mg / CZP 400 mg | C-Reactive Protein (CRP) Level at Week 8 | 16.70 mg/L |
Secondary
Percentage of Crohn's Disease Activity Index (CDAI) Responders at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CZP 400 mg / Placebo | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) | Percentage of CDAI responders | 66.7 Percentage of subjects |
| CZP 400 mg / Placebo | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) | Percentage of CDAI non-responders | 33.3 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) | Percentage of CDAI responders | 28.6 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) | Percentage of CDAI non-responders | 71.4 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) | Percentage of CDAI responders | 42.9 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) | Percentage of CDAI non-responders | 57.1 Percentage of subjects |
Secondary
Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 10
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CZP 400 mg / Placebo | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 10 | Percentage of CDAI responders | 41.7 Percentage of subjects |
| CZP 400 mg / Placebo | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 10 | Percentage of CDAI non-responders | 58.3 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 10 | Percentage of CDAI responders | 71.4 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 10 | Percentage of CDAI non-responders | 28.6 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 10 | Percentage of CDAI responders | 42.9 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 10 | Percentage of CDAI non-responders | 57.1 Percentage of subjects |
Secondary
Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 12
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CZP 400 mg / Placebo | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 12 | Percentage of CDAI responders | 50.0 Percentage of subjects |
| CZP 400 mg / Placebo | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 12 | Percentage of CDAI non-responders | 50.0 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 12 | Percentage of CDAI responders | 71.4 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 12 | Percentage of CDAI non-responders | 28.6 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 12 | Percentage of CDAI responders | 57.1 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 12 | Percentage of CDAI non-responders | 42.9 Percentage of subjects |
Secondary
Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 14
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CZP 400 mg / Placebo | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 14 | Percentage of CDAI responders | 100.0 Percentage of subjects |
| CZP 400 mg / Placebo | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 14 | Percentage of CDAI non-responders | 0.0 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 14 | Percentage of CDAI responders | 100.0 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 14 | Percentage of CDAI non-responders | 0.0 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 14 | Percentage of CDAI responders | 100.0 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 14 | Percentage of CDAI non-responders | 0.0 Percentage of subjects |
Secondary
Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 16
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CZP 400 mg / Placebo | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 16 | Percentage of CDAI responders | 66.7 Percentage of subjects |
| CZP 400 mg / Placebo | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 16 | Percentage of CDAI non-responders | 33.3 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 16 | Percentage of CDAI responders | 42.9 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 16 | Percentage of CDAI non-responders | 57.1 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 16 | Percentage of CDAI responders | 85.7 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 16 | Percentage of CDAI non-responders | 14.3 Percentage of subjects |
Secondary
Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 20
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CZP 400 mg / Placebo | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 20 | Percentage of CDAI responders | 41.7 Percentage of subjects |
| CZP 400 mg / Placebo | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 20 | Percentage of CDAI non-responders | 58.3 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 20 | Percentage of CDAI responders | 28.6 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 20 | Percentage of CDAI non-responders | 71.4 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 20 | Percentage of CDAI responders | 85.7 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 20 | Percentage of CDAI non-responders | 14.3 Percentage of subjects |
Secondary
Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 24
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CZP 400 mg / Placebo | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 24 | Percentage of CDAI responders | 41.7 Percentage of subjects |
| CZP 400 mg / Placebo | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 24 | Percentage of CDAI non-responders | 58.3 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 24 | Percentage of CDAI responders | 57.1 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 24 | Percentage of CDAI non-responders | 42.9 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 24 | Percentage of CDAI responders | 71.4 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 24 | Percentage of CDAI non-responders | 28.6 Percentage of subjects |
Secondary
Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 28
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CZP 400 mg / Placebo | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 28 | Percentage of CDAI responders | 50.0 Percentage of subjects |
| CZP 400 mg / Placebo | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 28 | Percentage of CDAI non-responders | 50.0 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 28 | Percentage of CDAI responders | 28.6 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 28 | Percentage of CDAI non-responders | 71.4 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 28 | Percentage of CDAI responders | 57.1 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 28 | Percentage of CDAI non-responders | 42.9 Percentage of subjects |
Secondary
Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 32
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CZP 400 mg / Placebo | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 32 | Percentage of CDAI responders | 33.3 Percentage of subjects |
| CZP 400 mg / Placebo | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 32 | Percentage of CDAI non-responders | 66.7 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 32 | Percentage of CDAI responders | 28.6 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 32 | Percentage of CDAI non-responders | 71.4 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 32 | Percentage of CDAI responders | 57.1 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 32 | Percentage of CDAI non-responders | 42.9 Percentage of subjects |
Secondary
Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 8
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CZP 400 mg / Placebo | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 8 | Percentage of CDAI responders | 8.3 Percentage of subjects |
| CZP 400 mg / Placebo | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 8 | Percentage of CDAI non-responders | 91.7 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 8 | Percentage of CDAI responders | 14.3 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 8 | Percentage of CDAI non-responders | 85.7 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 8 | Percentage of CDAI responders | 14.3 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 8 | Percentage of CDAI non-responders | 85.7 Percentage of subjects |
Secondary
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)
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CZP 400 mg / Placebo | 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) | Percentage of 70-point responders | 66.7 percentage of subjects |
| CZP 400 mg / Placebo | 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) | Percentage of 70-point non-responders | 33.3 percentage of subjects |
| CZP 400 mg / CZP 200 mg | 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) | Percentage of 70-point responders | 42.9 percentage of subjects |
| CZP 400 mg / CZP 200 mg | 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) | Percentage of 70-point non-responders | 57.1 percentage of subjects |
| CZP 400 mg / CZP 400 mg | 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) | Percentage of 70-point responders | 42.9 percentage of subjects |
| CZP 400 mg / CZP 400 mg | 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) | Percentage of 70-point non-responders | 57.1 percentage of subjects |
Secondary
Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 10
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CZP 400 mg / Placebo | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 10 | Percentage of 70-point responders | 66.7 percentage of subjects |
| CZP 400 mg / Placebo | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 10 | Percentage of 70-point non-responders | 33.3 percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 10 | Percentage of 70-point responders | 85.7 percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 10 | Percentage of 70-point non-responders | 14.3 percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 10 | Percentage of 70-point responders | 100.0 percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 10 | Percentage of 70-point non-responders | 0.0 percentage of subjects |
Secondary
Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 12
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CZP 400 mg / Placebo | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 12 | Percentage of 70-point responders | 75.0 percentage of subjects |
| CZP 400 mg / Placebo | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 12 | Percentage of 70-point non-responders | 25.0 percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 12 | Percentage of 70-point responders | 71.4 percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 12 | Percentage of 70-point non-responders | 28.6 percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 12 | Percentage of 70-point responders | 85.7 percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 12 | Percentage of 70-point non-responders | 14.3 percentage of subjects |
Secondary
Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 14
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CZP 400 mg / Placebo | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 14 | Percentage of 70-point responders | 100.0 percentage of subjects |
| CZP 400 mg / Placebo | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 14 | Percentage of 70-point non-responders | 0.0 percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 14 | Percentage of 70-point responders | 100.0 percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 14 | Percentage of 70-point non-responders | 0.0 percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 14 | Percentage of 70-point responders | 100.0 percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 14 | Percentage of 70-point non-responders | 0.0 percentage of subjects |
Secondary
Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 16
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CZP 400 mg / Placebo | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 16 | Percentage of 70-point responders | 83.3 percentage of subjects |
| CZP 400 mg / Placebo | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 16 | Percentage of 70-point non-responders | 16.7 percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 16 | Percentage of 70-point responders | 57.1 percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 16 | Percentage of 70-point non-responders | 42.9 percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 16 | Percentage of 70-point responders | 100.0 percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 16 | Percentage of 70-point non-responders | 0.0 percentage of subjects |
Secondary
Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 20
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CZP 400 mg / Placebo | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 20 | Percentage of 70-point responders | 75.0 percentage of subjects |
| CZP 400 mg / Placebo | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 20 | Percentage of 70-point non-responders | 25.0 percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 20 | Percentage of 70-point responders | 71.4 percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 20 | Percentage of 70-point non-responders | 28.6 percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 20 | Percentage of 70-point responders | 85.7 percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 20 | Percentage of 70-point non-responders | 14.3 percentage of subjects |
Secondary
Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 24
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CZP 400 mg / Placebo | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 24 | Percentage of 70-point responders | 50.0 percentage of subjects |
| CZP 400 mg / Placebo | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 24 | Percentage of 70-point non-responders | 50.0 percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 24 | Percentage of 70-point responders | 71.4 percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 24 | Percentage of 70-point non-responders | 28.6 percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 24 | Percentage of 70-point responders | 100.0 percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 24 | Percentage of 70-point non-responders | 0.0 percentage of subjects |
Secondary
Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 28
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CZP 400 mg / Placebo | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 28 | Percentage of 70-point responders | 58.3 percentage of subjects |
| CZP 400 mg / Placebo | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 28 | Percentage of 70-point non-responders | 41.7 percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 28 | Percentage of 70-point responders | 71.4 percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 28 | Percentage of 70-point non-responders | 28.6 percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 28 | Percentage of 70-point responders | 85.7 percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 28 | Percentage of 70-point non-responders | 14.3 percentage of subjects |
Secondary
Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 32
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CZP 400 mg / Placebo | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 32 | Percentage of 70-point responders | 41.7 percentage of subjects |
| CZP 400 mg / Placebo | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 32 | Percentage of 70-point non-responders | 58.3 percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 32 | Percentage of 70-point responders | 57.1 percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 32 | Percentage of 70-point non-responders | 42.9 percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 32 | Percentage of 70-point responders | 57.1 percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 32 | Percentage of 70-point non-responders | 42.9 percentage of subjects |
Secondary
Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 34
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CZP 400 mg / Placebo | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 34 | Percentage of 70-point responders | 66.7 percentage of subjects |
| CZP 400 mg / Placebo | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 34 | Percentage of 70-point non-responders | 33.3 percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 34 | Percentage of 70-point responders | 42.9 percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 34 | Percentage of 70-point non-responders | 57.1 percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 34 | Percentage of 70-point responders | 42.9 percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 34 | Percentage of 70-point non-responders | 57.1 percentage of subjects |
Secondary
Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 8
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CZP 400 mg / Placebo | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 8 | Percentage of 70-point responders | 33.3 percentage of subjects |
| CZP 400 mg / Placebo | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 8 | Percentage of 70-point non-responders | 66.7 percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 8 | Percentage of 70-point responders | 28.6 percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 8 | Percentage of 70-point non-responders | 71.4 percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 8 | Percentage of 70-point responders | 42.9 percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 8 | Percentage of 70-point non-responders | 57.1 percentage of subjects |
Secondary
Percentage of Subjects Achieving Remission at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CZP 400 mg / Placebo | Percentage of Subjects Achieving Remission at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) | Percentage of subjects in remission | 33.3 Percentage of subjects |
| CZP 400 mg / Placebo | Percentage of Subjects Achieving Remission at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) | Percentage of subjects not in remission | 66.7 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects Achieving Remission at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) | Percentage of subjects in remission | 28.6 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects Achieving Remission at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) | Percentage of subjects not in remission | 71.4 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects Achieving Remission at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) | Percentage of subjects in remission | 42.9 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects Achieving Remission at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) | Percentage of subjects not in remission | 57.1 Percentage of subjects |
Secondary
Percentage of Subjects Achieving Remission at Week 10
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CZP 400 mg / Placebo | Percentage of Subjects Achieving Remission at Week 10 | Percentage of subjects in remission | 33.3 Percentage of subjects |
| CZP 400 mg / Placebo | Percentage of Subjects Achieving Remission at Week 10 | Percentage of subjects not in remission | 66.7 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects Achieving Remission at Week 10 | Percentage of subjects in remission | 42.9 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects Achieving Remission at Week 10 | Percentage of subjects not in remission | 57.1 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects Achieving Remission at Week 10 | Percentage of subjects in remission | 14.3 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects Achieving Remission at Week 10 | Percentage of subjects not in remission | 85.7 Percentage of subjects |
Secondary
Percentage of Subjects Achieving Remission at Week 12
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CZP 400 mg / Placebo | Percentage of Subjects Achieving Remission at Week 12 | Percentage of subjects in remission | 25.0 Percentage of subjects |
| CZP 400 mg / Placebo | Percentage of Subjects Achieving Remission at Week 12 | Percentage of subjects not in remission | 75.0 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects Achieving Remission at Week 12 | Percentage of subjects in remission | 42.9 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects Achieving Remission at Week 12 | Percentage of subjects not in remission | 57.1 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects Achieving Remission at Week 12 | Percentage of subjects in remission | 42.9 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects Achieving Remission at Week 12 | Percentage of subjects not in remission | 57.1 Percentage of subjects |
Secondary
Percentage of Subjects Achieving Remission at Week 14
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CZP 400 mg / Placebo | Percentage of Subjects Achieving Remission at Week 14 | Percentage of subjects in remission | 66.7 Percentage of subjects |
| CZP 400 mg / Placebo | Percentage of Subjects Achieving Remission at Week 14 | Percentage of subjects not in remission | 33.3 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects Achieving Remission at Week 14 | Percentage of subjects in remission | 71.4 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects Achieving Remission at Week 14 | Percentage of subjects not in remission | 28.6 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects Achieving Remission at Week 14 | Percentage of subjects in remission | 71.4 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects Achieving Remission at Week 14 | Percentage of subjects not in remission | 28.6 Percentage of subjects |
Secondary
Percentage of Subjects Achieving Remission at Week 16
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CZP 400 mg / Placebo | Percentage of Subjects Achieving Remission at Week 16 | Percentage of subjects in remission | 33.3 Percentage of subjects |
| CZP 400 mg / Placebo | Percentage of Subjects Achieving Remission at Week 16 | Percentage of subjects not in remission | 66.7 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects Achieving Remission at Week 16 | Percentage of subjects in remission | 28.6 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects Achieving Remission at Week 16 | Percentage of subjects not in remission | 71.4 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects Achieving Remission at Week 16 | Percentage of subjects in remission | 57.1 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects Achieving Remission at Week 16 | Percentage of subjects not in remission | 42.9 Percentage of subjects |
Secondary
Percentage of Subjects Achieving Remission at Week 20
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CZP 400 mg / Placebo | Percentage of Subjects Achieving Remission at Week 20 | Percentage of subjects in remission | 33.3 Percentage of subjects |
| CZP 400 mg / Placebo | Percentage of Subjects Achieving Remission at Week 20 | Percentage of subjects not in remission | 66.7 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects Achieving Remission at Week 20 | Percentage of subjects in remission | 28.6 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects Achieving Remission at Week 20 | Percentage of subjects not in remission | 71.4 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects Achieving Remission at Week 20 | Percentage of subjects in remission | 57.1 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects Achieving Remission at Week 20 | Percentage of subjects not in remission | 42.9 Percentage of subjects |
Secondary
Percentage of Subjects Achieving Remission at Week 24
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CZP 400 mg / Placebo | Percentage of Subjects Achieving Remission at Week 24 | Percentage of subjects in remission | 16.7 Percentage of subjects |
| CZP 400 mg / Placebo | Percentage of Subjects Achieving Remission at Week 24 | Percentage of subjects not in remission | 83.3 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects Achieving Remission at Week 24 | Percentage of subjects in remission | 42.9 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects Achieving Remission at Week 24 | Percentage of subjects not in remission | 57.1 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects Achieving Remission at Week 24 | Percentage of subjects in remission | 71.4 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects Achieving Remission at Week 24 | Percentage of subjects not in remission | 28.6 Percentage of subjects |
Secondary
Percentage of Subjects Achieving Remission at Week 28
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CZP 400 mg / Placebo | Percentage of Subjects Achieving Remission at Week 28 | Percentage of subjects in remission | 25.0 Percentage of subjects |
| CZP 400 mg / Placebo | Percentage of Subjects Achieving Remission at Week 28 | Percentage of subjects not in remission | 75.0 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects Achieving Remission at Week 28 | Percentage of subjects in remission | 28.6 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects Achieving Remission at Week 28 | Percentage of subjects not in remission | 71.4 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects Achieving Remission at Week 28 | Percentage of subjects in remission | 57.1 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects Achieving Remission at Week 28 | Percentage of subjects not in remission | 42.9 Percentage of subjects |
Secondary
Percentage of Subjects Achieving Remission at Week 32
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CZP 400 mg / Placebo | Percentage of Subjects Achieving Remission at Week 32 | Percentage of subjects in remission | 16.7 Percentage of subjects |
| CZP 400 mg / Placebo | Percentage of Subjects Achieving Remission at Week 32 | Percentage of subjects not in remission | 83.3 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects Achieving Remission at Week 32 | Percentage of subjects in remission | 28.6 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects Achieving Remission at Week 32 | Percentage of subjects not in remission | 71.4 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects Achieving Remission at Week 32 | Percentage of subjects in remission | 42.9 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects Achieving Remission at Week 32 | Percentage of subjects not in remission | 57.1 Percentage of subjects |
Secondary
Percentage of Subjects Achieving Remission at Week 34
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CZP 400 mg / Placebo | Percentage of Subjects Achieving Remission at Week 34 | Percentage of subjects in remission | 33.3 Percentage of subjects |
| CZP 400 mg / Placebo | Percentage of Subjects Achieving Remission at Week 34 | Percentage of subjects not in remission | 66.7 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects Achieving Remission at Week 34 | Percentage of subjects in remission | 28.6 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects Achieving Remission at Week 34 | Percentage of subjects not in remission | 71.4 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects Achieving Remission at Week 34 | Percentage of subjects in remission | 42.9 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects Achieving Remission at Week 34 | Percentage of subjects not in remission | 57.1 Percentage of subjects |
Secondary
Percentage of Subjects Achieving Remission at Week 8
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.
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CZP 400 mg / Placebo | Percentage of Subjects Achieving Remission at Week 8 | Percentage of subjects in remission | 0.0 Percentage of subjects |
| CZP 400 mg / Placebo | Percentage of Subjects Achieving Remission at Week 8 | Percentage of subjects not in remission | 100.0 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects Achieving Remission at Week 8 | Percentage of subjects in remission | 0.0 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects Achieving Remission at Week 8 | Percentage of subjects not in remission | 100.0 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects Achieving Remission at Week 8 | Percentage of subjects in remission | 14.3 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects Achieving Remission at Week 8 | Percentage of subjects not in remission | 85.7 Percentage of subjects |
Secondary
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
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
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| CZP 400 mg / Placebo | 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 | 0.59 ratio |
| CZP 400 mg / CZP 200 mg | 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 | 0.54 ratio |
| CZP 400 mg / CZP 400 mg | 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 | 1.07 ratio |
Secondary
Ratio of C-Reactive Protein (CRP) Level at Week 10 to CRP Level at Week 0
The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 10 divided by the CRP Level at Week 0
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| CZP 400 mg / Placebo | Ratio of C-Reactive Protein (CRP) Level at Week 10 to CRP Level at Week 0 | 0.4 ratio |
| CZP 400 mg / CZP 200 mg | Ratio of C-Reactive Protein (CRP) Level at Week 10 to CRP Level at Week 0 | 0.38 ratio |
| CZP 400 mg / CZP 400 mg | Ratio of C-Reactive Protein (CRP) Level at Week 10 to CRP Level at Week 0 | 0.45 ratio |
Secondary
Ratio of C-Reactive Protein (CRP) Level at Week 12 to CRP Level at Week 0
The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 12 divided by the CRP Level at Week 0
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| CZP 400 mg / Placebo | Ratio of C-Reactive Protein (CRP) Level at Week 12 to CRP Level at Week 0 | 0.4 ratio |
| CZP 400 mg / CZP 200 mg | Ratio of C-Reactive Protein (CRP) Level at Week 12 to CRP Level at Week 0 | 0.47 ratio |
| CZP 400 mg / CZP 400 mg | Ratio of C-Reactive Protein (CRP) Level at Week 12 to CRP Level at Week 0 | 0.51 ratio |
Secondary
Ratio of C-Reactive Protein (CRP) Level at Week 14 to CRP Level at Week 0
The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 14 divided by the CRP Level at Week 0
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| CZP 400 mg / Placebo | Ratio of C-Reactive Protein (CRP) Level at Week 14 to CRP Level at Week 0 | 0.49 ratio |
| CZP 400 mg / CZP 200 mg | Ratio of C-Reactive Protein (CRP) Level at Week 14 to CRP Level at Week 0 | 0.42 ratio |
| CZP 400 mg / CZP 400 mg | Ratio of C-Reactive Protein (CRP) Level at Week 14 to CRP Level at Week 0 | 0.58 ratio |
Secondary
Ratio of C-Reactive Protein (CRP) Level at Week 16 to CRP Level at Week 0
The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 16 divided by the CRP Level at Week 0
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| CZP 400 mg / Placebo | Ratio of C-Reactive Protein (CRP) Level at Week 16 to CRP Level at Week 0 | 0.64 ratio |
| CZP 400 mg / CZP 200 mg | Ratio of C-Reactive Protein (CRP) Level at Week 16 to CRP Level at Week 0 | 0.82 ratio |
| CZP 400 mg / CZP 400 mg | Ratio of C-Reactive Protein (CRP) Level at Week 16 to CRP Level at Week 0 | 0.57 ratio |
Secondary
Ratio of C-Reactive Protein (CRP) Level at Week 20 to CRP Level at Week 0
The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 20 divided by the CRP Level at Week 0
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| CZP 400 mg / Placebo | Ratio of C-Reactive Protein (CRP) Level at Week 20 to CRP Level at Week 0 | 0.64 ratio |
| CZP 400 mg / CZP 200 mg | Ratio of C-Reactive Protein (CRP) Level at Week 20 to CRP Level at Week 0 | 0.88 ratio |
| CZP 400 mg / CZP 400 mg | Ratio of C-Reactive Protein (CRP) Level at Week 20 to CRP Level at Week 0 | 0.57 ratio |
Secondary
Ratio of C-Reactive Protein (CRP) Level at Week 24 to CRP Level at Week 0
The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 24 divided by the CRP Level at Week 0
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| CZP 400 mg / Placebo | Ratio of C-Reactive Protein (CRP) Level at Week 24 to CRP Level at Week 0 | 0.48 ratio |
| CZP 400 mg / CZP 200 mg | Ratio of C-Reactive Protein (CRP) Level at Week 24 to CRP Level at Week 0 | 0.95 ratio |
| CZP 400 mg / CZP 400 mg | Ratio of C-Reactive Protein (CRP) Level at Week 24 to CRP Level at Week 0 | 0.59 ratio |
Secondary
Ratio of C-Reactive Protein (CRP) Level at Week 28 to CRP Level at Week 0
The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 28 divided by the CRP Level at Week 0
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| CZP 400 mg / Placebo | Ratio of C-Reactive Protein (CRP) Level at Week 28 to CRP Level at Week 0 | 0.46 ratio |
| CZP 400 mg / CZP 200 mg | Ratio of C-Reactive Protein (CRP) Level at Week 28 to CRP Level at Week 0 | 0.95 ratio |
| CZP 400 mg / CZP 400 mg | Ratio of C-Reactive Protein (CRP) Level at Week 28 to CRP Level at Week 0 | 1.06 ratio |
Secondary
Ratio of C-Reactive Protein (CRP) Level at Week 32 to CRP Level at Week 0
The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 32 divided by the CRP Level at Week 0
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| CZP 400 mg / Placebo | Ratio of C-Reactive Protein (CRP) Level at Week 32 to CRP Level at Week 0 | 0.90 ratio |
| CZP 400 mg / CZP 200 mg | Ratio of C-Reactive Protein (CRP) Level at Week 32 to CRP Level at Week 0 | 0.64 ratio |
| CZP 400 mg / CZP 400 mg | Ratio of C-Reactive Protein (CRP) Level at Week 32 to CRP Level at Week 0 | 0.62 ratio |
Secondary
Ratio of C-Reactive Protein (CRP) Level at Week 34 to CRP Level at Week 0
The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 34 divided by the CRP Level at Week 0
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| CZP 400 mg / Placebo | Ratio of C-Reactive Protein (CRP) Level at Week 34 to CRP Level at Week 0 | 0.54 ratio |
| CZP 400 mg / CZP 200 mg | Ratio of C-Reactive Protein (CRP) Level at Week 34 to CRP Level at Week 0 | 0.39 ratio |
| CZP 400 mg / CZP 400 mg | Ratio of C-Reactive Protein (CRP) Level at Week 34 to CRP Level at Week 0 | 1.07 ratio |
Secondary
Ratio of C-Reactive Protein (CRP) Level at Week 8 to CRP Level at Week 0
The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 8 divided by the CRP Level at Week 0
Time frame: 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.
Population: Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| CZP 400 mg / Placebo | Ratio of C-Reactive Protein (CRP) Level at Week 8 to CRP Level at Week 0 | 1.13 ratio |
| CZP 400 mg / CZP 200 mg | Ratio of C-Reactive Protein (CRP) Level at Week 8 to CRP Level at Week 0 | 0.80 ratio |
| CZP 400 mg / CZP 400 mg | Ratio of C-Reactive Protein (CRP) Level at Week 8 to CRP Level at Week 0 | 0.63 ratio |
Secondary
Time to Disease Progression
Time to disease progression is defined as the earliest of: * time to an increase from Week 14 of ≥100 points in Crohn's Disease Activity Index (CDAI) score and CDAI\>175 points for at least 2 consecutive visits, * time to use of rescue therapy, or, * time to subject withdrawal from the study.
Time frame: 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.
Population: Non-responders at Week 6 of Study C87037 (NCT00291668) could enter this extension study, C87048 (NCT00329420). As so few subjects experienced disease progression in this study it was not possible to calculate the median time to disease progression. Please see outcome measure 124 where the number of subjects with disease progression is presented.
Post Hoc
Number of Subjects With Disease Progression
Disease progression is defined as: * an increase from Week 14 of ≥100 points in Crohn's Disease Activity Index (CDAI) score and CDAI\>175 points for at least 2 consecutive visits, * use of rescue therapy, or, * subject withdrawal from the study.
Time frame: 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.
Population: Non-responders at Week 6 of Study C87037 (NCT00291668) could enter this extension study C87048 (NCT00329420). As it was not possible to calculate the time to disease progression (outcome measure 34) due to the very small number of subjects meeting this definition, the post-hoc outcome of number of subjects with disease progression is presented here
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CZP 400 mg / Placebo | Number of Subjects With Disease Progression | 1 subjects |
| CZP 400 mg / CZP 200 mg | Number of Subjects With Disease Progression | 1 subjects |
| CZP 400 mg / CZP 400 mg | Number of Subjects With Disease Progression | 1 subjects |