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

• 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: UCB Pharma
• 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

Participant Flow

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
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

Baseline Characteristics

Arm/Group Title		Overall
Arm/Group Description		Overall Induction
Overall Number of Baseline Participants		539
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

Outcome Measures

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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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

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
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

Outcome Measure Data

Analysis Population Description

ITTI population: all subjects who received at least one dose of study drug in the induction phase

Arm/Group Title	Overall
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

Analysis Population Description

ITTI population: subjects who received at least one dose of study drug in the induction phase

Arm/Group Title	Overall
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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.
Description	Remission is defined as CDAI score ≤ 150.
Time Frame	Week 10

Outcome Measure Data

Analysis Population Description

ITTR population taking steroids at baseline

Arm/Group Title	Q4W Regimen	Q2W Regimen
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.
Description	Remission is defined as CDAI score ≤ 150.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

ITTR population taking steroids at baseline

Arm/Group Title	Q4W Regimen	Q2W Regimen
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.
Description	Remission is defined as CDAI score ≤ 150.
Time Frame	Week 14

Outcome Measure Data

Analysis Population Description

ITTR population taking steroids at baseline

Arm/Group Title	Q4W Regimen	Q2W Regimen
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.
Description	Remission is defined as CDAI score ≤ 150.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

ITTR population taking steroids at baseline

Arm/Group Title	Q4W Regimen	Q2W Regimen
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.
Description	Remission is defined as CDAI score ≤ 150.
Time Frame	Week 18

Outcome Measure Data

Analysis Population Description

ITTR population taking steroids at baseline

Arm/Group Title	Q4W Regimen	Q2W Regimen
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.
Description	Remission is defined as CDAI score ≤ 150.
Time Frame	Week 20

Outcome Measure Data

Analysis Population Description

ITTR population taking steroids at baseline

Arm/Group Title	Q4W Regimen	Q2W Regimen
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.
Description	Remission is defined as CDAI score ≤ 150.
Time Frame	Week 22

Outcome Measure Data

Analysis Population Description

ITTR population taking steroids at baseline

Arm/Group Title	Q4W Regimen	Q2W Regimen
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.
Description	Remission is defined as CDAI score ≤ 150.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

ITTR population taking steroids at baseline

Arm/Group Title	Q4W Regimen	Q2W Regimen
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.
Description	Remission is defined as CDAI score ≤ 150.
Time Frame	Week 26

Outcome Measure Data

Analysis Population Description

ITTR population taking steroids at baseline

Arm/Group Title	Q4W Regimen	Q2W Regimen
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.
Description	Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Time Frame	Week 10

Outcome Measure Data

Analysis Population Description

ITTR population taking steroids at baseline

Arm/Group Title	Q4W Regimen	Q2W Regimen
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.
Description	Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

ITTR population taking steroids at baseline

Arm/Group Title	Q4W Regimen	Q2W Regimen
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.
Description	Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Time Frame	Week 14

Outcome Measure Data

Analysis Population Description

ITTR population taking steroids at baseline

Arm/Group Title	Q4W Regimen	Q2W Regimen
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.
Description	Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

ITTR population taking steroids at baseline

Arm/Group Title	Q4W Regimen	Q2W Regimen
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.
Description	Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Time Frame	Week 18

Outcome Measure Data

Analysis Population Description

ITTR population taking steroids at baseline

Arm/Group Title	Q4W Regimen	Q2W Regimen
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.
Description	Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Time Frame	Week 20

Outcome Measure Data

Analysis Population Description

ITTR population taking steroids at baseline

Arm/Group Title	Q4W Regimen	Q2W Regimen
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.
Description	Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Time Frame	Week 22

Outcome Measure Data

Analysis Population Description

ITTR population taking steroids at baseline

Arm/Group Title	Q4W Regimen	Q2W Regimen
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.
Description	Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

ITTR population taking steroids at baseline

Arm/Group Title	Q4W Regimen	Q2W Regimen
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.
Description	Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Time Frame	Week 26

Outcome Measure Data

Analysis Population Description

ITTR population taking steroids at baseline

Arm/Group Title	Q4W Regimen	Q2W Regimen
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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)

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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)

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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)

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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)

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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)

Adverse Events

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
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	--/--		--/--		--/--
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
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

Limitations and Caveats

[Not Specified]

More Information

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

• Name/Title: UCB Clinical Trial Call Center
• Organization: UCB Pharma
• Phone: +1 877 822 9493

Publications of Results:

Sandborn WJ, Abreu MT, D'Haens G, Colombel JF, Vermeire S, Mitchev K, Jamoul C, Fedorak RN, Spehlmann ME, Wolf DC, Lee S, Rutgeerts P. Certolizumab pegol in patients with moderate to severe Crohn's disease and secondary failure to infliximab. Clin Gastroenterol Hepatol. 2010 Aug;8(8):688-695.e2. doi: 10.1016/j.cgh.2010.04.021. Epub 2010 May 6.

Feagan BG, Sandborn WJ, Wolf DC, Coteur G, Purcaru O, Brabant Y, Rutgeerts PJ. Randomised clinical trial: improvement in health outcomes with certolizumab pegol in patients with active Crohn's disease with prior loss of response to infliximab. Aliment Pharmacol Ther. 2011 Mar;33(5):541-50. doi: 10.1111/j.1365-2036.2010.04568.x. Epub 2011 Jan 12.

Other Publications:

Taylor P, Manger B, Alvaro-Gracia J, Johnstone R, Gomez-Reino J, Eberhardt E, Wolfe F, Schwartzman S, Furfaro N, Kavanaugh A. Patient perceptions concerning pain management in the treatment of rheumatoid arthritis. J Int Med Res. 2010 Jul-Aug;38(4):1213-24. doi: 10.1177/147323001003800402.

• 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