Crohn's Disease
Conditions
Keywords
Certolizumab pegol, Cimzia, CZP
Brief summary
This is a multi-centre, open-label extension study in subjects who showed clinical response to induction therapy in the treatment of subjects with active Crohn's disease in the double-blind main study C87037 (NCT00291668).
Detailed description
In the double-blind main study subjects were dosed at Weeks 0, 2 and 4, with the primary outcome, clinical response, being assessed at Week 6. Subjects who showed clinical response at Week 6 were eligible to enter this open-label extension study. The first visit in this extension study was 2 weeks after Week 6, i.e., Week 8. Subjects in this extension study were dosed at Weeks 8, 12, 16, 20 and 24, with the primary outcome, clinical response, being assessed at Week 26. All week numbers quoted are relative to the start of the double-blind main study.
Interventions
BIOLOGICALCertolizumab pegol (CZP)
Certolizumab pegol (CZP) 400 mg administered subcutaneously in a liquid formulation at Weeks 8, 12, 16, 20 and 24 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 Japan Co. Ltd.
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 participated in main double-blind induction study C87037 (NCT00291668) and showed clinical efficacy
Exclusion criteria
* Subjects who experienced aggravation of Crohn's disease during main double-blind induction study C87037 (NCT00291668) and required treatment change
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 26 | Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study. | 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 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. | 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. | 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. | 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. | 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 26 | Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study. | 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 26 for Completers or the Withdrawal Visit for Premature Withdrawals] | Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study. | 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 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score | 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. |
| 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. | 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. | 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. | 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. | 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. | 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 26 for Completers or the Withdrawal Visit for Premature Withdrawals] | Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study. | 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. | The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI 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. | The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI 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. | The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI 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. | The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI 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. | The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. |
| Percentage of Subjects Achieving Remission at Week 26 | Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study. | The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI 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 26 for Completers or the Withdrawal Visit for Premature Withdrawals) | Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study. | The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. |
| Time to Disease Progression | Week 6 to Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 6' is the last visit in the double-blind main study and 'Week 26' is 18 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 6 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 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score | 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 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score | 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 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score | 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 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score | 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 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score | Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 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 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score | Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 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 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score | 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 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score | 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 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score | 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 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score | 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 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score | 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 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score | Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 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 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score | Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 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 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score | 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 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score | 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 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score | 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 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score | 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 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score | 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 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score | Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 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 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score | Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 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 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score | 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 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score | 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 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score | 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 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score | 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 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score | 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 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score | Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 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 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score | Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 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 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score | 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 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score | 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 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score | 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 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score | 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 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score | 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 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score | Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 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 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score | Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 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 (NCT00291668)). '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 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 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. | — |
| 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 26 | Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study. | — |
| C-Reactive Protein (CRP) Level at Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) | Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study. | — |
| Ratio of C-Reactive Protein (CRP) Level at Week 8 to 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. | — |
| Ratio of C-Reactive Protein (CRP) Level at Week 12 to 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. | — |
| Ratio of C-Reactive Protein (CRP) Level at Week 16 to 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. | — |
| Ratio of C-Reactive Protein (CRP) Level at Week 20 to 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. | — |
| Ratio of C-Reactive Protein (CRP) Level at Week 24 to 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. | — |
| 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. | 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 Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) to Week 0 | Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study. | — |
| Percentage of Subjects at Week 8 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From 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. | 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 Subjects at Week 12 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From 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. | 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 Subjects at Week 16 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From 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. | 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 Subjects at Week 20 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From 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. | 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 Subjects at Week 24 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From 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. | 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 Subjects at Week 26 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 | Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study. | 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 Subjects at Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 | Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study. | 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 26 to Week 0 | Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study. | — |
Countries
Japan
Participant flow
Recruitment details
Recruitment into this extension study was between March 2006 and April 2008. Of the 26 hospitals and medical centers throughout Japan in the main study, 16 sites went on to enter subjects in this extension study.
Pre-assignment details
To enter this single-group extension study, C87047 (NCT00329550), subjects had to have responded at Week 6 of the double-blind main study, C87037 (NCT00291668). Recruitment details are provided for the 40 subjects who entered this extension study by the three possible treatment sequences received across both studies.
Participants by arm
| Arm | Count |
|---|---|
| CZP 400 mg / Placebo Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | 9 |
| CZP 400 mg / CZP 200 mg Certolizumab pegol (CZP) 400 mg (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) | 15 |
| CZP 400 mg / CZP 400 mg Certolizumab pegol (CZP) 400 mg (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) | 16 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 3 | 4 | 2 |
| Overall Study | Due to Relocation | 0 | 0 | 1 |
| Overall Study | Withdrawal of Consent | 1 | 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 | 3 Participants | 2 Participants | 1 Participants | 6.0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0.0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 14 Participants | 8 Participants | 34.0 Participants |
| Age, Continuous | 29.3 years STANDARD_DEVIATION 9.1 | 33.3 years STANDARD_DEVIATION 10 | 32.7 years STANDARD_DEVIATION 10.4 | 31.7 years STANDARD_DEVIATION 9.7 |
| Region of Enrollment Japan | 15 participants | 16 participants | 9 participants | 40.0 participants |
| Sex: Female, Male Female | 3 Participants | 4 Participants | 2 Participants | 9.0 Participants |
| Sex: Female, Male Male | 12 Participants | 12 Participants | 7 Participants | 31.0 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 | 8 / 9 | 12 / 15 | 15 / 16 | 35 / 40 | 35 / 40 |
| serious Total, serious adverse events | 2 / 9 | 5 / 15 | 5 / 16 | 12 / 40 | 13 / 40 |
Outcome results
Primary
Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 26
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 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.
Population: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CZP 400 mg / Placebo | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 26 | Percentage of CDAI responders | 44.4 Percentage of subjects |
| CZP 400 mg / Placebo | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 26 | Percentage of CDAI non-responders | 55.6 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 26 | Percentage of CDAI responders | 73.3 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 26 | Percentage of CDAI non-responders | 26.7 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 26 | Percentage of CDAI responders | 60.0 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 26 | Percentage of CDAI non-responders | 40.0 Percentage of subjects |
Secondary
Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Last Visit [Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals]
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 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.
Population: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 Crohn's Disease Activity Index (CDAI) Score at Last Visit [Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals] | -132.7 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 Last Visit [Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals] | -143.2 score on a scale | Standard Deviation 88.5 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Last Visit [Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals] | -152.5 score on a scale | Standard Deviation 67.9 |
Secondary
Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 12
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: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 Crohn's Disease Activity Index (CDAI) Score at Week 12 | -152.6 score on a scale | Standard Deviation 96.8 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 12 | -145.4 score on a scale | Standard Deviation 80.5 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 12 | -152.8 score on a scale | Standard Deviation 54.7 |
Secondary
Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 16
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: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 Crohn's Disease Activity Index (CDAI) Score at Week 16 | -162.8 score on a scale | Standard Deviation 98.9 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 16 | -142.2 score on a scale | Standard Deviation 84.3 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 16 | -143.3 score on a scale | Standard Deviation 69.6 |
Secondary
Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 20
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: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 Crohn's Disease Activity Index (CDAI) Score at Week 20 | -147.0 score on a scale | Standard Deviation 38.8 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 20 | -149.4 score on a scale | Standard Deviation 85.6 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 20 | -130.7 score on a scale | Standard Deviation 70.1 |
Secondary
Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 24
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: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 Crohn's Disease Activity Index (CDAI) Score at Week 24 | -158.6 score on a scale | Standard Deviation 53.7 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 24 | -153.3 score on a scale | Standard Deviation 53.7 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 24 | -138.9 score on a scale | Standard Deviation 80 |
Secondary
Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 26
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 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.
Population: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 Crohn's Disease Activity Index (CDAI) Score at Week 26 | -131.1 score on a scale | Standard Deviation 32.8 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 26 | -173.8 score on a scale | Standard Deviation 46.5 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 26 | -153.1 score on a scale | Standard Deviation 70.8 |
Secondary
Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 8
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: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy have been set to missing in that study. \[Week 8 is the start of Study C87047\].
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 8 | -126.7 score on a scale | Standard Deviation 100.9 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 8 | -124.9 score on a scale | Standard Deviation 76.7 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 8 | -141.8 score on a scale | Standard Deviation 62.4 |
Secondary
Change From Week 0 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score
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 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.
Population: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score | 9.6 score on a scale | Standard Deviation 5.8 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score | 10.7 score on a scale | Standard Deviation 10.1 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score | 8.1 score on a scale | Standard Deviation 9.8 |
Secondary
Change From Week 0 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score
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 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.
Population: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score | 7.4 score on a scale | Standard Deviation 6.8 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score | 9.0 score on a scale | Standard Deviation 11.6 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score | 5.8 score on a scale | Standard Deviation 9 |
Secondary
Change From Week 0 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score
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 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.
Population: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score | 28.0 score on a scale | Standard Deviation 21.5 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score | 33.3 score on a scale | Standard Deviation 27.7 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score | 26.1 score on a scale | Standard Deviation 20.1 |
Secondary
Change From Week 0 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score
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 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.
Population: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score | 5.9 score on a scale | Standard Deviation 6 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score | 4.8 score on a scale | Standard Deviation 8.5 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score | 5.2 score on a scale | Standard Deviation 5.2 |
Secondary
Change From Week 0 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score
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 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.
Population: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score | 5.1 score on a scale | Standard Deviation 6.8 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score | 8.8 score on a scale | Standard Deviation 5.1 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score | 7.2 score on a scale | Standard Deviation 3.4 |
Secondary
Change From Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score
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: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score | 12.6 score on a scale | Standard Deviation 6.9 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score | 10.2 score on a scale | Standard Deviation 10.8 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score | 9.8 score on a scale | Standard Deviation 8.5 |
Secondary
Change From Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score
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: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score | 10.8 score on a scale | Standard Deviation 7.6 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score | 7.7 score on a scale | Standard Deviation 8.2 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score | 5.4 score on a scale | Standard Deviation 9.6 |
Secondary
Change From Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score
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: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score | 37.6 score on a scale | Standard Deviation 27 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score | 29.9 score on a scale | Standard Deviation 28.6 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score | 25.5 score on a scale | Standard Deviation 20.3 |
Secondary
Change From Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score
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: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score | 6.9 score on a scale | Standard Deviation 7.9 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score | 4.5 score on a scale | Standard Deviation 8.9 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score | 4.5 score on a scale | Standard Deviation 4.1 |
Secondary
Change From Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score
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: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score | 7.4 score on a scale | Standard Deviation 7.8 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score | 7.4 score on a scale | Standard Deviation 6 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score | 5.9 score on a scale | Standard Deviation 5.4 |
Secondary
Change From Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score
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: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score | 9.9 score on a scale | Standard Deviation 8.3 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score | 8.8 score on a scale | Standard Deviation 9.6 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score | 6.7 score on a scale | Standard Deviation 7.2 |
Secondary
Change From Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score
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: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score | 8.0 score on a scale | Standard Deviation 8.2 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score | 7.8 score on a scale | Standard Deviation 8.4 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score | 6.1 score on a scale | Standard Deviation 9.6 |
Secondary
Change From Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score
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: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score | 31.0 score on a scale | Standard Deviation 31.6 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score | 30.1 score on a scale | Standard Deviation 25.4 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score | 22.6 score on a scale | Standard Deviation 22.4 |
Secondary
Change From Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score
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: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score | 6.4 score on a scale | Standard Deviation 7.7 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score | 5.6 score on a scale | Standard Deviation 7.3 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score | 4.0 score on a scale | Standard Deviation 4.2 |
Secondary
Change From Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score
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: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score | 6.8 score on a scale | Standard Deviation 9.1 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score | 7.9 score on a scale | Standard Deviation 5.9 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score | 5.9 score on a scale | Standard Deviation 6.5 |
Secondary
Change From Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score
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: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score | 9.5 score on a scale | Standard Deviation 8.3 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score | 11.3 score on a scale | Standard Deviation 9.7 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score | 6.7 score on a scale | Standard Deviation 8.8 |
Secondary
Change From Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score
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: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score | 8.5 score on a scale | Standard Deviation 9.4 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score | 6.8 score on a scale | Standard Deviation 9.4 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score | 4.1 score on a scale | Standard Deviation 10.3 |
Secondary
Change From Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score
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: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score | 32.2 score on a scale | Standard Deviation 20.7 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score | 31.6 score on a scale | Standard Deviation 27.6 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score | 19.2 score on a scale | Standard Deviation 25.9 |
Secondary
Change From Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score
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: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score | 6.7 score on a scale | Standard Deviation 5.8 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score | 6.1 score on a scale | Standard Deviation 7.9 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score | 3.6 score on a scale | Standard Deviation 5.9 |
Secondary
Change From Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score
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: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score | 7.5 score on a scale | Standard Deviation 3.4 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score | 7.3 score on a scale | Standard Deviation 6.6 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score | 4.9 score on a scale | Standard Deviation 6.2 |
Secondary
Change From Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score
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: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score | 11.0 score on a scale | Standard Deviation 3 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score | 10.4 score on a scale | Standard Deviation 8.7 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score | 8.0 score on a scale | Standard Deviation 9.5 |
Secondary
Change From Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score
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: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score | 8.3 score on a scale | Standard Deviation 6.1 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score | 8.6 score on a scale | Standard Deviation 9.1 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score | 6.2 score on a scale | Standard Deviation 10.3 |
Secondary
Change From Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score
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: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score | 34.0 score on a scale | Standard Deviation 13.4 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score | 32.7 score on a scale | Standard Deviation 24.6 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score | 23.6 score on a scale | Standard Deviation 22.5 |
Secondary
Change From Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score
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: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score | 6.5 score on a scale | Standard Deviation 6.1 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score | 6.2 score on a scale | Standard Deviation 7.8 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score | 3.3 score on a scale | Standard Deviation 4.3 |
Secondary
Change From Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score
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: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score | 8.2 score on a scale | Standard Deviation 3.1 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score | 7.5 score on a scale | Standard Deviation 6.7 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score | 6.2 score on a scale | Standard Deviation 3.5 |
Secondary
Change From Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score
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 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.
Population: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score | 11.6 score on a scale | Standard Deviation 4.2 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score | 12.0 score on a scale | Standard Deviation 10.4 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score | 8.8 score on a scale | Standard Deviation 9.9 |
Secondary
Change From Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score
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 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.
Population: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score | 9.4 score on a scale | Standard Deviation 7.2 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score | 11.3 score on a scale | Standard Deviation 11.1 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score | 6.8 score on a scale | Standard Deviation 8.6 |
Secondary
Change From Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score
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 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.
Population: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score | 33.4 score on a scale | Standard Deviation 17 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score | 38.4 score on a scale | Standard Deviation 27 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score | 28.2 score on a scale | Standard Deviation 19.5 |
Secondary
Change From Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score
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 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.
Population: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score | 6.0 score on a scale | Standard Deviation 5.8 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score | 6.4 score on a scale | Standard Deviation 7.8 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score | 5.7 score on a scale | Standard Deviation 5.2 |
Secondary
Change From Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score
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 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.
Population: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score | 6.4 score on a scale | Standard Deviation 3.5 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score | 8.7 score on a scale | Standard Deviation 5.6 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score | 7.2 score on a scale | Standard Deviation 3.6 |
Secondary
Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score
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: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy have been set to missing in that study. \[Week 8 is the start of Study C87047\].
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score | 10.7 score on a scale | Standard Deviation 5.8 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score | 10.3 score on a scale | Standard Deviation 8.6 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score | 9.5 score on a scale | Standard Deviation 10.2 |
Secondary
Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score
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: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy have been set to missing in that study. \[Week 8 is the start of Study C87047\].
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score | 9.4 score on a scale | Standard Deviation 7 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score | 7.5 score on a scale | Standard Deviation 8.6 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score | 5.1 score on a scale | Standard Deviation 8.7 |
Secondary
Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score
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: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy have been set to missing in that study. \[Week 8 is the start of Study C87047\].
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score | 33.8 score on a scale | Standard Deviation 25.6 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score | 30.4 score on a scale | Standard Deviation 25.8 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score | 23.7 score on a scale | Standard Deviation 20.3 |
Secondary
Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score
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: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy have been set to missing in that study. \[Week 8 is the start of Study C87047\].
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score | 6.1 score on a scale | Standard Deviation 7.4 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score | 5.5 score on a scale | Standard Deviation 7.1 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score | 3.5 score on a scale | Standard Deviation 4 |
Secondary
Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score
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: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy have been set to missing in that study. \[Week 8 is the start of Study C87047\].
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CZP 400 mg / Placebo | Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score | 7.6 score on a scale | Standard Deviation 7 |
| CZP 400 mg / CZP 200 mg | Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score | 7.1 score on a scale | Standard Deviation 5.9 |
| CZP 400 mg / CZP 400 mg | Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score | 5.7 score on a scale | Standard Deviation 4.7 |
Secondary
C-Reactive Protein (CRP) Level at Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals)
Time frame: Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.
Population: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 26 for Completers or the Withdrawal Visit for Premature Withdrawals) | 19.81 mg/L |
| CZP 400 mg / CZP 200 mg | C-Reactive Protein (CRP) Level at Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) | 13.12 mg/L |
| CZP 400 mg / CZP 400 mg | C-Reactive Protein (CRP) Level at Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) | 14.04 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 (NCT00291668)). 'Week 0' is the Baseline visit in the double-blind main study.
Population: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 | 21.37 mg/L |
| CZP 400 mg / CZP 200 mg | C-Reactive Protein (CRP) Level at Week 0 | 26.31 mg/L |
| CZP 400 mg / CZP 400 mg | C-Reactive Protein (CRP) Level at Week 0 | 25.88 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: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 | 12.55 mg/L |
| CZP 400 mg / CZP 200 mg | C-Reactive Protein (CRP) Level at Week 12 | 14.91 mg/L |
| CZP 400 mg / CZP 400 mg | C-Reactive Protein (CRP) Level at Week 12 | 11.64 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: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 | 16.12 mg/L |
| CZP 400 mg / CZP 200 mg | C-Reactive Protein (CRP) Level at Week 16 | 16.06 mg/L |
| CZP 400 mg / CZP 400 mg | C-Reactive Protein (CRP) Level at Week 16 | 14.05 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: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 | 17.16 mg/L |
| CZP 400 mg / CZP 200 mg | C-Reactive Protein (CRP) Level at Week 20 | 13.16 mg/L |
| CZP 400 mg / CZP 400 mg | C-Reactive Protein (CRP) Level at Week 20 | 17.44 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: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 | 10.97 mg/L |
| CZP 400 mg / CZP 200 mg | C-Reactive Protein (CRP) Level at Week 24 | 12.44 mg/L |
| CZP 400 mg / CZP 400 mg | C-Reactive Protein (CRP) Level at Week 24 | 16.84 mg/L |
Secondary
C-Reactive Protein (CRP) Level at Week 26
Time frame: Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.
Population: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 26 | 15.94 mg/L |
| CZP 400 mg / CZP 200 mg | C-Reactive Protein (CRP) Level at Week 26 | 9.96 mg/L |
| CZP 400 mg / CZP 400 mg | C-Reactive Protein (CRP) Level at Week 26 | 13.11 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: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at this time-point are included. Data collected after receipt of rescue therapy have been set to missing in that study. \[Week 8 is the start of Study C87047\].
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| CZP 400 mg / Placebo | C-Reactive Protein (CRP) Level at Week 8 | 23.80 mg/L |
| CZP 400 mg / CZP 200 mg | C-Reactive Protein (CRP) Level at Week 8 | 19.11 mg/L |
| CZP 400 mg / CZP 400 mg | C-Reactive Protein (CRP) Level at Week 8 | 11.61 mg/L |
Secondary
Percentage of Crohn's Disease Activity Index (CDAI) Responders at Last Visit [Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals]
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 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.
Population: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CZP 400 mg / Placebo | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Last Visit [Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals] | Percentage of CDAI responders | 44.4 Percentage of subjects |
| CZP 400 mg / Placebo | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Last Visit [Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals] | Percentage of CDAI non-responders | 55.6 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Last Visit [Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals] | Percentage of CDAI responders | 73.3 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Last Visit [Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals] | Percentage of CDAI non-responders | 26.7 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Last Visit [Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals] | Percentage of CDAI responders | 60.0 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Last Visit [Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals] | Percentage of CDAI non-responders | 40.0 Percentage of subjects |
Secondary
Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 12
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: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.
| 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 | 77.8 Percentage of subjects |
| CZP 400 mg / Placebo | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 12 | Percentage of CDAI non-responders | 22.2 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 | 73.3 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 | 26.7 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 | 86.7 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 | 13.3 Percentage of subjects |
Secondary
Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 16
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: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.
| 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 | 77.8 Percentage of subjects |
| CZP 400 mg / Placebo | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 16 | Percentage of CDAI non-responders | 22.2 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 | 60.0 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 | 40.0 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 | 66.7 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 | 33.3 Percentage of subjects |
Secondary
Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 20
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: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.
| 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 | 66.7 Percentage of subjects |
| CZP 400 mg / Placebo | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 20 | Percentage of CDAI non-responders | 33.3 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 | 60.0 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 | 40.0 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 | 60.0 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 | 40.0 Percentage of subjects |
Secondary
Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 24
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: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.
| 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 | 44.4 Percentage of subjects |
| CZP 400 mg / Placebo | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 24 | Percentage of CDAI non-responders | 55.6 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 | 60.0 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 | 40.0 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 | 53.3 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 | 46.7 Percentage of subjects |
Secondary
Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 8
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: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.
| 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 | 55.6 Percentage of subjects |
| CZP 400 mg / Placebo | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 8 | Percentage of CDAI non-responders | 44.4 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 | 66.7 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 8 | Percentage of CDAI non-responders | 33.3 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 8 | Percentage of CDAI responders | 80.0 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 | 20.0 Percentage of subjects |
Secondary
Percentage of Subjects Achieving Remission at Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals)
The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
Time frame: Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.
Population: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. 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 26 for Completers or the Withdrawal Visit for Premature Withdrawals) | Percentage of subjects in remission | 22.2 Percentage of subjects |
| CZP 400 mg / Placebo | Percentage of Subjects Achieving Remission at Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) | Percentage of subjects not in remission | 77.8 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects Achieving Remission at Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) | Percentage of subjects in remission | 46.7 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects Achieving Remission at Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) | Percentage of subjects not in remission | 53.3 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects Achieving Remission at Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) | Percentage of subjects in remission | 46.7 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects Achieving Remission at Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) | Percentage of subjects not in remission | 53.3 Percentage of subjects |
Secondary
Percentage of Subjects Achieving Remission at Week 12
The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI 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: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. 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 | 44.4 Percentage of subjects |
| CZP 400 mg / Placebo | Percentage of Subjects Achieving Remission at Week 12 | Percentage of subjects not in remission | 55.6 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects Achieving Remission at Week 12 | Percentage of subjects in remission | 46.7 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects Achieving Remission at Week 12 | Percentage of subjects not in remission | 53.3 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects Achieving Remission at Week 12 | Percentage of subjects in remission | 53.3 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects Achieving Remission at Week 12 | Percentage of subjects not in remission | 46.7 Percentage of subjects |
Secondary
Percentage of Subjects Achieving Remission at Week 16
The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI 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: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. 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 | 44.4 Percentage of subjects |
| CZP 400 mg / Placebo | Percentage of Subjects Achieving Remission at Week 16 | Percentage of subjects not in remission | 55.6 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects Achieving Remission at Week 16 | Percentage of subjects in remission | 46.7 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects Achieving Remission at Week 16 | Percentage of subjects not in remission | 53.3 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects Achieving Remission at Week 16 | Percentage of subjects in remission | 40.0 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects Achieving Remission at Week 16 | Percentage of subjects not in remission | 60.0 Percentage of subjects |
Secondary
Percentage of Subjects Achieving Remission at Week 20
The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI 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: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. 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 | 22.2 Percentage of subjects |
| CZP 400 mg / Placebo | Percentage of Subjects Achieving Remission at Week 20 | Percentage of subjects not in remission | 77.8 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects Achieving Remission at Week 20 | Percentage of subjects in remission | 53.3 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects Achieving Remission at Week 20 | Percentage of subjects not in remission | 46.7 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects Achieving Remission at Week 20 | Percentage of subjects in remission | 40.0 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects Achieving Remission at Week 20 | Percentage of subjects not in remission | 60.0 Percentage of subjects |
Secondary
Percentage of Subjects Achieving Remission at Week 24
The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI 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: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. 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 | 22.2 Percentage of subjects |
| CZP 400 mg / Placebo | Percentage of Subjects Achieving Remission at Week 24 | Percentage of subjects not in remission | 77.8 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects Achieving Remission at Week 24 | Percentage of subjects in remission | 46.7 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects Achieving Remission at Week 24 | Percentage of subjects not in remission | 53.3 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects Achieving Remission at Week 24 | Percentage of subjects in remission | 40.0 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects Achieving Remission at Week 24 | Percentage of subjects not in remission | 60.0 Percentage of subjects |
Secondary
Percentage of Subjects Achieving Remission at Week 26
The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
Time frame: Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.
Population: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. 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 26 | Percentage of subjects in remission | 22.2 Percentage of subjects |
| CZP 400 mg / Placebo | Percentage of Subjects Achieving Remission at Week 26 | Percentage of subjects not in remission | 77.8 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects Achieving Remission at Week 26 | Percentage of subjects in remission | 46.7 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects Achieving Remission at Week 26 | Percentage of subjects not in remission | 53.3 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects Achieving Remission at Week 26 | Percentage of subjects in remission | 46.7 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects Achieving Remission at Week 26 | Percentage of subjects not in remission | 53.3 Percentage of subjects |
Secondary
Percentage of Subjects Achieving Remission at Week 8
The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI 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: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. 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 | 33.3 Percentage of subjects |
| CZP 400 mg / Placebo | Percentage of Subjects Achieving Remission at Week 8 | Percentage of subjects not in remission | 66.7 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects Achieving Remission at Week 8 | Percentage of subjects in remission | 40.0 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects Achieving Remission at Week 8 | Percentage of subjects not in remission | 60.0 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects Achieving Remission at Week 8 | Percentage of subjects in remission | 53.3 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects Achieving Remission at Week 8 | Percentage of subjects not in remission | 46.7 Percentage of subjects |
Secondary
Percentage of Subjects at Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) 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. A decrease in CDAI over time indicates improvement in disease activity.
Time frame: Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.
Population: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CZP 400 mg / Placebo | Percentage of Subjects at Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 | Percentage of 70-point responders | 55.6 Percentage of subjects |
| CZP 400 mg / Placebo | Percentage of Subjects at Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 | Percentage of 70-point non-responders | 44.4 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects at Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 | Percentage of 70-point responders | 73.3 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects at Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 | Percentage of 70-point non-responders | 26.7 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects at Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 | Percentage of 70-point responders | 73.3 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects at Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 | Percentage of 70-point non-responders | 26.7 Percentage of subjects |
Secondary
Percentage of Subjects at Week 12 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. 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: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CZP 400 mg / Placebo | Percentage of Subjects at Week 12 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 | Percentage of 70-point responders | 77.8 Percentage of subjects |
| CZP 400 mg / Placebo | Percentage of Subjects at Week 12 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 | Percentage of 70-point non-responders | 22.2 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects at Week 12 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 | Percentage of 70-point responders | 80.0 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects at Week 12 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 | Percentage of 70-point non-responders | 20.0 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects at Week 12 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 | Percentage of 70-point responders | 93.3 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects at Week 12 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 | Percentage of 70-point non-responders | 6.7 Percentage of subjects |
Secondary
Percentage of Subjects at Week 16 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. 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: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CZP 400 mg / Placebo | Percentage of Subjects at Week 16 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 | Percentage of 70-point responders | 77.8 Percentage of subjects |
| CZP 400 mg / Placebo | Percentage of Subjects at Week 16 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 | Percentage of 70-point non-responders | 22.2 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects at Week 16 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 | Percentage of 70-point responders | 66.7 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects at Week 16 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 | Percentage of 70-point non-responders | 33.3 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects at Week 16 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 | Percentage of 70-point responders | 66.7 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects at Week 16 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 | Percentage of 70-point non-responders | 33.3 Percentage of subjects |
Secondary
Percentage of Subjects at Week 20 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. 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: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CZP 400 mg / Placebo | Percentage of Subjects at Week 20 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 | Percentage of 70-point responders | 66.7 Percentage of subjects |
| CZP 400 mg / Placebo | Percentage of Subjects at Week 20 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 | Percentage of 70-point non-responders | 33.3 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects at Week 20 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 | Percentage of 70-point responders | 60.0 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects at Week 20 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 | Percentage of 70-point non-responders | 40.0 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects at Week 20 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 | Percentage of 70-point responders | 73.3 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects at Week 20 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 | Percentage of 70-point non-responders | 26.7 Percentage of subjects |
Secondary
Percentage of Subjects at Week 24 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. 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: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CZP 400 mg / Placebo | Percentage of Subjects at Week 24 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 | Percentage of 70-point responders | 55.6 Percentage of subjects |
| CZP 400 mg / Placebo | Percentage of Subjects at Week 24 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 | Percentage of 70-point non-responders | 44.4 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects at Week 24 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 | Percentage of 70-point responders | 66.7 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects at Week 24 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 | Percentage of 70-point non-responders | 33.3 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects at Week 24 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 | Percentage of 70-point responders | 60.0 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects at Week 24 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 | Percentage of 70-point non-responders | 40.0 Percentage of subjects |
Secondary
Percentage of Subjects at Week 26 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. A decrease in CDAI over time indicates improvement in disease activity.
Time frame: Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.
Population: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CZP 400 mg / Placebo | Percentage of Subjects at Week 26 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 | Percentage of 70-point responders | 55.6 Percentage of subjects |
| CZP 400 mg / Placebo | Percentage of Subjects at Week 26 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 | Percentage of 70-point non-responders | 44.4 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects at Week 26 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 | Percentage of 70-point responders | 73.3 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects at Week 26 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 | Percentage of 70-point non-responders | 26.7 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects at Week 26 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 | Percentage of 70-point responders | 73.3 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects at Week 26 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 | Percentage of 70-point non-responders | 26.7 Percentage of subjects |
Secondary
Percentage of Subjects at Week 8 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. 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: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CZP 400 mg / Placebo | Percentage of Subjects at Week 8 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 | Percentage of 70-point responders | 77.8 Percentage of subjects |
| CZP 400 mg / Placebo | Percentage of Subjects at Week 8 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 | Percentage of 70-point non-responders | 22.2 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects at Week 8 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 | Percentage of 70-point responders | 73.3 Percentage of subjects |
| CZP 400 mg / CZP 200 mg | Percentage of Subjects at Week 8 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 | Percentage of 70-point non-responders | 26.7 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects at Week 8 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 | Percentage of 70-point responders | 86.7 Percentage of subjects |
| CZP 400 mg / CZP 400 mg | Percentage of Subjects at Week 8 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 | Percentage of 70-point non-responders | 13.3 Percentage of subjects |
Secondary
Ratio of C-Reactive Protein (CRP) Level at Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) to Week 0
Time frame: Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.
Population: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 26 for Completers or the Withdrawal Visit for Premature Withdrawals) to Week 0 | 0.72 ratio |
| CZP 400 mg / CZP 200 mg | Ratio of C-Reactive Protein (CRP) Level at Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) to Week 0 | 0.48 ratio |
| CZP 400 mg / CZP 400 mg | Ratio of C-Reactive Protein (CRP) Level at Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) to Week 0 | 0.52 ratio |
Secondary
Ratio of C-Reactive Protein (CRP) Level at Week 12 to 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: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 Week 0 | 0.63 ratio |
| CZP 400 mg / CZP 200 mg | Ratio of C-Reactive Protein (CRP) Level at Week 12 to Week 0 | 0.55 ratio |
| CZP 400 mg / CZP 400 mg | Ratio of C-Reactive Protein (CRP) Level at Week 12 to Week 0 | 0.45 ratio |
Secondary
Ratio of C-Reactive Protein (CRP) Level at Week 16 to 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: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 Week 0 | 0.81 ratio |
| CZP 400 mg / CZP 200 mg | Ratio of C-Reactive Protein (CRP) Level at Week 16 to Week 0 | 0.59 ratio |
| CZP 400 mg / CZP 400 mg | Ratio of C-Reactive Protein (CRP) Level at Week 16 to Week 0 | 0.53 ratio |
Secondary
Ratio of C-Reactive Protein (CRP) Level at Week 20 to 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: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 Week 0 | 0.65 ratio |
| CZP 400 mg / CZP 200 mg | Ratio of C-Reactive Protein (CRP) Level at Week 20 to Week 0 | 0.53 ratio |
| CZP 400 mg / CZP 400 mg | Ratio of C-Reactive Protein (CRP) Level at Week 20 to Week 0 | 0.66 ratio |
Secondary
Ratio of C-Reactive Protein (CRP) Level at Week 24 to 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: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 Week 0 | 0.72 ratio |
| CZP 400 mg / CZP 200 mg | Ratio of C-Reactive Protein (CRP) Level at Week 24 to Week 0 | 0.5 ratio |
| CZP 400 mg / CZP 400 mg | Ratio of C-Reactive Protein (CRP) Level at Week 24 to Week 0 | 0.62 ratio |
Secondary
Ratio of C-Reactive Protein (CRP) Level at Week 26 to Week 0
Time frame: Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.
Population: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) 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 26 to Week 0 | 0.63 ratio |
| CZP 400 mg / CZP 200 mg | Ratio of C-Reactive Protein (CRP) Level at Week 26 to Week 0 | 0.4 ratio |
| CZP 400 mg / CZP 400 mg | Ratio of C-Reactive Protein (CRP) Level at Week 26 to Week 0 | 0.47 ratio |
Secondary
Ratio of C-Reactive Protein (CRP) Level at Week 8 to 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: Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy have been set to missing in that study. \[Week 8 is the start of Study C87047\].
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| CZP 400 mg / Placebo | Ratio of C-Reactive Protein (CRP) Level at Week 8 to Week 0 | 1.11 ratio |
| CZP 400 mg / CZP 200 mg | Ratio of C-Reactive Protein (CRP) Level at Week 8 to Week 0 | 0.73 ratio |
| CZP 400 mg / CZP 400 mg | Ratio of C-Reactive Protein (CRP) Level at Week 8 to Week 0 | 0.45 ratio |
Secondary
Time to Disease Progression
Time to disease progression is defined as the earliest of: * time to an increase from Week 6 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 6 to Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 6' is the last visit in the double-blind main study and 'Week 26' is 18 weeks after the first visit in this extension study.
Population: Responders at Week 6 of Study C87037 (NCT00291668) could enter this extension study C87047 (NCT00329550). As so few subjects experienced disease progression in this study it was not possible to calculate the median time to disease progression. Please see post-hoc outcome measure 80 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 6 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 6 to Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 6' is the last visit in the double-blind main study and 'Week 26' is 18 weeks after the first visit in this extension study.
Population: Responders at Week 6 of Study C87037 (NCT00291668) could enter this extension study, C87047 (NCT00329550). As it was not possible to calculate the time to disease progression (outcome measure 22) 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 | 2 subjects |
| CZP 400 mg / CZP 200 mg | Number of Subjects With Disease Progression | 3 subjects |
| CZP 400 mg / CZP 400 mg | Number of Subjects With Disease Progression | 1 subjects |