Trial Outcomes & Findings for Clinical Study of CDP870/Certolizumab Pegol in Patients With Active Crohn's Disease (NCT NCT00291668)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

94 participants

Primary outcome timeframe

Baseline, Week 6

Results posted on

2020-08-03

Participant Flow

This study started to enroll subjects in March 2006 and conluded in November 2007.

Participant Flow refers to the Safety Set, including all randomized subjects who received at least one dose of study medication (Placebo or Certolizumab Pegol).

Participant milestones

Participant milestones
Measure	Placebo Subjects received two subcutaneous (sc) injections of Placebo on Weeks 0 (first dose), 2 and 4.	Certolizumab Pegol 200 mg 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.	Certolizumab Pegol 400 mg Subjects received two subcutaneous (sc) injections of 200 mg CZP on Weeks 0 (first dose), 2 and 4.
Overall Study STARTED	32	30	32
Overall Study COMPLETED	28	29	31
Overall Study NOT COMPLETED	4	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Subjects received two subcutaneous (sc) injections of Placebo on Weeks 0 (first dose), 2 and 4.	Certolizumab Pegol 200 mg 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.	Certolizumab Pegol 400 mg Subjects received two subcutaneous (sc) injections of 200 mg CZP on Weeks 0 (first dose), 2 and 4.
Overall Study Lack of Efficacy	1	0	0
Overall Study SAE, non-fatal	1	1	1
Overall Study AE, non-serious non-fatal	1	0	0
Overall Study SAE, non-fatal+AE, non-serious non-fatal	1	0	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=32 Participants Subjects received two subcutaneous (sc) injections of Placebo on Weeks 0 (first dose), 2 and 4.	Certolizumab Pegol 200 mg n=30 Participants 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.	Certolizumab Pegol 400 mg n=32 Participants Subjects received two subcutaneous (sc) injections of 200 mg CZP on Weeks 0 (first dose), 2 and 4.	Total Title n=94 Participants
Age, Categorical <=18 years	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants	28 Participants n=7 Participants	30 Participants n=5 Participants	88 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	30.6 years STANDARD_DEVIATION 8.16 • n=5 Participants	32.7 years STANDARD_DEVIATION 9.34 • n=7 Participants	31.4 years STANDARD_DEVIATION 8.27 • n=5 Participants	31.5 years STANDARD_DEVIATION 8.54 • n=4 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	8 Participants n=7 Participants	7 Participants n=5 Participants	21 Participants n=4 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	22 Participants n=7 Participants	25 Participants n=5 Participants	73 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline, Week 6

Population: 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

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.

Outcome measures

Outcome measures
Measure	Full Analysis Set (Placebo Treated Subjects) n=32 Participants 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	Full Analysis Set (CZP 200 mg Treated Subjects) n=30 Participants 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	Full Analysis Set (CZP 400 mg Treated Subjects) n=31 Participants 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
Crohn's Disease Activity Index (CDAI) Response (Clinical Response or Remission) at Week 6	25.0 percentage of subjects Interval 10.0 to 40.0	43.3 percentage of subjects Interval 25.6 to 61.1	48.4 percentage of subjects Interval 30.8 to 66.0

SECONDARY outcome

Timeframe: Week 2

Population: 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

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.

Outcome measures

Outcome measures
Measure	Full Analysis Set (Placebo Treated Subjects) n=29 Participants 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	Full Analysis Set (CZP 200 mg Treated Subjects) n=29 Participants 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	Full Analysis Set (CZP 400 mg Treated Subjects) n=31 Participants 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
Crohn's Disease Activity Index (CDAI) Score at Week 2	255.9 units on a scale Standard Deviation 68.02	214.2 units on a scale Standard Deviation 83.51	224.9 units on a scale Standard Deviation 85.05

SECONDARY outcome

Timeframe: Week 4

Population: 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

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.

Outcome measures

Outcome measures
Measure	Full Analysis Set (Placebo Treated Subjects) n=28 Participants 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	Full Analysis Set (CZP 200 mg Treated Subjects) n=27 Participants 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	Full Analysis Set (CZP 400 mg Treated Subjects) n=30 Participants 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
Crohn's Disease Activity Index (CDAI) Score at Week 4	243.1 units on a scale Standard Deviation 68.57	199.7 units on a scale Standard Deviation 91.25	204.6 units on a scale Standard Deviation 75.10

SECONDARY outcome

Timeframe: Week 6

Population: 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

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.

Outcome measures

Outcome measures
Measure	Full Analysis Set (Placebo Treated Subjects) n=28 Participants 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	Full Analysis Set (CZP 200 mg Treated Subjects) n=27 Participants 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	Full Analysis Set (CZP 400 mg Treated Subjects) n=30 Participants 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
Crohn's Disease Activity Index (CDAI) Score at Week 6	232.4 units on a scale Standard Deviation 89.28	211.0 units on a scale Standard Deviation 99.91	198.1 units on a scale Standard Deviation 87.88

SECONDARY outcome

Timeframe: Baseline, Week 2

Population: 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

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.

Outcome measures

Outcome measures
Measure	Full Analysis Set (Placebo Treated Subjects) n=32 Participants 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	Full Analysis Set (CZP 200 mg Treated Subjects) n=30 Participants 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	Full Analysis Set (CZP 400 mg Treated Subjects) n=31 Participants 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
Percentage of Subjects Who Achieve CDAI Response at Week 2	15.6 percentage of subjects Interval 3.0 to 28.2	40.0 percentage of subjects Interval 22.5 to 57.5	32.3 percentage of subjects Interval 15.8 to 48.7

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: 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

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.

Outcome measures

Outcome measures
Measure	Full Analysis Set (Placebo Treated Subjects) n=32 Participants 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	Full Analysis Set (CZP 200 mg Treated Subjects) n=30 Participants 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	Full Analysis Set (CZP 400 mg Treated Subjects) n=31 Participants 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
Percentage of Subjects Who Achieve CDAI Response at Week 4	21.9 percentage of subjects Interval 7.6 to 36.2	46.7 percentage of subjects Interval 28.8 to 64.5	38.7 percentage of subjects Interval 21.6 to 55.9

SECONDARY outcome

Timeframe: Baseline, Week 2

Population: 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

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.

Outcome measures

Outcome measures
Measure	Full Analysis Set (Placebo Treated Subjects) n=32 Participants 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	Full Analysis Set (CZP 200 mg Treated Subjects) n=30 Participants 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	Full Analysis Set (CZP 400 mg Treated Subjects) n=31 Participants 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
Percentage of Subjects Who Achieve a Reduction in CDAI Scores of at Least 70 Points at Week 2	28.1 percentage of subjects Interval 12.5 to 43.7	46.7 percentage of subjects Interval 28.8 to 64.5	45.2 percentage of subjects Interval 27.6 to 62.7

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: 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

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.

Outcome measures

Outcome measures
Measure	Full Analysis Set (Placebo Treated Subjects) n=32 Participants 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	Full Analysis Set (CZP 200 mg Treated Subjects) n=30 Participants 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	Full Analysis Set (CZP 400 mg Treated Subjects) n=31 Participants 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
Percentage of Subjects Who Achieve a Reduction in CDAI Scores of at Least 70 Points at Week 4	25.0 percentage of subjects Interval 10.0 to 40.0	56.7 percentage of subjects Interval 38.9 to 74.4	54.8 percentage of subjects Interval 37.3 to 72.4

SECONDARY outcome

Timeframe: Baseline, Week 6

Population: 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

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.

Outcome measures

Outcome measures
Measure	Full Analysis Set (Placebo Treated Subjects) n=32 Participants 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	Full Analysis Set (CZP 200 mg Treated Subjects) n=30 Participants 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	Full Analysis Set (CZP 400 mg Treated Subjects) n=31 Participants 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
Percentage of Subjects Who Achieve a Reduction in CDAI Scores of at Least 70 Points at Week 6	43.8 percentage of subjects Interval 26.6 to 60.9	53.3 percentage of subjects Interval 35.5 to 71.2	61.3 percentage of subjects Interval 44.1 to 78.4

SECONDARY outcome

Timeframe: Week 2

Population: 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

Remission at Week 2 is defined as a CDAI score \<= 150 points at Week 2.

Outcome measures

Outcome measures
Measure	Full Analysis Set (Placebo Treated Subjects) n=32 Participants 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	Full Analysis Set (CZP 200 mg Treated Subjects) n=30 Participants 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	Full Analysis Set (CZP 400 mg Treated Subjects) n=31 Participants 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
Percentage of Subjects Who Achieve Remission (CDAI <= 150) at Week 2	3.1 percentage of subjects Interval 0.0 to 9.2	20.0 percentage of subjects Interval 5.7 to 34.3	16.1 percentage of subjects Interval 3.2 to 29.1

SECONDARY outcome

Timeframe: Week 4

Population: 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

Remission at Week 4 is defined as a CDAI score \<= 150 points at Week 4.

Outcome measures

Outcome measures
Measure	Full Analysis Set (Placebo Treated Subjects) n=32 Participants 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	Full Analysis Set (CZP 200 mg Treated Subjects) n=30 Participants 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	Full Analysis Set (CZP 400 mg Treated Subjects) n=31 Participants 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
Percentage of Subjects Who Achieve Remission (CDAI <= 150) at Week 4	6.3 percentage of subjects Interval 0.0 to 14.6	26.7 percentage of subjects Interval 10.8 to 42.5	22.6 percentage of subjects Interval 7.9 to 37.3

SECONDARY outcome

Timeframe: Week 6

Population: 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

Remission at Week 6 is defined as a CDAI score \<= 150 points at Week 6.

Outcome measures

Outcome measures
Measure	Full Analysis Set (Placebo Treated Subjects) n=32 Participants 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	Full Analysis Set (CZP 200 mg Treated Subjects) n=30 Participants 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	Full Analysis Set (CZP 400 mg Treated Subjects) n=31 Participants 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
Percentage of Subjects Who Achieve Remission (CDAI <= 150) at Week 6	15.6 percentage of subjects Interval 3.0 to 28.2	26.7 percentage of subjects Interval 10.8 to 42.5	32.3 percentage of subjects Interval 15.8 to 48.7

SECONDARY outcome

Timeframe: Baseline, Week 2

Population: 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

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).

Outcome measures

Outcome measures
Measure	Full Analysis Set (Placebo Treated Subjects) n=32 Participants 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	Full Analysis Set (CZP 200 mg Treated Subjects) n=30 Participants 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	Full Analysis Set (CZP 400 mg Treated Subjects) n=31 Participants 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
Percentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) at Week 2	15.6 percentage of subjects Interval 3.0 to 28.2	36.7 percentage of subjects Interval 19.4 to 53.9	29.0 percentage of subjects Interval 13.1 to 45.0

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: 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

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).

Outcome measures

Outcome measures
Measure	Full Analysis Set (Placebo Treated Subjects) n=32 Participants 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	Full Analysis Set (CZP 200 mg Treated Subjects) n=30 Participants 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	Full Analysis Set (CZP 400 mg Treated Subjects) n=31 Participants 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
Percentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) at Week 4	18.8 percentage of subjects Interval 5.2 to 32.3	36.7 percentage of subjects Interval 19.4 to 53.9	32.3 percentage of subjects Interval 15.8 to 48.7

SECONDARY outcome

Timeframe: Baseline, Week 6

Population: 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

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).

Outcome measures

Outcome measures
Measure	Full Analysis Set (Placebo Treated Subjects) n=32 Participants 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	Full Analysis Set (CZP 200 mg Treated Subjects) n=30 Participants 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	Full Analysis Set (CZP 400 mg Treated Subjects) n=31 Participants 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
Percentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) at Week 6	21.9 percentage of subjects Interval 7.6 to 36.2	36.7 percentage of subjects Interval 19.4 to 53.9	41.9 percentage of subjects Interval 24.6 to 59.3

SECONDARY outcome

Timeframe: Week 2

Population: 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

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.

Outcome measures

Outcome measures
Measure	Full Analysis Set (Placebo Treated Subjects) n=29 Participants 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	Full Analysis Set (CZP 200 mg Treated Subjects) n=29 Participants 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	Full Analysis Set (CZP 400 mg Treated Subjects) n=31 Participants 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
Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 2	171.3 units on a scale Standard Deviation 22.45	166.1 units on a scale Standard Deviation 22.14	169.7 units on a scale Standard Deviation 23.24

SECONDARY outcome

Timeframe: Week 4

Population: 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

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.

Outcome measures

Outcome measures
Measure	Full Analysis Set (Placebo Treated Subjects) n=28 Participants 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	Full Analysis Set (CZP 200 mg Treated Subjects) n=27 Participants 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	Full Analysis Set (CZP 400 mg Treated Subjects) n=30 Participants 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
Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 4	172.6 units on a scale Standard Deviation 24.04	169.4 units on a scale Standard Deviation 21.75	170.3 units on a scale Standard Deviation 23.72

SECONDARY outcome

Timeframe: Week 6

Population: 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

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.

Outcome measures

Outcome measures
Measure	Full Analysis Set (Placebo Treated Subjects) n=28 Participants 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	Full Analysis Set (CZP 200 mg Treated Subjects) n=27 Participants 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	Full Analysis Set (CZP 400 mg Treated Subjects) n=30 Participants 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
Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 6	173.1 units on a scale Standard Deviation 25.49	165.6 units on a scale Standard Deviation 23.25	170.8 units on a scale Standard Deviation 24.54

SECONDARY outcome

Timeframe: Week 2

Population: 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

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 )

Outcome measures

Outcome measures
Measure	Full Analysis Set (Placebo Treated Subjects) n=32 Participants 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	Full Analysis Set (CZP 200 mg Treated Subjects) n=30 Participants 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	Full Analysis Set (CZP 400 mg Treated Subjects) n=31 Participants 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
Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 2 Bowel Symptoms Domain Score	54.4 units on a scale Standard Deviation 7.17	53.4 units on a scale Standard Deviation 8.18	54.7 units on a scale Standard Deviation 8.77
Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 2 Systemic Symptoms Domain Score	22.4 units on a scale Standard Deviation 5.01	22.4 units on a scale Standard Deviation 5.17	22.7 units on a scale Standard Deviation 4.51
Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 2 Emotional Function Domain Score	65.3 units on a scale Standard Deviation 8.91	62.3 units on a scale Standard Deviation 9.54	63.3 units on a scale Standard Deviation 8.53
Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 2 Social Function Domain Score	29.4 units on a scale Standard Deviation 5.64	28.0 units on a scale Standard Deviation 4.33	29.0 units on a scale Standard Deviation 5.03

SECONDARY outcome

Timeframe: Week 4

Population: 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

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 )

Outcome measures

Outcome measures
Measure	Full Analysis Set (Placebo Treated Subjects) n=32 Participants 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	Full Analysis Set (CZP 200 mg Treated Subjects) n=30 Participants 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	Full Analysis Set (CZP 400 mg Treated Subjects) n=31 Participants 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
Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 4 Bowel Symptoms Domain Score	55.4 units on a scale Standard Deviation 7.22	54.0 units on a scale Standard Deviation 9.00	55.5 units on a scale Standard Deviation 8.04
Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 4 Systemic Symptoms Domain Score	23.3 units on a scale Standard Deviation 5.49	23.4 units on a scale Standard Deviation 4.21	22.9 units on a scale Standard Deviation 4.44
Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 4 Emotional Function Domain Score	65.3 units on a scale Standard Deviation 8.85	63.1 units on a scale Standard Deviation 8.90	63.2 units on a scale Standard Deviation 9.55
Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 4 Social Function Domain Score	28.8 units on a scale Standard Deviation 6.73	28.9 units on a scale Standard Deviation 4.82	28.7 units on a scale Standard Deviation 5.62

SECONDARY outcome

Timeframe: Week 6

Population: 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

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 )

Outcome measures

Outcome measures
Measure	Full Analysis Set (Placebo Treated Subjects) n=32 Participants 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	Full Analysis Set (CZP 200 mg Treated Subjects) n=30 Participants 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	Full Analysis Set (CZP 400 mg Treated Subjects) n=31 Participants 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
Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 6 Bowel Symptoms Domain Score	55.4 units on a scale Standard Deviation 7.77	51.8 units on a scale Standard Deviation 8.44	55.8 units on a scale Standard Deviation 8.43
Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 6 Systemic Symptoms Domain Score	23.3 units on a scale Standard Deviation 6.74	22.4 units on a scale Standard Deviation 4.49	23.4 units on a scale Standard Deviation 4.62
Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 6 Emotional Function Domain Score	65.3 units on a scale Standard Deviation 8.76	63.2 units on a scale Standard Deviation 9.45	62.1 units on a scale Standard Deviation 10.43
Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 6 Social Function Domain Score	29.2 units on a scale Standard Deviation 6.48	28.1 units on a scale Standard Deviation 5.69	29.5 units on a scale Standard Deviation 5.09

SECONDARY outcome

Timeframe: Week 2

Population: 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