Clinical Study of CDP870/Certolizumab Pegol in Patients W... | NCT00291668

ID	Type	Description	Link
2014-004399-42	EudraCT Number

Label	Type	Description	Intervention Names
Certolizumab pegol 200 mg	Experimental	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.	Biological: Certolizumab Pegol Other: Placebo
Certolizumab pegol 400 mg	Experimental	Subjects received two subcutaneous (sc) injections of 200 mg CZP on Weeks 0 (first dose), 2 and 4.	Biological: Certolizumab Pegol
Placebo	Placebo Comparator	Subjects received two subcutaneous (sc) injections of Placebo on Weeks 0 (first dose), 2 and 4.	Other: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Certolizumab Pegol	Biological	Active Substance: Certolizumab Pegol Pharmaceutical Form: Solution for injection in pre-filled syringe Concentration: 200 mg/mL Route of Administration: Subcutaneous use

Measure	Description	Time Frame
Crohn's Disease Activity Index (CDAI) Response (Clinical Response or Remission) at Week 6	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.	Baseline, Week 6

Measure	Description	Time Frame
Crohn's Disease Activity Index (CDAI) Score at Week 2	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.

Label	URL
FDA Safety Alerts and Recalls	View source

ID	Title	Description
FG000	Placebo	Subjects received two subcutaneous (sc) injections of Placebo on Weeks 0 (first dose), 2 and 4.
FG001	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.

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Crohn's Disease Activity Index (CDAI) Response (Clinical Response or Remission) at Week 6

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.

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

Posted

Number

95% Confidence Interval

percentage of subjects

Baseline, Week 6

ID	Title	Description
OG000	Full Analysis Set (Placebo Treated Subjects)	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
OG001	Full Analysis Set (CZP 200 mg Treated Subjects)	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
OG002	Full Analysis Set (CZP 400 mg Treated Subjects)	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

Units	Counts
Participants	OG00032 OG00130 OG00231

Title

Denominators

Categories

Title	Measurements
	OG00025.0(10.0 to 40.0) OG00143.3(25.6 to 61.1) OG00248.4(30.8 to 66.0)

Secondary

Crohn's Disease Activity Index (CDAI) Score at Week 2

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.

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

Posted

Mean

Standard Deviation

units on a scale

Week 2

ID	Title	Description
OG000	Full Analysis Set (Placebo Treated Subjects)	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
OG001	Full Analysis Set (CZP 200 mg Treated Subjects)	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

Secondary

Crohn's Disease Activity Index (CDAI) Score at Week 4

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

Posted

Mean

Standard Deviation

units on a scale

Week 4

ID	Title	Description
OG000	Full Analysis Set (Placebo Treated Subjects)	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
OG001	Full Analysis Set (CZP 200 mg Treated Subjects)	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

Secondary

Crohn's Disease Activity Index (CDAI) Score at Week 6

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

Posted

Mean

Standard Deviation

units on a scale

Week 6

ID	Title	Description
OG000	Full Analysis Set (Placebo Treated Subjects)	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
OG001	Full Analysis Set (CZP 200 mg Treated Subjects)	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

Secondary

Percentage of Subjects Who Achieve CDAI Response at Week 2

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.

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

Posted

Number

95% Confidence Interval

percentage of subjects

Baseline, Week 2

ID	Title	Description
OG000	Full Analysis Set (Placebo Treated Subjects)	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
OG001	Full Analysis Set (CZP 200 mg Treated Subjects)	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

Secondary

Percentage of Subjects Who Achieve CDAI Response at Week 4

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.

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

Posted

Number

95% Confidence Interval

percentage of subjects

Baseline, Week 4

ID	Title	Description
OG000	Full Analysis Set (Placebo Treated Subjects)	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
OG001	Full Analysis Set (CZP 200 mg Treated Subjects)	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

Secondary

Percentage of Subjects Who Achieve a Reduction in CDAI Scores of at Least 70 Points at Week 2

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.

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

Posted

Number

95% Confidence Interval

percentage of subjects

Baseline, Week 2

ID	Title	Description
OG000	Full Analysis Set (Placebo Treated Subjects)	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
OG001	Full Analysis Set (CZP 200 mg Treated Subjects)	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

Secondary

Percentage of Subjects Who Achieve a Reduction in CDAI Scores of at Least 70 Points at Week 4

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

Posted

Number

95% Confidence Interval

percentage of subjects

Baseline, Week 4

ID	Title	Description
OG000	Full Analysis Set (Placebo Treated Subjects)	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
OG001	Full Analysis Set (CZP 200 mg Treated Subjects)	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

Secondary

Percentage of Subjects Who Achieve a Reduction in CDAI Scores of at Least 70 Points at Week 6

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

Posted

Number

95% Confidence Interval

percentage of subjects

Baseline, Week 6

ID	Title	Description
OG000	Full Analysis Set (Placebo Treated Subjects)	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
OG001	Full Analysis Set (CZP 200 mg Treated Subjects)	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

Secondary

Percentage of Subjects Who Achieve Remission (CDAI <= 150) at Week 2

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

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

Posted

Number

95% Confidence Interval

percentage of subjects

Week 2

ID	Title	Description
OG000	Full Analysis Set (Placebo Treated Subjects)	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
OG001	Full Analysis Set (CZP 200 mg Treated Subjects)	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

Secondary

Percentage of Subjects Who Achieve Remission (CDAI <= 150) at Week 4

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

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

Posted

Number

95% Confidence Interval

percentage of subjects

Week 4

ID	Title	Description
OG000	Full Analysis Set (Placebo Treated Subjects)	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
OG001	Full Analysis Set (CZP 200 mg Treated Subjects)	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

Secondary

Percentage of Subjects Who Achieve Remission (CDAI <= 150) at Week 6

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

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

Posted

Number

95% Confidence Interval

percentage of subjects

Week 6

ID	Title	Description
OG000	Full Analysis Set (Placebo Treated Subjects)	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
OG001	Full Analysis Set (CZP 200 mg Treated Subjects)	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

Secondary

Percentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) 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).

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

Posted

Number

95% Confidence Interval

percentage of subjects

Baseline, Week 2

ID	Title	Description
OG000	Full Analysis Set (Placebo Treated Subjects)	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
OG001	Full Analysis Set (CZP 200 mg Treated Subjects)	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

Secondary

Percentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) 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).

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

Posted

Number

95% Confidence Interval

percentage of subjects

Baseline, Week 4

ID	Title	Description
OG000	Full Analysis Set (Placebo Treated Subjects)	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
OG001	Full Analysis Set (CZP 200 mg Treated Subjects)	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

Secondary

Percentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) 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).

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

Posted

Number

95% Confidence Interval

percentage of subjects

Baseline, Week 6

ID	Title	Description
OG000	Full Analysis Set (Placebo Treated Subjects)	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
OG001	Full Analysis Set (CZP 200 mg Treated Subjects)	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

Secondary

Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 2

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.

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

Posted

Mean

Standard Deviation

units on a scale

Week 2

ID	Title	Description
OG000	Full Analysis Set (Placebo Treated Subjects)	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
OG001	Full Analysis Set (CZP 200 mg Treated Subjects)	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

Secondary

Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 4

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

Posted

Mean

Standard Deviation

units on a scale

Week 4

ID	Title	Description
OG000	Full Analysis Set (Placebo Treated Subjects)	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
OG001	Full Analysis Set (CZP 200 mg Treated Subjects)	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

Secondary

Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 6

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

Posted

Mean

Standard Deviation

units on a scale

Week 6

ID	Title	Description
OG000	Full Analysis Set (Placebo Treated Subjects)	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
OG001	Full Analysis Set (CZP 200 mg Treated Subjects)	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

Secondary

Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 2

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 )

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

Posted

Mean

Standard Deviation

units on a scale

Week 2

ID	Title	Description
OG000	Full Analysis Set (Placebo Treated Subjects)	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
OG001	Full Analysis Set (CZP 200 mg Treated Subjects)

Secondary

Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 4

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 )

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

Posted

Mean

Standard Deviation

units on a scale

Week 4

ID	Title	Description
OG000	Full Analysis Set (Placebo Treated Subjects)	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
OG001	Full Analysis Set (CZP 200 mg Treated Subjects)

Secondary

Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 6

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 )

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

Posted

Mean

Standard Deviation

units on a scale

Week 6

ID	Title	Description
OG000	Full Analysis Set (Placebo Treated Subjects)	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
OG001	Full Analysis Set (CZP 200 mg Treated Subjects)

Secondary

Concentration of C-reactive Protein (CRP) Value at Week 2

CRP data for subjects receiving rescue medication were excluded.

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

Posted

Geometric Mean

95% Confidence Interval

mg/L

Week 2

ID	Title	Description
OG000	Full Analysis Set (Placebo Treated Subjects)	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
OG001	Full Analysis Set (CZP 200 mg Treated Subjects)	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

Secondary

Concentration of C-reactive Protein (CRP) Value at Week 4

CRP data for subjects receiving rescue medication were excluded.

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

Posted

Geometric Mean

95% Confidence Interval

mg/L

Week 4

ID	Title	Description
OG000	Full Analysis Set (Placebo Treated Subjects)	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
OG001	Full Analysis Set (CZP 200 mg Treated Subjects)	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

Secondary

Concentration of C-reactive Protein (CRP) Value at Week 6

CRP data for subjects receiving rescue medication were excluded.

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

Posted

Geometric Mean

95% Confidence Interval

mg/L

Week 6

ID	Title	Description
OG000	Full Analysis Set (Placebo Treated Subjects)	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
OG001	Full Analysis Set (CZP 200 mg Treated Subjects)	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

Secondary

C-reactive Protein (CRP) Ratio to Baseline at Week 2

CRP data for subjects receiving rescue medication were excluded.

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

Posted

Geometric Mean

95% Confidence Interval

ratio

Baseline, Week 2

ID	Title	Description
OG000	Full Analysis Set (Placebo Treated Subjects)	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
OG001	Full Analysis Set (CZP 200 mg Treated Subjects)	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

Secondary

C-reactive Protein (CRP) Ratio to Baseline at Week 4

CRP data for subjects receiving rescue medication were excluded.

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

Posted

Geometric Mean

95% Confidence Interval

ratio

Baseline, Week 4

ID	Title	Description
OG000	Full Analysis Set (Placebo Treated Subjects)	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
OG001	Full Analysis Set (CZP 200 mg Treated Subjects)	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

Secondary

C-reactive Protein (CRP) Ratio to Baseline at Week 6

CRP data for subjects receiving rescue medication were excluded.

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

Posted

Geometric Mean

95% Confidence Interval

ratio

Baseline, Week 6

ID	Title	Description
OG000	Full Analysis Set (Placebo Treated Subjects)	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
OG001	Full Analysis Set (CZP 200 mg Treated Subjects)	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

Facility	Status	City	State	ZIP	Country	Contacts
		Aichi-Gun	Aichi-ken		Japan

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA9.0	Non-systematic Assessment	EG0000 events0 affected32 at risk EG0010 events0 affected30 at risk EG0021 events1 affected32 at risk
Crohn's disease	Gastrointestinal disorders	MedDRA9.0	Non-systematic Assessment	EG0003 events3 affected32 at risk EG0010 events0 affected30 at risk EG0020 events0 affected32 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA9.0	Non-systematic Assessment	EG0000 events0 affected32 at risk EG0010 events0 affected30 at risk EG0021 events1 affected32 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA9.0	Non-systematic Assessment	EG0001 events1 affected32 at risk EG0010 events0 affected30 at risk EG0020 events0 affected32 at risk
Peritonitis	Gastrointestinal disorders	MedDRA9.0	Non-systematic Assessment	EG0001 events1 affected32 at risk EG0010 events0 affected30 at risk EG0020 events0 affected32 at risk
Pyrexia	General disorders	MedDRA9.0	Non-systematic Assessment	EG0000 events0 affected32 at risk EG0010 events0 affected30 at risk EG0022 events2 affected32 at risk
Sepsis	Infections and infestations	MedDRA9.0	Non-systematic Assessment	EG0000 events0 affected32 at risk EG0010 events0 affected30 at risk EG0021 events1 affected32 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA9.0	Non-systematic Assessment	EG0000 events0 affected32 at risk EG0013 events1 affected30 at risk EG0020 events0 affected32 at risk

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA9.0	Non-systematic Assessment	EG0001 events1 affected32 at risk EG0013 events2 affected30 at risk EG0022 events2 affected32 at risk
Vomiting	Gastrointestinal disorders	MedDRA9.0	Non-systematic Assessment	EG0000 events0 affected32 at risk EG0013 events2 affected30 at risk EG0021 events1 affected32 at risk
Pyrexia	General disorders	MedDRA9.0	Non-systematic Assessment	EG0002 events2 affected32 at risk EG0013 events2 affected30 at risk EG0021 events1 affected32 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA9.0	Non-systematic Assessment	EG0002 events2 affected32 at risk EG0010 events0 affected30 at risk EG0020 events0 affected32 at risk
Nasopharyngitis	Infections and infestations	MedDRA9.0	Non-systematic Assessment	EG00011 events10 affected32 at risk EG0018 events7 affected30 at risk EG0029 events7 affected32 at risk
White blood cell count decreased	Investigations	MedDRA9.0	Non-systematic Assessment	EG0000 events0 affected32 at risk EG0010 events0 affected30 at risk EG0022 events2 affected32 at risk
Headache	Nervous system disorders	MedDRA9.0	Non-systematic Assessment	EG0002 events2 affected32 at risk EG0010 events0 affected30 at risk EG0021 events1 affected32 at risk
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA9.0	Non-systematic Assessment	EG0000 events0 affected32 at risk EG0012 events2 affected30 at risk EG0021 events1 affected32 at risk
Pharynx discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA9.0	Non-systematic Assessment	EG0000 events0 affected32 at risk EG0011 events1 affected30 at risk EG0022 events2 affected32 at risk
Upper respiratory tract inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA9.0	Non-systematic Assessment	EG0001 events1 affected32 at risk EG0010 events0 affected30 at risk EG0022 events2 affected32 at risk
Comedone	Skin and subcutaneous tissue disorders	MedDRA9.0	Non-systematic Assessment	EG0002 events2 affected32 at risk EG0010 events0 affected30 at risk EG0020 events0 affected32 at risk

ID	Term
D015212	Inflammatory Bowel Diseases
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D007410	Intestinal Diseases

ID	Term
D011092	Polyethylene Glycols
D011108	Polymers
D046911	Macromolecular Substances
D007140	Immunoglobulin Fab Fragments
D007128	Immunoglobulin Fragments
D010446	Peptide Fragments
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D012712	Serum Globulins
D005916	Globulins

ID	Title	Description
BG000	Placebo	Subjects received two subcutaneous (sc) injections of Placebo on Weeks 0 (first dose), 2 and 4.
BG001	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.
BG002	Certolizumab Pegol 400 mg	Subjects received two subcutaneous (sc) injections of 200 mg CZP on Weeks 0 (first dose), 2 and 4.
BG003	Total Title

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Subjects received two subcutaneous (sc) injections of Placebo on Weeks 0 (first dose), 2 and 4.	32	3	32	16	32
EG001	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.	30	1	30	11	30
EG002	Certolizumab Pegol 400 mg	Subjects received two subcutaneous (sc) injections of 200 mg CZP on Weeks 0 (first dose), 2 and 4.	32	3	32	14	32