Trial Outcomes & Findings for Study to Evaluate Efficacy and Safety of Certolizumab Pegol for Induction of Remission in Patients With Crohn's Disease (NCT NCT00552058)
NCT ID: NCT00552058
Last Updated: 2018-08-09
Results Overview
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.
COMPLETED
PHASE3
439 participants
Week 6
2018-08-09
Participant Flow
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.
Participant milestones
| Measure |
Certolizumab Pegol
Certolizumab pegol 400 mg for subcutaneous (sc) injection
|
Placebo
Placebo, saline solution for sc injection
|
|---|---|---|
|
Overall Study
STARTED
|
223
|
216
|
|
Overall Study
COMPLETED
|
207
|
192
|
|
Overall Study
NOT COMPLETED
|
16
|
24
|
Reasons for withdrawal
| Measure |
Certolizumab Pegol
Certolizumab pegol 400 mg for subcutaneous (sc) injection
|
Placebo
Placebo, saline solution for sc injection
|
|---|---|---|
|
Overall Study
Adverse Event
|
8
|
7
|
|
Overall Study
Lack of Efficacy
|
1
|
5
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
4
|
|
Overall Study
Other: Protocol Violation
|
0
|
1
|
|
Overall Study
Other: Non Compliance
|
1
|
2
|
|
Overall Study
Other: Crossed Over to a Follow-up Study
|
0
|
1
|
|
Overall Study
Other: Low CDAI score, entry violation
|
0
|
1
|
|
Overall Study
Other: Positive Stool Result
|
0
|
1
|
|
Overall Study
Other: Randomized in error
|
0
|
1
|
|
Overall Study
Other: Sponsors Decision
|
0
|
1
|
|
Overall Study
Other: Early Roll Over
|
1
|
0
|
Baseline Characteristics
Study to Evaluate Efficacy and Safety of Certolizumab Pegol for Induction of Remission in Patients With Crohn's Disease
Baseline characteristics by cohort
| Measure |
Certolizumab Pegol
n=223 Participants
Certolizumab pegol 400 mg for subcutaneous (sc) injection
|
Placebo
n=215 Participants
Placebo, saline solution for sc injection
|
Total
n=438 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
213 Participants
n=5 Participants
|
205 Participants
n=7 Participants
|
418 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Continuous
|
36.3 years
STANDARD_DEVIATION 12.63 • n=5 Participants
|
38.8 years
STANDARD_DEVIATION 12.76 • n=7 Participants
|
37.5 years
STANDARD_DEVIATION 12.74 • n=5 Participants
|
|
Sex: Female, Male
Female
|
118 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
243 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
105 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
195 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=5 Participants
|
41 participants
n=7 Participants
|
83 participants
n=5 Participants
|
|
Region of Enrollment
Estonia
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Ukraine
|
10 participants
n=5 Participants
|
13 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
|
8 participants
n=5 Participants
|
7 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
12 participants
n=5 Participants
|
10 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
5 participants
n=5 Participants
|
8 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
13 participants
n=5 Participants
|
9 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
25 participants
n=5 Participants
|
25 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
34 participants
n=5 Participants
|
32 participants
n=7 Participants
|
66 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
16 participants
n=5 Participants
|
10 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
8 participants
n=5 Participants
|
12 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Region of Enrollment
Latvia
|
3 participants
n=5 Participants
|
5 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
10 participants
n=5 Participants
|
9 participants
n=7 Participants
|
19 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 6Population: 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.
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.
Outcome measures
| Measure |
Certolizumab Pegol
n=215 Participants
Certolizumab pegol 400 mg for subcutaneous (sc) injection
|
Placebo
n=209 Participants
Placebo, saline solution for sc injection
|
|---|---|---|
|
Percentage of Subjects in Clinical Remission at Week 6
|
31.6 percentage of subjects
Interval 25.4 to 37.8
|
25.4 percentage of subjects
Interval 19.5 to 31.3
|
SECONDARY outcome
Timeframe: Week 0, Week 6Population: 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.
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.
Outcome measures
| Measure |
Certolizumab Pegol
n=215 Participants
Certolizumab pegol 400 mg for subcutaneous (sc) injection
|
Placebo
n=209 Participants
Placebo, saline solution for sc injection
|
|---|---|---|
|
Percentage of Subjects Achieving a Clinical Response at Week 6
|
40.5 percentage of subjects
Interval 33.9 to 47.0
|
34.0 percentage of subjects
Interval 27.6 to 40.4
|
SECONDARY outcome
Timeframe: Week 6Population: 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.
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.
Outcome measures
| Measure |
Certolizumab Pegol
n=215 Participants
Certolizumab pegol 400 mg for subcutaneous (sc) injection
|
Placebo
n=209 Participants
Placebo, saline solution for sc injection
|
|---|---|---|
|
Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 6
|
36.7 percentage of subjects
Interval 30.3 to 43.2
|
28.7 percentage of subjects
Interval 22.6 to 34.8
|
SECONDARY outcome
Timeframe: Week 0 to Week 6Population: 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.
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.
Outcome measures
| Measure |
Certolizumab Pegol
n=192 Participants
Certolizumab pegol 400 mg for subcutaneous (sc) injection
|
Placebo
n=183 Participants
Placebo, saline solution for sc injection
|
|---|---|---|
|
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
|
-73.1 score on a scale
Standard Deviation 95.07
|
SECONDARY outcome
Timeframe: Week 0 to Week 6Population: 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.
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.
Outcome measures
| Measure |
Certolizumab Pegol
n=196 Participants
Certolizumab pegol 400 mg for subcutaneous (sc) injection
|
Placebo
n=187 Participants
Placebo, saline solution for sc injection
|
|---|---|---|
|
Change in Harvey Bradshaw Index (HBI) Score From Week 0 to Week 6
|
-3.3 score on a scale
Standard Deviation 4.00
|
-2.6 score on a scale
Standard Deviation 3.90
|
SECONDARY outcome
Timeframe: Week 2Population: 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.
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.
Outcome measures
| Measure |
Certolizumab Pegol
n=215 Participants
Certolizumab pegol 400 mg for subcutaneous (sc) injection
|
Placebo
n=209 Participants
Placebo, saline solution for sc injection
|
|---|---|---|
|
Percentage of Subjects in Clinical Remission at Week 2
|
23.3 percentage of subjects
Interval 17.6 to 28.9
|
15.8 percentage of subjects
Interval 10.8 to 20.7
|
SECONDARY outcome
Timeframe: Week 4Population: 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.
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.
Outcome measures
| Measure |
Certolizumab Pegol
n=215 Participants
Certolizumab pegol 400 mg for subcutaneous (sc) injection
|
Placebo
n=209 Participants
Placebo, saline solution for sc injection
|
|---|---|---|
|
Percentage of Subjects in Clinical Remission at Week 4
|
26.5 percentage of subjects
Interval 20.6 to 32.4
|
19.1 percentage of subjects
Interval 13.8 to 24.5
|
SECONDARY outcome
Timeframe: Week 0, Week 2Population: 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.
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.
Outcome measures
| Measure |
Certolizumab Pegol
n=215 Participants
Certolizumab pegol 400 mg for subcutaneous (sc) injection
|
Placebo
n=209 Participants
Placebo, saline solution for sc injection
|
|---|---|---|
|
Percentage of Subjects Achieving a Clinical Response at Week 2
|
33.0 percentage of subjects
Interval 26.7 to 39.3
|
20.1 percentage of subjects
Interval 14.7 to 25.5
|
SECONDARY outcome
Timeframe: Week 0, Week 4Population: 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.
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.
Outcome measures
| Measure |
Certolizumab Pegol
n=215 Participants
Certolizumab pegol 400 mg for subcutaneous (sc) injection
|
Placebo
n=209 Participants
Placebo, saline solution for sc injection
|
|---|---|---|
|
Percentage of Subjects Achieving a Clinical Response at Week 4
|
35.3 percentage of subjects
Interval 29.0 to 41.7
|
26.3 percentage of subjects
Interval 20.3 to 32.3
|
SECONDARY outcome
Timeframe: Week 0 to Week 2Population: 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.
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.
Outcome measures
| Measure |
Certolizumab Pegol
n=204 Participants
Certolizumab pegol 400 mg for subcutaneous (sc) injection
|
Placebo
n=198 Participants
Placebo, saline solution for sc injection
|
|---|---|---|
|
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
|
-41.8 score on a scale
Standard Deviation 82.06
|
SECONDARY outcome
Timeframe: Week 0, Week 4Population: 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.
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.
Outcome measures
| Measure |
Certolizumab Pegol
n=198 Participants
Certolizumab pegol 400 mg for subcutaneous (sc) injection
|
Placebo
n=184 Participants
Placebo, saline solution for sc injection
|
|---|---|---|
|
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
|
-65.7 score on a scale
Standard Deviation 83.06
|
SECONDARY outcome
Timeframe: Week 2Population: 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.
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.
Outcome measures
| Measure |
Certolizumab Pegol
n=215 Participants
Certolizumab pegol 400 mg for subcutaneous (sc) injection
|
Placebo
n=209 Participants
Placebo, saline solution for sc injection
|
|---|---|---|
|
Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 2
|
25.6 percentage of subjects
Interval 19.7 to 31.4
|
18.2 percentage of subjects
Interval 13.0 to 23.4
|
SECONDARY outcome
Timeframe: Week 4Population: 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.
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.
Outcome measures
| Measure |
Certolizumab Pegol
n=215 Participants
Certolizumab pegol 400 mg for subcutaneous (sc) injection
|
Placebo
n=209 Participants
Placebo, saline solution for sc injection
|
|---|---|---|
|
Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 4
|
33.5 percentage of subjects
Interval 27.2 to 39.8
|
23.9 percentage of subjects
Interval 18.1 to 29.7
|
SECONDARY outcome
Timeframe: Week 6Population: 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.
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.
Outcome measures
| Measure |
Certolizumab Pegol
n=122 Participants
Certolizumab pegol 400 mg for subcutaneous (sc) injection
|
Placebo
n=113 Participants
Placebo, saline solution for sc injection
|
|---|---|---|
|
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
Interval 22.2 to 38.5
|
30.1 percentage of subjects
Interval 21.6 to 38.5
|
SECONDARY outcome
Timeframe: Week 6Population: 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.
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.
Outcome measures
| Measure |
Certolizumab Pegol
n=93 Participants
Certolizumab pegol 400 mg for subcutaneous (sc) injection
|
Placebo
n=96 Participants
Placebo, saline solution for sc injection
|
|---|---|---|
|
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
Interval 23.8 to 42.9
|
19.8 percentage of subjects
Interval 11.8 to 27.8
|
SECONDARY outcome
Timeframe: Week 0, Week 6Population: 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.
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.
Outcome measures
| Measure |
Certolizumab Pegol
n=122 Participants
Certolizumab pegol 400 mg for subcutaneous (sc) injection
|
Placebo
n=113 Participants
Placebo, saline solution for sc injection
|
|---|---|---|
|
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
Interval 29.1 to 46.3
|
35.4 percentage of subjects
Interval 26.6 to 44.2
|
SECONDARY outcome
Timeframe: Week 0, Week 6Population: 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
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.
Outcome measures
| Measure |
Certolizumab Pegol
n=93 Participants
Certolizumab pegol 400 mg for subcutaneous (sc) injection
|
Placebo
n=96 Participants
Placebo, saline solution for sc injection
|
|---|---|---|
|
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
Interval 34.0 to 54.2
|
32.3 percentage of subjects
Interval 22.9 to 41.6
|
Adverse Events
Certolizumab Pegol
Placebo
Serious adverse events
| Measure |
Certolizumab Pegol
n=223 participants at risk
Certolizumab pegol 400 mg for subcutaneous (sc) injection
|
Placebo
n=215 participants at risk
Placebo, saline solution for sc injection
|
|---|---|---|
|
Blood and lymphatic system disorders
SPLENOMEGALY
|
0.45%
1/223 • Number of events 1 • up to 6 weeks
|
0.00%
0/215 • up to 6 weeks
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.45%
1/223 • Number of events 1 • up to 6 weeks
|
0.00%
0/215 • up to 6 weeks
|
|
Gastrointestinal disorders
CROHN'S DISEASE
|
1.3%
3/223 • Number of events 3 • up to 6 weeks
|
0.47%
1/215 • Number of events 1 • up to 6 weeks
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
0.90%
2/223 • Number of events 4 • up to 6 weeks
|
0.00%
0/215 • up to 6 weeks
|
|
Gastrointestinal disorders
LARGE INTESTINAL OBSTRUCTION
|
0.00%
0/223 • up to 6 weeks
|
0.47%
1/215 • Number of events 1 • up to 6 weeks
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.45%
1/223 • Number of events 1 • up to 6 weeks
|
0.00%
0/215 • up to 6 weeks
|
|
Gastrointestinal disorders
PROCTALGIA
|
0.45%
1/223 • Number of events 1 • up to 6 weeks
|
0.00%
0/215 • up to 6 weeks
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
0.00%
0/223 • up to 6 weeks
|
0.47%
1/215 • Number of events 1 • up to 6 weeks
|
|
General disorders
PYREXIA
|
0.90%
2/223 • Number of events 2 • up to 6 weeks
|
0.00%
0/215 • up to 6 weeks
|
|
Infections and infestations
ABSCESS
|
0.00%
0/223 • up to 6 weeks
|
0.47%
1/215 • Number of events 1 • up to 6 weeks
|
|
Infections and infestations
CLOSTRIDIAL INFECTION
|
0.45%
1/223 • Number of events 1 • up to 6 weeks
|
0.00%
0/215 • up to 6 weeks
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.00%
0/223 • up to 6 weeks
|
0.47%
1/215 • Number of events 1 • up to 6 weeks
|
|
Infections and infestations
HIV INFECTION
|
0.45%
1/223 • Number of events 1 • up to 6 weeks
|
0.00%
0/215 • up to 6 weeks
|
|
Infections and infestations
PERIANAL ABSCESS
|
0.00%
0/223 • up to 6 weeks
|
0.47%
1/215 • Number of events 1 • up to 6 weeks
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.45%
1/223 • Number of events 1 • up to 6 weeks
|
0.00%
0/215 • up to 6 weeks
|
|
Musculoskeletal and connective tissue disorders
FISTULA
|
0.00%
0/223 • up to 6 weeks
|
0.47%
1/215 • Number of events 1 • up to 6 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTATIC NEOPLASM
|
0.45%
1/223 • Number of events 1 • up to 6 weeks
|
0.00%
0/215 • up to 6 weeks
|
|
Renal and urinary disorders
RENAL COLIC
|
0.00%
0/223 • up to 6 weeks
|
0.47%
1/215 • Number of events 1 • up to 6 weeks
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHOSPASM
|
0.00%
0/223 • up to 6 weeks
|
0.47%
1/215 • Number of events 1 • up to 6 weeks
|
Other adverse events
| Measure |
Certolizumab Pegol
n=223 participants at risk
Certolizumab pegol 400 mg for subcutaneous (sc) injection
|
Placebo
n=215 participants at risk
Placebo, saline solution for sc injection
|
|---|---|---|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
4.5%
10/223 • Number of events 10 • up to 6 weeks
|
3.7%
8/215 • Number of events 8 • up to 6 weeks
|
|
Gastrointestinal disorders
NAUSEA
|
4.0%
9/223 • Number of events 9 • up to 6 weeks
|
4.7%
10/215 • Number of events 11 • up to 6 weeks
|
|
General disorders
FATIGUE
|
4.0%
9/223 • Number of events 9 • up to 6 weeks
|
0.93%
2/215 • Number of events 2 • up to 6 weeks
|
|
General disorders
PYREXIA
|
3.1%
7/223 • Number of events 9 • up to 6 weeks
|
4.7%
10/215 • Number of events 14 • up to 6 weeks
|
|
Infections and infestations
URINARY TRACT INFECTION
|
3.1%
7/223 • Number of events 7 • up to 6 weeks
|
2.3%
5/215 • Number of events 5 • up to 6 weeks
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
4.0%
9/223 • Number of events 9 • up to 6 weeks
|
2.8%
6/215 • Number of events 6 • up to 6 weeks
|
|
Nervous system disorders
HEADACHE
|
5.4%
12/223 • Number of events 13 • up to 6 weeks
|
4.7%
10/215 • Number of events 14 • up to 6 weeks
|
Additional Information
Study Director
UCB
Results disclosure agreements
- Principal investigator is a sponsor employee UCB has \> 60 days but \<= 180 days to review results communications prior to public release and may delete information that is confidential and compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
- Publication restrictions are in place
Restriction type: OTHER