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Certolizumab in Crohn's Disease Patients With Loss of Response or Intolerance to Infliximab

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: NCT00308581
Recruitment Status : Completed
First Posted : March 29, 2006
Results First Posted : November 17, 2009
Last Update Posted : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Crohn's Disease
Interventions Biological: Certolizumab pegol
Other: Placebo
Enrollment 539
Recruitment Details  
Pre-assignment Details Of the 539 subjects that have been enrolled in the induction phase, 373 have been included in the randomized maintenance phase. The Baseline Characteristics module only includes the Intent-to-treat (ITTI) population of the induction phase.
Arm/Group Title Q4W Regimen Q2W Regimen Overall
Hide Arm/Group Description every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol every 2 weeks: 400 mg Certolizumab Pegol Overall Induction
Period Title: Induction Phase
Started 0 [1] 0 [1] 539
Completed 0 [1] 0 [1] 373
Not Completed 0 0 166
Reason Not Completed
Adverse Event             0             0             37
Lack of Efficacy             0             0             121
Withdrawal by Subject             0             0             5
Unknown reason             0             0             3
[1]
Not applicable in this period
Period Title: Randomized Maintenance Phase
Started 187 186 0
Completed 82 83 0
Not Completed 105 103 0
Reason Not Completed
Adverse Event             10             17             0
Lack of Efficacy             9             21             0
Lost to Follow-up             0             2             0
Withdrawal by Subject             1             4             0
Switched to Q2W open-label treatment             82             59             0
Unknown reason             3             0             0
Arm/Group Title Overall
Hide Arm/Group Description Overall Induction
Overall Number of Baseline Participants 539
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 539 participants
<=18 years
0
   0.0%
Between 18 and 65 years
526
  97.6%
>=65 years
13
   2.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 539 participants
37.67  (12.19)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 539 participants
Female
345
  64.0%
Male
194
  36.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 539 participants
United States 141
Spain 11
Austria 16
United Kingdom 29
Italy 53
Switzerland 8
France 45
Canada 43
Belgium 88
Denmark 11
Germany 64
Netherlands 17
Norway 9
Sweden 4
1.Primary Outcome
Title Response Status With Response Defined as at Least 100 Point Decrease in Crohn's Disease Activity Score (CDAI Score) From Baseline in the Induction Phase
Hide Description

Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score) from baseline, otherwise there is a non-response.

The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.

Time Frame Baseline to Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat Induction Phase (ITTI) population: subjects who received at least one dose of study drug in the induction phase
Arm/Group Title Overall
Hide Arm/Group Description:
Overall Induction
Overall Number of Participants Analyzed 539
Measure Type: Number
Unit of Measure: participants
Response 334
Non-Response 205
2.Secondary Outcome
Title Response Status With Response Defined as at Least 100 Point Decrease in CDAI Score From Baseline in the Randomized Maintenance Phase
Hide Description Response is defined as at least 100 point decrease in CDAI score from baseline. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Baseline to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat Randomized Maintenance Phase (ITTR) population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase
Arm/Group Title Q4W Regimen Q2W Regimen
Hide Arm/Group Description:
every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
every 2 weeks: 400 mg Certolizumab Pegol
Overall Number of Participants Analyzed 187 186
Measure Type: Number
Unit of Measure: participants
Response 70 66
Non-Response 117 120
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Q4W Regimen, Q2W Regimen
Comments With a sample size of 165 patients per treatment arm, assuming a percentage of responders of 45% with the Q4W regimen, the study had 80% power to show a statistically significant difference in percentage of responders at Week 26 between the two treatment groups, when there is a true difference of 16% in percentage of responders in favor of the Q2W regimen, and using a 2-sided chi-square at the 5% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.696
Comments Logistic regression model including terms for treatment arm and geographical region (North America versus Europe).
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.1
Confidence Interval 95%
0.7 to 1.7
Estimation Comments Direction of comparison is Q4W regimen (active 1) versus Q2W regimen (active 2).
3.Secondary Outcome
Title Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Induction Phase
Hide Description Response is defined as at least 70 points reduction in CDAI score. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Baseline to Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITTI population: all subjects who received at least one dose of study drug in the induction phase
Arm/Group Title Overall
Hide Arm/Group Description:
Overall Induction
Overall Number of Participants Analyzed 539
Measure Type: Number
Unit of Measure: participants
Response 373
Non-response 166
4.Secondary Outcome
Title Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Randomized Maintenance Phase
Hide Description Response is defined as at least 70 points reduction in CDAI score. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Baseline to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase
Arm/Group Title Q4W Regimen Q2W Regimen
Hide Arm/Group Description:
every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
every 2 weeks: 400 mg Certolizumab Pegol
Overall Number of Participants Analyzed 187 186
Measure Type: Number
Unit of Measure: participants
Response 75 75
Non-response 112 111
5.Secondary Outcome
Title Remission Status With Remission Defined as CDAI Score ≤ 150 in the Induction Phase
Hide Description Remission is defined as CDAI score ≤ 150. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITTI population: subjects who received at least one dose of study drug in the induction phase
Arm/Group Title Overall
Hide Arm/Group Description:
Overall Induction
Overall Number of Participants Analyzed 539
Measure Type: Number
Unit of Measure: participants
Remission 212
No remission 327
6.Secondary Outcome
Title Remission Status With Remission Defined as CDAI Score ≤ 150 in the Randomized Maintenance Phase
Hide Description Remission is defined as CDAI score ≤ 150. The CDAI score is used to quantify the symptoms with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase
Arm/Group Title Q4W Regimen Q2W Regimen
Hide Arm/Group Description:
every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
every 2 weeks: 400 mg Certolizumab Pegol
Overall Number of Participants Analyzed 187 186
Measure Type: Number
Unit of Measure: participants
Remission 51 52
No remission 136 134
7.Secondary Outcome
Title CDAI Score at Week 2 of the Induction Phase
Hide Description The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)
Arm/Group Title Overall
Hide Arm/Group Description:
Overall Induction
Overall Number of Participants Analyzed 535
Mean (Standard Deviation)
Unit of Measure: points on a scale
241.53  (97.03)
8.Secondary Outcome
Title CDAI Score at Week 4 of the Induction Phase
Hide Description The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)
Arm/Group Title Overall
Hide Arm/Group Description:
Overall Induction
Overall Number of Participants Analyzed 522
Mean (Standard Deviation)
Unit of Measure: points on a scale
220.87  (101.05)
9.Secondary Outcome
Title CDAI Score at Week 6 of the Induction Phase
Hide Description The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)
Arm/Group Title Overall
Hide Arm/Group Description:
Overall Induction
Overall Number of Participants Analyzed 499
Mean (Standard Deviation)
Unit of Measure: points on a scale
187.81  (103.34)
10.Secondary Outcome
Title CDAI Score at Week 8 in the Randomized Maintenance Phase
Hide Description The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)
Arm/Group Title Q4W Regimen Q2W Regimen
Hide Arm/Group Description:
every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
every 2 weeks: 400 mg Certolizumab Pegol
Overall Number of Participants Analyzed 184 181
Mean (Standard Deviation)
Unit of Measure: points on a scale
175.62  (94.08) 169.18  (86.63)
11.Secondary Outcome
Title CDAI Score at Week 10 in the Randomized Maintenance Phase
Hide Description The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)
Arm/Group Title Q4W Regimen Q2W Regimen
Hide Arm/Group Description:
every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
every 2 weeks: 400 mg Certolizumab Pegol
Overall Number of Participants Analyzed 178 167
Mean (Standard Deviation)
Unit of Measure: points on a scale
164.65  (98.16) 162.86  (88.66)
12.Secondary Outcome
Title CDAI Score at Week 12 in the Randomized Maintenance Phase
Hide Description The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)
Arm/Group Title Q4W Regimen Q2W Regimen
Hide Arm/Group Description:
every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
every 2 weeks: 400 mg Certolizumab Pegol
Overall Number of Participants Analyzed 161 153
Mean (Standard Deviation)
Unit of Measure: points on a scale
173.83  (103.89) 163.78  (96.19)
13.Secondary Outcome
Title CDAI Score at Week 14 in the Randomized Maintenance Phase
Hide Description The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)
Arm/Group Title Q4W Regimen Q2W Regimen
Hide Arm/Group Description:
every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
every 2 weeks: 400 mg Certolizumab Pegol
Overall Number of Participants Analyzed 143 142
Mean (Standard Deviation)
Unit of Measure: points on a scale
162.34  (99.74) 158.68  (90.76)
14.Secondary Outcome
Title CDAI Score at Week 16 in the Randomized Maintenance Phase
Hide Description The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)
Arm/Group Title Q4W Regimen Q2W Regimen
Hide Arm/Group Description:
every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
every 2 weeks: 400 mg Certolizumab Pegol
Overall Number of Participants Analyzed 129 131
Mean (Standard Deviation)
Unit of Measure: points on a scale
163.73  (103.65) 156.05  (90.49)
15.Secondary Outcome
Title CDAI Score at Week 18 in the Randomized Maintenance Phase
Hide Description The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)
Arm/Group Title Q4W Regimen Q2W Regimen
Hide Arm/Group Description:
every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
every 2 weeks: 400 mg Certolizumab Pegol
Overall Number of Participants Analyzed 114 113
Mean (Standard Deviation)
Unit of Measure: points on a scale
153.38  (95.65) 156.64  (90.99)
16.Secondary Outcome
Title CDAI Score at Week 20 in the Randomized Maintenance Phase
Hide Description The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Week 20
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)
Arm/Group Title Q4W Regimen Q2W Regimen
Hide Arm/Group Description:
every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
every 2 weeks: 400 mg Certolizumab Pegol
Overall Number of Participants Analyzed 104 98
Mean (Standard Deviation)
Unit of Measure: points on a scale
162.79  (112.53) 138.60  (80.78)
17.Secondary Outcome
Title CDAI Score at Week 22 in the Randomized Maintenance Phase
Hide Description The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Week 22
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)
Arm/Group Title Q4W Regimen Q2W Regimen
Hide Arm/Group Description:
every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
every 2 weeks: 400 mg Certolizumab Pegol
Overall Number of Participants Analyzed 88 91
Mean (Standard Deviation)
Unit of Measure: points on a scale
128.13  (85.34) 141.89  (90.43)
18.Secondary Outcome
Title CDAI Score at Week 24 in the Randomized Maintenance Phase
Hide Description The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)
Arm/Group Title Q4W Regimen Q2W Regimen
Hide Arm/Group Description:
every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
every 2 weeks: 400 mg Certolizumab Pegol
Overall Number of Participants Analyzed 82 85
Mean (Standard Deviation)
Unit of Measure: points on a scale
135.49  (99.92) 139.50  (75.98)
19.Secondary Outcome
Title CDAI Score at Week 26 in the Randomized Maintenance Phase
Hide Description The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)
Arm/Group Title Q4W Regimen Q2W Regimen
Hide Arm/Group Description:
every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
every 2 weeks: 400 mg Certolizumab Pegol
Overall Number of Participants Analyzed 81 83
Mean (Standard Deviation)
Unit of Measure: points on a scale
122.37  (87.49) 131.41  (79.52)
20.Secondary Outcome
Title Change From Baseline in CDAI Score at Week 2 of the Induction Phase
Hide Description The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Baseline to Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)
Arm/Group Title Overall
Hide Arm/Group Description:
Overall Induction
Overall Number of Participants Analyzed 534
Mean (Standard Deviation)
Unit of Measure: points on a scale
-66.57  (85.73)
21.Secondary Outcome
Title Change From Baseline in CDAI Score at Week 4 of the Induction Phase
Hide Description The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)
Arm/Group Title Overall
Hide Arm/Group Description:
Overall Induction
Overall Number of Participants Analyzed 521
Mean (Standard Deviation)
Unit of Measure: points on a scale
-87.63  (93.89)
22.Secondary Outcome
Title Change From Baseline in CDAI Score at Week 6 of the Induction Phase
Hide Description The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Baseline to Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)
Arm/Group Title Overall
Hide Arm/Group Description:
Overall Induction
Overall Number of Participants Analyzed 498
Mean (Standard Deviation)
Unit of Measure: points on a scale
-120.33  (90.81)
23.Secondary Outcome
Title Change From Baseline in CDAI Score at Week 8 in the Randomized Maintenance Phase
Hide Description The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)
Arm/Group Title Q4W Regimen Q2W Regimen
Hide Arm/Group Description:
every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
every 2 weeks: 400 mg Certolizumab Pegol
Overall Number of Participants Analyzed 184 181
Mean (Standard Deviation)
Unit of Measure: points on a scale
-133.35  (85.90) -137.70  (75.89)
24.Secondary Outcome
Title Change From Baseline in CDAI Score at Week 10 in the Randomized Maintenance Phase
Hide Description The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Baseline to Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)
Arm/Group Title Q4W Regimen Q2W Regimen
Hide Arm/Group Description:
every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
every 2 weeks: 400 mg Certolizumab Pegol
Overall Number of Participants Analyzed 178 167
Mean (Standard Deviation)
Unit of Measure: points on a scale
-145.16  (90.76) -145.26  (76.97)
25.Secondary Outcome
Title Change From Baseline in CDAI Score at Week 12 in the Randomized Maintenance Phase
Hide Description The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)
Arm/Group Title Q4W Regimen Q2W Regimen
Hide Arm/Group Description:
every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
every 2 weeks: 400 mg Certolizumab Pegol
Overall Number of Participants Analyzed 161 153
Mean (Standard Deviation)
Unit of Measure: points on a scale
-134.51  (91.52) -145.17  (78.88)
26.Secondary Outcome
Title Change From Baseline in CDAI Score at Week 14 in the Randomized Maintenance Phase
Hide Description The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Baseline to Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)
Arm/Group Title Q4W Regimen Q2W Regimen
Hide Arm/Group Description:
every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
every 2 weeks: 400 mg Certolizumab Pegol
Overall Number of Participants Analyzed 143 142
Mean (Standard Deviation)
Unit of Measure: points on a scale
-145.54  (86.85) -144.08  (86.34)
27.Secondary Outcome
Title Change From Baseline in CDAI Score at Week 16 in the Randomized Maintenance Phase
Hide Description The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Baseline to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)
Arm/Group Title Q4W Regimen Q2W Regimen
Hide Arm/Group Description:
every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
every 2 weeks: 400 mg Certolizumab Pegol
Overall Number of Participants Analyzed 129 131
Mean (Standard Deviation)
Unit of Measure: points on a scale
-141.90  (98.56) -144.89  (83.81)
28.Secondary Outcome
Title Change From Baseline in CDAI Score at Week 18 in the Randomized Maintenance Phase
Hide Description The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Baseline to Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)
Arm/Group Title Q4W Regimen Q2W Regimen
Hide Arm/Group Description:
every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
every 2 weeks: 400 mg Certolizumab Pegol
Overall Number of Participants Analyzed 114 113
Mean (Standard Deviation)
Unit of Measure: points on a scale
-150.38  (88.68) -144.66  (85.43)
29.Secondary Outcome
Title Change From Baseline in CDAI Score at Week 20 in the Randomized Maintenance Phase
Hide Description The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Baseline to Week 20
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)
Arm/Group Title Q4W Regimen Q2W Regimen
Hide Arm/Group Description:
every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
every 2 weeks: 400 mg Certolizumab Pegol
Overall Number of Participants Analyzed 104 98
Mean (Standard Deviation)
Unit of Measure: points on a scale
-139.98  (104.52) -162.85  (80.93)
30.Secondary Outcome
Title Change From Baseline in CDAI Score at Week 22 in the Randomized Maintenance Phase
Hide Description The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Baseline to Week 22
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)
Arm/Group Title Q4W Regimen Q2W Regimen
Hide Arm/Group Description:
every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
every 2 weeks: 400 mg Certolizumab Pegol
Overall Number of Participants Analyzed 88 91
Mean (Standard Deviation)
Unit of Measure: points on a scale
-171.52  (82.56) -159.13  (88.94)
31.Secondary Outcome
Title Change From Baseline in CDAI Score at Week 24 in the Randomized Maintenance Phase
Hide Description The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)
Arm/Group Title Q4W Regimen Q2W Regimen
Hide Arm/Group Description:
every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
every 2 weeks: 400 mg Certolizumab Pegol
Overall Number of Participants Analyzed 82 85
Mean (Standard Deviation)
Unit of Measure: points on a scale
-165.06  (90.54) -160.44  (76.11)
32.Secondary Outcome
Title Change From Baseline in CDAI Score at Week 26 in the Randomized Maintenance Phase
Hide Description The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Baseline to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)
Arm/Group Title Q4W Regimen Q2W Regimen
Hide Arm/Group Description:
every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
every 2 weeks: 400 mg Certolizumab Pegol
Overall Number of Participants Analyzed 81 83
Mean (Standard Deviation)
Unit of Measure: points on a scale
-176.85  (80.44) -168.59  (77.03)
33.Secondary Outcome
Title Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 10 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Hide Description Remission is defined as CDAI score ≤ 150.
Time Frame Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR population taking steroids at baseline
Arm/Group Title Q4W Regimen Q2W Regimen
Hide Arm/Group Description:
every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
every 2 weeks: 400 mg Certolizumab Pegol
Overall Number of Participants Analyzed 76 78
Measure Type: Number
Unit of Measure: participants
2 2
34.Secondary Outcome
Title Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 12 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Hide Description Remission is defined as CDAI score ≤ 150.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR population taking steroids at baseline
Arm/Group Title Q4W Regimen Q2W Regimen
Hide Arm/Group Description:
every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
every 2 weeks: 400 mg Certolizumab Pegol
Overall Number of Participants Analyzed 76 78
Measure Type: Number
Unit of Measure: participants
3 4
35.Secondary Outcome
Title Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 14 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Hide Description Remission is defined as CDAI score ≤ 150.
Time Frame Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR population taking steroids at baseline
Arm/Group Title Q4W Regimen Q2W Regimen
Hide Arm/Group Description:
every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
every 2 weeks: 400 mg Certolizumab Pegol
Overall Number of Participants Analyzed 76 78
Measure Type: Number
Unit of Measure: participants
3 3
36.Secondary Outcome
Title Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 16 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Hide Description Remission is defined as CDAI score ≤ 150.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR population taking steroids at baseline
Arm/Group Title Q4W Regimen Q2W Regimen
Hide Arm/Group Description:
every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
every 2 weeks: 400 mg Certolizumab Pegol
Overall Number of Participants Analyzed 76 78
Measure Type: Number
Unit of Measure: participants
5 8
37.Secondary Outcome
Title Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 18 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Hide Description Remission is defined as CDAI score ≤ 150.
Time Frame Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR population taking steroids at baseline
Arm/Group Title Q4W Regimen Q2W Regimen
Hide Arm/Group Description:
every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
every 2 weeks: 400 mg Certolizumab Pegol
Overall Number of Participants Analyzed 76 78
Measure Type: Number
Unit of Measure: participants
7 7
38.Secondary Outcome
Title Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 20 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Hide Description Remission is defined as CDAI score ≤ 150.
Time Frame Week 20
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR population taking steroids at baseline
Arm/Group Title Q4W Regimen Q2W Regimen
Hide Arm/Group Description:
every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
every 2 weeks: 400 mg Certolizumab Pegol
Overall Number of Participants Analyzed 76 78
Measure Type: Number
Unit of Measure: participants
8 6
39.Secondary Outcome
Title Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 22 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Hide Description Remission is defined as CDAI score ≤ 150.
Time Frame Week 22
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR population taking steroids at baseline
Arm/Group Title Q4W Regimen Q2W Regimen
Hide Arm/Group Description:
every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
every 2 weeks: 400 mg Certolizumab Pegol
Overall Number of Participants Analyzed 76 78
Measure Type: Number
Unit of Measure: participants
8 7
40.Secondary Outcome
Title Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 24 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Hide Description Remission is defined as CDAI score ≤ 150.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR population taking steroids at baseline
Arm/Group Title Q4W Regimen Q2W Regimen
Hide Arm/Group Description:
every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
every 2 weeks: 400 mg Certolizumab Pegol
Overall Number of Participants Analyzed 76 78
Measure Type: Number
Unit of Measure: participants
9 5
41.Secondary Outcome
Title Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 26 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Hide Description Remission is defined as CDAI score ≤ 150.
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR population taking steroids at baseline
Arm/Group Title Q4W Regimen Q2W Regimen
Hide Arm/Group Description:
every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
every 2 weeks: 400 mg Certolizumab Pegol
Overall Number of Participants Analyzed 76 78
Measure Type: Number
Unit of Measure: participants
8 5
42.Secondary Outcome
Title Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 10 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Hide Description Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Time Frame Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR population taking steroids at baseline
Arm/Group Title Q4W Regimen Q2W Regimen
Hide Arm/Group Description:
every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
every 2 weeks: 400 mg Certolizumab Pegol
Overall Number of Participants Analyzed 76 78
Measure Type: Number
Unit of Measure: participants
2 2
43.Secondary Outcome
Title Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 12 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Hide Description Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR population taking steroids at baseline
Arm/Group Title Q4W Regimen Q2W Regimen
Hide Arm/Group Description:
every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
every 2 weeks: 400 mg Certolizumab Pegol
Overall Number of Participants Analyzed 76 78
Measure Type: Number
Unit of Measure: participants
4 4
44.Secondary Outcome
Title Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 14 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Hide Description Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Time Frame Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR population taking steroids at baseline
Arm/Group Title Q4W Regimen Q2W Regimen
Hide Arm/Group Description:
every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
every 2 weeks: 400 mg Certolizumab Pegol
Overall Number of Participants Analyzed 76 78
Measure Type: Number
Unit of Measure: participants
5 5
45.Secondary Outcome
Title Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 16 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Hide Description Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR population taking steroids at baseline
Arm/Group Title Q4W Regimen Q2W Regimen
Hide Arm/Group Description:
every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
every 2 weeks: 400 mg Certolizumab Pegol
Overall Number of Participants Analyzed 76 78
Measure Type: Number
Unit of Measure: participants
8 10
46.Secondary Outcome
Title Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 18 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Hide Description Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Time Frame Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR population taking steroids at baseline
Arm/Group Title Q4W Regimen Q2W Regimen
Hide Arm/Group Description:
every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
every 2 weeks: 400 mg Certolizumab Pegol
Overall Number of Participants Analyzed 76 78
Measure Type: Number
Unit of Measure: participants
9 8
47.Secondary Outcome
Title Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 20 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Hide Description Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Time Frame Week 20
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR population taking steroids at baseline
Arm/Group Title Q4W Regimen Q2W Regimen
Hide Arm/Group Description:
every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
every 2 weeks: 400 mg Certolizumab Pegol
Overall Number of Participants Analyzed 76 78
Measure Type: Number
Unit of Measure: participants
9 7
48.Secondary Outcome
Title Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 22 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Hide Description Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Time Frame Week 22
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR population taking steroids at baseline
Arm/Group Title Q4W Regimen Q2W Regimen
Hide Arm/Group Description:
every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
every 2 weeks: 400 mg Certolizumab Pegol
Overall Number of Participants Analyzed 76 78
Measure Type: Number
Unit of Measure: participants
9 8
49.Secondary Outcome
Title Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 24 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Hide Description Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR population taking steroids at baseline
Arm/Group Title Q4W Regimen Q2W Regimen
Hide Arm/Group Description:
every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
every 2 weeks: 400 mg Certolizumab Pegol
Overall Number of Participants Analyzed 76 78
Measure Type: Number
Unit of Measure: participants
11 5
50.Secondary Outcome
Title Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 26 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Hide Description Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR population taking steroids at baseline
Arm/Group Title Q4W Regimen Q2W Regimen
Hide Arm/Group Description:
every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
every 2 weeks: 400 mg Certolizumab Pegol
Overall Number of Participants Analyzed 76 78
Measure Type: Number
Unit of Measure: participants
10 6
51.Secondary Outcome
Title C - Reactive Protein (CRP) Level at Baseline (Week 0) of the Induction Phase
Hide Description High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Time Frame Week 0
Hide Outcome Measure Data
Hide Analysis Population Description
ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)
Arm/Group Title Overall
Hide Arm/Group Description:
Overall Induction
Overall Number of Participants Analyzed 529
Median (Inter-Quartile Range)
Unit of Measure: mg/L
9.5
(2.5 to 27.8)
52.Secondary Outcome
Title CRP Level at Week 2 of the Induction Phase
Hide Description High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)
Arm/Group Title Overall
Hide Arm/Group Description:
Overall Induction
Overall Number of Participants Analyzed 528
Median (Inter-Quartile Range)
Unit of Measure: mg/L
4.2
(1.3 to 14.8)
53.Secondary Outcome
Title CRP Level at Week 4 of the Induction Phase
Hide Description High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)
Arm/Group Title Overall
Hide Arm/Group Description:
Overall Induction
Overall Number of Participants Analyzed 514
Median (Inter-Quartile Range)
Unit of Measure: mg/L
3.8
(1.2 to 16.0)
54.Secondary Outcome
Title CRP Level at Week 6 of the Induction Phase
Hide Description High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)
Arm/Group Title Overall
Hide Arm/Group Description:
Overall Induction
Overall Number of Participants Analyzed 493
Median (Inter-Quartile Range)
Unit of Measure: mg/L
4.2
(1.4 to 16.4)
55.Secondary Outcome
Title CRP Level at Week 8 in the Randomized Maintenance Phase
Hide Description High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)
Arm/Group Title Q4W Regimen Q2W Regimen
Hide Arm/Group Description:
every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
every 2 weeks: 400 mg Certolizumab Pegol
Overall Number of Participants Analyzed 182 181
Median (Inter-Quartile Range)
Unit of Measure: mg/L
5.6
(1.4 to 20.4)
4.6
(1.2 to 15.8)
56.Secondary Outcome
Title CRP Level at Week 10 in the Randomized Maintenance Phase
Hide Description High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Time Frame Week 10 (optional measurement)
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements, measurements are optional)
Arm/Group Title Q4W Regimen Q2W Regimen
Hide Arm/Group Description:
every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
every 2 weeks: 400 mg Certolizumab Pegol
Overall Number of Participants Analyzed 0 4
Median (Inter-Quartile Range)
Unit of Measure: mg/L
5.3
(4.3 to 11.1)
57.Secondary Outcome
Title CRP Level at Week 12 in the Randomized Maintenance Phase
Hide Description High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)
Arm/Group Title Q4W Regimen Q2W Regimen
Hide Arm/Group Description:
every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
every 2 weeks: 400 mg Certolizumab Pegol
Overall Number of Participants Analyzed 158 149
Median (Inter-Quartile Range)
Unit of Measure: mg/L
5.4
(1.8 to 18.9)
3.7
(1.3 to 14.1)
58.Secondary Outcome
Title CRP Level at Week 14 in the Randomized Maintenance Phase
Hide Description High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Time Frame Week 14 (optional measurement)
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements, measurements are optional)
Arm/Group Title Q4W Regimen Q2W Regimen
Hide Arm/Group Description:
every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
every 2 weeks: 400 mg Certolizumab Pegol
Overall Number of Participants Analyzed 1 1
Median (Inter-Quartile Range)
Unit of Measure: mg/L
0.6
(0.6 to 0.6)
3.0
(3.0 to 3.0)
59.Secondary Outcome
Title CRP Level at Week 16 in the Randomized Maintenance Phase
Hide Description High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)
Arm/Group Title Q4W Regimen Q2W Regimen
Hide Arm/Group Description:
every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
every 2 weeks: 400 mg Certolizumab Pegol
Overall Number of Participants Analyzed 125 130
Median (Inter-Quartile Range)
Unit of Measure: mg/L
5.5
(1.8 to 19.4)
4.4
(1.3 to 12.1)
60.Secondary Outcome
Title CRP Level at Week 18 in the Randomized Maintenance Phase
Hide Description High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Time Frame Week 18 (optional measurement)
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements, measurements are optional)
Arm/Group Title Q4W Regimen Q2W Regimen
Hide Arm/Group Description:
every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
every 2 weeks: 400 mg Certolizumab Pegol
Overall Number of Participants Analyzed 3 3
Median (Inter-Quartile Range)
Unit of Measure: mg/L
18.4
(3.4 to 110.2)
5.9
(0.7 to 10.1)
61.Secondary Outcome
Title CRP Level at Week 20 in the Randomized Maintenance Phase
Hide Description High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Time Frame Week 20
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)
Arm/Group Title Q4W Regimen Q2W Regimen
Hide Arm/Group Description:
every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
every 2 weeks: 400 mg Certolizumab Pegol
Overall Number of Participants Analyzed 100 97
Median (Inter-Quartile Range)
Unit of Measure: mg/L
6.8
(1.9 to 26.0)
4.4
(1.6 to 13.7)
62.Secondary Outcome
Title CRP Level at Week 22 in the Randomized Maintenance Phase
Hide Description High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Time Frame Week 22 (optional measurement)
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements, measurements are optional)
Arm/Group Title Q4W Regimen Q2W Regimen
Hide Arm/Group Description:
every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
every 2 weeks: 400 mg Certolizumab Pegol
Overall Number of Participants Analyzed 0 2
Median (Inter-Quartile Range)
Unit of Measure: mg/L
13.0
(1.6 to 24.4)
63.Secondary Outcome
Title CRP Level at Week 24 in the Randomized Maintenance Phase
Hide Description High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)
Arm/Group Title Q4W Regimen Q2W Regimen
Hide Arm/Group Description:
every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
every 2 weeks: 400 mg Certolizumab Pegol
Overall Number of Participants Analyzed 82 83
Median (Inter-Quartile Range)
Unit of Measure: mg/L
5.2
(1.6 to 24.4)
4.6
(1.7 to 13.2)
64.Secondary Outcome
Title CRP Level at Week 26 in the Randomized Maintenance Phase
Hide Description High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)
Arm/Group Title Q4W Regimen Q2W Regimen
Hide Arm/Group Description:
every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
every 2 weeks: 400 mg Certolizumab Pegol
Overall Number of Participants Analyzed 79 82
Median (Inter-Quartile Range)
Unit of Measure: mg/L
5.4
(1.6 to 17.0)
5.1
(1.5 to 14.8)
65.Secondary Outcome
Title CRP Level at Endpoint (Last Visit) in the Randomized Maintenance Phase
Hide Description High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L. Endpoint is the visit when the last observation was taken, either at week 26 or at a visit before in case of early dropout.
Time Frame Last visit on or before Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)
Arm/Group Title Q4W Regimen Q2W Regimen
Hide Arm/Group Description:
every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
every 2 weeks: 400 mg Certolizumab Pegol
Overall Number of Participants Analyzed 183 184
Median (Inter-Quartile Range)
Unit of Measure: mg/L
6.9
(1.9 to 22.4)
4.8
(1.5 to 18.7)
66.Other Pre-specified Outcome
Title Time to Loss of Response (CDAI Score > 150 and Minimum Increase in CDAI of 70) After Week 6
Hide Description Median time to loss of response in the maintenance period (from Kaplan-Meier analysis); range is time of first event to time of last event. Loss of response is defined as both a CDAI score > 150 points and a minimum increase in CDAI of 70 points versus Week 6 at two consecutive visits.
Time Frame Week 6 to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)
Arm/Group Title Q4W Regimen Q2W Regimen
Hide Arm/Group Description:
every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
every 2 weeks: 400 mg Certolizumab Pegol
Overall Number of Participants Analyzed 168 161
Median (Full Range)
Unit of Measure: days
128
(10 to 133)
125
(14 to 141)
Time Frame Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Q4W Regimen Q2W Regimen Induction Phase
Hide Arm/Group Description Subjects who were randomized to and received Q4W regimen (every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol); randomized maintenance phase + safety follow-up period following randomized maintenance phase. Subjects who were randomized to and received Q2W regimen (every 2 weeks: 400 mg Certolizumab Pegol); randomized maintenance phase + safety follow-up period following randomized maintenance phase. Overall population in the Induction phase + safety follow-up period following induction phase.
All-Cause Mortality
Q4W Regimen Q2W Regimen Induction Phase
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Q4W Regimen Q2W Regimen Induction Phase
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   25/187 (13.37%)      25/186 (13.44%)      40/539 (7.42%)    
Blood and lymphatic system disorders       
Anaemia * 1  1/187 (0.53%)  1 1/186 (0.54%)  1 4/539 (0.74%)  5
Eosinophilia * 1  0/187 (0.00%)  0 0/186 (0.00%)  0 1/539 (0.19%)  1
Hypercoagulation * 1  1/187 (0.53%)  1 0/186 (0.00%)  0 0/539 (0.00%)  0
Eye disorders       
Blindness transient * 1  0/187 (0.00%)  0 1/186 (0.54%)  1 0/539 (0.00%)  0
Gastrointestinal disorders       
Abdominal pain * 1  0/187 (0.00%)  0 2/186 (1.08%)  3 4/539 (0.74%)  4
Anal fistula * 1  1/187 (0.53%)  1 0/186 (0.00%)  0 1/539 (0.19%)  1
Anal stenosis * 1  1/187 (0.53%)  1 0/186 (0.00%)  0 0/539 (0.00%)  0
Crohn's disease * 1  10/187 (5.35%)  11 5/186 (2.69%)  5 23/539 (4.27%)  26
Diarrhoea * 1  1/187 (0.53%)  1 0/186 (0.00%)  0 1/539 (0.19%)  1
Gastrointestinal haemorrhage * 1  0/187 (0.00%)  0 0/186 (0.00%)  0 1/539 (0.19%)  1
Ileal stenosis * 1  0/187 (0.00%)  0 1/186 (0.54%)  1 0/539 (0.00%)  0
Intestinal obstruction * 1  1/187 (0.53%)  1 2/186 (1.08%)  2 3/539 (0.56%)  4
Intestinal stenosis * 1  0/187 (0.00%)  0 0/186 (0.00%)  0 1/539 (0.19%)  1
Nausea * 1  0/187 (0.00%)  0 1/186 (0.54%)  1 3/539 (0.56%)  3
Obstruction gastric * 1  0/187 (0.00%)  0 1/186 (0.54%)  2 0/539 (0.00%)  0
Small intestinal obstruction * 1  2/187 (1.07%)  3 1/186 (0.54%)  1 1/539 (0.19%)  1
Subileus * 1  1/187 (0.53%)  1 1/186 (0.54%)  1 2/539 (0.37%)  2
Vomiting * 1  1/187 (0.53%)  1 2/186 (1.08%)  2 3/539 (0.56%)  3
General disorders       
Asthenia * 1  0/187 (0.00%)  0 0/186 (0.00%)  0 1/539 (0.19%)  1
Cyst * 1  0/187 (0.00%)  0 1/186 (0.54%)  1 0/539 (0.00%)  0
Obstruction * 1  0/187 (0.00%)  0 0/186 (0.00%)  0 2/539 (0.37%)  2
Pyrexia * 1  1/187 (0.53%)  1 1/186 (0.54%)  1 4/539 (0.74%)  4
Sudden cardiac death * 1  0/187 (0.00%)  0 0/186 (0.00%)  0 1/539 (0.19%)  1
Hepatobiliary disorders       
Cholecystitis acute * 1  0/187 (0.00%)  0 1/186 (0.54%)  1 0/539 (0.00%)  0
Infections and infestations       
Abdominal abscess * 1  0/187 (0.00%)  0 2/186 (1.08%)  2 1/539 (0.19%)  1
Abdominal wall abscess * 1  0/187 (0.00%)  0 0/186 (0.00%)  0 1/539 (0.19%)  1
Abscess * 1  1/187 (0.53%)  1 0/186 (0.00%)  0 0/539 (0.00%)  0
Abscess intestinal * 1  0/187 (0.00%)  0 1/186 (0.54%)  1 0/539 (0.00%)  0
Anal abscess * 1  1/187 (0.53%)  1 1/186 (0.54%)  1 0/539 (0.00%)  0
Bacterial infection * 1  0/187 (0.00%)  0 1/186 (0.54%)  1 0/539 (0.00%)  0
Bartholin's abscess * 1  0/187 (0.00%)  0 1/186 (0.54%)  1 0/539 (0.00%)  0
Douglas' abscess * 1  0/187 (0.00%)  0 0/186 (0.00%)  0 1/539 (0.19%)  1
Erysipelas * 1  0/187 (0.00%)  0 0/186 (0.00%)  0 1/539 (0.19%)  1
Gastrointestinal infection * 1  0/187 (0.00%)  0 0/186 (0.00%)  0 1/539 (0.19%)  1
Perianal abscess * 1  1/187 (0.53%)  1 0/186 (0.00%)  0 1/539 (0.19%)  1
Perirectal abscess * 1  0/187 (0.00%)  0 0/186 (0.00%)  0 1/539 (0.19%)  1
Peritoneal abscess * 1  1/187 (0.53%)  1 0/186 (0.00%)  0 0/539 (0.00%)  0
Pneumonia * 1  1/187 (0.53%)  1 0/186 (0.00%)  0 2/539 (0.37%)  2
Rectal abscess * 1  1/187 (0.53%)  1 0/186 (0.00%)  0 0/539 (0.00%)  0
Salpingitis * 1  1/187 (0.53%)  1 0/186 (0.00%)  0 0/539 (0.00%)  0
Subcutaneous abscess * 1  0/187 (0.00%)  0 0/186 (0.00%)  0 1/539 (0.19%)  1
Tubo-ovarian abscess * 1  0/187 (0.00%)  0 0/186 (0.00%)  0 1/539 (0.19%)  1
Upper respiratory tract infection * 1  0/187 (0.00%)  0 1/186 (0.54%)  1 1/539 (0.19%)  1
Vulval abscess * 1  0/187 (0.00%)  0 1/186 (0.54%)  1 0/539 (0.00%)  0
Wound infection * 1  0/187 (0.00%)  0 0/186 (0.00%)  0 1/539 (0.19%)  1
Injury, poisoning and procedural complications       
Incisional hernia * 1  0/187 (0.00%)  0 1/186 (0.54%)  1 0/539 (0.00%)  0
Investigations       
Transaminases increased * 1  0/187 (0.00%)  0 0/186 (0.00%)  0 1/539 (0.19%)  1
Metabolism and nutrition disorders       
Dehydration * 1  1/187 (0.53%)  1 0/186 (0.00%)  0 4/539 (0.74%)  4
Hyperhomocysteinaemia * 1  1/187 (0.53%)  1 0/186 (0.00%)  0 0/539 (0.00%)  0
Hypokalaemia * 1  1/187 (0.53%)  1 0/186 (0.00%)  0 0/539 (0.00%)  0
Hypoproteinaemia * 1  1/187 (0.53%)  1 0/186 (0.00%)  0 0/539 (0.00%)  0
Malnutrition * 1  1/187 (0.53%)  1 1/186 (0.54%)  1 2/539 (0.37%)  2
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  1/187 (0.53%)  1 0/186 (0.00%)  0 0/539 (0.00%)  0
Arthritis * 1  0/187 (0.00%)  0 1/186 (0.54%)  1 0/539 (0.00%)  0
Back pain * 1  0/187 (0.00%)  0 1/186 (0.54%)  1 0/539 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Pituitary tumour benign * 1  0/187 (0.00%)  0 0/186 (0.00%)  0 1/539 (0.19%)  1
Squamous cell carcinoma of skin * 1  1/187 (0.53%)  1 0/186 (0.00%)  0 0/539 (0.00%)  0
Nervous system disorders       
Syncope * 1  0/187 (0.00%)  0 0/186 (0.00%)  0 1/539 (0.19%)  1
Pregnancy, puerperium and perinatal conditions       
Pregnancy * 1  1/187 (0.53%)  1 0/186 (0.00%)  0 0/539 (0.00%)  0
Renal and urinary disorders       
Nephrolithiasis * 1  1/187 (0.53%)  1 0/186 (0.00%)  0 1/539 (0.19%)  1
Renal failure acute * 1  0/187 (0.00%)  0 1/186 (0.54%)  1 2/539 (0.37%)  2
Reproductive system and breast disorders       
Female genital tract fistula * 1  0/187 (0.00%)  0 1/186 (0.54%)  1 0/539 (0.00%)  0
Menorrhagia * 1  0/187 (0.00%)  0 1/186 (0.54%)  1 0/539 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Hiccups * 1  0/187 (0.00%)  0 0/186 (0.00%)  0 1/539 (0.19%)  1
Pneumomediastinum * 1  0/187 (0.00%)  0 0/186 (0.00%)  0 1/539 (0.19%)  1
Pneumothorax * 1  0/187 (0.00%)  0 0/186 (0.00%)  0 1/539 (0.19%)  1
Pulmonary embolism * 1  0/187 (0.00%)  0 0/186 (0.00%)  0 1/539 (0.19%)  1
Skin and subcutaneous tissue disorders       
Erythema multiforme * 1  1/187 (0.53%)  1 0/186 (0.00%)  0 0/539 (0.00%)  0
Rash * 1  1/187 (0.53%)  1 0/186 (0.00%)  0 0/539 (0.00%)  0
Surgical and medical procedures       
Colectomy * 1  0/187 (0.00%)  0 0/186 (0.00%)  0 1/539 (0.19%)  1
Vascular disorders       
Arterial thrombosis limb * 1  1/187 (0.53%)  1 0/186 (0.00%)  0 0/539 (0.00%)  0
Deep vein thrombosis * 1  0/187 (0.00%)  0 0/186 (0.00%)  0 1/539 (0.19%)  1
Thrombophlebitis * 1  0/187 (0.00%)  0 0/186 (0.00%)  0 1/539 (0.19%)  1
Vasculitis * 1  0/187 (0.00%)  0 1/186 (0.54%)  1 0/539 (0.00%)  0
Vena cava thrombosis * 1  0/187 (0.00%)  0 0/186 (0.00%)  0 1/539 (0.19%)  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 5%
Q4W Regimen Q2W Regimen Induction Phase
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   97/187 (51.87%)      106/186 (56.99%)      277/539 (51.39%)    
Gastrointestinal disorders       
Abdominal Pain * 1  16/187 (8.56%)  18 18/186 (9.68%)  20 40/539 (7.42%)  42
Crohn's disease * 1  8/187 (4.28%)  9 15/186 (8.06%)  15 21/539 (3.90%)  23
Nausea * 2  21/187 (11.23%)  27 20/186 (10.75%)  22 58/539 (10.76%)  65
Vomiting * 1  17/187 (9.09%)  17 12/186 (6.45%)  13 44/539 (8.16%)  48
General disorders       
Fatigue * 1  14/187 (7.49%)  15 10/186 (5.38%)  14 37/539 (6.86%)  40
Pyrexia * 2  20/187 (10.70%)  21 22/186 (11.83%)  25 46/539 (8.53%)  53
Infections and infestations       
Herpes simplex * 1  11/187 (5.88%)  16 6/186 (3.23%)  9 8/539 (1.48%)  8
Nasopharyngitis * 2  23/187 (12.30%)  28 32/186 (17.20%)  35 41/539 (7.61%)  43
Urinary tract infection * 1  10/187 (5.35%)  12 7/186 (3.76%)  9 14/539 (2.60%)  14
Musculoskeletal and connective tissue disorders       
Arthralgia * 2  14/187 (7.49%)  19 20/186 (10.75%)  22 51/539 (9.46%)  62
Nervous system disorders       
Headache * 2  31/187 (16.58%)  53 20/186 (10.75%)  21 86/539 (15.96%)  95
Reproductive system and breast disorders       
Pharyngolaryngeal pain * 1  12/187 (6.42%)  13 8/186 (4.30%)  10 20/539 (3.71%)  22
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.0)
2
Term from vocabulary, MedDRA 9.0
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 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
Layout table for Results Point of Contact information
Name/Title: UCB Clinical Trial Call Center
Organization: UCB Pharma
Phone: +1 877 822 9493
Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00308581    
Other Study ID Numbers: C87042
Eudract number: 2005-004104-37
First Submitted: March 28, 2006
First Posted: March 29, 2006
Results First Submitted: July 7, 2009
Results First Posted: November 17, 2009
Last Update Posted: August 7, 2018