| Primary | Response Status With Response Defined as at Least 100 Point Decrease in Crohn's Disease Activity Score (CDAI Score) From Baseline in the Induction Phase | Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score) from baseline, otherwise there is a non-response. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | Intent-to-treat Induction Phase (ITTI) population: subjects who received at least one dose of study drug in the induction phase | Posted | | Number | | participants | | Baseline to Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Overall | |
| | | Title | Denominators | Categories |
|---|
| Response | | | | Non-Response | | |
| |
| Secondary | Response Status With Response Defined as at Least 100 Point Decrease in CDAI Score From Baseline in the Randomized Maintenance Phase | Response is defined as at least 100 point decrease in CDAI score from baseline. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | Intent-to-treat Randomized Maintenance Phase (ITTR) population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase | Posted | | Number | | participants | | Baseline to Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Q4W Regimen | every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol | | OG001 | Q2W Regimen | every 2 weeks: 400 mg Certolizumab Pegol |
| |
| Secondary | Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Induction Phase | Response is defined as at least 70 points reduction in CDAI score. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | ITTI population: all subjects who received at least one dose of study drug in the induction phase | Posted | | Number | | participants | | Baseline to Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Overall | |
| |
| Secondary | Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Randomized Maintenance Phase | Response is defined as at least 70 points reduction in CDAI score. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase | Posted | | Number | | participants | | Baseline to Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Q4W Regimen | every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol | | OG001 | Q2W Regimen | every 2 weeks: 400 mg Certolizumab Pegol |
| |
| Secondary | Remission Status With Remission Defined as CDAI Score ≤ 150 in the Induction Phase | Remission is defined as CDAI score ≤ 150. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | ITTI population: subjects who received at least one dose of study drug in the induction phase | Posted | | Number | | participants | | Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Overall | |
| |
| Secondary | Remission Status With Remission Defined as CDAI Score ≤ 150 in the Randomized Maintenance Phase | Remission is defined as CDAI score ≤ 150. The CDAI score is used to quantify the symptoms with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase | Posted | | Number | | participants | | Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Q4W Regimen | every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol | | OG001 | Q2W Regimen | every 2 weeks: 400 mg Certolizumab Pegol |
| |
| Secondary | CDAI Score at Week 2 of the Induction Phase | The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements) | Posted | | Mean | Standard Deviation | points on a scale | | Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Overall | |
| |
| Secondary | CDAI Score at Week 4 of the Induction Phase | The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements) | Posted | | Mean | Standard Deviation | points on a scale | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Overall | |
| |
| Secondary | CDAI Score at Week 6 of the Induction Phase | The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements) | Posted | | Mean | Standard Deviation | points on a scale | | Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Overall | |
| |
| Secondary | CDAI Score at Week 8 in the Randomized Maintenance Phase | The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements) | Posted | | Mean | Standard Deviation | points on a scale | | Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Q4W Regimen | every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol | | OG001 | Q2W Regimen | every 2 weeks: 400 mg Certolizumab Pegol |
| |
| Secondary | CDAI Score at Week 10 in the Randomized Maintenance Phase | The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements) | Posted | | Mean | Standard Deviation | points on a scale | | Week 10 | | | | ID | Title | Description |
|---|
| OG000 | Q4W Regimen | every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol | | OG001 | Q2W Regimen | every 2 weeks: 400 mg Certolizumab Pegol |
| |
| Secondary | CDAI Score at Week 12 in the Randomized Maintenance Phase | The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements) | Posted | | Mean | Standard Deviation | points on a scale | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Q4W Regimen | every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol | | OG001 | Q2W Regimen | every 2 weeks: 400 mg Certolizumab Pegol |
| |
| Secondary | CDAI Score at Week 14 in the Randomized Maintenance Phase | The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements) | Posted | | Mean | Standard Deviation | points on a scale | | Week 14 | | | | ID | Title | Description |
|---|
| OG000 | Q4W Regimen | every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol | | OG001 | Q2W Regimen | every 2 weeks: 400 mg Certolizumab Pegol |
| |
| Secondary | CDAI Score at Week 16 in the Randomized Maintenance Phase | The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements) | Posted | | Mean | Standard Deviation | points on a scale | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Q4W Regimen | every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol | | OG001 | Q2W Regimen | every 2 weeks: 400 mg Certolizumab Pegol |
| |
| Secondary | CDAI Score at Week 18 in the Randomized Maintenance Phase | The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements) | Posted | | Mean | Standard Deviation | points on a scale | | Week 18 | | | | ID | Title | Description |
|---|
| OG000 | Q4W Regimen | every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol | | OG001 | Q2W Regimen | every 2 weeks: 400 mg Certolizumab Pegol |
| |
| Secondary | CDAI Score at Week 20 in the Randomized Maintenance Phase | The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements) | Posted | | Mean | Standard Deviation | points on a scale | | Week 20 | | | | ID | Title | Description |
|---|
| OG000 | Q4W Regimen | every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol | | OG001 | Q2W Regimen | every 2 weeks: 400 mg Certolizumab Pegol |
| |
| Secondary | CDAI Score at Week 22 in the Randomized Maintenance Phase | The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements) | Posted | | Mean | Standard Deviation | points on a scale | | Week 22 | | | | ID | Title | Description |
|---|
| OG000 | Q4W Regimen | every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol | | OG001 | Q2W Regimen | every 2 weeks: 400 mg Certolizumab Pegol |
| |
| Secondary | CDAI Score at Week 24 in the Randomized Maintenance Phase | The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements) | Posted | | Mean | Standard Deviation | points on a scale | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Q4W Regimen | every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol | | OG001 | Q2W Regimen | every 2 weeks: 400 mg Certolizumab Pegol |
| |
| Secondary | CDAI Score at Week 26 in the Randomized Maintenance Phase | The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements) | Posted | | Mean | Standard Deviation | points on a scale | | Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Q4W Regimen | every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol | | OG001 | Q2W Regimen | every 2 weeks: 400 mg Certolizumab Pegol |
| |
| Secondary | Change From Baseline in CDAI Score at Week 2 of the Induction Phase | The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements) | Posted | | Mean | Standard Deviation | points on a scale | | Baseline to Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Overall | |
| |
| Secondary | Change From Baseline in CDAI Score at Week 4 of the Induction Phase | The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements) | Posted | | Mean | Standard Deviation | points on a scale | | Baseline to Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Overall | |
| |
| Secondary | Change From Baseline in CDAI Score at Week 6 of the Induction Phase | The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements) | Posted | | Mean | Standard Deviation | points on a scale | | Baseline to Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Overall | |
| |
| Secondary | Change From Baseline in CDAI Score at Week 8 in the Randomized Maintenance Phase | The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements) | Posted | | Mean | Standard Deviation | points on a scale | | Baseline to Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Q4W Regimen | every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol | | OG001 | Q2W Regimen | every 2 weeks: 400 mg Certolizumab Pegol |
| |
| Secondary | Change From Baseline in CDAI Score at Week 10 in the Randomized Maintenance Phase | The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements) | Posted | | Mean | Standard Deviation | points on a scale | | Baseline to Week 10 | | | | ID | Title | Description |
|---|
| OG000 | Q4W Regimen | every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol | | OG001 | Q2W Regimen | every 2 weeks: 400 mg Certolizumab Pegol |
| |
| Secondary | Change From Baseline in CDAI Score at Week 12 in the Randomized Maintenance Phase | The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements) | Posted | | Mean | Standard Deviation | points on a scale | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Q4W Regimen | every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol | | OG001 | Q2W Regimen | every 2 weeks: 400 mg Certolizumab Pegol |
| |
| Secondary | Change From Baseline in CDAI Score at Week 14 in the Randomized Maintenance Phase | The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements) | Posted | | Mean | Standard Deviation | points on a scale | | Baseline to Week 14 | | | | ID | Title | Description |
|---|
| OG000 | Q4W Regimen | every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol | | OG001 | Q2W Regimen | every 2 weeks: 400 mg Certolizumab Pegol |
| |
| Secondary | Change From Baseline in CDAI Score at Week 16 in the Randomized Maintenance Phase | The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements) | Posted | | Mean | Standard Deviation | points on a scale | | Baseline to Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Q4W Regimen | every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol | | OG001 | Q2W Regimen | every 2 weeks: 400 mg Certolizumab Pegol |
| |
| Secondary | Change From Baseline in CDAI Score at Week 18 in the Randomized Maintenance Phase | The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements) | Posted | | Mean | Standard Deviation | points on a scale | | Baseline to Week 18 | | | | ID | Title | Description |
|---|
| OG000 | Q4W Regimen | every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol | | OG001 | Q2W Regimen | every 2 weeks: 400 mg Certolizumab Pegol |
| |
| Secondary | Change From Baseline in CDAI Score at Week 20 in the Randomized Maintenance Phase | The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements) | Posted | | Mean | Standard Deviation | points on a scale | | Baseline to Week 20 | | | | ID | Title | Description |
|---|
| OG000 | Q4W Regimen | every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol | | OG001 | Q2W Regimen | every 2 weeks: 400 mg Certolizumab Pegol |
| |
| Secondary | Change From Baseline in CDAI Score at Week 22 in the Randomized Maintenance Phase | The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements) | Posted | | Mean | Standard Deviation | points on a scale | | Baseline to Week 22 | | | | ID | Title | Description |
|---|
| OG000 | Q4W Regimen | every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol | | OG001 | Q2W Regimen | every 2 weeks: 400 mg Certolizumab Pegol |
| |
| Secondary | Change From Baseline in CDAI Score at Week 24 in the Randomized Maintenance Phase | The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements) | Posted | | Mean | Standard Deviation | points on a scale | | Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Q4W Regimen | every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol | | OG001 | Q2W Regimen | every 2 weeks: 400 mg Certolizumab Pegol |
| |
| Secondary | Change From Baseline in CDAI Score at Week 26 in the Randomized Maintenance Phase | The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements) | Posted | | Mean | Standard Deviation | points on a scale | | Baseline to Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Q4W Regimen | every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol | | OG001 | Q2W Regimen | every 2 weeks: 400 mg Certolizumab Pegol |
| |
| Other Pre-specified | Time to Loss of Response (CDAI Score > 150 and Minimum Increase in CDAI of 70) After Week 6 | Median time to loss of response in the maintenance period (from Kaplan-Meier analysis); range is time of first event to time of last event. Loss of response is defined as both a CDAI score > 150 points and a minimum increase in CDAI of 70 points versus Week 6 at two consecutive visits. | ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements) | Posted | | Median | Full Range | days | | Week 6 to Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Q4W Regimen | every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol | | OG001 | Q2W Regimen | every 2 weeks: 400 mg Certolizumab Pegol |
| |
| Secondary | Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 10 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. | Remission is defined as CDAI score ≤ 150. | ITTR population taking steroids at baseline | Posted | | Number | | participants | | Week 10 | | | | ID | Title | Description |
|---|
| OG000 | Q4W Regimen | every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol | | OG001 | Q2W Regimen | every 2 weeks: 400 mg Certolizumab Pegol |
| |
| Secondary | Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 12 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. | Remission is defined as CDAI score ≤ 150. | ITTR population taking steroids at baseline | Posted | | Number | | participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Q4W Regimen | every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol | | OG001 | Q2W Regimen | every 2 weeks: 400 mg Certolizumab Pegol |
| |
| Secondary | Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 14 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. | Remission is defined as CDAI score ≤ 150. | ITTR population taking steroids at baseline | Posted | | Number | | participants | | Week 14 | | | | ID | Title | Description |
|---|
| OG000 | Q4W Regimen | every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol | | OG001 | Q2W Regimen | every 2 weeks: 400 mg Certolizumab Pegol |
| |
| Secondary | Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 16 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. | Remission is defined as CDAI score ≤ 150. | ITTR population taking steroids at baseline | Posted | | Number | | participants | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Q4W Regimen | every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol | | OG001 | Q2W Regimen | every 2 weeks: 400 mg Certolizumab Pegol |
| |
| Secondary | Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 18 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. | Remission is defined as CDAI score ≤ 150. | ITTR population taking steroids at baseline | Posted | | Number | | participants | | Week 18 | | | | ID | Title | Description |
|---|
| OG000 | Q4W Regimen | every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol | | OG001 | Q2W Regimen | every 2 weeks: 400 mg Certolizumab Pegol |
| |
| Secondary | Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 20 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. | Remission is defined as CDAI score ≤ 150. | ITTR population taking steroids at baseline | Posted | | Number | | participants | | Week 20 | | | | ID | Title | Description |
|---|
| OG000 | Q4W Regimen | every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol | | OG001 | Q2W Regimen | every 2 weeks: 400 mg Certolizumab Pegol |
| |
| Secondary | Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 22 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. | Remission is defined as CDAI score ≤ 150. | ITTR population taking steroids at baseline | Posted | | Number | | participants | | Week 22 | | | | ID | Title | Description |
|---|
| OG000 | Q4W Regimen | every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol | | OG001 | Q2W Regimen | every 2 weeks: 400 mg Certolizumab Pegol |
| |
| Secondary | Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 24 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. | Remission is defined as CDAI score ≤ 150. | ITTR population taking steroids at baseline | Posted | | Number | | participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Q4W Regimen | every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol | | OG001 | Q2W Regimen | every 2 weeks: 400 mg Certolizumab Pegol |
| |
| Secondary | Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 26 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. | Remission is defined as CDAI score ≤ 150. | ITTR population taking steroids at baseline | Posted | | Number | | participants | | Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Q4W Regimen | every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol | | OG001 | Q2W Regimen | every 2 weeks: 400 mg Certolizumab Pegol |
| |
| Secondary | Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 10 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. | Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score). | ITTR population taking steroids at baseline | Posted | | Number | | participants | | Week 10 | | | | ID | Title | Description |
|---|
| OG000 | Q4W Regimen | every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol | | OG001 | Q2W Regimen | every 2 weeks: 400 mg Certolizumab Pegol |
| |
| Secondary | Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 12 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. | Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score). | ITTR population taking steroids at baseline | Posted | | Number | | participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Q4W Regimen | every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol | | OG001 | Q2W Regimen | every 2 weeks: 400 mg Certolizumab Pegol |
| |
| Secondary | Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 14 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. | Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score). | ITTR population taking steroids at baseline | Posted | | Number | | participants | | Week 14 | | | | ID | Title | Description |
|---|
| OG000 | Q4W Regimen | every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol | | OG001 | Q2W Regimen | every 2 weeks: 400 mg Certolizumab Pegol |
| |
| Secondary | Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 16 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. | Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score). | ITTR population taking steroids at baseline | Posted | | Number | | participants | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Q4W Regimen | every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol | | OG001 | Q2W Regimen | every 2 weeks: 400 mg Certolizumab Pegol |
| |
| Secondary | Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 18 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. | Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score). | ITTR population taking steroids at baseline | Posted | | Number | | participants | | Week 18 | | | | ID | Title | Description |
|---|
| OG000 | Q4W Regimen | every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol | | OG001 | Q2W Regimen | every 2 weeks: 400 mg Certolizumab Pegol |
| |
| Secondary | Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 20 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. | Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score). | ITTR population taking steroids at baseline | Posted | | Number | | participants | | Week 20 | | | | ID | Title | Description |
|---|
| OG000 | Q4W Regimen | every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol | | OG001 | Q2W Regimen | every 2 weeks: 400 mg Certolizumab Pegol |
| |
| Secondary | Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 22 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. | Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score). | ITTR population taking steroids at baseline | Posted | | Number | | participants | | Week 22 | | | | ID | Title | Description |
|---|
| OG000 | Q4W Regimen | every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol | | OG001 | Q2W Regimen | every 2 weeks: 400 mg Certolizumab Pegol |
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| Secondary | Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 24 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. | Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score). | ITTR population taking steroids at baseline | Posted | | Number | | participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Q4W Regimen | every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol | | OG001 | Q2W Regimen | every 2 weeks: 400 mg Certolizumab Pegol |
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| Secondary | Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 26 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. | Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score). | ITTR population taking steroids at baseline | Posted | | Number | | participants | | Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Q4W Regimen | every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol | | OG001 | Q2W Regimen | every 2 weeks: 400 mg Certolizumab Pegol |
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| Secondary | C - Reactive Protein (CRP) Level at Baseline (Week 0) of the Induction Phase | High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L. | ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements) | Posted | | Median | Inter-Quartile Range | mg/L | | Week 0 | | | | ID | Title | Description |
|---|
| OG000 | Overall | |
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| Secondary | CRP Level at Week 2 of the Induction Phase | High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L. | ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements) | Posted | | Median | Inter-Quartile Range | mg/L | | Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Overall | |
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| Secondary | CRP Level at Week 4 of the Induction Phase | High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L. | ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements) | Posted | | Median | Inter-Quartile Range | mg/L | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Overall | |
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| Secondary | CRP Level at Week 6 of the Induction Phase | High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L. | ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements) | Posted | | Median | Inter-Quartile Range | mg/L | | Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Overall | |
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| Secondary | CRP Level at Week 8 in the Randomized Maintenance Phase | High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L. | ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements) | Posted | | Median | Inter-Quartile Range | mg/L | | Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Q4W Regimen | every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol | | OG001 | Q2W Regimen | every 2 weeks: 400 mg Certolizumab Pegol |
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| Secondary | CRP Level at Week 10 in the Randomized Maintenance Phase | High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L. | ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements, measurements are optional) | Posted | | Median | Inter-Quartile Range | mg/L | | Week 10 (optional measurement) | | | | ID | Title | Description |
|---|
| OG000 | Q4W Regimen | every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol | | OG001 | Q2W Regimen | every 2 weeks: 400 mg Certolizumab Pegol |
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| Secondary | CRP Level at Week 12 in the Randomized Maintenance Phase | High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L. | ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements) | Posted | | Median | Inter-Quartile Range | mg/L | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Q4W Regimen | every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol | | OG001 | Q2W Regimen | every 2 weeks: 400 mg Certolizumab Pegol |
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| Secondary | CRP Level at Week 14 in the Randomized Maintenance Phase | High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L. | ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements, measurements are optional) | Posted | | Median | Inter-Quartile Range | mg/L | | Week 14 (optional measurement) | | | | ID | Title | Description |
|---|
| OG000 | Q4W Regimen | every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol | | OG001 | Q2W Regimen | every 2 weeks: 400 mg Certolizumab Pegol |
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| Secondary | CRP Level at Week 16 in the Randomized Maintenance Phase | High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L. | ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements) | Posted | | Median | Inter-Quartile Range | mg/L | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Q4W Regimen | every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol | | OG001 | Q2W Regimen | every 2 weeks: 400 mg Certolizumab Pegol |
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| Secondary | CRP Level at Week 18 in the Randomized Maintenance Phase | High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L. | ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements, measurements are optional) | Posted | | Median | Inter-Quartile Range | mg/L | | Week 18 (optional measurement) | | | | ID | Title | Description |
|---|
| OG000 | Q4W Regimen | every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol | | OG001 | Q2W Regimen | every 2 weeks: 400 mg Certolizumab Pegol |
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| Secondary | CRP Level at Week 20 in the Randomized Maintenance Phase | High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L. | ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements) | Posted | | Median | Inter-Quartile Range | mg/L | | Week 20 | | | | ID | Title | Description |
|---|
| OG000 | Q4W Regimen | every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol | | OG001 | Q2W Regimen | every 2 weeks: 400 mg Certolizumab Pegol |
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| Secondary | CRP Level at Week 22 in the Randomized Maintenance Phase | High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L. | ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements, measurements are optional) | Posted | | Median | Inter-Quartile Range | mg/L | | Week 22 (optional measurement) | | | | ID | Title | Description |
|---|
| OG000 | Q4W Regimen | every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol | | OG001 | Q2W Regimen | every 2 weeks: 400 mg Certolizumab Pegol |
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| Secondary | CRP Level at Week 24 in the Randomized Maintenance Phase | High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L. | ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements) | Posted | | Median | Inter-Quartile Range | mg/L | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Q4W Regimen | every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol | | OG001 | Q2W Regimen | every 2 weeks: 400 mg Certolizumab Pegol |
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| Secondary | CRP Level at Week 26 in the Randomized Maintenance Phase | High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L. | ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements) | Posted | | Median | Inter-Quartile Range | mg/L | | Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Q4W Regimen | every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol | | OG001 | Q2W Regimen | every 2 weeks: 400 mg Certolizumab Pegol |
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| Secondary | CRP Level at Endpoint (Last Visit) in the Randomized Maintenance Phase | High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L. Endpoint is the visit when the last observation was taken, either at week 26 or at a visit before in case of early dropout. | ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements) | Posted | | Median | Inter-Quartile Range | mg/L | | Last visit on or before Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Q4W Regimen | every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol | | OG001 | Q2W Regimen | every 2 weeks: 400 mg Certolizumab Pegol |
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