Clinical Study of CDP870/Certolizumab Pegol in Patients With Active Crohn's Disease

• ClinicalTrials.gov Identifier: NCT00291668
• Recruitment Status: Completed
• First Posted: February 14, 2006
• Results First Posted: August 3, 2020
• Last Update Posted: August 3, 2020
• Sponsor: UCB Pharma
• Information provided by (Responsible Party): UCB Pharma

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Crohn's Disease
• Interventions: Biological: Certolizumab Pegol; Other: Placebo
• Enrollment: 94

Participant Flow

Recruitment Details	This study started to enroll subjects in March 2006 and conluded in November 2007.
Pre-assignment Details	Participant Flow refers to the Safety Set, including all randomized subjects who received at least one dose of study medication (Placebo or Certolizumab Pegol).

Arm/Group Title	Placebo	Certolizumab Pegol 200 mg	Certolizumab Pegol 400 mg
Arm/Group Description	Subjects received two subcutaneous (sc) injections of Placebo on Weeks 0 (first dose), 2 and 4.	Subjects received one subcutaneous (sc) injection of 200 mg CZP and one injection of Placebo to maintain the study blind on Weeks 0 (first dose), 2 and 4.	Subjects received two subcutaneous (sc) injections of 200 mg CZP on Weeks 0 (first dose), 2 and 4.
Period Title: Overall Study
Started	32	30	32
Completed	28	29	31
Not Completed	4	1	1
Reason Not Completed
Lack of Efficacy	1	0	0
SAE, non-fatal	1	1	1
AE, non-serious non-fatal	1	0	0
SAE, non-fatal+AE, non-serious non-fatal	1	0	0

Baseline Characteristics

Arm/Group Title		Placebo	Certolizumab Pegol 200 mg	Certolizumab Pegol 400 mg	Total Title
Arm/Group Description		Subjects received two subcutaneous (sc) injections of Placebo on Weeks 0 (first dose), 2 and 4.	Subjects received one subcutaneous (sc) injection of 200 mg CZP and one injection of Placebo to maintain the study blind on Weeks 0 (first dose), 2 and 4.	Subjects received two subcutaneous (sc) injections of 200 mg CZP on Weeks 0 (first dose), 2 and 4.	[Not Specified]
Overall Number of Baseline Participants		32	30	32	94
Baseline Analysis Population Description		Baseline Characteristics refer to the Safety Population, including all randomized subjects who received at least one dose of study medication (Placebo or Certolizumab Pegol).
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	32 participants	30 participants	32 participants	94 participants
	<=18 years	2 6.3%	2 6.7%	2 6.3%	6 6.4%
	Between 18 and 65 years	30 93.8%	28 93.3%	30 93.8%	88 93.6%
	>=65 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	32 participants	30 participants	32 participants	94 participants
		30.6 (8.16)	32.7 (9.34)	31.4 (8.27)	31.5 (8.54)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	32 participants	30 participants	32 participants	94 participants
	Female	6 18.8%	8 26.7%	7 21.9%	21 22.3%
	Male	26 81.3%	22 73.3%	25 78.1%	73 77.7%

Outcome Measures

1. Primary Outcome

Title	Crohn's Disease Activity Index (CDAI) Response (Clinical Response or Remission) at Week 6
Description	CDAI Response is presented as the percentage of subjects with clinical response at Week 6 or remission at Week 6. Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 6) - (CDAI score at Week 0). Remission is defined as a CDAI of <= 150 at Week 6.
Time Frame	Baseline, Week 6

Outcome Measure Data

Analysis Population Description

Full Analysis Set defined as subjects randomized and allocated to study medication, excluding the following subjects determined by data review prior to unblinding:

Subjects

• with Good Clinical Practice (GCP) violations
• who were not diagnosed (definitely) with CD
• who received no dose of study medication
• with no data after randomization

Arm/Group Title	Full Analysis Set (Placebo Treated Subjects)	Full Analysis Set (CZP 200 mg Treated Subjects)	Full Analysis Set (CZP 400 mg Treated Subjects)
Arm/Group Description:	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization
Overall Number of Participants Analyzed	32	30	31
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of subjects
	25.0; (10.0 to 40.0)	43.3; (25.6 to 61.1)	48.4; (30.8 to 66.0)

2. Secondary Outcome

Title	Crohn's Disease Activity Index (CDAI) Score at Week 2
Description	The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. The CDAI score can range from 0-600 (600 indicating the worst disease). It is the sum of 8 subscores, only the summary score is used here. A CDAI score of 150 or less is considered as 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

Full Analysis Set defined as subjects randomized and allocated to study medication, excluding the following subjects determined by data review prior to unblinding:

Subjects

• with Good Clinical Practice (GCP) violations
• who were not diagnosed (definitely) with CD
• who received no dose of study medication
• with no data after randomization

Arm/Group Title	Full Analysis Set (Placebo Treated Subjects)	Full Analysis Set (CZP 200 mg Treated Subjects)	Full Analysis Set (CZP 400 mg Treated Subjects)
Arm/Group Description:	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization
Overall Number of Participants Analyzed	29	29	31
Mean (Standard Deviation); Unit of Measure: units on a scale
	255.9 (68.02)	214.2 (83.51)	224.9 (85.05)

3. Secondary Outcome

Title	Crohn's Disease Activity Index (CDAI) Score at Week 4
Description	The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. The CDAI score can range from 0-600 (600 indicating the worst disease). It is the sum of 8 subscores, only the summary score is used here. A CDAI score of 150 or less is considered as 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

Full Analysis Set defined as subjects randomized and allocated to study medication, excluding the following subjects determined by data review prior to unblinding:

Subjects

• with Good Clinical Practice (GCP) violations
• who were not diagnosed (definitely) with CD
• who received no dose of study medication
• with no data after randomization

Arm/Group Title	Full Analysis Set (Placebo Treated Subjects)	Full Analysis Set (CZP 200 mg Treated Subjects)	Full Analysis Set (CZP 400 mg Treated Subjects)
Arm/Group Description:	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization
Overall Number of Participants Analyzed	28	27	30
Mean (Standard Deviation); Unit of Measure: units on a scale
	243.1 (68.57)	199.7 (91.25)	204.6 (75.10)

4. Secondary Outcome

Title	Crohn's Disease Activity Index (CDAI) Score at Week 6
Description	The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. The CDAI score can range from 0-600 (600 indicating the worst disease). It is the sum of 8 subscores, only the summary score is used here. A CDAI score of 150 or less is considered as 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

Full Analysis Set defined as subjects randomized and allocated to study medication, excluding the following subjects determined by data review prior to unblinding:

Subjects

• with Good Clinical Practice (GCP) violations
• who were not diagnosed (definitely) with CD
• who received no dose of study medication
• with no data after randomization

Arm/Group Title	Full Analysis Set (Placebo Treated Subjects)	Full Analysis Set (CZP 200 mg Treated Subjects)	Full Analysis Set (CZP 400 mg Treated Subjects)
Arm/Group Description:	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization
Overall Number of Participants Analyzed	28	27	30
Mean (Standard Deviation); Unit of Measure: units on a scale
	232.4 (89.28)	211.0 (99.91)	198.1 (87.88)

5. Secondary Outcome

Title	Percentage of Subjects Who Achieve CDAI Response at Week 2
Description	CDAI Response at Week 2 is defined as clinical response at Week 2 or remission at Week 2. Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 2) - (CDAI score at Week 0). Remission is defined as a CDAI score of <= 150 points.
Time Frame	Baseline, Week 2

Outcome Measure Data

Analysis Population Description

Full Analysis Set defined as subjects randomized and allocated to study medication, excluding the following subjects determined by data review prior to unblinding:

Subjects

• with Good Clinical Practice (GCP) violations
• who were not diagnosed (definitely) with CD
• who received no dose of study medication
• with no data after randomization

Arm/Group Title	Full Analysis Set (Placebo Treated Subjects)	Full Analysis Set (CZP 200 mg Treated Subjects)	Full Analysis Set (CZP 400 mg Treated Subjects)
Arm/Group Description:	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization
Overall Number of Participants Analyzed	32	30	31
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of subjects
	15.6; (3.0 to 28.2)	40.0; (22.5 to 57.5)	32.3; (15.8 to 48.7)

6. Secondary Outcome

Title	Percentage of Subjects Who Achieve CDAI Response at Week 4
Description	CDAI Response at Week 4 is defined as clinical response at Week 4 or remission at Week 4. Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 4) - (CDAI score at Week 0). Remission is defined as a CDAI score of <= 150 points.
Time Frame	Baseline, Week 4

Outcome Measure Data

Analysis Population Description

Full Analysis Set defined as subjects randomized and allocated to study medication, excluding the following subjects determined by data review prior to unblinding:

Subjects

• with Good Clinical Practice (GCP) violations
• who were not diagnosed (definitely) with CD
• who received no dose of study medication
• with no data after randomization

Arm/Group Title	Full Analysis Set (Placebo Treated Subjects)	Full Analysis Set (CZP 200 mg Treated Subjects)	Full Analysis Set (CZP 400 mg Treated Subjects)
Arm/Group Description:	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization
Overall Number of Participants Analyzed	32	30	31
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of subjects
	21.9; (7.6 to 36.2)	46.7; (28.8 to 64.5)	38.7; (21.6 to 55.9)

7. Secondary Outcome

Title	Percentage of Subjects Who Achieve a Reduction in CDAI Scores of at Least 70 Points at Week 2
Description	The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame	Baseline, Week 2

Outcome Measure Data

Analysis Population Description

Full Analysis Set defined as subjects randomized and allocated to study medication, excluding the following subjects determined by data review prior to unblinding:

Subjects

• with Good Clinical Practice (GCP) violations
• who were not diagnosed (definitely) with CD
• who received no dose of study medication
• with no data after randomization

Arm/Group Title	Full Analysis Set (Placebo Treated Subjects)	Full Analysis Set (CZP 200 mg Treated Subjects)	Full Analysis Set (CZP 400 mg Treated Subjects)
Arm/Group Description:	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization
Overall Number of Participants Analyzed	32	30	31
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of subjects
	28.1; (12.5 to 43.7)	46.7; (28.8 to 64.5)	45.2; (27.6 to 62.7)

8. Secondary Outcome

Title	Percentage of Subjects Who Achieve a Reduction in CDAI Scores of at Least 70 Points at Week 4
Description	The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame	Baseline, Week 4

Outcome Measure Data

Analysis Population Description

Full Analysis Set defined as subjects randomized and allocated to study medication, excluding the following subjects determined by data review prior to unblinding:

Subjects

• with Good Clinical Practice (GCP) violations
• who were not diagnosed (definitely) with CD
• who received no dose of study medication
• with no data after randomization

Arm/Group Title	Full Analysis Set (Placebo Treated Subjects)	Full Analysis Set (CZP 200 mg Treated Subjects)	Full Analysis Set (CZP 400 mg Treated Subjects)
Arm/Group Description:	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization
Overall Number of Participants Analyzed	32	30	31
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of subjects
	25.0; (10.0 to 40.0)	56.7; (38.9 to 74.4)	54.8; (37.3 to 72.4)

9. Secondary Outcome

Title	Percentage of Subjects Who Achieve a Reduction in CDAI Scores of at Least 70 Points at Week 6
Description	The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame	Baseline, Week 6

Outcome Measure Data

Analysis Population Description

Full Analysis Set defined as subjects randomized and allocated to study medication, excluding the following subjects determined by data review prior to unblinding:

Subjects

• with Good Clinical Practice (GCP) violations
• who were not diagnosed (definitely) with CD
• who received no dose of study medication
• with no data after randomization

Arm/Group Title	Full Analysis Set (Placebo Treated Subjects)	Full Analysis Set (CZP 200 mg Treated Subjects)	Full Analysis Set (CZP 400 mg Treated Subjects)
Arm/Group Description:	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization
Overall Number of Participants Analyzed	32	30	31
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of subjects
	43.8; (26.6 to 60.9)	53.3; (35.5 to 71.2)	61.3; (44.1 to 78.4)

10. Secondary Outcome

Title	Percentage of Subjects Who Achieve Remission (CDAI <= 150) at Week 2
Description	Remission at Week 2 is defined as a CDAI score <= 150 points at Week 2.
Time Frame	Week 2

Outcome Measure Data

Analysis Population Description

Full Analysis Set defined as subjects randomized and allocated to study medication, excluding the following subjects determined by data review prior to unblinding:

Subjects

• with Good Clinical Practice (GCP) violations
• who were not diagnosed (definitely) with CD
• who received no dose of study medication
• with no data after randomization

Arm/Group Title	Full Analysis Set (Placebo Treated Subjects)	Full Analysis Set (CZP 200 mg Treated Subjects)	Full Analysis Set (CZP 400 mg Treated Subjects)
Arm/Group Description:	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization
Overall Number of Participants Analyzed	32	30	31
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of subjects
	3.1; (0.0 to 9.2)	20.0; (5.7 to 34.3)	16.1; (3.2 to 29.1)

11. Secondary Outcome

Title	Percentage of Subjects Who Achieve Remission (CDAI <= 150) at Week 4
Description	Remission at Week 4 is defined as a CDAI score <= 150 points at Week 4.
Time Frame	Week 4

Outcome Measure Data

Analysis Population Description

Full Analysis Set defined as subjects randomized and allocated to study medication, excluding the following subjects determined by data review prior to unblinding:

Subjects

• with Good Clinical Practice (GCP) violations
• who were not diagnosed (definitely) with CD
• who received no dose of study medication
• with no data after randomization

Arm/Group Title	Full Analysis Set (Placebo Treated Subjects)	Full Analysis Set (CZP 200 mg Treated Subjects)	Full Analysis Set (CZP 400 mg Treated Subjects)
Arm/Group Description:	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization
Overall Number of Participants Analyzed	32	30	31
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of subjects
	6.3; (0.0 to 14.6)	26.7; (10.8 to 42.5)	22.6; (7.9 to 37.3)

12. Secondary Outcome

Title	Percentage of Subjects Who Achieve Remission (CDAI <= 150) at Week 6
Description	Remission at Week 6 is defined as a CDAI score <= 150 points at Week 6.
Time Frame	Week 6

Outcome Measure Data

Analysis Population Description

Full Analysis Set defined as subjects randomized and allocated to study medication, excluding the following subjects determined by data review prior to unblinding:

Subjects

• with Good Clinical Practice (GCP) violations
• who were not diagnosed (definitely) with CD
• who received no dose of study medication
• with no data after randomization

Arm/Group Title	Full Analysis Set (Placebo Treated Subjects)	Full Analysis Set (CZP 200 mg Treated Subjects)	Full Analysis Set (CZP 400 mg Treated Subjects)
Arm/Group Description:	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization
Overall Number of Participants Analyzed	32	30	31
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of subjects
	15.6; (3.0 to 28.2)	26.7; (10.8 to 42.5)	32.3; (15.8 to 48.7)

13. Secondary Outcome

Title	Percentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) at Week 2
Description	Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 2) - (CDAI score at Week 0).
Time Frame	Baseline, Week 2

Outcome Measure Data

Analysis Population Description

Full Analysis Set defined as subjects randomized and allocated to study medication, excluding the following subjects determined by data review prior to unblinding:

Subjects

• with Good Clinical Practice (GCP) violations
• who were not diagnosed (definitely) with CD
• who received no dose of study medication
• with no data after randomization

Arm/Group Title	Full Analysis Set (Placebo Treated Subjects)	Full Analysis Set (CZP 200 mg Treated Subjects)	Full Analysis Set (CZP 400 mg Treated Subjects)
Arm/Group Description:	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization
Overall Number of Participants Analyzed	32	30	31
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of subjects
	15.6; (3.0 to 28.2)	36.7; (19.4 to 53.9)	29.0; (13.1 to 45.0)

14. Secondary Outcome

Title	Percentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) at Week 4
Description	Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 4) - (CDAI score at Week 0).
Time Frame	Baseline, Week 4

Outcome Measure Data

Analysis Population Description

Full Analysis Set defined as subjects randomized and allocated to study medication, excluding the following subjects determined by data review prior to unblinding:

Subjects

• with Good Clinical Practice (GCP) violations
• who were not diagnosed (definitely) with CD
• who received no dose of study medication
• with no data after randomization

Arm/Group Title	Full Analysis Set (Placebo Treated Subjects)	Full Analysis Set (CZP 200 mg Treated Subjects)	Full Analysis Set (CZP 400 mg Treated Subjects)
Arm/Group Description:	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization
Overall Number of Participants Analyzed	32	30	31
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of subjects
	18.8; (5.2 to 32.3)	36.7; (19.4 to 53.9)	32.3; (15.8 to 48.7)

15. Secondary Outcome

Title	Percentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) at Week 6
Description	Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 6) - (CDAI score at Week 0).
Time Frame	Baseline, Week 6

Outcome Measure Data

Analysis Population Description

Full Analysis Set defined as subjects randomized and allocated to study medication, excluding the following subjects determined by data review prior to unblinding:

Subjects

• with Good Clinical Practice (GCP) violations
• who were not diagnosed (definitely) with CD
• who received no dose of study medication
• with no data after randomization

Arm/Group Title	Full Analysis Set (Placebo Treated Subjects)	Full Analysis Set (CZP 200 mg Treated Subjects)	Full Analysis Set (CZP 400 mg Treated Subjects)
Arm/Group Description:	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization
Overall Number of Participants Analyzed	32	30	31
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of subjects
	21.9; (7.6 to 36.2)	36.7; (19.4 to 53.9)	41.9; (24.6 to 59.3)

16. Secondary Outcome

Title	Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 2
Description	The IBDQ global score is calculated as the sum of the responses (each ranging from 1 to 7) to all 32 questions on the IBDQ and can therefore range from 32 to 224. A higher score indicates a better quality of life.
Time Frame	Week 2

Outcome Measure Data

Analysis Population Description

Full Analysis Set defined as subjects randomized and allocated to study medication, excluding the following subjects determined by data review prior to unblinding:

Subjects

• with Good Clinical Practice (GCP) violations
• who were not diagnosed (definitely) with CD
• who received no dose of study medication
• with no data after randomization

Arm/Group Title	Full Analysis Set (Placebo Treated Subjects)	Full Analysis Set (CZP 200 mg Treated Subjects)	Full Analysis Set (CZP 400 mg Treated Subjects)
Arm/Group Description:	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization
Overall Number of Participants Analyzed	29	29	31
Mean (Standard Deviation); Unit of Measure: units on a scale
	171.3 (22.45)	166.1 (22.14)	169.7 (23.24)

17. Secondary Outcome

Title	Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 4
Description	The IBDQ global score is calculated as the sum of the responses (each ranging from 1 to 7) to all 32 questions on the IBDQ and can therefore range from 32 to 224. A higher score indicates a better quality of life.
Time Frame	Week 4

Outcome Measure Data

Analysis Population Description

Full Analysis Set defined as subjects randomized and allocated to study medication, excluding the following subjects determined by data review prior to unblinding:

Subjects

• with Good Clinical Practice (GCP) violations
• who were not diagnosed (definitely) with CD
• who received no dose of study medication
• with no data after randomization

Arm/Group Title	Full Analysis Set (Placebo Treated Subjects)	Full Analysis Set (CZP 200 mg Treated Subjects)	Full Analysis Set (CZP 400 mg Treated Subjects)
Arm/Group Description:	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization
Overall Number of Participants Analyzed	28	27	30
Mean (Standard Deviation); Unit of Measure: units on a scale
	172.6 (24.04)	169.4 (21.75)	170.3 (23.72)

18. Secondary Outcome

Title	Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 6
Description	The IBDQ global score is calculated as the sum of the responses (each ranging from 1 to 7) to all 32 questions on the IBDQ and can therefore range from 32 to 224. A higher score indicates a better quality of life.
Time Frame	Week 6

Outcome Measure Data

Analysis Population Description

Full Analysis Set defined as subjects randomized and allocated to study medication, excluding the following subjects determined by data review prior to unblinding:

Subjects

• with Good Clinical Practice (GCP) violations
• who were not diagnosed (definitely) with CD
• who received no dose of study medication
• with no data after randomization

Arm/Group Title	Full Analysis Set (Placebo Treated Subjects)	Full Analysis Set (CZP 200 mg Treated Subjects)	Full Analysis Set (CZP 400 mg Treated Subjects)
Arm/Group Description:	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization
Overall Number of Participants Analyzed	28	27	30
Mean (Standard Deviation); Unit of Measure: units on a scale
	173.1 (25.49)	165.6 (23.25)	170.8 (24.54)

19. Secondary Outcome

Title	Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 2
Description	The total IBDQ score consists of 32 questions, each ranging from 1 to 7, with higher scores indicating a better quality of life. There are 4 IBDQ Domain Scores: Bowel Symptoms Domain Score, ranging from 10 to 70 (10 questions ranging from 1 to 7); Systemic Symptoms Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 ); Emotional Function Domain Score, ranging from 12 to 84 (12 questions ranging from 1 to 7); Social Function Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 )
Time Frame	Week 2

Outcome Measure Data

Analysis Population Description

Full Analysis Set defined as subjects randomized and allocated to study medication, excluding the following subjects determined by data review prior to unblinding:

Subjects

• with Good Clinical Practice (GCP) violations
• who were not diagnosed (definitely) with CD
• who received no dose of study medication
• with no data after randomization

Arm/Group Title		Full Analysis Set (Placebo Treated Subjects)	Full Analysis Set (CZP 200 mg Treated Subjects)	Full Analysis Set (CZP 400 mg Treated Subjects)
Arm/Group Description:		The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization
Overall Number of Participants Analyzed		32	30	31
Mean (Standard Deviation); Unit of Measure: units on a scale
Bowel Symptoms Domain Score	Number Analyzed	29 participants	29 participants	31 participants
		54.4 (7.17)	53.4 (8.18)	54.7 (8.77)
Systemic Symptoms Domain Score	Number Analyzed	29 participants	29 participants	31 participants
		22.4 (5.01)	22.4 (5.17)	22.7 (4.51)
Emotional Function Domain Score	Number Analyzed	29 participants	29 participants	31 participants
		65.3 (8.91)	62.3 (9.54)	63.3 (8.53)
Social Function Domain Score	Number Analyzed	28 participants	29 participants	31 participants
		29.4 (5.64)	28.0 (4.33)	29.0 (5.03)

20. Secondary Outcome

Title	Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 4
Description	The total IBDQ score consists of 32 questions, each ranging from 1 to 7, with higher scores indicating a better quality of life. There are 4 IBDQ Domain Scores: Bowel Symptoms Domain Score, ranging from 10 to 70 (10 questions ranging from 1 to 7); Systemic Symptoms Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 ); Emotional Function Domain Score, ranging from 12 to 84 (12 questions ranging from 1 to 7); Social Function Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 )
Time Frame	Week 4

Outcome Measure Data

Analysis Population Description

Full Analysis Set defined as subjects randomized and allocated to study medication, excluding the following subjects determined by data review prior to unblinding:

Subjects

• with Good Clinical Practice (GCP) violations
• who were not diagnosed (definitely) with CD
• who received no dose of study medication
• with no data after randomization

Arm/Group Title		Full Analysis Set (Placebo Treated Subjects)	Full Analysis Set (CZP 200 mg Treated Subjects)	Full Analysis Set (CZP 400 mg Treated Subjects)
Arm/Group Description:		The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization
Overall Number of Participants Analyzed		32	30	31
Mean (Standard Deviation); Unit of Measure: units on a scale
Bowel Symptoms Domain Score	Number Analyzed	28 participants	27 participants	30 participants
		55.4 (7.22)	54.0 (9.00)	55.5 (8.04)
Systemic Symptoms Domain Score	Number Analyzed	28 participants	27 participants	30 participants
		23.3 (5.49)	23.4 (4.21)	22.9 (4.44)
Emotional Function Domain Score	Number Analyzed	28 participants	27 participants	30 participants
		65.3 (8.85)	63.1 (8.90)	63.2 (9.55)
Social Function Domain Score	Number Analyzed	27 participants	27 participants	30 participants
		28.8 (6.73)	28.9 (4.82)	28.7 (5.62)

21. Secondary Outcome

Title	Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 6
Description	The total IBDQ score consists of 32 questions, each ranging from 1 to 7, with higher scores indicating a better quality of life. There are 4 IBDQ Domain Scores: Bowel Symptoms Domain Score, ranging from 10 to 70 (10 questions ranging from 1 to 7); Systemic Symptoms Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 ); Emotional Function Domain Score, ranging from 12 to 84 (12 questions ranging from 1 to 7); Social Function Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 )
Time Frame	Week 6

Outcome Measure Data

Analysis Population Description

Full Analysis Set defined as subjects randomized and allocated to study medication, excluding the following subjects determined by data review prior to unblinding:

Subjects

• with Good Clinical Practice (GCP) violations
• who were not diagnosed (definitely) with CD
• who received no dose of study medication
• with no data after randomization

Arm/Group Title		Full Analysis Set (Placebo Treated Subjects)	Full Analysis Set (CZP 200 mg Treated Subjects)	Full Analysis Set (CZP 400 mg Treated Subjects)
Arm/Group Description:		The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization
Overall Number of Participants Analyzed		32	30	31
Mean (Standard Deviation); Unit of Measure: units on a scale
Bowel Symptoms Domain Score	Number Analyzed	28 participants	27 participants	30 participants
		55.4 (7.77)	51.8 (8.44)	55.8 (8.43)
Systemic Symptoms Domain Score	Number Analyzed	28 participants	27 participants	30 participants
		23.3 (6.74)	22.4 (4.49)	23.4 (4.62)
Emotional Function Domain Score	Number Analyzed	28 participants	27 participants	30 participants
		65.3 (8.76)	63.2 (9.45)	62.1 (10.43)
Social Function Domain Score	Number Analyzed	27 participants	27 participants	30 participants
		29.2 (6.48)	28.1 (5.69)	29.5 (5.09)

22. Secondary Outcome

Title	Concentration of C-reactive Protein (CRP) Value at Week 2
Description	CRP data for subjects receiving rescue medication were excluded.
Time Frame	Week 2

Outcome Measure Data

Analysis Population Description

Full Analysis Set defined as subjects randomized and allocated to study medication, excluding the following subjects determined by data review prior to unblinding:

Subjects

• with Good Clinical Practice (GCP) violations
• who were not diagnosed (definitely) with CD
• who received no dose of study medication
• with no data after randomization

Arm/Group Title	Full Analysis Set (Placebo Treated Subjects)	Full Analysis Set (CZP 200 mg Treated Subjects)	Full Analysis Set (CZP 400 mg Treated Subjects)
Arm/Group Description:	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization
Overall Number of Participants Analyzed	29	29	31
Geometric Mean (95% Confidence Interval); Unit of Measure: mg/L
	22.15; (15.43 to 31.80)	13.58; (9.45 to 19.52)	13.86; (9.11 to 21.09)

23. Secondary Outcome

Title	Concentration of C-reactive Protein (CRP) Value at Week 4
Description	CRP data for subjects receiving rescue medication were excluded.
Time Frame	Week 4

Outcome Measure Data

Analysis Population Description

Full Analysis Set defined as subjects randomized and allocated to study medication, excluding the following subjects determined by data review prior to unblinding:

Subjects

• with Good Clinical Practice (GCP) violations
• who were not diagnosed (definitely) with CD
• who received no dose of study medication
• with no data after randomization

Arm/Group Title	Full Analysis Set (Placebo Treated Subjects)	Full Analysis Set (CZP 200 mg Treated Subjects)	Full Analysis Set (CZP 400 mg Treated Subjects)
Arm/Group Description:	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization
Overall Number of Participants Analyzed	28	27	30
Geometric Mean (95% Confidence Interval); Unit of Measure: mg/L
	23.47; (16.02 to 34.40)	12.87; (8.56 to 19.36)	12.02; (8.68 to 16.65)

24. Secondary Outcome

Title	Concentration of C-reactive Protein (CRP) Value at Week 6
Description	CRP data for subjects receiving rescue medication were excluded.
Time Frame	Week 6

Outcome Measure Data

Analysis Population Description

Full Analysis Set defined as subjects randomized and allocated to study medication, excluding the following subjects determined by data review prior to unblinding:

Subjects

• with Good Clinical Practice (GCP) violations
• who were not diagnosed (definitely) with CD
• who received no dose of study medication
• with no data after randomization

Arm/Group Title	Full Analysis Set (Placebo Treated Subjects)	Full Analysis Set (CZP 200 mg Treated Subjects)	Full Analysis Set (CZP 400 mg Treated Subjects)
Arm/Group Description:	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization
Overall Number of Participants Analyzed	28	27	30
Geometric Mean (95% Confidence Interval); Unit of Measure: mg/L
	23.32; (16.95 to 32.07)	15.10; (9.46 to 24.11)	12.62; (8.79 to 18.11)

25. Secondary Outcome

Title	C-reactive Protein (CRP) Ratio to Baseline at Week 2
Description	CRP data for subjects receiving rescue medication were excluded.
Time Frame	Baseline, Week 2

Outcome Measure Data

Analysis Population Description

Full Analysis Set defined as subjects randomized and allocated to study medication, excluding the following subjects determined by data review prior to unblinding:

Subjects

• with Good Clinical Practice (GCP) violations
• who were not diagnosed (definitely) with CD
• who received no dose of study medication
• with no data after randomization

Arm/Group Title	Full Analysis Set (Placebo Treated Subjects)	Full Analysis Set (CZP 200 mg Treated Subjects)	Full Analysis Set (CZP 400 mg Treated Subjects)
Arm/Group Description:	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization
Overall Number of Participants Analyzed	29	29	31
Geometric Mean (95% Confidence Interval); Unit of Measure: ratio
	0.85; (0.64 to 1.13)	0.58; (0.42 to 0.80)	0.50; (0.35 to 0.72)

26. Secondary Outcome

Title	C-reactive Protein (CRP) Ratio to Baseline at Week 4
Description	CRP data for subjects receiving rescue medication were excluded.
Time Frame	Baseline, Week 4

Outcome Measure Data

Analysis Population Description

Full Analysis Set defined as subjects randomized and allocated to study medication, excluding the following subjects determined by data review prior to unblinding:

Subjects

• with Good Clinical Practice (GCP) violations
• who were not diagnosed (definitely) with CD
• who received no dose of study medication
• with no data after randomization

Arm/Group Title	Full Analysis Set (Placebo Treated Subjects)	Full Analysis Set (CZP 200 mg Treated Subjects)	Full Analysis Set (CZP 400 mg Treated Subjects)
Arm/Group Description:	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization
Overall Number of Participants Analyzed	28	27	30
Geometric Mean (95% Confidence Interval); Unit of Measure: ratio
	1.04; (0.83 to 1.31)	0.53; (0.37 to 0.76)	0.44; (0.32 to 0.60)

27. Secondary Outcome

Title	C-reactive Protein (CRP) Ratio to Baseline at Week 6
Description	CRP data for subjects receiving rescue medication were excluded.
Time Frame	Baseline, Week 6

Outcome Measure Data

Analysis Population Description

Full Analysis Set defined as subjects randomized and allocated to study medication, excluding the following subjects determined by data review prior to unblinding:

Subjects

• with Good Clinical Practice (GCP) violations
• who were not diagnosed (definitely) with CD
• who received no dose of study medication
• with no data after randomization

Arm/Group Title	Full Analysis Set (Placebo Treated Subjects)	Full Analysis Set (CZP 200 mg Treated Subjects)	Full Analysis Set (CZP 400 mg Treated Subjects)
Arm/Group Description:	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization	The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: Subjects with Good Clinical Practice (GCP) violations; Subjects who were not diagnosed (definitely) with Crohn's Disease; Subjects who received no dose of study medication; Subjects with no data after randomization
Overall Number of Participants Analyzed	28	27	30
Geometric Mean (95% Confidence Interval); Unit of Measure: ratio
	1.03; (0.85 to 1.25)	0.63; (0.40 to 0.98)	0.46; (0.32 to 0.66)

Adverse Events

Time Frame	Adverse Events were collected from the time of signing the informed consent through the last Observation (up to 28 weeks).
Adverse Event Reporting Description	Adverse Events refer to the Safety Population, including all randomized subjects who received at least one dose of study medication (Placebo or Certolizumab Pegol).
Arm/Group Title	Placebo		Certolizumab Pegol 200 mg		Certolizumab Pegol 400 mg
Arm/Group Description	Subjects received two subcutaneous (sc) injections of Placebo on Weeks 0 (first dose), 2 and 4.		Subjects received one subcutaneous (sc) injection of 200 mg CZP and one injection of Placebo to maintain the study blind on Weeks 0 (first dose), 2 and 4.		Subjects received two subcutaneous (sc) injections of 200 mg CZP on Weeks 0 (first dose), 2 and 4.
All-Cause Mortality
	Placebo		Certolizumab Pegol 200 mg		Certolizumab Pegol 400 mg
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	0/32 (0.00%)		0/30 (0.00%)		0/32 (0.00%)
Serious Adverse Events
	Placebo		Certolizumab Pegol 200 mg		Certolizumab Pegol 400 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/32 (9.38%)		1/30 (3.33%)		3/32 (9.38%)
Blood and lymphatic system disorders
Disseminated intravascular coagulation * 1	0/32 (0.00%)	0	0/30 (0.00%)	0	1/32 (3.13%)	1
Gastrointestinal disorders
Crohn's disease * 1	3/32 (9.38%)	3	0/30 (0.00%)	0	0/32 (0.00%)	0
Abdominal pain * 1	0/32 (0.00%)	0	0/30 (0.00%)	0	1/32 (3.13%)	1
Gastrointestinal haemorrhage * 1	1/32 (3.13%)	1	0/30 (0.00%)	0	0/32 (0.00%)	0
Peritonitis * 1	1/32 (3.13%)	1	0/30 (0.00%)	0	0/32 (0.00%)	0
General disorders
Pyrexia * 1	0/32 (0.00%)	0	0/30 (0.00%)	0	2/32 (6.25%)	2
Infections and infestations
Sepsis * 1	0/32 (0.00%)	0	0/30 (0.00%)	0	1/32 (3.13%)	1
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration * 1	0/32 (0.00%)	0	1/30 (3.33%)	3	0/32 (0.00%)	0
1 Term from vocabulary, MedDRA9.0; * Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Placebo		Certolizumab Pegol 200 mg		Certolizumab Pegol 400 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	16/32 (50.00%)		11/30 (36.67%)		14/32 (43.75%)
Gastrointestinal disorders
Nausea * 1	1/32 (3.13%)	1	2/30 (6.67%)	3	2/32 (6.25%)	2
Vomiting * 1	0/32 (0.00%)	0	2/30 (6.67%)	3	1/32 (3.13%)	1
General disorders
Pyrexia * 1	2/32 (6.25%)	2	2/30 (6.67%)	3	1/32 (3.13%)	1
Hepatobiliary disorders
Hepatic function abnormal * 1	2/32 (6.25%)	2	0/30 (0.00%)	0	0/32 (0.00%)	0
Infections and infestations
Nasopharyngitis * 1	10/32 (31.25%)	11	7/30 (23.33%)	8	7/32 (21.88%)	9
Investigations
White blood cell count decreased * 1	0/32 (0.00%)	0	0/30 (0.00%)	0	2/32 (6.25%)	2
Nervous system disorders
Headache * 1	2/32 (6.25%)	2	0/30 (0.00%)	0	1/32 (3.13%)	1
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain * 1	0/32 (0.00%)	0	2/30 (6.67%)	2	1/32 (3.13%)	1
Pharynx discomfort * 1	0/32 (0.00%)	0	1/30 (3.33%)	1	2/32 (6.25%)	2
Upper respiratory tract inflammation * 1	1/32 (3.13%)	1	0/30 (0.00%)	0	2/32 (6.25%)	2
Skin and subcutaneous tissue disorders
Comedone * 1	2/32 (6.25%)	2	0/30 (0.00%)	0	0/32 (0.00%)	0
1 Term from vocabulary, MedDRA9.0; * Indicates events were collected by non-systematic assessment

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.

Results Point of Contact

• Name/Title: UCB
• Organization: Cares
• Phone: +1844 599 ext 2273
• EMail: UCBCares@ucb.com

• Responsible Party: UCB Pharma
• ClinicalTrials.gov Identifier: NCT00291668
• Other Study ID Numbers: C87037; 2014-004399-42 ( EudraCT Number )
• First Submitted: February 10, 2006
• First Posted: February 14, 2006
• Results First Submitted: February 8, 2018
• Results First Posted: August 3, 2020
• Last Update Posted: August 3, 2020