Crohn Disease
Conditions
Keywords
CDP 870, Certolizumab Pegol, CIMZIA ®, Crohn's disease, Induction, Clinical remission, Clinical response
Brief summary
The primary objective of the study is to evaluate efficacy of certolizumab pegol in inducing clinical remission in patients with moderate to severe Crohn's disease as compared with placebo based on Crohn's Disease Activity Index (CDAI) score at Week 6.
Interventions
OTHERPlacebo
Saline 0.9% sc injection 2 x 1 mL Placebo at Week 0, 2 and 4
BIOLOGICALcertolizumab pegol (CDP870, CZP)
Certolizumab Pegol 400 mg CZP sc injection 2 x 1 mL CZP (200 mg/mL) at Week 0, 2, and 4
Sponsors
UCB Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* male/female * 18 - 75 years inclusive * diagnosis of Crohn's disease confirmed * moderate to severe disease activity (Crohn's Disease Activity Index (CDAI) 225 - 450) * no previous treatment with anti-tumor necrosis factor (anti-TNF) medications
Exclusion criteria
* previous participation in a certolizumab pegol study * general
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects in Clinical Remission at Week 6 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 6 | 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. |
| Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 6 | 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. |
| Change in Harvey Bradshaw Index (HBI) Score From Week 0 to Week 6 | 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. |
| Percentage of Subjects in Clinical Remission at Week 2 | 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. |
| Percentage of Subjects in Clinical Remission at Week 4 | 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. |
| Percentage of Subjects Achieving a Clinical Response at Week 2 | Week 0, 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. |
| Percentage of Subjects Achieving a Clinical Response at Week 4 | Week 0, 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. |
| Percentage of Subjects Achieving a Clinical Response at Week 6 | Week 0, 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. |
| Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 4 | Week 0, 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. |
| Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 2 | 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. |
| Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 4 | 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. |
| 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 | 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. |
| 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 | 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. |
| Percentage of Subjects in Subgroup With Less Than 10 mg/L C-reactive Protein (CRP) at Entry Achieving a Clinical Response at Week 6 | Week 0, 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. |
| Percentage of Subjects in Subgroup With 10 mg/L or Greater C-reactive Protein (CRP) at Entry Achieving a Clinical Response at Week 6 | Week 0, 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. |
| Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 2 | 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. |
Countries
Australia, Austria, Belgium, Brazil, Canada, Chile, Czechia, Estonia, Finland, Germany, Hungary, Israel, Italy, Latvia, New Zealand, Poland, Romania, Russia, Ukraine, United States
Participant flow
Pre-assignment details
Participants flow shows all subjects randomized. Safety analyses are based on actual treatment received; 1 subject randomized to placebo did not receive any treatment thus would be excluded due to the definition of the safety population.
Participants by arm
| Arm | Count |
|---|---|
| Certolizumab Pegol Certolizumab pegol 400 mg for subcutaneous (sc) injection | 223 |
| Placebo Placebo, saline solution for sc injection | 215 |
| Total | 438 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 8 | 7 |
| Overall Study | Lack of Efficacy | 1 | 5 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Other: Crossed Over to a Follow-up Study | 0 | 1 |
| Overall Study | Other: Early Roll Over | 1 | 0 |
| Overall Study | Other: Low CDAI score, entry violation | 0 | 1 |
| Overall Study | Other: Non Compliance | 1 | 2 |
| Overall Study | Other: Positive Stool Result | 0 | 1 |
| Overall Study | Other: Protocol Violation | 0 | 1 |
| Overall Study | Other: Randomized in error | 0 | 1 |
| Overall Study | Other: Sponsors Decision | 0 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 4 |
Baseline characteristics
| Characteristic | Certolizumab Pegol | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 6 Participants | 4 Participants | 10 Participants |
| Age, Categorical >=65 years | 4 Participants | 6 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 213 Participants | 205 Participants | 418 Participants |
| Age, Continuous | 36.3 years STANDARD_DEVIATION 12.63 | 38.8 years STANDARD_DEVIATION 12.76 | 37.5 years STANDARD_DEVIATION 12.74 |
| Region of Enrollment Australia | 8 participants | 12 participants | 20 participants |
| Region of Enrollment Austria | 5 participants | 3 participants | 8 participants |
| Region of Enrollment Belgium | 7 participants | 7 participants | 14 participants |
| Region of Enrollment Brazil | 16 participants | 10 participants | 26 participants |
| Region of Enrollment Canada | 34 participants | 32 participants | 66 participants |
| Region of Enrollment Czech Republic | 13 participants | 9 participants | 22 participants |
| Region of Enrollment Estonia | 2 participants | 2 participants | 4 participants |
| Region of Enrollment Germany | 4 participants | 4 participants | 8 participants |
| Region of Enrollment Hungary | 25 participants | 25 participants | 50 participants |
| Region of Enrollment Israel | 12 participants | 10 participants | 22 participants |
| Region of Enrollment Italy | 5 participants | 8 participants | 13 participants |
| Region of Enrollment Latvia | 3 participants | 5 participants | 8 participants |
| Region of Enrollment New Zealand | 10 participants | 9 participants | 19 participants |
| Region of Enrollment Poland | 15 participants | 15 participants | 30 participants |
| Region of Enrollment Romania | 4 participants | 3 participants | 7 participants |
| Region of Enrollment Russian Federation | 8 participants | 7 participants | 15 participants |
| Region of Enrollment Ukraine | 10 participants | 13 participants | 23 participants |
| Region of Enrollment United States | 42 participants | 41 participants | 83 participants |
| Sex: Female, Male Female | 118 Participants | 125 Participants | 243 Participants |
| Sex: Female, Male Male | 105 Participants | 90 Participants | 195 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 48 / 223 | 42 / 215 |
| serious Total, serious adverse events | 12 / 223 | 8 / 215 |
Outcome results
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.
Time frame: Week 6
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certolizumab Pegol | Percentage of Subjects in Clinical Remission at Week 6 | 31.6 percentage of subjects |
| Placebo | Percentage of Subjects in Clinical Remission at Week 6 | 25.4 percentage of subjects |
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.
Time frame: Week 0 to Week 6
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Certolizumab Pegol | Change in Harvey Bradshaw Index (HBI) Score From Week 0 to Week 6 | -3.3 score on a scale | Standard Deviation 4 |
| Placebo | Change in Harvey Bradshaw Index (HBI) Score From Week 0 to Week 6 | -2.6 score on a scale | Standard Deviation 3.9 |
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.
Time frame: Week 0 to Week 2
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Certolizumab Pegol | Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 2 | -72.6 score on a scale | Standard Deviation 81.26 |
| Placebo | Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 2 | -41.8 score on a scale | Standard Deviation 82.06 |
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.
Time frame: Week 0, Week 4
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Certolizumab Pegol | Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 4 | -88.8 score on a scale | Standard Deviation 91.36 |
| Placebo | Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 4 | -65.7 score on a scale | Standard Deviation 83.06 |
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.
Time frame: Week 0 to Week 6
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Certolizumab Pegol | Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 6 | -96.7 score on a scale | Standard Deviation 100.86 |
| Placebo | Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 6 | -73.1 score on a scale | Standard Deviation 95.07 |
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.
Time frame: Week 0, Week 2
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certolizumab Pegol | Percentage of Subjects Achieving a Clinical Response at Week 2 | 33.0 percentage of subjects |
| Placebo | Percentage of Subjects Achieving a Clinical Response at Week 2 | 20.1 percentage of subjects |
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.
Time frame: Week 0, Week 4
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certolizumab Pegol | Percentage of Subjects Achieving a Clinical Response at Week 4 | 35.3 percentage of subjects |
| Placebo | Percentage of Subjects Achieving a Clinical Response at Week 4 | 26.3 percentage of subjects |
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.
Time frame: Week 0, Week 6
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certolizumab Pegol | Percentage of Subjects Achieving a Clinical Response at Week 6 | 40.5 percentage of subjects |
| Placebo | Percentage of Subjects Achieving a Clinical Response at Week 6 | 34.0 percentage of subjects |
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.
Time frame: Week 2
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certolizumab Pegol | Percentage of Subjects in Clinical Remission at Week 2 | 23.3 percentage of subjects |
| Placebo | Percentage of Subjects in Clinical Remission at Week 2 | 15.8 percentage of subjects |
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.
Time frame: Week 4
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certolizumab Pegol | Percentage of Subjects in Clinical Remission at Week 4 | 26.5 percentage of subjects |
| Placebo | Percentage of Subjects in Clinical Remission at Week 4 | 19.1 percentage of subjects |
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.
Time frame: Week 2
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certolizumab Pegol | Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 2 | 25.6 percentage of subjects |
| Placebo | Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 2 | 18.2 percentage of subjects |
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.
Time frame: Week 4
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certolizumab Pegol | Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 4 | 33.5 percentage of subjects |
| Placebo | Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 4 | 23.9 percentage of subjects |
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.
Time frame: Week 6
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certolizumab Pegol | Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 6 | 36.7 percentage of subjects |
| Placebo | Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 6 | 28.7 percentage of subjects |
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.
Time frame: Week 0, Week 6
Population: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certolizumab Pegol | Percentage of Subjects in Subgroup With 10 mg/L or Greater C-reactive Protein (CRP) at Entry Achieving a Clinical Response at Week 6 | 44.1 percentage of subjects |
| Placebo | Percentage of Subjects in Subgroup With 10 mg/L or Greater C-reactive Protein (CRP) at Entry Achieving a Clinical Response at Week 6 | 32.3 percentage of subjects |
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.
Time frame: Week 6
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certolizumab Pegol | 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 | 33.3 percentage of subjects |
| Placebo | 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 | 19.8 percentage of subjects |
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.
Time frame: Week 0, Week 6
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certolizumab Pegol | Percentage of Subjects in Subgroup With Less Than 10 mg/L C-reactive Protein (CRP) at Entry Achieving a Clinical Response at Week 6 | 37.7 percentage of subjects |
| Placebo | Percentage of Subjects in Subgroup With Less Than 10 mg/L C-reactive Protein (CRP) at Entry Achieving a Clinical Response at Week 6 | 35.4 percentage of subjects |
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.
Time frame: Week 6
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certolizumab Pegol | 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 | 30.3 percentage of subjects |
| Placebo | 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 | 30.1 percentage of subjects |