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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00291668
Recruitment Status : Completed
First Posted : February 14, 2006
Results First Posted : August 3, 2020
Last Update Posted : August 3, 2020
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Crohn's Disease
Interventions Biological: Certolizumab Pegol
Other: Placebo
Enrollment 94
Recruitment Details This study started to enroll subjects in March 2006 and conluded in November 2007.
Pre-assignment Details Participant Flow refers to the Safety Set, including all randomized subjects who received at least one dose of study medication (Placebo or Certolizumab Pegol).
Arm/Group Title Placebo Certolizumab Pegol 200 mg Certolizumab Pegol 400 mg
Hide Arm/Group Description Subjects received two subcutaneous (sc) injections of Placebo on Weeks 0 (first dose), 2 and 4. Subjects received one subcutaneous (sc) injection of 200 mg CZP and one injection of Placebo to maintain the study blind on Weeks 0 (first dose), 2 and 4. Subjects received two subcutaneous (sc) injections of 200 mg CZP on Weeks 0 (first dose), 2 and 4.
Period Title: Overall Study
Started 32 30 32
Completed 28 29 31
Not Completed 4 1 1
Reason Not Completed
Lack of Efficacy             1             0             0
SAE, non-fatal             1             1             1
AE, non-serious non-fatal             1             0             0
SAE, non-fatal+AE, non-serious non-fatal             1             0             0
Arm/Group Title Placebo Certolizumab Pegol 200 mg Certolizumab Pegol 400 mg Total Title
Hide Arm/Group Description Subjects received two subcutaneous (sc) injections of Placebo on Weeks 0 (first dose), 2 and 4. Subjects received one subcutaneous (sc) injection of 200 mg CZP and one injection of Placebo to maintain the study blind on Weeks 0 (first dose), 2 and 4. Subjects received two subcutaneous (sc) injections of 200 mg CZP on Weeks 0 (first dose), 2 and 4. [Not Specified]
Overall Number of Baseline Participants 32 30 32 94
Hide Baseline Analysis Population Description
Baseline Characteristics refer to the Safety Population, including all randomized subjects who received at least one dose of study medication (Placebo or Certolizumab Pegol).
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 30 participants 32 participants 94 participants
<=18 years
2
   6.3%
2
   6.7%
2
   6.3%
6
   6.4%
Between 18 and 65 years
30
  93.8%
28
  93.3%
30
  93.8%
88
  93.6%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants 30 participants 32 participants 94 participants
30.6  (8.16) 32.7  (9.34) 31.4  (8.27) 31.5  (8.54)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 30 participants 32 participants 94 participants
Female
6
  18.8%
8
  26.7%
7
  21.9%
21
  22.3%
Male
26
  81.3%
22
  73.3%
25
  78.1%
73
  77.7%
1.Primary Outcome
Title Crohn's Disease Activity Index (CDAI) Response (Clinical Response or Remission) at Week 6
Hide Description CDAI Response is presented as the percentage of subjects with clinical response at Week 6 or remission at Week 6. Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 6) - (CDAI score at Week 0). Remission is defined as a CDAI of <= 150 at Week 6.
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description

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

Subjects

  • with Good Clinical Practice (GCP) violations
  • who were not diagnosed (definitely) with CD
  • who received no dose of study medication
  • with no data after randomization
Arm/Group Title Full Analysis Set (Placebo Treated Subjects) Full Analysis Set (CZP 200 mg Treated Subjects) Full Analysis Set (CZP 400 mg Treated Subjects)
Hide Arm/Group Description:

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization
Overall Number of Participants Analyzed 32 30 31
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
25.0
(10.0 to 40.0)
43.3
(25.6 to 61.1)
48.4
(30.8 to 66.0)
2.Secondary Outcome
Title Crohn's Disease Activity Index (CDAI) Score at Week 2
Hide Description The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. The CDAI score can range from 0-600 (600 indicating the worst disease). It is the sum of 8 subscores, only the summary score is used here. A CDAI score of 150 or less is considered as remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description

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

Subjects

  • with Good Clinical Practice (GCP) violations
  • who were not diagnosed (definitely) with CD
  • who received no dose of study medication
  • with no data after randomization
Arm/Group Title Full Analysis Set (Placebo Treated Subjects) Full Analysis Set (CZP 200 mg Treated Subjects) Full Analysis Set (CZP 400 mg Treated Subjects)
Hide Arm/Group Description:

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization
Overall Number of Participants Analyzed 29 29 31
Mean (Standard Deviation)
Unit of Measure: units on a scale
255.9  (68.02) 214.2  (83.51) 224.9  (85.05)
3.Secondary Outcome
Title Crohn's Disease Activity Index (CDAI) Score at Week 4
Hide Description The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. The CDAI score can range from 0-600 (600 indicating the worst disease). It is the sum of 8 subscores, only the summary score is used here. A CDAI score of 150 or less is considered as remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description

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

Subjects

  • with Good Clinical Practice (GCP) violations
  • who were not diagnosed (definitely) with CD
  • who received no dose of study medication
  • with no data after randomization
Arm/Group Title Full Analysis Set (Placebo Treated Subjects) Full Analysis Set (CZP 200 mg Treated Subjects) Full Analysis Set (CZP 400 mg Treated Subjects)
Hide Arm/Group Description:

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization
Overall Number of Participants Analyzed 28 27 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
243.1  (68.57) 199.7  (91.25) 204.6  (75.10)
4.Secondary Outcome
Title Crohn's Disease Activity Index (CDAI) Score at Week 6
Hide Description The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. The CDAI score can range from 0-600 (600 indicating the worst disease). It is the sum of 8 subscores, only the summary score is used here. A CDAI score of 150 or less is considered as remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description

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

Subjects

  • with Good Clinical Practice (GCP) violations
  • who were not diagnosed (definitely) with CD
  • who received no dose of study medication
  • with no data after randomization
Arm/Group Title Full Analysis Set (Placebo Treated Subjects) Full Analysis Set (CZP 200 mg Treated Subjects) Full Analysis Set (CZP 400 mg Treated Subjects)
Hide Arm/Group Description:

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization
Overall Number of Participants Analyzed 28 27 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
232.4  (89.28) 211.0  (99.91) 198.1  (87.88)
5.Secondary Outcome
Title Percentage of Subjects Who Achieve CDAI Response at Week 2
Hide Description CDAI Response at Week 2 is defined as clinical response at Week 2 or remission at Week 2. Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 2) - (CDAI score at Week 0). Remission is defined as a CDAI score of <= 150 points.
Time Frame Baseline, Week 2
Hide Outcome Measure Data
Hide Analysis Population Description

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

Subjects

  • with Good Clinical Practice (GCP) violations
  • who were not diagnosed (definitely) with CD
  • who received no dose of study medication
  • with no data after randomization
Arm/Group Title Full Analysis Set (Placebo Treated Subjects) Full Analysis Set (CZP 200 mg Treated Subjects) Full Analysis Set (CZP 400 mg Treated Subjects)
Hide Arm/Group Description:

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization
Overall Number of Participants Analyzed 32 30 31
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
15.6
(3.0 to 28.2)
40.0
(22.5 to 57.5)
32.3
(15.8 to 48.7)
6.Secondary Outcome
Title Percentage of Subjects Who Achieve CDAI Response at Week 4
Hide Description CDAI Response at Week 4 is defined as clinical response at Week 4 or remission at Week 4. Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 4) - (CDAI score at Week 0). Remission is defined as a CDAI score of <= 150 points.
Time Frame Baseline, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description

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

Subjects

  • with Good Clinical Practice (GCP) violations
  • who were not diagnosed (definitely) with CD
  • who received no dose of study medication
  • with no data after randomization
Arm/Group Title Full Analysis Set (Placebo Treated Subjects) Full Analysis Set (CZP 200 mg Treated Subjects) Full Analysis Set (CZP 400 mg Treated Subjects)
Hide Arm/Group Description:

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization
Overall Number of Participants Analyzed 32 30 31
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
21.9
(7.6 to 36.2)
46.7
(28.8 to 64.5)
38.7
(21.6 to 55.9)
7.Secondary Outcome
Title Percentage of Subjects Who Achieve a Reduction in CDAI Scores of at Least 70 Points at Week 2
Hide Description The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Baseline, Week 2
Hide Outcome Measure Data
Hide Analysis Population Description

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

Subjects

  • with Good Clinical Practice (GCP) violations
  • who were not diagnosed (definitely) with CD
  • who received no dose of study medication
  • with no data after randomization
Arm/Group Title Full Analysis Set (Placebo Treated Subjects) Full Analysis Set (CZP 200 mg Treated Subjects) Full Analysis Set (CZP 400 mg Treated Subjects)
Hide Arm/Group Description:

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization
Overall Number of Participants Analyzed 32 30 31
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
28.1
(12.5 to 43.7)
46.7
(28.8 to 64.5)
45.2
(27.6 to 62.7)
8.Secondary Outcome
Title Percentage of Subjects Who Achieve a Reduction in CDAI Scores of at Least 70 Points at Week 4
Hide Description The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Baseline, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description

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

Subjects

  • with Good Clinical Practice (GCP) violations
  • who were not diagnosed (definitely) with CD
  • who received no dose of study medication
  • with no data after randomization
Arm/Group Title Full Analysis Set (Placebo Treated Subjects) Full Analysis Set (CZP 200 mg Treated Subjects) Full Analysis Set (CZP 400 mg Treated Subjects)
Hide Arm/Group Description:

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization
Overall Number of Participants Analyzed 32 30 31
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
25.0
(10.0 to 40.0)
56.7
(38.9 to 74.4)
54.8
(37.3 to 72.4)
9.Secondary Outcome
Title Percentage of Subjects Who Achieve a Reduction in CDAI Scores of at Least 70 Points at Week 6
Hide Description The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description

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

Subjects

  • with Good Clinical Practice (GCP) violations
  • who were not diagnosed (definitely) with CD
  • who received no dose of study medication
  • with no data after randomization
Arm/Group Title Full Analysis Set (Placebo Treated Subjects) Full Analysis Set (CZP 200 mg Treated Subjects) Full Analysis Set (CZP 400 mg Treated Subjects)
Hide Arm/Group Description:

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization
Overall Number of Participants Analyzed 32 30 31
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
43.8
(26.6 to 60.9)
53.3
(35.5 to 71.2)
61.3
(44.1 to 78.4)
10.Secondary Outcome
Title Percentage of Subjects Who Achieve Remission (CDAI <= 150) at Week 2
Hide Description Remission at Week 2 is defined as a CDAI score <= 150 points at Week 2.
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description

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

Subjects

  • with Good Clinical Practice (GCP) violations
  • who were not diagnosed (definitely) with CD
  • who received no dose of study medication
  • with no data after randomization
Arm/Group Title Full Analysis Set (Placebo Treated Subjects) Full Analysis Set (CZP 200 mg Treated Subjects) Full Analysis Set (CZP 400 mg Treated Subjects)
Hide Arm/Group Description:

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization
Overall Number of Participants Analyzed 32 30 31
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
3.1
(0.0 to 9.2)
20.0
(5.7 to 34.3)
16.1
(3.2 to 29.1)
11.Secondary Outcome
Title Percentage of Subjects Who Achieve Remission (CDAI <= 150) at Week 4
Hide Description Remission at Week 4 is defined as a CDAI score <= 150 points at Week 4.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description

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

Subjects

  • with Good Clinical Practice (GCP) violations
  • who were not diagnosed (definitely) with CD
  • who received no dose of study medication
  • with no data after randomization
Arm/Group Title Full Analysis Set (Placebo Treated Subjects) Full Analysis Set (CZP 200 mg Treated Subjects) Full Analysis Set (CZP 400 mg Treated Subjects)
Hide Arm/Group Description:

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization
Overall Number of Participants Analyzed 32 30 31
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
6.3
(0.0 to 14.6)
26.7
(10.8 to 42.5)
22.6
(7.9 to 37.3)
12.Secondary Outcome
Title Percentage of Subjects Who Achieve Remission (CDAI <= 150) at Week 6
Hide Description Remission at Week 6 is defined as a CDAI score <= 150 points at Week 6.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description

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

Subjects

  • with Good Clinical Practice (GCP) violations
  • who were not diagnosed (definitely) with CD
  • who received no dose of study medication
  • with no data after randomization
Arm/Group Title Full Analysis Set (Placebo Treated Subjects) Full Analysis Set (CZP 200 mg Treated Subjects) Full Analysis Set (CZP 400 mg Treated Subjects)
Hide Arm/Group Description:

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization
Overall Number of Participants Analyzed 32 30 31
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
15.6
(3.0 to 28.2)
26.7
(10.8 to 42.5)
32.3
(15.8 to 48.7)
13.Secondary Outcome
Title Percentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) at Week 2
Hide Description Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 2) - (CDAI score at Week 0).
Time Frame Baseline, Week 2
Hide Outcome Measure Data
Hide Analysis Population Description

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

Subjects

  • with Good Clinical Practice (GCP) violations
  • who were not diagnosed (definitely) with CD
  • who received no dose of study medication
  • with no data after randomization
Arm/Group Title Full Analysis Set (Placebo Treated Subjects) Full Analysis Set (CZP 200 mg Treated Subjects) Full Analysis Set (CZP 400 mg Treated Subjects)
Hide Arm/Group Description:

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization
Overall Number of Participants Analyzed 32 30 31
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
15.6
(3.0 to 28.2)
36.7
(19.4 to 53.9)
29.0
(13.1 to 45.0)
14.Secondary Outcome
Title Percentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) at Week 4
Hide Description Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 4) - (CDAI score at Week 0).
Time Frame Baseline, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description

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

Subjects

  • with Good Clinical Practice (GCP) violations
  • who were not diagnosed (definitely) with CD
  • who received no dose of study medication
  • with no data after randomization
Arm/Group Title Full Analysis Set (Placebo Treated Subjects) Full Analysis Set (CZP 200 mg Treated Subjects) Full Analysis Set (CZP 400 mg Treated Subjects)
Hide Arm/Group Description:

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization
Overall Number of Participants Analyzed 32 30 31
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
18.8
(5.2 to 32.3)
36.7
(19.4 to 53.9)
32.3
(15.8 to 48.7)
15.Secondary Outcome
Title Percentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) at Week 6
Hide Description Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 6) - (CDAI score at Week 0).
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description

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

Subjects

  • with Good Clinical Practice (GCP) violations
  • who were not diagnosed (definitely) with CD
  • who received no dose of study medication
  • with no data after randomization
Arm/Group Title Full Analysis Set (Placebo Treated Subjects) Full Analysis Set (CZP 200 mg Treated Subjects) Full Analysis Set (CZP 400 mg Treated Subjects)
Hide Arm/Group Description:

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization
Overall Number of Participants Analyzed 32 30 31
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
21.9
(7.6 to 36.2)
36.7
(19.4 to 53.9)
41.9
(24.6 to 59.3)
16.Secondary Outcome
Title Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 2
Hide Description The IBDQ global score is calculated as the sum of the responses (each ranging from 1 to 7) to all 32 questions on the IBDQ and can therefore range from 32 to 224. A higher score indicates a better quality of life.
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description

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

Subjects

  • with Good Clinical Practice (GCP) violations
  • who were not diagnosed (definitely) with CD
  • who received no dose of study medication
  • with no data after randomization
Arm/Group Title Full Analysis Set (Placebo Treated Subjects) Full Analysis Set (CZP 200 mg Treated Subjects) Full Analysis Set (CZP 400 mg Treated Subjects)
Hide Arm/Group Description:

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization
Overall Number of Participants Analyzed 29 29 31
Mean (Standard Deviation)
Unit of Measure: units on a scale
171.3  (22.45) 166.1  (22.14) 169.7  (23.24)
17.Secondary Outcome
Title Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 4
Hide Description The IBDQ global score is calculated as the sum of the responses (each ranging from 1 to 7) to all 32 questions on the IBDQ and can therefore range from 32 to 224. A higher score indicates a better quality of life.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description

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

Subjects

  • with Good Clinical Practice (GCP) violations
  • who were not diagnosed (definitely) with CD
  • who received no dose of study medication
  • with no data after randomization
Arm/Group Title Full Analysis Set (Placebo Treated Subjects) Full Analysis Set (CZP 200 mg Treated Subjects) Full Analysis Set (CZP 400 mg Treated Subjects)
Hide Arm/Group Description:

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization
Overall Number of Participants Analyzed 28 27 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
172.6  (24.04) 169.4  (21.75) 170.3  (23.72)
18.Secondary Outcome
Title Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 6
Hide Description The IBDQ global score is calculated as the sum of the responses (each ranging from 1 to 7) to all 32 questions on the IBDQ and can therefore range from 32 to 224. A higher score indicates a better quality of life.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description

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

Subjects

  • with Good Clinical Practice (GCP) violations
  • who were not diagnosed (definitely) with CD
  • who received no dose of study medication
  • with no data after randomization
Arm/Group Title Full Analysis Set (Placebo Treated Subjects) Full Analysis Set (CZP 200 mg Treated Subjects) Full Analysis Set (CZP 400 mg Treated Subjects)
Hide Arm/Group Description:

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization
Overall Number of Participants Analyzed 28 27 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
173.1  (25.49) 165.6  (23.25) 170.8  (24.54)
19.Secondary Outcome
Title Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 2
Hide Description

The total IBDQ score consists of 32 questions, each ranging from 1 to 7, with higher scores indicating a better quality of life.

There are 4 IBDQ Domain Scores:

  • Bowel Symptoms Domain Score, ranging from 10 to 70 (10 questions ranging from 1 to 7)
  • Systemic Symptoms Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 )
  • Emotional Function Domain Score, ranging from 12 to 84 (12 questions ranging from 1 to 7)
  • Social Function Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 )
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description

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

Subjects

  • with Good Clinical Practice (GCP) violations
  • who were not diagnosed (definitely) with CD
  • who received no dose of study medication
  • with no data after randomization
Arm/Group Title Full Analysis Set (Placebo Treated Subjects) Full Analysis Set (CZP 200 mg Treated Subjects) Full Analysis Set (CZP 400 mg Treated Subjects)
Hide Arm/Group Description:

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization
Overall Number of Participants Analyzed 32 30 31
Mean (Standard Deviation)
Unit of Measure: units on a scale
Bowel Symptoms Domain Score Number Analyzed 29 participants 29 participants 31 participants
54.4  (7.17) 53.4  (8.18) 54.7  (8.77)
Systemic Symptoms Domain Score Number Analyzed 29 participants 29 participants 31 participants
22.4  (5.01) 22.4  (5.17) 22.7  (4.51)
Emotional Function Domain Score Number Analyzed 29 participants 29 participants 31 participants
65.3  (8.91) 62.3  (9.54) 63.3  (8.53)
Social Function Domain Score Number Analyzed 28 participants 29 participants 31 participants
29.4  (5.64) 28.0  (4.33) 29.0  (5.03)
20.Secondary Outcome
Title Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 4
Hide Description

The total IBDQ score consists of 32 questions, each ranging from 1 to 7, with higher scores indicating a better quality of life.

There are 4 IBDQ Domain Scores:

  • Bowel Symptoms Domain Score, ranging from 10 to 70 (10 questions ranging from 1 to 7)
  • Systemic Symptoms Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 )
  • Emotional Function Domain Score, ranging from 12 to 84 (12 questions ranging from 1 to 7)
  • Social Function Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 )
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description

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

Subjects

  • with Good Clinical Practice (GCP) violations
  • who were not diagnosed (definitely) with CD
  • who received no dose of study medication
  • with no data after randomization
Arm/Group Title Full Analysis Set (Placebo Treated Subjects) Full Analysis Set (CZP 200 mg Treated Subjects) Full Analysis Set (CZP 400 mg Treated Subjects)
Hide Arm/Group Description:

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization
Overall Number of Participants Analyzed 32 30 31
Mean (Standard Deviation)
Unit of Measure: units on a scale
Bowel Symptoms Domain Score Number Analyzed 28 participants 27 participants 30 participants
55.4  (7.22) 54.0  (9.00) 55.5  (8.04)
Systemic Symptoms Domain Score Number Analyzed 28 participants 27 participants 30 participants
23.3  (5.49) 23.4  (4.21) 22.9  (4.44)
Emotional Function Domain Score Number Analyzed 28 participants 27 participants 30 participants
65.3  (8.85) 63.1  (8.90) 63.2  (9.55)
Social Function Domain Score Number Analyzed 27 participants 27 participants 30 participants
28.8  (6.73) 28.9  (4.82) 28.7  (5.62)
21.Secondary Outcome
Title Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 6
Hide Description

The total IBDQ score consists of 32 questions, each ranging from 1 to 7, with higher scores indicating a better quality of life.

There are 4 IBDQ Domain Scores:

  • Bowel Symptoms Domain Score, ranging from 10 to 70 (10 questions ranging from 1 to 7)
  • Systemic Symptoms Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 )
  • Emotional Function Domain Score, ranging from 12 to 84 (12 questions ranging from 1 to 7)
  • Social Function Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 )
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description

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

Subjects

  • with Good Clinical Practice (GCP) violations
  • who were not diagnosed (definitely) with CD
  • who received no dose of study medication
  • with no data after randomization
Arm/Group Title Full Analysis Set (Placebo Treated Subjects) Full Analysis Set (CZP 200 mg Treated Subjects) Full Analysis Set (CZP 400 mg Treated Subjects)
Hide Arm/Group Description:

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization
Overall Number of Participants Analyzed 32 30 31
Mean (Standard Deviation)
Unit of Measure: units on a scale
Bowel Symptoms Domain Score Number Analyzed 28 participants 27 participants 30 participants
55.4  (7.77) 51.8  (8.44) 55.8  (8.43)
Systemic Symptoms Domain Score Number Analyzed 28 participants 27 participants 30 participants
23.3  (6.74) 22.4  (4.49) 23.4  (4.62)
Emotional Function Domain Score Number Analyzed 28 participants 27 participants 30 participants
65.3  (8.76) 63.2  (9.45) 62.1  (10.43)
Social Function Domain Score Number Analyzed 27 participants 27 participants 30 participants
29.2  (6.48) 28.1  (5.69) 29.5  (5.09)
22.Secondary Outcome
Title Concentration of C-reactive Protein (CRP) Value at Week 2
Hide Description CRP data for subjects receiving rescue medication were excluded.
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description

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

Subjects

  • with Good Clinical Practice (GCP) violations
  • who were not diagnosed (definitely) with CD
  • who received no dose of study medication
  • with no data after randomization
Arm/Group Title Full Analysis Set (Placebo Treated Subjects) Full Analysis Set (CZP 200 mg Treated Subjects) Full Analysis Set (CZP 400 mg Treated Subjects)
Hide Arm/Group Description:

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization
Overall Number of Participants Analyzed 29 29 31
Geometric Mean (95% Confidence Interval)
Unit of Measure: mg/L
22.15
(15.43 to 31.80)
13.58
(9.45 to 19.52)
13.86
(9.11 to 21.09)
23.Secondary Outcome
Title Concentration of C-reactive Protein (CRP) Value at Week 4
Hide Description CRP data for subjects receiving rescue medication were excluded.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description

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

Subjects

  • with Good Clinical Practice (GCP) violations
  • who were not diagnosed (definitely) with CD
  • who received no dose of study medication
  • with no data after randomization
Arm/Group Title Full Analysis Set (Placebo Treated Subjects) Full Analysis Set (CZP 200 mg Treated Subjects) Full Analysis Set (CZP 400 mg Treated Subjects)
Hide Arm/Group Description:

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization
Overall Number of Participants Analyzed 28 27 30
Geometric Mean (95% Confidence Interval)
Unit of Measure: mg/L
23.47
(16.02 to 34.40)
12.87
(8.56 to 19.36)
12.02
(8.68 to 16.65)
24.Secondary Outcome
Title Concentration of C-reactive Protein (CRP) Value at Week 6
Hide Description CRP data for subjects receiving rescue medication were excluded.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description

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

Subjects

  • with Good Clinical Practice (GCP) violations
  • who were not diagnosed (definitely) with CD
  • who received no dose of study medication
  • with no data after randomization
Arm/Group Title Full Analysis Set (Placebo Treated Subjects) Full Analysis Set (CZP 200 mg Treated Subjects) Full Analysis Set (CZP 400 mg Treated Subjects)
Hide Arm/Group Description:

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization
Overall Number of Participants Analyzed 28 27 30
Geometric Mean (95% Confidence Interval)
Unit of Measure: mg/L
23.32
(16.95 to 32.07)
15.10
(9.46 to 24.11)
12.62
(8.79 to 18.11)
25.Secondary Outcome
Title C-reactive Protein (CRP) Ratio to Baseline at Week 2
Hide Description CRP data for subjects receiving rescue medication were excluded.
Time Frame Baseline, Week 2
Hide Outcome Measure Data
Hide Analysis Population Description

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

Subjects

  • with Good Clinical Practice (GCP) violations
  • who were not diagnosed (definitely) with CD
  • who received no dose of study medication
  • with no data after randomization
Arm/Group Title Full Analysis Set (Placebo Treated Subjects) Full Analysis Set (CZP 200 mg Treated Subjects) Full Analysis Set (CZP 400 mg Treated Subjects)
Hide Arm/Group Description:

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization
Overall Number of Participants Analyzed 29 29 31
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio
0.85
(0.64 to 1.13)
0.58
(0.42 to 0.80)
0.50
(0.35 to 0.72)
26.Secondary Outcome
Title C-reactive Protein (CRP) Ratio to Baseline at Week 4
Hide Description CRP data for subjects receiving rescue medication were excluded.
Time Frame Baseline, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description

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

Subjects

  • with Good Clinical Practice (GCP) violations
  • who were not diagnosed (definitely) with CD
  • who received no dose of study medication
  • with no data after randomization
Arm/Group Title Full Analysis Set (Placebo Treated Subjects) Full Analysis Set (CZP 200 mg Treated Subjects) Full Analysis Set (CZP 400 mg Treated Subjects)
Hide Arm/Group Description:

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization
Overall Number of Participants Analyzed 28 27 30
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio
1.04
(0.83 to 1.31)
0.53
(0.37 to 0.76)
0.44
(0.32 to 0.60)
27.Secondary Outcome
Title C-reactive Protein (CRP) Ratio to Baseline at Week 6
Hide Description CRP data for subjects receiving rescue medication were excluded.
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description

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

Subjects

  • with Good Clinical Practice (GCP) violations
  • who were not diagnosed (definitely) with CD
  • who received no dose of study medication
  • with no data after randomization
Arm/Group Title Full Analysis Set (Placebo Treated Subjects) Full Analysis Set (CZP 200 mg Treated Subjects) Full Analysis Set (CZP 400 mg Treated Subjects)
Hide Arm/Group Description:

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization

The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:

  • Subjects with Good Clinical Practice (GCP) violations
  • Subjects who were not diagnosed (definitely) with Crohn's Disease
  • Subjects who received no dose of study medication
  • Subjects with no data after randomization
Overall Number of Participants Analyzed 28 27 30
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio
1.03
(0.85 to 1.25)
0.63
(0.40 to 0.98)
0.46
(0.32 to 0.66)
Time Frame Adverse Events were collected from the time of signing the informed consent through the last Observation (up to 28 weeks).
Adverse Event Reporting Description Adverse Events refer to the Safety Population, including all randomized subjects who received at least one dose of study medication (Placebo or Certolizumab Pegol).
 
Arm/Group Title Placebo Certolizumab Pegol 200 mg Certolizumab Pegol 400 mg
Hide Arm/Group Description Subjects received two subcutaneous (sc) injections of Placebo on Weeks 0 (first dose), 2 and 4. Subjects received one subcutaneous (sc) injection of 200 mg CZP and one injection of Placebo to maintain the study blind on Weeks 0 (first dose), 2 and 4. Subjects received two subcutaneous (sc) injections of 200 mg CZP on Weeks 0 (first dose), 2 and 4.
All-Cause Mortality
Placebo Certolizumab Pegol 200 mg Certolizumab Pegol 400 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)      0/30 (0.00%)      0/32 (0.00%)    
Hide Serious Adverse Events
Placebo Certolizumab Pegol 200 mg Certolizumab Pegol 400 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/32 (9.38%)      1/30 (3.33%)      3/32 (9.38%)    
Blood and lymphatic system disorders       
Disseminated intravascular coagulation * 1  0/32 (0.00%)  0 0/30 (0.00%)  0 1/32 (3.13%)  1
Gastrointestinal disorders       
Crohn's disease * 1  3/32 (9.38%)  3 0/30 (0.00%)  0 0/32 (0.00%)  0
Abdominal pain * 1  0/32 (0.00%)  0 0/30 (0.00%)  0 1/32 (3.13%)  1
Gastrointestinal haemorrhage * 1  1/32 (3.13%)  1 0/30 (0.00%)  0 0/32 (0.00%)  0
Peritonitis * 1  1/32 (3.13%)  1 0/30 (0.00%)  0 0/32 (0.00%)  0
General disorders       
Pyrexia * 1  0/32 (0.00%)  0 0/30 (0.00%)  0 2/32 (6.25%)  2
Infections and infestations       
Sepsis * 1  0/32 (0.00%)  0 0/30 (0.00%)  0 1/32 (3.13%)  1
Respiratory, thoracic and mediastinal disorders       
Pneumonia aspiration * 1  0/32 (0.00%)  0 1/30 (3.33%)  3 0/32 (0.00%)  0
1
Term from vocabulary, MedDRA9.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Certolizumab Pegol 200 mg Certolizumab Pegol 400 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/32 (50.00%)      11/30 (36.67%)      14/32 (43.75%)    
Gastrointestinal disorders       
Nausea * 1  1/32 (3.13%)  1 2/30 (6.67%)  3 2/32 (6.25%)  2
Vomiting * 1  0/32 (0.00%)  0 2/30 (6.67%)  3 1/32 (3.13%)  1
General disorders       
Pyrexia * 1  2/32 (6.25%)  2 2/30 (6.67%)  3 1/32 (3.13%)  1
Hepatobiliary disorders       
Hepatic function abnormal * 1  2/32 (6.25%)  2 0/30 (0.00%)  0 0/32 (0.00%)  0
Infections and infestations       
Nasopharyngitis * 1  10/32 (31.25%)  11 7/30 (23.33%)  8 7/32 (21.88%)  9
Investigations       
White blood cell count decreased * 1  0/32 (0.00%)  0 0/30 (0.00%)  0 2/32 (6.25%)  2
Nervous system disorders       
Headache * 1  2/32 (6.25%)  2 0/30 (0.00%)  0 1/32 (3.13%)  1
Respiratory, thoracic and mediastinal disorders       
Pharyngolaryngeal pain * 1  0/32 (0.00%)  0 2/30 (6.67%)  2 1/32 (3.13%)  1
Pharynx discomfort * 1  0/32 (0.00%)  0 1/30 (3.33%)  1 2/32 (6.25%)  2
Upper respiratory tract inflammation * 1  1/32 (3.13%)  1 0/30 (0.00%)  0 2/32 (6.25%)  2
Skin and subcutaneous tissue disorders       
Comedone * 1  2/32 (6.25%)  2 0/30 (0.00%)  0 0/32 (0.00%)  0
1
Term from vocabulary, MedDRA9.0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB
Organization: Cares
Phone: +1844 599 ext 2273
EMail: UCBCares@ucb.com
Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00291668    
Other Study ID Numbers: C87037
2014-004399-42 ( EudraCT Number )
First Submitted: February 10, 2006
First Posted: February 14, 2006
Results First Submitted: February 8, 2018
Results First Posted: August 3, 2020
Last Update Posted: August 3, 2020