| Primary | Percentage of Subjects in Clinical Remission at Week 6 | The percentage of subjects in clinical remission at Week 6 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease. | Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose. | Posted | | Number | 95% Confidence Interval | percentage of subjects | | Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol | Certolizumab pegol 400 mg for subcutaneous (sc) injection | | OG001 | Placebo | Placebo, saline solution for sc injection |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00031.6(25.4 to 37.8)
- OG00125.4(19.5 to 31.3)
|
|
| |
| Secondary | Percentage of Subjects Achieving a Clinical Response at Week 6 | The percentage of subjects achieving a clinical response at Week 6 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates clinical remission and a score above 450 points indicates extremely severe disease. | Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose. | Posted | | Number | 95% Confidence Interval | percentage of subjects | | Week 0, Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol | Certolizumab pegol 400 mg for subcutaneous (sc) injection | | OG001 | Placebo | Placebo, saline solution for sc injection |
| |
| Secondary | Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 6 | The percentage of subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 6 (IBDQ remission is defined as a total IBDQ score of 170 points or more). 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. | Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose. | Posted | | Number | 95% Confidence Interval | percentage of subjects | | Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol | Certolizumab pegol 400 mg for subcutaneous (sc) injection | | OG001 | Placebo | Placebo, saline solution for sc injection |
| |
| Secondary | Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 6 | The change in total Crohn's Disease Activity Index (CDAI) score from Week 0 to Week 6. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease. | Of the 215 (Certolizumab Pegol 400 mg) and 209 (Placebo) subjects in the Intent-to-treat (ITT) population, 192 and 183 subjects respectively are included in this summary and have assessments at both Weeks 0 and 6. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose. | Posted | | Mean | Standard Deviation | score on a scale | | Week 0 to Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol | Certolizumab pegol 400 mg for subcutaneous (sc) injection | | OG001 | Placebo | Placebo, saline solution for sc injection |
| |
| Secondary | Change in Harvey Bradshaw Index (HBI) Score From Week 0 to Week 6 | The change in Harvey Bradshaw Index (HBI) score from Week 0 to Week 6. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (score 1 per item). The first three items are scored for the previous day. Lower scores indicated better well being. | Of the 215 (Certolizumab Pegol 400 mg) and 209 (Placebo) subjects in the Intent-to-treat (ITT) population, 196 and 187 subjects respectively are included in this summary and have assessments at both Weeks 0 and 6. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose. | Posted | | Mean | Standard Deviation | score on a scale | | Week 0 to Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol | Certolizumab pegol 400 mg for subcutaneous (sc) injection | | OG001 | Placebo | Placebo, saline solution for sc injection |
| |
| Secondary | Percentage of Subjects in Clinical Remission at Week 2 | The percentage of subjects in clinical remission at Week 2 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease. | Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose. | Posted | | Number | 95% Confidence Interval | percentage of subjects | | Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol | Certolizumab pegol 400 mg for subcutaneous (sc) injection | | OG001 | Placebo | Placebo, saline solution for sc injection |
| |
| Secondary | Percentage of Subjects in Clinical Remission at Week 4 | The percentage of subjects in clinical remission at Week 4 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease. | Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose. | Posted | | Number | 95% Confidence Interval | percentage of subjects | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol | Certolizumab pegol 400 mg for subcutaneous (sc) injection | | OG001 | Placebo | Placebo, saline solution for sc injection |
| |
| Secondary | Percentage of Subjects Achieving a Clinical Response at Week 2 | The percentage of subjects achieving a clinical response at Week 2 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease. | Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose. | Posted | | Number | 95% Confidence Interval | percentage of subjects | | Week 0, Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol | Certolizumab pegol 400 mg for subcutaneous (sc) injection | | OG001 | Placebo | Placebo, saline solution for sc injection |
| |
| Secondary | Percentage of Subjects Achieving a Clinical Response at Week 4 | The percentage of subjects achieving a clinical response at Week 4 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease. | Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose. | Posted | | Number | 95% Confidence Interval | percentage of subjects | | Week 0, Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol | Certolizumab pegol 400 mg for subcutaneous (sc) injection | | OG001 | Placebo | Placebo, saline solution for sc injection |
| |
| Secondary | Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 2 | The change in total Crohn's Disease Activity Index (CDAI) score from Week 0 to Week 2. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease. | Of the 215 (Certolizumab Pegol 400 mg) and 209 (Placebo) subjects in the Intent-to-treat (ITT) population, 204 and 198 subjects respectively are included in this summary and have assessments at both Weeks 0 and 2. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose. | Posted | | Mean | Standard Deviation | score on a scale | | Week 0 to Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol | Certolizumab pegol 400 mg for subcutaneous (sc) injection | | OG001 | Placebo | Placebo, saline solution for sc injection |
| |
| Secondary | Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 4 | The change in total Crohn's Disease Activity Index (CDAI) score from Week 0 to Week 4. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease. | Of the 215 (Certolizumab Pegol 400 mg) and 209 (Placebo) subjects in the Intent-to-treat (ITT) population, 198 and 184 subjects respectively are included in this summary and have assessments at both Weeks 0 and 4. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose. | Posted | | Mean | Standard Deviation | score on a scale | | Week 0, Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol | Certolizumab pegol 400 mg for subcutaneous (sc) injection | | OG001 | Placebo | Placebo, saline solution for sc injection |
| |
| Secondary | Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 2 | The percentage of subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 2 (IBDQ remission is defined as a total IBDQ score of 170 points or more). 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. | Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose. | Posted | | Number | 95% Confidence Interval | percentage of subjects | | Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol | Certolizumab pegol 400 mg for subcutaneous (sc) injection | | OG001 | Placebo | Placebo, saline solution for sc injection |
| |
| Secondary | Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 4 | The percentage of subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 4 (IBDQ remission is defined as a total IBDQ score of 170 points or more). 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. | Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose. | Posted | | Number | 95% Confidence Interval | percentage of subjects | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol | Certolizumab pegol 400 mg for subcutaneous (sc) injection | | OG001 | Placebo | Placebo, saline solution for sc injection |
| |
| Secondary | Percentage of Subjects in Subgroup With Less Than 10 mg/L C-reactive Protein (CRP) at Entry Who Are in Clinical Remission at Week 6 | The percentage of subjects in the subgroup with less than 10 mg/L of C-reactive Protein (CRP) at Entry who are in clinical remission at Week 6 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease. | Of 215 (Certolizumab Pegol 400 mg) and 209 (Placebo) subjects in the Intent-to-treat (ITT) population, 122 and 113 subjects are in the less than 10 mg/L C-reactive Protein (CRP) subgroup at Entry, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose. | Posted | | Number | 95% Confidence Interval | percentage of subjects | | Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol | Certolizumab pegol 400 mg for subcutaneous (sc) injection | | OG001 | Placebo | Placebo, saline solution for sc injection |
| |
| Secondary | Percentage of Subjects in Subgroup With 10 mg/L or Greater C-reactive Protein (CRP) at Entry Who Are in Clinical Remission at Week 6 | The percentage of subjects in the subgroup with 10 mg/L or greater C-reactive Protein (CRP) at Entry in clinical remission at Week 6 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease. | Of the 215 (Certolizumab Pegol 400 mg) and 209 (Placebo) subjects in the Intent-to-treat (ITT) population, 93 and 96 subjects are in the 10 mg/L or greater C-reactive Protein (CRP) subgroup at Entry, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose. | Posted | | Number | 95% Confidence Interval | percentage of subjects | | Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol | Certolizumab pegol 400 mg for subcutaneous (sc) injection | | OG001 | Placebo | Placebo, saline solution for sc injection |
| |
| Secondary | Percentage of Subjects in Subgroup With Less Than 10 mg/L C-reactive Protein (CRP) at Entry Achieving a Clinical Response at Week 6 | The percentage of subjects in the subgroup with less than 10 mg/L C-reactive Protein (CRP) at Entry achieving a clinical response at Week 6 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease. | Of 215 (Certolizumab Pegol 400 mg) and 209 (Placebo) subjects in the Intent-to-treat (ITT) population, 122 and 113 subjects are in the less than 10 mg/L C-reactive Protein (CRP) subgroup at Entry, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose. | Posted | | Number | 95% Confidence Interval | percentage of subjects | | Week 0, Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol | Certolizumab pegol 400 mg for subcutaneous (sc) injection | | OG001 | Placebo | Placebo, saline solution for sc injection |
| |
| Secondary | Percentage of Subjects in Subgroup With 10 mg/L or Greater C-reactive Protein (CRP) at Entry Achieving a Clinical Response at Week 6 | The percentage of subjects in the subgroup with 10 mg/L or greater C-reactive Protein (CRP) at Entry achieving a clinical response at Week 6 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease. | Of the 215 (Certolizumab Pegol 400 mg) and 209 (Placebo) subjects in the Intent-to-treat (ITT) population, 93 and 96 subjects are in the 10 mg/L or greater C-reactive Protein (CRP) subgroup at Entry, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose | Posted | | Number | 95% Confidence Interval | percentage of subjects | | Week 0, Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol | Certolizumab pegol 400 mg for subcutaneous (sc) injection | | OG001 | Placebo | Placebo, saline solution for sc injection |
| |