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Trial record 1 of 1 for:    NCT00297648
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Mucosal Healing Study in Crohn's Disease (CD) (MUSIC)

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: NCT00297648
Recruitment Status : Completed
First Posted : February 28, 2006
Results First Posted : January 18, 2010
Last Update Posted : August 31, 2011
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Crohn's Disease
Intervention Biological: Certolizumab pegol
Enrollment 89
Recruitment Details Patients were recruited in sites from Germany, France and Belgium between February 2006 and October 2007. The last patient attended their Week 54 visit in December 2009.
Pre-assignment Details  
Arm/Group Title CDP870 400 mg
Hide Arm/Group Description Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Period Title: Overall Study
Started 89
Completed 53
Not Completed 36
Reason Not Completed
Adverse Event             13
Lack of Efficacy             18
Lost to Follow-up             1
Withdrawal by Subject             3
Other: Incompliance             1
Arm/Group Title CDP870 400 mg
Hide Arm/Group Description Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Overall Number of Baseline Participants 89
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 89 participants
<=18 years
4
   4.5%
Between 18 and 65 years
85
  95.5%
>=65 years
0
   0.0%
[1]
Measure Description: Note: The 4 patients in the '<=18 years' category were all 18 years of age at Baseline.
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 89 participants
30.19  (9.88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 89 participants
Female
59
  66.3%
Male
30
  33.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 89 participants
France 68
Belgium 16
Germany 5
1.Primary Outcome
Title Mean Change From Baseline in CDEIS (Crohn's Disease Endoscopic Index of Severity) Score at Week 10 Using Local Non-blinded Assessments
Hide Description The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation, thus a negative change from Baseline (i.e., Week 10 score minus Baseline score) indicates improvement.
Time Frame Baseline, Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 89 patients in the Intent to Treat Population, 78 patients had data at both Baseline and Week 10, and are included in this summary. Change from Baseline has been calculated as the Week 10 score minus the Baseline score, thus a negative Change from Baseline indicates improvement.
Arm/Group Title CDP870 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Overall Number of Participants Analyzed 78
Mean (95% Confidence Interval)
Unit of Measure: score on a scale
-6.47
(-7.60 to -5.34)
2.Primary Outcome
Title Mean Change From Baseline in CDEIS (Crohn's Disease Endoscopic Index of Severity) Score at Week 10 Using Central Blinded Assessments
Hide Description The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation, thus a negative change from Baseline (i.e., Week 10 score minus Baseline score) indicates improvement.
Time Frame Baseline, Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 89 patients in the Intent to Treat Population, 44 patients were in the subpopulation with a blinded assessment at Week 10 and Baseline, and are included in this summary. Change from Baseline has been calculated as the Week 10 score minus the Baseline score, thus a negative Change from Baseline indicates improvement.
Arm/Group Title CDP870 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Overall Number of Participants Analyzed 44
Mean (95% Confidence Interval)
Unit of Measure: Score on a scale
-3.79
(-5.08 to -2.50)
3.Secondary Outcome
Title Percentage of Patients Achieving Mucosal Healing at Week 10 Using Local Non-blinded Assessments
Hide Description Mucosal healing is defined as complete absence of ulceration contribution in the CDEIS (Crohn's Disease Endoscopic Index of Severity) score
Time Frame Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 89 patients in the Intent to Treat Population, 78 patients had data at Week 10, and are included in this summary. Percentage of patients is calculated by dividing the number of patients who achieved mucosal healing at Week 10 by the total number of patients with data collected, multiplied by 100.
Arm/Group Title CDP870 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Overall Number of Participants Analyzed 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
5.1
(1.4 to 12.6)
4.Secondary Outcome
Title Percentage of Patients Achieving Mucosal Healing at Week 10 Using Central Blinded Assessments
Hide Description Mucosal healing is defined as complete absence of ulceration contribution in the CDEIS (Crohn's Disease Endoscopic Index of Severity) score
Time Frame Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 89 patients in the Intent to Treat Population, 51 patients were in the subpopulation who had a blinded assessment at Week 10 and are included here. Percentage of patients is calculated by dividing the number of patients who achieved mucosal healing at Week 10 by the total number of patients with data collected, multiplied by 100.
Arm/Group Title CDP870 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Overall Number of Participants Analyzed 51
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
3.9
(0.5 to 13.5)
5.Secondary Outcome
Title Percentage of Patients Achieving Mucosal Healing at Week 54 Using Local Non-blinded Assessments
Hide Description Mucosal healing is defined as complete absence of ulceration contribution in the CDEIS (Crohn's Disease Endoscopic Index of Severity) score
Time Frame Week 54
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 89 patients in the Intent to Treat Population, 53 patients had data at Week 54, and are included in this summary. Percentage of patients is calculated by dividing the number of patients who achieved mucosal healing at Week 54 by the total number of patients with data collected, multiplied by 100.
Arm/Group Title CDP870 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Overall Number of Participants Analyzed 53
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
13.2
(5.5 to 25.3)
6.Secondary Outcome
Title Percentage of Patients Achieving Mucosal Healing at Week 54 Using Central Blinded Assessments
Hide Description Mucosal healing is defined as complete absence of ulceration contribution in the CDEIS (Crohn's Disease Endoscopic Index of Severity) score
Time Frame Week 54
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 89 patients in the Intent to Treat Population, 33 patients were in the subpopulation who had a blinded assessment at Week 54 and are included here. Percentage of patients is calculated by dividing the number of patients who achieved mucosal healing at Week 54 by the total number of patients with data collected, multiplied by 100.
Arm/Group Title CDP870 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Overall Number of Participants Analyzed 33
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
3.0
(0.1 to 15.8)
7.Secondary Outcome
Title Percentage of Patients With Endoscopic Response (Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of More Than 5 Points) at Week 10 Using Local Non-blinded Assessments
Hide Description The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.
Time Frame Baseline, Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 89 patients in the Intent to Treat Population, 78 patients had data at Week 10 and at Baseline, and are included here. Percentage of patients is calculated by dividing the number of patients with a CDEIS decrease of at least 5 points at Week 10 by the number of patients with CDEIS data at both Baseline and Week 10, multiplied by 100.
Arm/Group Title CDP870 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Overall Number of Participants Analyzed 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
61.5
(49.8 to 72.3)
8.Secondary Outcome
Title Percentage of Patients With Endoscopic Response (Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of More Than 5 Points) at Week 10 Using Central Blinded Assessments
Hide Description The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.
Time Frame Baseline, Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 89 patients in the Intent to Treat Population, 44 patients had a blinded assessment at Week 10 and at Baseline, and are included here. Percentage patients is calculated by dividing the number of patients with a CDEIS decrease of at least 5 points at Week 10 by the number of patients with CDEIS data at Baseline and Week 10, multiplied by 100.
Arm/Group Title CDP870 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Overall Number of Participants Analyzed 44
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
38.6
(24.4 to 54.5)
9.Secondary Outcome
Title Percentage of Patients With Endoscopic Response (Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of More Than 5 Points) at Week 54 Using Local Non-blinded Assessments
Hide Description The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.
Time Frame Baseline, Week 54
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 89 patients in the Intent to Treat Population, 53 patients had data at Week 54 and at Baseline, and are included here. Percentage of patients is calculated by dividing the number of patients with a CDEIS decrease of at least 5 points at Week 54 by the number of patients with CDEIS data at both Baseline and Week 54, multiplied by 100.
Arm/Group Title CDP870 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Overall Number of Participants Analyzed 53
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
62.3
(47.9 to 75.2)
10.Secondary Outcome
Title Percentage of Patients With Endoscopic Response (Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of More Than 5 Points) at Week 54 Using Central Blinded Assessments
Hide Description The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.
Time Frame Baseline, Week 54
Hide Outcome Measure Data
Hide Analysis Population Description
Of 89 patients in the Intent to Treat Population 28 had matching nonblinded/blinded assessments and are in the subpopulation with blinded assessment at Week 54 and Baseline. Percentage is calculated by dividing the number patients with CDEIS decrease of at least 5 points at Week 54 by the number with CDEIS at Baseline and Week 54, multiplied by 100
Arm/Group Title CDP870 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Overall Number of Participants Analyzed 28
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
39.3
(21.5 to 59.4)
11.Secondary Outcome
Title Percentage of Patients With Endoscopic Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 6) at Week 10 Using Local Non-blinded Assessments
Hide Description The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.
Time Frame Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 89 patients in the Intent to Treat Population, 78 patients had data at Week 10, and are included in this summary. Percentage of patients is calculated by dividing the number of patients with a CDEIS score <6 at Week 10 by the total number of patients with CDEIS data at Week 10, multiplied by 100.
Arm/Group Title CDP870 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Overall Number of Participants Analyzed 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
42.3
(31.2 to 54.0)
12.Secondary Outcome
Title Percentage of Patients With Endoscopic Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 6) at Week 10 Using Central Blinded Assessments
Hide Description The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.
Time Frame Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 89 patients in the Intent to Treat Population, 44 patients had a blinded assessment at Week 10 and Baseline, and are included in this summary. Percentage of patients is calculated by dividing the number of patients with a CDEIS score <6 at Week 10 by the total number of patients with CDEIS data at Week 10, multiplied by 100.
Arm/Group Title CDP870 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Overall Number of Participants Analyzed 44
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
45.5
(30.4 to 61.2)
13.Secondary Outcome
Title Percentage of Patients With Endoscopic Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 6) at Week 54 Using Local Non-blinded Assessments
Hide Description The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.
Time Frame Week 54
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 89 patients in the Intent to Treat Population, 53 patients had data at Week 54, and are included in this summary. Percentage of patients is calculated by dividing the number of patients with a CDEIS score <6 at Week 54 by the total number of patients with CDEIS data at Week 54, multiplied by 100.
Arm/Group Title CDP870 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Overall Number of Participants Analyzed 53
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
28.3
(16.8 to 42.3)
14.Secondary Outcome
Title Percentage of Patients With Endoscopic Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 6) at Week 54 Using Central Blinded Assessments
Hide Description The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.
Time Frame Week 54
Hide Outcome Measure Data
Hide Analysis Population Description
Of 89 patients in the Intent to Treat Population, 28 had matching nonblinded/blinded assessments and were in the subpopulation with a blinded assessment at Week 54 and Baseline. Percentage is calculated by dividing the number of patients with a CDEIS score <6 at Week 54 by the total number of patients with CDEIS data at Week 54, multiplied by 100.
Arm/Group Title CDP870 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Overall Number of Participants Analyzed 28
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
32.1
(15.9 to 52.4)
15.Secondary Outcome
Title Percentage of Patients With Endoscopic Complete Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 3) at Week 10 Using Local Non-blinded Assessments
Hide Description The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.
Time Frame Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 89 patients in the Intent to Treat Population, 78 patients had data at Week 10, and are included in this summary. Percentage of patients is calculated by dividing the number of patients with a CDEIS score <3 at Week 10 by the total number of patients with CDEIS data at Week 10, multiplied by 100.
Arm/Group Title CDP870 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Overall Number of Participants Analyzed 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
11.5
(5.4 to 20.8)
16.Secondary Outcome
Title Percentage of Patients With Endoscopic Complete Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 3) at Week 10 Using Central Blinded Assessments
Hide Description The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.
Time Frame Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 89 patients in the Intent to Treat Population, 44 patients had a blinded assessment at Week 10 and Baseline, and are included in this summary. Percentage of patients is calculated by dividing the number of patients with a CDEIS score <3 at Week 10 by the total number of patients with CDEIS data at Week 10, multiplied by 100.
Arm/Group Title CDP870 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Overall Number of Participants Analyzed 44
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
20.5
(9.8 to 35.3)
17.Secondary Outcome
Title Percentage of Patients With Endoscopic Complete Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 3) at Week 54 Using Local Non-blinded Assessments
Hide Description The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.
Time Frame Week 54
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 89 patients in the Intent to Treat Population, 53 patients had data at Week 54, and are included in this summary. Percentage of patients is calculated by dividing the number of patients with a CDEIS score <3 at Week 54 by the total number of patients with CDEIS data at Week 54, multiplied by 100.
Arm/Group Title CDP870 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Overall Number of Participants Analyzed 53
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
18.9
(9.4 to 32.0)
18.Secondary Outcome
Title Percentage of Patients With Endoscopic Complete Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 3) at Week 54 Using Central Blinded Assessments
Hide Description The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.
Time Frame Week 54
Hide Outcome Measure Data
Hide Analysis Population Description
Of 89 patients in the Intent to Treat Population, 28 had matching nonblinded/blinded assessments and were in the subpopulation with a blinded assessment at Week 54 and Baseline. Percentage is calculated by dividing the number of patients with a CDEIS score <3 at Week 54 by the total number of patients with CDEIS data at Week 54, multiplied by 100.
Arm/Group Title CDP870 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Overall Number of Participants Analyzed 28
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
17.9
(6.1 to 36.9)
19.Secondary Outcome
Title Change From Baseline in Histological Crohn's Disease Score at Week 10 Using Central Blinded Assessment
Hide Description The histological Crohn's disease score combines active inflammatory changes: infiltration of mononuclear cells, polymorphonuclear cells, presence of erosions and/or ulcers, and chronic architectural changes. Scores range from 0 to 44, with higher scores indicating greater disease.
Time Frame Baseline, Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 89 patients in the Intent to Treat Population, 75 patients had data at Week 10 and at Baseline for the blinded assessment, and are included in this summary. Change from Baseline has been calculated as the Week 10 score minus the Baseline score, thus a negative change from Baseline indicates improvement.
Arm/Group Title CDP870 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Overall Number of Participants Analyzed 75
Mean (Standard Deviation)
Unit of Measure: score on a scale
-1.4  (3.7)
20.Secondary Outcome
Title Change From Baseline in Histological Crohn's Disease Score at Week 54 Using Central Blinded Assessment
Hide Description The histological Crohn's disease score combines active inflammatory changes: infiltration of mononuclear cells, polymorphonuclear cells, presence of erosions and/or ulcers, and chronic architectural changes. Scores range from 0 to 44, with higher scores indicating greater disease.
Time Frame Baseline, Week 54
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 89 patients in the Intent to Treat Population, 52 patients had data at Week 54 and at Baseline for blinded assessment, and are included in this summary. Change from Baseline has been calculated as the Week 54 score minus the Baseline score, thus a negative Change from Baseline indicates improvement.
Arm/Group Title CDP870 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Overall Number of Participants Analyzed 52
Mean (Standard Deviation)
Unit of Measure: score on a scale
-2.5  (4.3)
21.Secondary Outcome
Title Percentage of Patients Achieving Crohn's Disease Activity Index (CDAI) Response (Defined as a Decrease of at Least 100 Points in CDAI Score From Baseline) at Week 10
Hide Description Crohn's disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline). CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
Time Frame Baseline, Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
The 89 patients from Intent to Treat Population are included in this summary. In case of missing CDAI score, patients are counted as non-responders. Percentage is calculated by dividing the number of patients with a CDAI decrease of at least 100 points at Week 10 by the total number of patients in the Intent to Treat Population, multiplied by 100.
Arm/Group Title CDP870 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Overall Number of Participants Analyzed 89
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
50.6
(39.8 to 61.3)
22.Secondary Outcome
Title Percentage of Patients Achieving Crohn's Disease Activity Index (CDAI) Response (Defined as a Decrease of at Least 100 Points in CDAI Score From Baseline) at Week 54
Hide Description Crohn's disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline). CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
Time Frame Baseline, Week 54
Hide Outcome Measure Data
Hide Analysis Population Description
The 89 patients from Intent to Treat Population are included in this summary. In case of missing CDAI score, patients are counted as non-responders. Percentage is calculated by dividing the number of patients with a CDAI decrease of at least 100 points at Week 54 by the total number of patients in the Intent to Treat Population, multiplied by 100.
Arm/Group Title CDP870 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Overall Number of Participants Analyzed 89
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
32.6
(23.0 to 43.3)
23.Secondary Outcome
Title Percentage of Patients Achieving Crohn's Disease Activity Index (CDAI) Remission (Defined as a CDAI Score Less Than or Equal to 150) at Week 10
Hide Description Crohn's disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline). CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
Time Frame Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
The 89 patients from Intent to Treat Population are included in this summary. In case of missing CDAI score, patients are counted as remitters. Percentage is calculated by dividing the number of patients with a CDAI less than or equal to 150 points at Week 10 by the total number of patients in the Intent to Treat Population, multiplied by 100.
Arm/Group Title CDP870 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Overall Number of Participants Analyzed 89
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
46.1
(35.4 to 57.0)
24.Secondary Outcome
Title Percentage of Patients Achieving Crohn's Disease Activity Index (CDAI) Remission (Defined as a CDAI Score Less Than or Equal to 150) at Week 54
Hide Description Crohn's disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline). CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
Time Frame Week 54
Hide Outcome Measure Data
Hide Analysis Population Description
The 89 patients from Intent to Treat Population are included in this summary. In case of missing CDAI score, patients are counted as remitters. Percentage is calculated by dividing the number of patients with a CDAI less than or equal to 150 points at Week 54 by the total number of patients in the Intent to Treat Population, multiplied by 100.
Arm/Group Title CDP870 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Overall Number of Participants Analyzed 89
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
27.0
(18.1 to 37.4)
25.Secondary Outcome
Title Geometric Mean C-Reactive Protein (CRP) Level (mg/L) at Week 10
Hide Description [Not Specified]
Time Frame Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 89 patients in the Intent to Treat Population, 76 patients had plasma level data at Week 10 and are included in this summary.
Arm/Group Title CDP870 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Overall Number of Participants Analyzed 76
Geometric Mean (Full Range)
Unit of Measure: mg/L
6.84
(0.2 to 219.3)
26.Secondary Outcome
Title Ratio to Baseline of C-Reactive Protein (CRP) Level (mg/L) at Week 10
Hide Description Ratio is calculated as the Week 10 value divided by the Baseline value for patients with data at both timepoints.
Time Frame Baseline, Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 89 patients in the Intent to Treat Population, 76 patients had plasma levels taken at Week 10 and Baseline and are included in this summary. Ratio is calculated as the Week 10 value divided by the Baseline value for patients with data at both timepoints.
Arm/Group Title CDP870 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Overall Number of Participants Analyzed 76
Geometric Mean (Full Range)
Unit of Measure: ratio
0.40
(0 to 23.1)
27.Secondary Outcome
Title Geometric Mean C-Reactive Protein (CRP) Level (mg/L) at Week 52
Hide Description [Not Specified]
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 89 patients in the Intent to Treat Population, 51 patients had plasma level data at Week 54 and are included in this summary.
Arm/Group Title CDP870 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Overall Number of Participants Analyzed 51
Geometric Mean (Full Range)
Unit of Measure: mg/L
10.24
(0.3 to 99.5)
28.Secondary Outcome
Title Ratio to Baseline of C-Reactive Protein (CRP) Level (mg/L) at Week 52
Hide Description The ratio is calculated as the Week 52 value divided by Baseline value for patients with data at both timepoints.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 89 patients in the Intent to Treat Population, 51 patients had plasma level data at Week 54 and Baseline and are included in this summary. Ratio was calculated by dividing the Week 54 value by the Baseline value for the patients with data at both timepoints.
Arm/Group Title CDP870 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Overall Number of Participants Analyzed 51
Geometric Mean (Full Range)
Unit of Measure: ratio
0.52
(0 to 16.6)
29.Secondary Outcome
Title Correlation Between Mean C-Reactive Protein (CRP) Plasma Level and Crohn's Disease Activity Index (CDAI) Score at Week 10
Hide Description Crohn's disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline). CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
Time Frame Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 89 patients in the Intent to Treat Population, 73 patients had plasma level data and a CDAI score at Week 10 and are included in this summary.
Arm/Group Title CDP870 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Overall Number of Participants Analyzed 73
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Pearson Correlation Coefficient
0.043
(0.000 to 0.270)
30.Secondary Outcome
Title Correlation Between Mean C-Reactive Protein (CRP) Plasma Level and Crohn's Disease Endoscopic Index of Severity (CDEIS) Score at Week 10 Using Local Non-blinded Assessment
Hide Description The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.
Time Frame Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 89 patients in the Intent to Treat Population, 76 patients had plasma level data and a CDEIS score at Week 10 and are included in this summary.
Arm/Group Title CDP870 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Overall Number of Participants Analyzed 76
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Pearson Correlation Coefficient
0.131
(0.000 to 0.346)
31.Secondary Outcome
Title Correlation Between Mean C-Reactive Protein (CRP) Plasma Level and Crohn's Disease Endoscopic Index of Severity (CDEIS) Score at Week 10 Using Central Blinded Assessment
Hide Description The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.
Time Frame Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 89 patients in the Intent to Treat Population, 51 patients were in the subpopulation with a blinded assessment at Week 10. 48 patients had both CDEIS and CRP data at Week 10.
Arm/Group Title CDP870 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Overall Number of Participants Analyzed 48
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Pearson Correlation Coefficient
0.646
(0.443 to 0.786)
32.Secondary Outcome
Title Correlation Between Mean C-Reactive Protein (CRP) Plasma Level and Histological Crohn's Disease Score at Week 10 Using Central Blinded Assessment
Hide Description The histological Crohn's disease score combines active inflammatory changes: infiltration of mononuclear cells, polymorphonuclear cells, presence of erosions and/or ulcers, and chronic architectural changes. Scores range from 0 to 44, with higher scores indicating greater disease
Time Frame Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 89 patients in the Intent to Treat Population, 72 patients had plasma data and histological Crohn's disease score assessment at Week 10, and are included in this summary.
Arm/Group Title CDP870 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Overall Number of Participants Analyzed 72
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Pearson Correlation Coefficient
0.086
(0.000 to 0.312)
33.Secondary Outcome
Title Change From Baseline in Crohn's Disease Endoscopic Index of Severity (CDEIS) Score at Week 54 Using Local Non-blinded Assessment
Hide Description The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.
Time Frame Baseline, Week 54
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 89 patients in the Intent to Treat Population, 52 had a CDEIS score at Week 54 and at Baseline and are included here. Change from Baseline has been calculated as the Week 54 score minus the Baseline score, thus a negative Change from Baseline indicates improvement.
Arm/Group Title CDP870 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Overall Number of Participants Analyzed 52
Mean (Standard Deviation)
Unit of Measure: score on a scale
-5.49  (7.02)
34.Secondary Outcome
Title Change From Baseline in Crohn's Disease Endoscopic Index of Severity (CDEIS) Score at Week 54 Using Central Blinded Assessment
Hide Description The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.
Time Frame Baseline, Week 54
Hide Outcome Measure Data
Hide Analysis Population Description
Of 89 patients in the Intent to Treat Population, 28 had matching nonblinded/blinded assessments and were in the subpopulation with a blinded assessment at Week 54 and Baseline. Change from Baseline has been calculated as the Week 54 score minus the Baseline score, thus a negative Change from Baseline indicates improvement.
Arm/Group Title CDP870 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Overall Number of Participants Analyzed 28
Mean (Standard Deviation)
Unit of Measure: score on a scale
-2.95  (7.13)
35.Secondary Outcome
Title Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 10
Hide Description Crohn's disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline). CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
Time Frame Baseline, Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 89 patients in the Intent to Treat Population, 73 patients had data at both Baseline and Week 10, and are included in this summary. Change from Baseline has been calculated as the Week 10 score minus the Baseline score, thus a negative Change from Baseline indicates improvement.
Arm/Group Title CDP870 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Overall Number of Participants Analyzed 73
Mean (Standard Deviation)
Unit of Measure: score on a scale
-148.82  (109.61)
36.Secondary Outcome
Title Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 54
Hide Description Crohn's disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline). CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
Time Frame Baseline, Week 54
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 89 patients in the Intent to Treat Population, 39 had CDAI scores at Week 54 and Baseline and are included in this summary. Change from Baseline has been calculated as the Week 54 score minus the Baseline score, thus a negative Change from Baseline indicates improvement.
Arm/Group Title CDP870 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
Overall Number of Participants Analyzed 39
Mean (Standard Deviation)
Unit of Measure: score on a scale
-169.59  (109.98)
Time Frame The adverse event summaries are based on data collected during the 54 weeks of the study for all 89 patients.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CDP870 400 mg
Hide Arm/Group Description Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
All-Cause Mortality
CDP870 400 mg
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
CDP870 400 mg
Affected / at Risk (%) # Events
Total   34/89 (38.20%)    
Blood and lymphatic system disorders   
Anaemia * 1  1/89 (1.12%)  1
Gastrointestinal disorders   
Abdominal pain * 1  3/89 (3.37%)  3
Abdominal wall mass * 1  1/89 (1.12%)  1
Anal fistula * 1  2/89 (2.25%)  2
Crohn's disease * 1  5/89 (5.62%)  6
Diarrhoea * 1  4/89 (4.49%)  4
Enterocutaneous fistula * 1  1/89 (1.12%)  1
Gastrointestinal haemorrhage * 1  1/89 (1.12%)  1
Haematochezia * 1  1/89 (1.12%)  1
Ileal stenosis * 1  1/89 (1.12%)  1
Intestinal obstruction * 1  1/89 (1.12%)  1
Large intestine perforation * 1  1/89 (1.12%)  1
Vomiting * 1  1/89 (1.12%)  1
General disorders   
Asthenia * 1  1/89 (1.12%)  1
Hyperthermia * 1  1/89 (1.12%)  1
Pyrexia * 1  2/89 (2.25%)  2
Hepatobiliary disorders   
Cholelithiasis * 1  1/89 (1.12%)  1
Immune system disorders   
Serum sickness * 1  1/89 (1.12%)  1
Infections and infestations   
Abdominal abscess * 1  1/89 (1.12%)  1
Abdominal wall abscess * 1  1/89 (1.12%)  1
Anal abscess * 1  5/89 (5.62%)  6
Bacteraemia * 1  1/89 (1.12%)  1
Clostridial infection * 1  1/89 (1.12%)  1
Colitis pseudomembranous * 1  1/89 (1.12%)  1
Genital abscess * 1  1/89 (1.12%)  1
Herpes zoster * 1  1/89 (1.12%)  1
Localised infection * 1  1/89 (1.12%)  1
Perianal abscess * 1  3/89 (3.37%)  3
Perineal abscess * 1  1/89 (1.12%)  1
Pyelonephritis * 1  1/89 (1.12%)  1
Injury, poisoning and procedural complications   
Joint dislocation * 1  1/89 (1.12%)  1
Keratorhexis * 1  1/89 (1.12%)  1
Metabolism and nutrition disorders   
Dehydration * 1  1/89 (1.12%)  1
Malnutrition * 1  2/89 (2.25%)  2
Musculoskeletal and connective tissue disorders   
Arthritis * 1  1/89 (1.12%)  2
Pain in extremity * 1  1/89 (1.12%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Colon cancer * 1  1/89 (1.12%)  1
Pregnancy on oral contraceptive * 1  1/89 (1.12%)  1
Reproductive system and breast disorders   
Perineal fistula * 1  2/89 (2.25%)  2
Uterine haemorrhage * 1  1/89 (1.12%)  1
Skin and subcutaneous tissue disorders   
Purpura * 1  1/89 (1.12%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CDP870 400 mg
Affected / at Risk (%) # Events
Total   83/89 (93.26%)    
Blood and lymphatic system disorders   
Anaemia * 1  8/89 (8.99%)  10
Gastrointestinal disorders   
Abdominal pain * 1  18/89 (20.22%)  21
Abdominal pain upper * 1  10/89 (11.24%)  14
Anal fissure * 1  15/89 (16.85%)  18
Anal fistula * 1  6/89 (6.74%)  6
Aphthous stomatitis * 1  10/89 (11.24%)  10
Crohn's disease * 1  11/89 (12.36%)  11
Diarrhoea * 1  13/89 (14.61%)  20
Dyspepsia * 1  6/89 (6.74%)  7
Haemorrhoids * 1  8/89 (8.99%)  10
Nausea * 1  16/89 (17.98%)  26
Proctalgia * 1  5/89 (5.62%)  6
Rectal haemorrhage * 1  5/89 (5.62%)  5
Vomiting * 1  11/89 (12.36%)  14
General disorders   
Asthenia * 1  18/89 (20.22%)  22
Fatigue * 1  7/89 (7.87%)  7
Influenza like illness * 1  7/89 (7.87%)  7
Injection site erythema * 1  7/89 (7.87%)  8
Pyrexia * 1  15/89 (16.85%)  20
Infections and infestations   
Bronchitis * 1  9/89 (10.11%)  12
Gastroenteritis * 1  8/89 (8.99%)  9
Herpes simplex * 1  11/89 (12.36%)  16
Influenza * 1  7/89 (7.87%)  7
Nasopharyngitis * 1  21/89 (23.60%)  37
Pharyngitis * 1  11/89 (12.36%)  12
Rhinitis * 1  8/89 (8.99%)  9
Sinusitis * 1  6/89 (6.74%)  7
Urinary tract infection * 1  8/89 (8.99%)  14
Metabolism and nutrition disorders   
Iron deficiency * 1  5/89 (5.62%)  5
Vitamin B12 deficiency * 1  6/89 (6.74%)  6
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  27/89 (30.34%)  43
Back pain * 1  7/89 (7.87%)  10
Muscle spasms * 1  6/89 (6.74%)  8
Nervous system disorders   
Dizziness * 1  7/89 (7.87%)  8
Headache * 1  30/89 (33.71%)  56
Psychiatric disorders   
Anxiety * 1  5/89 (5.62%)  7
Insomnia * 1  10/89 (11.24%)  10
Respiratory, thoracic and mediastinal disorders   
Cough * 1  5/89 (5.62%)  6
Pharyngolaryngeal pain * 1  11/89 (12.36%)  12
Skin and subcutaneous tissue disorders   
Acne * 1  9/89 (10.11%)  9
Night sweats * 1  5/89 (5.62%)  5
Pruritus * 1  7/89 (7.87%)  7
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
UCB has > 60 days but <= 180 days to review results communications prior to public release and may delete information that is confidential and compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
Results Point of Contact
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Name/Title: UCB Clinical Trial Call Center
Organization: UCB Pharma
Phone: +1 877 822 9493
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Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00297648    
Other Study ID Numbers: C87043
EudraCT Number 2005-003977-25 ( Other Identifier: EudraCT )
First Submitted: February 27, 2006
First Posted: February 28, 2006
Results First Submitted: December 10, 2009
Results First Posted: January 18, 2010
Last Update Posted: August 31, 2011