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Trial record 1 of 2 for:    NCT00552058
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Study to Evaluate Efficacy and Safety of Certolizumab Pegol for Induction of Remission in Patients With Crohn's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00552058
Recruitment Status : Completed
First Posted : November 1, 2007
Results First Posted : December 30, 2010
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Crohn Disease
Interventions Biological: certolizumab pegol (CDP870, CZP)
Other: Placebo
Enrollment 439
Recruitment Details  
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.
Arm/Group Title Certolizumab Pegol Placebo
Hide Arm/Group Description Certolizumab pegol 400 mg for subcutaneous (sc) injection Placebo, saline solution for sc injection
Period Title: Overall Study
Started 223 216
Completed 207 192
Not Completed 16 24
Reason Not Completed
Adverse Event             8             7
Lack of Efficacy             1             5
Lost to Follow-up             1             0
Withdrawal by Subject             4             4
Other: Protocol Violation             0             1
Other: Non Compliance             1             2
Other: Crossed Over to a Follow-up Study             0             1
Other: Low CDAI score, entry violation             0             1
Other: Positive Stool Result             0             1
Other: Randomized in error             0             1
Other: Sponsors Decision             0             1
Other: Early Roll Over             1             0
Arm/Group Title Certolizumab Pegol Placebo Total
Hide Arm/Group Description Certolizumab pegol 400 mg for subcutaneous (sc) injection Placebo, saline solution for sc injection Total of all reporting groups
Overall Number of Baseline Participants 223 215 438
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 223 participants 215 participants 438 participants
<=18 years
6
   2.7%
4
   1.9%
10
   2.3%
Between 18 and 65 years
213
  95.5%
205
  95.3%
418
  95.4%
>=65 years
4
   1.8%
6
   2.8%
10
   2.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 223 participants 215 participants 438 participants
36.3  (12.63) 38.8  (12.76) 37.5  (12.74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 223 participants 215 participants 438 participants
Female
118
  52.9%
125
  58.1%
243
  55.5%
Male
105
  47.1%
90
  41.9%
195
  44.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 223 participants 215 participants 438 participants
United States 42 41 83
Estonia 2 2 4
Ukraine 10 13 23
Austria 5 3 8
Russian Federation 8 7 15
Israel 12 10 22
Italy 5 8 13
Czech Republic 13 9 22
Hungary 25 25 50
Canada 34 32 66
Poland 15 15 30
Belgium 7 7 14
Brazil 16 10 26
Romania 4 3 7
Australia 8 12 20
Latvia 3 5 8
Germany 4 4 8
New Zealand 10 9 19
1.Primary Outcome
Title Percentage of Subjects in Clinical Remission at Week 6
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Certolizumab Pegol Placebo
Hide Arm/Group Description:
Certolizumab pegol 400 mg for subcutaneous (sc) injection
Placebo, saline solution for sc injection
Overall Number of Participants Analyzed 215 209
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
31.6
(25.4 to 37.8)
25.4
(19.5 to 31.3)
2.Secondary Outcome
Title Percentage of Subjects Achieving a Clinical Response at Week 6
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Certolizumab Pegol Placebo
Hide Arm/Group Description:
Certolizumab pegol 400 mg for subcutaneous (sc) injection
Placebo, saline solution for sc injection
Overall Number of Participants Analyzed 215 209
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
40.5
(33.9 to 47.0)
34.0
(27.6 to 40.4)
3.Secondary Outcome
Title Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 6
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Certolizumab Pegol Placebo
Hide Arm/Group Description:
Certolizumab pegol 400 mg for subcutaneous (sc) injection
Placebo, saline solution for sc injection
Overall Number of Participants Analyzed 215 209
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
36.7
(30.3 to 43.2)
28.7
(22.6 to 34.8)
4.Secondary Outcome
Title Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 6
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Certolizumab Pegol Placebo
Hide Arm/Group Description:
Certolizumab pegol 400 mg for subcutaneous (sc) injection
Placebo, saline solution for sc injection
Overall Number of Participants Analyzed 192 183
Mean (Standard Deviation)
Unit of Measure: score on a scale
-96.7  (100.86) -73.1  (95.07)
5.Secondary Outcome
Title Change in Harvey Bradshaw Index (HBI) Score From Week 0 to Week 6
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Certolizumab Pegol Placebo
Hide Arm/Group Description:
Certolizumab pegol 400 mg for subcutaneous (sc) injection
Placebo, saline solution for sc injection
Overall Number of Participants Analyzed 196 187
Mean (Standard Deviation)
Unit of Measure: score on a scale
-3.3  (4.00) -2.6  (3.90)
6.Secondary Outcome
Title Percentage of Subjects in Clinical Remission at Week 2
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Certolizumab Pegol Placebo
Hide Arm/Group Description:
Certolizumab pegol 400 mg for subcutaneous (sc) injection
Placebo, saline solution for sc injection
Overall Number of Participants Analyzed 215 209
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
23.3
(17.6 to 28.9)
15.8
(10.8 to 20.7)
7.Secondary Outcome
Title Percentage of Subjects in Clinical Remission at Week 4
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Certolizumab Pegol Placebo
Hide Arm/Group Description:
Certolizumab pegol 400 mg for subcutaneous (sc) injection
Placebo, saline solution for sc injection
Overall Number of Participants Analyzed 215 209
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
26.5
(20.6 to 32.4)
19.1
(13.8 to 24.5)
8.Secondary Outcome
Title Percentage of Subjects Achieving a Clinical Response at Week 2
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Certolizumab Pegol Placebo
Hide Arm/Group Description:
Certolizumab pegol 400 mg for subcutaneous (sc) injection
Placebo, saline solution for sc injection
Overall Number of Participants Analyzed 215 209
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
33.0
(26.7 to 39.3)
20.1
(14.7 to 25.5)
9.Secondary Outcome
Title Percentage of Subjects Achieving a Clinical Response at Week 4
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Certolizumab Pegol Placebo
Hide Arm/Group Description:
Certolizumab pegol 400 mg for subcutaneous (sc) injection
Placebo, saline solution for sc injection
Overall Number of Participants Analyzed 215 209
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
35.3
(29.0 to 41.7)
26.3
(20.3 to 32.3)
10.Secondary Outcome
Title Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 2
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Certolizumab Pegol Placebo
Hide Arm/Group Description:
Certolizumab pegol 400 mg for subcutaneous (sc) injection
Placebo, saline solution for sc injection
Overall Number of Participants Analyzed 204 198
Mean (Standard Deviation)
Unit of Measure: score on a scale
-72.6  (81.26) -41.8  (82.06)
11.Secondary Outcome
Title Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 4
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Certolizumab Pegol Placebo
Hide Arm/Group Description:
Certolizumab pegol 400 mg for subcutaneous (sc) injection
Placebo, saline solution for sc injection
Overall Number of Participants Analyzed 198 184
Mean (Standard Deviation)
Unit of Measure: score on a scale
-88.8  (91.36) -65.7  (83.06)
12.Secondary Outcome
Title Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 2
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Certolizumab Pegol Placebo
Hide Arm/Group Description:
Certolizumab pegol 400 mg for subcutaneous (sc) injection
Placebo, saline solution for sc injection
Overall Number of Participants Analyzed 215 209
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
25.6
(19.7 to 31.4)
18.2
(13.0 to 23.4)
13.Secondary Outcome
Title Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 4
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Certolizumab Pegol Placebo
Hide Arm/Group Description:
Certolizumab pegol 400 mg for subcutaneous (sc) injection
Placebo, saline solution for sc injection
Overall Number of Participants Analyzed 215 209
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
33.5
(27.2 to 39.8)
23.9
(18.1 to 29.7)
14.Secondary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Certolizumab Pegol Placebo
Hide Arm/Group Description:
Certolizumab pegol 400 mg for subcutaneous (sc) injection
Placebo, saline solution for sc injection
Overall Number of Participants Analyzed 122 113
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
30.3
(22.2 to 38.5)
30.1
(21.6 to 38.5)
15.Secondary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Certolizumab Pegol Placebo
Hide Arm/Group Description:
Certolizumab pegol 400 mg for subcutaneous (sc) injection
Placebo, saline solution for sc injection
Overall Number of Participants Analyzed 93 96
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
33.3
(23.8 to 42.9)
19.8
(11.8 to 27.8)
16.Secondary Outcome
Title Percentage of Subjects in Subgroup With Less Than 10 mg/L C-reactive Protein (CRP) at Entry Achieving a Clinical Response at Week 6
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Certolizumab Pegol Placebo
Hide Arm/Group Description:
Certolizumab pegol 400 mg for subcutaneous (sc) injection
Placebo, saline solution for sc injection
Overall Number of Participants Analyzed 122 113
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
37.7
(29.1 to 46.3)
35.4
(26.6 to 44.2)
17.Secondary Outcome
Title Percentage of Subjects in Subgroup With 10 mg/L or Greater C-reactive Protein (CRP) at Entry Achieving a Clinical Response at Week 6
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Certolizumab Pegol Placebo
Hide Arm/Group Description:
Certolizumab pegol 400 mg for subcutaneous (sc) injection
Placebo, saline solution for sc injection
Overall Number of Participants Analyzed 93 96
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
44.1
(34.0 to 54.2)
32.3
(22.9 to 41.6)
Time Frame up to 6 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Certolizumab Pegol Placebo
Hide Arm/Group Description Certolizumab pegol 400 mg for subcutaneous (sc) injection Placebo, saline solution for sc injection
All-Cause Mortality
Certolizumab Pegol Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Certolizumab Pegol Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/223 (5.38%)      8/215 (3.72%)    
Blood and lymphatic system disorders     
SPLENOMEGALY * 1  1/223 (0.45%)  1 0/215 (0.00%)  0
Gastrointestinal disorders     
ABDOMINAL PAIN * 1  1/223 (0.45%)  1 0/215 (0.00%)  0
CROHN'S DISEASE * 1  3/223 (1.35%)  3 1/215 (0.47%)  1
INTESTINAL OBSTRUCTION * 1  2/223 (0.90%)  4 0/215 (0.00%)  0
LARGE INTESTINAL OBSTRUCTION * 1  0/223 (0.00%)  0 1/215 (0.47%)  1
PANCREATITIS * 1  1/223 (0.45%)  1 0/215 (0.00%)  0
PROCTALGIA * 1  1/223 (0.45%)  1 0/215 (0.00%)  0
SMALL INTESTINAL OBSTRUCTION * 1  0/223 (0.00%)  0 1/215 (0.47%)  1
General disorders     
PYREXIA * 1  2/223 (0.90%)  2 0/215 (0.00%)  0
Infections and infestations     
ABSCESS * 1  0/223 (0.00%)  0 1/215 (0.47%)  1
CLOSTRIDIAL INFECTION * 1  1/223 (0.45%)  1 0/215 (0.00%)  0
GASTROENTERITIS VIRAL * 1  0/223 (0.00%)  0 1/215 (0.47%)  1
HIV INFECTION * 1  1/223 (0.45%)  1 0/215 (0.00%)  0
PERIANAL ABSCESS * 1  0/223 (0.00%)  0 1/215 (0.47%)  1
Injury, poisoning and procedural complications     
CONTUSION * 1  1/223 (0.45%)  1 0/215 (0.00%)  0
Musculoskeletal and connective tissue disorders     
FISTULA * 1  0/223 (0.00%)  0 1/215 (0.47%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
METASTATIC NEOPLASM * 1  1/223 (0.45%)  1 0/215 (0.00%)  0
Renal and urinary disorders     
RENAL COLIC * 1  0/223 (0.00%)  0 1/215 (0.47%)  1
Respiratory, thoracic and mediastinal disorders     
BRONCHOSPASM * 1  0/223 (0.00%)  0 1/215 (0.47%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Certolizumab Pegol Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   48/223 (21.52%)      42/215 (19.53%)    
Gastrointestinal disorders     
ABDOMINAL PAIN * 1  10/223 (4.48%)  10 8/215 (3.72%)  8
NAUSEA * 1  9/223 (4.04%)  9 10/215 (4.65%)  11
General disorders     
FATIGUE * 1  9/223 (4.04%)  9 2/215 (0.93%)  2
PYREXIA * 1  7/223 (3.14%)  9 10/215 (4.65%)  14
Infections and infestations     
URINARY TRACT INFECTION * 1  7/223 (3.14%)  7 5/215 (2.33%)  5
Musculoskeletal and connective tissue disorders     
ARTHRALGIA * 1  9/223 (4.04%)  9 6/215 (2.79%)  6
Nervous system disorders     
HEADACHE * 1  12/223 (5.38%)  13 10/215 (4.65%)  14
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.0)
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
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Name/Title: Study Director
Organization: UCB
Phone: +1 877 822 9493
Publications of Results:
Sandborn WJ, Schreiber S, Feagan BG, Rutgeerts P, Younes ZH, Bloomfield R, Coteur G, Guzman JP, D'Haens GR. Certolizumab pegol for active Crohn's disease: a placebo-controlled, randomized trial. Clin Gastroenterol Hepatol. 2011 Aug;9(8):670-678.e3. doi: 10.1016/j.cgh.2011.04.031. Epub 2011 May 13.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00552058    
Other Study ID Numbers: C87085
2007-001913-41 ( EudraCT Number )
First Submitted: October 18, 2007
First Posted: November 1, 2007
Results First Submitted: October 8, 2010
Results First Posted: December 30, 2010
Last Update Posted: August 9, 2018