| Primary | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 34 | Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Non-responders at Week 6 of main study C87037 (NCT00291668) could enter this extension study, C87048 (NCT00329420). This summary is based on the 26 subjects in the Full Analysis Set (FAS) Population who responded to re-induction at Week 14. Subject withdrawal or use of rescue therapy is counted as non-response from that time onwards in that study. | Posted | | Number | | Percentage of subjects | | Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) |
| | | Title | Denominators | Categories |
|---|
| Percentage of CDAI responders | | | Title | Measurements |
|---|
| - OG00066.7
- OG00128.6
- OG00242.9
|
| | Percentage of CDAI non-responders | |
| |
| Secondary | Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 8 | Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. All those in this subgroup with data are included in this summary. | Posted | | Mean | Standard Deviation | score on a scale | | 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. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 |
|
| Secondary | Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 10 | Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. All those in this subgroup with data are included in this summary. | Posted | | Mean | Standard Deviation | score on a scale | | Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 |
|
| Secondary | Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 12 | Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. All those in this subgroup with data are included in this summary. | Posted | | Mean | Standard Deviation | score on a scale | | 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. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 |
|
| Secondary | Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 14 | Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. All those in this subgroup with data are included in this summary. | Posted | | Mean | Standard Deviation | score on a scale | | Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 |
|
| Secondary | Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 16 | Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. All those in this subgroup with data are included in this summary. | Posted | | Mean | Standard Deviation | score on a scale | | 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. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 |
|
| Secondary | Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 20 | Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. All those in this subgroup with data are included in this summary. | Posted | | Mean | Standard Deviation | score on a scale | | 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. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 |
|
| Secondary | Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 24 | Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. All those in this subgroup with data are included in this summary. | Posted | | Mean | Standard Deviation | score on a scale | | 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. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 |
|
| Secondary | Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 28 | Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. All those in this subgroup with data are included in this summary. | Posted | | Mean | Standard Deviation | score on a scale | | Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 |
|
| Secondary | Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 32 | Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. All those in this subgroup with data are included in this summary. | Posted | | Mean | Standard Deviation | score on a scale | | Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 |
|
| Secondary | Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 34 | Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. All those in this subgroup with data are included in this summary. | Posted | | Mean | Standard Deviation | score on a scale | | Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 |
|
| Secondary | Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) | Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. All those in this subgroup with data are included in this summary. | Posted | | Mean | Standard Deviation | score on a scale | | Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) |
|
| Secondary | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 8 | Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study. | Posted | | Number | | Percentage of subjects | | 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. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) |
|
| Secondary | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 10 | Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study. | Posted | | Number | | Percentage of subjects | | Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) |
|
| Secondary | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 12 | Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study. | Posted | | Number | | Percentage of subjects | | 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. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) |
|
| Secondary | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 14 | Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study. | Posted | | Number | | Percentage of subjects | | Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) |
|
| Secondary | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 16 | Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study. | Posted | | Number | | Percentage of subjects | | 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. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) |
|
| Secondary | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 20 | Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study. | Posted | | Number | | Percentage of subjects | | 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. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) |
|
| Secondary | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 24 | Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study. | Posted | | Number | | Percentage of subjects | | 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. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) |
|
| Secondary | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 28 | Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study. | Posted | | Number | | Percentage of subjects | | Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) |
|
| Secondary | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 32 | Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study. | Posted | | Number | | Percentage of subjects | | Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) |
|
| Secondary | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) | Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study. | Posted | | Number | | Percentage of subjects | | Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) |
|
| Secondary | Percentage of Subjects Achieving Remission at Week 8 | Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards. | Posted | | Number | | Percentage of subjects | | 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. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Percentage of Subjects Achieving Remission at Week 10 | Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards. | Posted | | Number | | Percentage of subjects | | Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Percentage of Subjects Achieving Remission at Week 12 | Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards. | Posted | | Number | | Percentage of subjects | | 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. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Percentage of Subjects Achieving Remission at Week 14 | Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards. | Posted | | Number | | Percentage of subjects | | Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Percentage of Subjects Achieving Remission at Week 16 | Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards. | Posted | | Number | | Percentage of subjects | | 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. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Percentage of Subjects Achieving Remission at Week 20 | Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards. | Posted | | Number | | Percentage of subjects | | 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. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Percentage of Subjects Achieving Remission at Week 24 | Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards. | Posted | | Number | | Percentage of subjects | | 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. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Percentage of Subjects Achieving Remission at Week 28 | Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards. | Posted | | Number | | Percentage of subjects | | Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Percentage of Subjects Achieving Remission at Week 32 | Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards. | Posted | | Number | | Percentage of subjects | | Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Percentage of Subjects Achieving Remission at Week 34 | Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards. | Posted | | Number | | Percentage of subjects | | Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Percentage of Subjects Achieving Remission at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) | Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards. | Posted | | Number | | Percentage of subjects | | Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) |
|
| Secondary | Time to Disease Progression | Time to disease progression is defined as the earliest of:
- time to an increase from Week 14 of ≥100 points in Crohn's Disease Activity Index (CDAI) score and CDAI>175 points for at least 2 consecutive visits,
- time to use of rescue therapy, or,
- time to subject withdrawal from the study.
| Non-responders at Week 6 of Study C87037 (NCT00291668) could enter this extension study, C87048 (NCT00329420). As so few subjects experienced disease progression in this study it was not possible to calculate the median time to disease progression. Please see outcome measure 124 where the number of subjects with disease progression is presented. | Posted | | | | | | Week 14 to Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is the visit at which response to re-induction is assessed and 'Week 34' is 26 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | |
|
| Secondary | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 8 | The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Mean | Standard Deviation | score on a scale | | 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. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 10 | The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Mean | Standard Deviation | score on a scale | | Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 12 | The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Mean | Standard Deviation | score on a scale | | 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. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 14 | The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Mean | Standard Deviation | score on a scale | | Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 16 | The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Mean | Standard Deviation | score on a scale | | 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. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 20 | The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Mean | Standard Deviation | score on a scale | | 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. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 24 | The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Mean | Standard Deviation | score on a scale | | 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. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 28 | The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Mean | Standard Deviation | score on a scale | | Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 32 | The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Mean | Standard Deviation | score on a scale | | Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 34 | The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Mean | Standard Deviation | score on a scale | | Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) | The Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Mean | Standard Deviation | score on a scale | | Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) |
|
| Secondary | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 8 | The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Mean | Standard Deviation | score on a scale | | 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. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 10 | The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Mean | Standard Deviation | score on a scale | | Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 12 | The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Mean | Standard Deviation | score on a scale | | 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. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 14 | The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Mean | Standard Deviation | score on a scale | | Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 16 | The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Mean | Standard Deviation | score on a scale | | 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. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 20 | The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Mean | Standard Deviation | score on a scale | | 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. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 24 | The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Mean | Standard Deviation | score on a scale | | 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. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 28 | The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Mean | Standard Deviation | score on a scale | | Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 32 | The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Mean | Standard Deviation | score on a scale | | Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 34 | The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Mean | Standard Deviation | score on a scale | | Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) | The Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Mean | Standard Deviation | score on a scale | | Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) |
|
| Secondary | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 8 | The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Mean | Standard Deviation | score on a scale | | 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. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 10 | The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Mean | Standard Deviation | score on a scale | | Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 12 | The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Mean | Standard Deviation | score on a scale | | 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. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 14 | The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Mean | Standard Deviation | score on a scale | | Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 16 | The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Mean | Standard Deviation | score on a scale | | 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. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 20 | The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Mean | Standard Deviation | score on a scale | | 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. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 24 | The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Mean | Standard Deviation | score on a scale | | 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. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 28 | The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Mean | Standard Deviation | score on a scale | | Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 32 | The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Mean | Standard Deviation | score on a scale | | Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 34 | The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Mean | Standard Deviation | score on a scale | | Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) | The Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Mean | Standard Deviation | score on a scale | | Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) |
|
| Secondary | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 8 | The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Mean | Standard Deviation | score on a scale | | 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. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 10 | The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Mean | Standard Deviation | score on a scale | | Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 12 | The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Mean | Standard Deviation | score on a scale | | 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. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 14 | The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Mean | Standard Deviation | score on a scale | | Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 16 | The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Mean | Standard Deviation | score on a scale | | 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. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 20 | The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Mean | Standard Deviation | score on a scale | | 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. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 24 | The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Mean | Standard Deviation | score on a scale | | 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. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 28 | The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Mean | Standard Deviation | score on a scale | | Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 32 | The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Mean | Standard Deviation | score on a scale | | Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 34 | The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Mean | Standard Deviation | score on a scale | | Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) | The Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Mean | Standard Deviation | score on a scale | | Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) |
|
| Secondary | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 8 | The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Mean | Standard Deviation | score on a scale | | 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. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 10 | The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Mean | Standard Deviation | score on a scale | | Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 12 | The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Mean | Standard Deviation | score on a scale | | 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. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 14 | The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Mean | Standard Deviation | score on a scale | | Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 16 | The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Mean | Standard Deviation | score on a scale | | 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. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 20 | The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Mean | Standard Deviation | score on a scale | | 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. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 24 | The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Mean | Standard Deviation | score on a scale | | 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. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 28 | The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Mean | Standard Deviation | score on a scale | | Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 32 | The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Mean | Standard Deviation | score on a scale | | Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 34 | The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Mean | Standard Deviation | score on a scale | | Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg |
|
| Secondary | Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) | The Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Mean | Standard Deviation | score on a scale | | Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) |
|
| Secondary | C-Reactive Protein (CRP) Level at Week 0 | | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Geometric Mean | Full Range | mg/L | | Week 0 (relative to the start of the 6-week double-blind main study (N00291668)). 'Week 0' is the Baseline visit in the double-blind main study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) |
|
| Secondary | C-Reactive Protein (CRP) Level at Week 8 | | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Geometric Mean | Full Range | mg/L | | 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. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) |
|
| Secondary | C-Reactive Protein (CRP) Level at Week 10 | | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Geometric Mean | Full Range | mg/L | | Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) |
|
| Secondary | C-Reactive Protein (CRP) Level at Week 12 | | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Geometric Mean | Full Range | mg/L | | 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. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) |
|
| Secondary | C-Reactive Protein (CRP) Level at Week 14 | | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Geometric Mean | Full Range | mg/L | | Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) |
|
| Secondary | C-Reactive Protein (CRP) Level at Week 16 | | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Geometric Mean | Full Range | mg/L | | 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. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) |
|
| Secondary | C-Reactive Protein (CRP) Level at Week 20 | | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Geometric Mean | Full Range | mg/L | | 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. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) |
|
| Secondary | C-Reactive Protein (CRP) Level at Week 24 | | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Geometric Mean | Full Range | mg/L | | 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. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) |
|
| Secondary | C-Reactive Protein (CRP) Level at Week 28 | | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Geometric Mean | Full Range | mg/L | | Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) |
|
| Secondary | C-Reactive Protein (CRP) Level at Week 32 | | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Geometric Mean | Full Range | mg/L | | Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) |
|
| Secondary | C-Reactive Protein (CRP) Level at Week 34 | | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Geometric Mean | Full Range | mg/L | | Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) |
|
| Secondary | C-Reactive Protein (CRP) Level at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) | | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Geometric Mean | Full Range | mg/L | | Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) |
|
| Secondary | Ratio of C-Reactive Protein (CRP) Level at Week 8 to CRP Level at Week 0 | The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 8 divided by the CRP Level at Week 0 | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Geometric Mean | Full Range | ratio | | 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. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) |
|
| Secondary | Ratio of C-Reactive Protein (CRP) Level at Week 10 to CRP Level at Week 0 | The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 10 divided by the CRP Level at Week 0 | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Geometric Mean | Full Range | ratio | | Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg | |
|
| Secondary | Ratio of C-Reactive Protein (CRP) Level at Week 12 to CRP Level at Week 0 | The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 12 divided by the CRP Level at Week 0 | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Geometric Mean | Full Range | ratio | | 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. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg | |
|
| Secondary | Ratio of C-Reactive Protein (CRP) Level at Week 14 to CRP Level at Week 0 | The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 14 divided by the CRP Level at Week 0 | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Geometric Mean | Full Range | ratio | | Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg | |
|
| Secondary | Ratio of C-Reactive Protein (CRP) Level at Week 16 to CRP Level at Week 0 | The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 16 divided by the CRP Level at Week 0 | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Geometric Mean | Full Range | ratio | | 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. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg | |
|
| Secondary | Ratio of C-Reactive Protein (CRP) Level at Week 20 to CRP Level at Week 0 | The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 20 divided by the CRP Level at Week 0 | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Geometric Mean | Full Range | ratio | | 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. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg | |
|
| Secondary | Ratio of C-Reactive Protein (CRP) Level at Week 24 to CRP Level at Week 0 | The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 24 divided by the CRP Level at Week 0 | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Geometric Mean | Full Range | ratio | | 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. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg | |
|
| Secondary | Ratio of C-Reactive Protein (CRP) Level at Week 28 to CRP Level at Week 0 | The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 28 divided by the CRP Level at Week 0 | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Geometric Mean | Full Range | ratio | | Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg | |
|
| Secondary | Ratio of C-Reactive Protein (CRP) Level at Week 32 to CRP Level at Week 0 | The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 32 divided by the CRP Level at Week 0 | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Geometric Mean | Full Range | ratio | | Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg | |
|
| Secondary | Ratio of C-Reactive Protein (CRP) Level at Week 34 to CRP Level at Week 0 | The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 34 divided by the CRP Level at Week 0 | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Geometric Mean | Full Range | ratio | | Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG002 | CZP 400 mg / CZP 400 mg | |
|
| Secondary | Ratio of C-Reactive Protein (CRP) Level at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) to CRP Level at Week 0 | The ratio is calculated as the C-Reactive Protein (CRP) Level at Last Visit (Week 34 for completers or the Withdrawal Visit for premature withdrawals)divided by the CRP Level at Week 0 | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study. | Posted | | Geometric Mean | Full Range | ratio | | Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) |
|
| Secondary | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 8 | 70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study. | Posted | | Number | | percentage of subjects | | 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. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) |
|
| Secondary | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 10 | 70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study. | Posted | | Number | | percentage of subjects | | Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) |
|
| Secondary | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 12 | 70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study. | Posted | | Number | | percentage of subjects | | 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. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) |
|
| Secondary | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 14 | 70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study. | Posted | | Number | | percentage of subjects | | Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) |
|
| Secondary | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 16 | 70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study. | Posted | | Number | | percentage of subjects | | 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. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) |
|
| Secondary | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 20 | 70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study. | Posted | | Number | | percentage of subjects | | 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. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) |
|
| Secondary | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 24 | 70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study. | Posted | | Number | | percentage of subjects | | 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. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) |
|
| Secondary | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 28 | 70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study. | Posted | | Number | | percentage of subjects | | Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) |
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| Secondary | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 32 | 70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study. | Posted | | Number | | percentage of subjects | | Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) |
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| Secondary | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 34 | 70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study. | Posted | | Number | | percentage of subjects | | Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) |
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| Secondary | Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) | 70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. | Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of "Responders to Re-induction", based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study. | Posted | | Number | | percentage of subjects | | Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) |
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| Post-Hoc | Number of Subjects With Disease Progression | Disease progression is defined as:
- an increase from Week 14 of ≥100 points in Crohn's Disease Activity Index (CDAI) score and CDAI>175 points for at least 2 consecutive visits,
- use of rescue therapy, or,
- subject withdrawal from the study.
| Non-responders at Week 6 of Study C87037 (NCT00291668) could enter this extension study C87048 (NCT00329420). As it was not possible to calculate the time to disease progression (outcome measure 34) due to the very small number of subjects meeting this definition, the post-hoc outcome of number of subjects with disease progression is presented here | Posted | | Number | | subjects | | Week 14 to Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is the visit at which response to re-induction is assessed and 'Week 34' is 26 weeks after the first visit in this extension study. | | | | ID | Title | Description |
|---|
| OG000 | CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | | OG001 | CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | |
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