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Trial record 1 of 2 for:    NCT00899678
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The Use of Certolizumab Pegol for Treatment of Active Crohn's Disease in Children and Adolescents (NURTURE)

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: NCT00899678
Recruitment Status : Terminated (higher than projected discontinuation rate during Maintenance Phase)
First Posted : May 12, 2009
Results First Posted : November 21, 2013
Last Update Posted : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Celltech )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Crohn's Disease
Intervention Drug: Certolizumab Pegol
Enrollment 99
Recruitment Details The Participant Flow refers to the Safety Set (SS) population. The Safety Population includes all subjects enrolled who received at least 1 injection of study treatment.
Pre-assignment Details

During an Induction Period (Weeks 0 to 6), subjects were administered Certolizumab Pegol (CZP) subcutaneously every 2 weeks (Q2W). Subjects who showed a clinical response at Week 6 were randomized in a 1:1 ratio to one of 2 dose groups.

Subjects who did not respond at Week 6 were withdrawn from the study.

Arm/Group Title Induction Only Maintenance Low-Dose Maintenance High-Dose
Hide Arm/Group Description

Induction Only is the period between the Week 0 dose and prior to first maintenance dose (Week 8). Induction Only includes all subjects who received a dose during the Induction Period but did not receive any treatment during the Maintenance Period. During the Induction Period (Weeks 0 to 6), subjects were administered Certolizumab Pegol (CZP) subcutaneously every 2 weeks (Q2W) (for a total of 3 administrations of drug) at a dose of either:

  • 400 mg for subjects ≥ 40 kg
  • 200 mg for subjects 20 to < 40 kg

Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg

*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg

Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg

*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg

Period Title: Induction Period (Weeks 0 to 6)
Started 27 [1] 37 35
Completed 2 [2] 37 35
Not Completed 25 0 0
Reason Not Completed
Adverse Event             6             0             0
Lack of Efficacy             17             0             0
Protocol Violation             1             0             0
Other reason             1             0             0
[1]
Induction only includes subjects that discontinued before Maintenance Period.
[2]
2 subjects completed the Induction Phase, but discontinued prior to receiving any Maintenance doses.
Period Title: Maintenance Period (Weeks 8 to 62)
Started 0 [1] 37 35
Completed 0 12 7
Not Completed 0 25 28
Reason Not Completed
Adverse Event             0             10             5
Lack of Efficacy             0             11             18
Protocol Violation             0             1             1
Withdrawal by Subject             0             1             2
Other reason             0             2             2
[1]
Induction only includes subjects that discontinued before Maintenance Period.
Arm/Group Title Induction Only Maintenance Low-Dose Maintenance High-Dose Total
Hide Arm/Group Description

Induction Only is the period between the Week 0 dose and prior to first maintenance dose (Week 8). Induction Only includes all subjects who received a dose during the Induction Period but did not receive any treatment during the Maintenance Period. During the Induction Period (Weeks 0 to 6), subjects were administered Certolizumab Pegol (CZP) subcutaneously every 2 weeks (Q2W) (for a total of 3 administrations of drug) at a dose of either:

  • 400 mg for subjects ≥ 40 kg
  • 200 mg for subjects 20 to < 40 kg

Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg

*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg

Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg

*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg

Total of all reporting groups
Overall Number of Baseline Participants 27 37 35 99
Hide Baseline Analysis Population Description
The Baseline characteristics refer to the Safety Set (SS) population. The Safety Population includes all subjects enrolled who received at least 1 injection of study treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants 37 participants 35 participants 99 participants
13.8  (2.67) 13.2  (2.41) 13.4  (2.46) 13.4  (2.48)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 27 participants 37 participants 35 participants 99 participants
6-11 years 6 9 8 23
12-17 years 21 28 27 76
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 37 participants 35 participants 99 participants
Female
10
  37.0%
10
  27.0%
21
  60.0%
41
  41.4%
Male
17
  63.0%
27
  73.0%
14
  40.0%
58
  58.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 27 participants 37 participants 35 participants 99 participants
American Indian / Alaskan Native 0 0 0 0
Asian 1 0 0 1
Black 3 3 8 14
Native Hawaiian or other Pacific islander 0 0 0 0
White 22 32 27 81
Other / Mixed 1 2 0 3
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram
Number Analyzed 27 participants 37 participants 35 participants 99 participants
46.50  (12.565) 45.67  (14.638) 50.35  (18.569) 47.55  (15.642)
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeter
Number Analyzed 27 participants 37 participants 35 participants 99 participants
157.46  (13.841) 155.32  (13.589) 157.22  (13.320) 156.57  (13.460)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kilogram per square meter
Number Analyzed 27 participants 37 participants 35 participants 99 participants
18.39  (2.504) 18.51  (3.531) 19.79  (4.897) 18.93  (3.869)
Body Surface Area (BSA)  
Mean (Standard Deviation)
Unit of measure:  Square meter
Number Analyzed 27 participants 37 participants 35 participants 99 participants
1.42  (0.250) 1.39  (0.272) 1.47  (0.319) 1.43  (0.283)
1.Primary Outcome
Title Percentage of Subjects in Clinical Remission at Week 62
Hide Description

Clinical remission is defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score ≤ 10.

The Pediatric Crohn's Disease Activity Index (PCDAI) consists of 4 domains (laboratory, height/weight, examination, and history) with several assessments that are converted into a PCDAI score which can range from 0 to 100 points, with a higher score indicating more severe disease activity.

Time Frame Week 62
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) population
Arm/Group Title Maintenance Low-Dose Maintenance High-Dose
Hide Arm/Group Description:

Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg

*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg

Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg

*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg

Overall Number of Participants Analyzed 37 35
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
24.3
(10.5 to 38.1)
17.1
(4.7 to 29.6)
2.Secondary Outcome
Title Absolute Pediatric Crohn's Disease Activity Index (PCDAI) Scores at Week 62
Hide Description The Pediatric Crohn's Disease Activity Index (PCDAI) consists of 4 domains (laboratory, height/weight, examination, and history) with several assessments that are converted into a PCDAI score which can range from 0 to 100 points, with a higher score indicating more severe disease activity.
Time Frame Week 62
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) population. At the start of the Maintenance Period, the FAS had 37 subjects in the Low-Dose group and 35 subjects in the High-Dose group. However, at Week 62, there were only 11 subjects in the Low-Dose group and 7 subjects in the High-Dose group with valid Pediatric Crohn's Disease Activity Index (PCDAI) scores.
Arm/Group Title Maintenance Low-Dose Maintenance High-Dose
Hide Arm/Group Description:

Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg

*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg

Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg

*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg

Overall Number of Participants Analyzed 11 7
Mean (Standard Deviation)
Unit of Measure: Score on a scale
8.18  (6.900) 7.14  (7.830)
3.Secondary Outcome
Title Change in Pediatric Crohn's Disease Activity Index (PCDAI) Scores From Week 0 to the End of the Study (Week 62)
Hide Description

The Pediatric Crohn's Disease Activity Index (PCDAI) consists of 4 domains (laboratory, height/weight, examination, and history) with several assessments that are converted into a PCDAI score which can range from 0 to 100 points, with a higher score indicating more severe disease activity.

A negative value in change from Baseline indicates an improvement from Baseline to Week 62.

Time Frame From Week 0 to Week 62
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) population. At the start of the Maintenance Period, the FAS had 37 subjects in the Low-Dose group and 35 subjects in the High- Dose group. However, at Week 62, there were only 11 subjects in the Low-Dose group and 7 subjects in the High-Dose group with valid Pediatric Crohn's Disease Activity Index (PCDAI) scores.
Arm/Group Title Maintenance Low-Dose Maintenance High-Dose
Hide Arm/Group Description:

Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg

*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg

Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg

*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg

Overall Number of Participants Analyzed 11 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
-29.77  (8.097) -27.14  (5.669)
4.Secondary Outcome
Title Percentage of Subjects Achieving Clinical Response From Week 0 to the End of the Study (Week 62)
Hide Description

Clinical response is defined as a decrease from Week 0 in Pediatric Crohn's Disease Activity Index (PCDAI) score of ≥ 15 points and a total PCDAI score ≤ 30 points.

The Pediatric Crohn's Disease Activity Index (PCDAI) consists of 4 domains (laboratory, height/weight, examination, and history) with several assessments that are converted into a PCDAI score which can range from 0 to 100 points, with a higher score indicating more severe disease activity.

Time Frame From Week 0 to Week 62
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) population
Arm/Group Title Maintenance Low-Dose Maintenance High-Dose
Hide Arm/Group Description:

Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg

*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg

Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg

*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg

Overall Number of Participants Analyzed 37 35
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
29.7
(15.0 to 44.5)
20.0
(6.7 to 33.3)
5.Secondary Outcome
Title C-Reactive Protein (CRP) Levels at Week 62
Hide Description The C-Reactive Protein (CRP) is a considered marker of inflammation in subjects with Crohn's Disease (CD)
Time Frame Week 62
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) population. At the start of the Maintenance Period, the FAS had 37 subjects in the Low-Dose group and 35 subjects in the High- Dose group. However, at Week 62, there were only 11 subjects in the Low-Dose group and 7 subjects in the High-Dose group with valid C-Reactive Protein (CRP) levels.
Arm/Group Title Maintenance Low-Dose Maintenance High-Dose
Hide Arm/Group Description:

Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg

*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg

Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg

*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg

Overall Number of Participants Analyzed 11 7
Geometric Mean (95% Confidence Interval)
Unit of Measure: mg/L
7.2
(2.5 to 20.7)
5.8
(2.1 to 15.7)
6.Secondary Outcome
Title Change in C-Reactive Protein (CRP) Levels From Week 0 to the End of the Study (Week 62)
Hide Description

The C-Reactive Protein (CRP) is a considered marker of inflammation in subjects with Crohn's Disease (CD).

Changes from Baseline in CRP levels are expressed as a ratio with the value measured at Baseline as the denominator.

Time Frame From Week 0 to Week 62
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) population. At the start of the Maintenance Period, the FAS had 37 subjects in the Low-Dose group and 35 subjects in the High- Dose group. However, at Week 62, there were only 11 subjects in the Low-Dose group and 7 subjects in the High-Dose group with valid C-Reactive Protein (CRP) levels.
Arm/Group Title Maintenance Low-Dose Maintenance High-Dose
Hide Arm/Group Description:

Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg

*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg

Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg

*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg

Overall Number of Participants Analyzed 11 7
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio
0.49
(0.17 to 1.41)
1.84
(0.27 to 12.71)
7.Secondary Outcome
Title Erythrocyte Sedimentation Rate (ESR) at Week 62
Hide Description The Erythrocyte Sedimentation Rate (ESR) is a considered biomarker of inflammation in subjects with Crohn's Disease (CD).
Time Frame Week 62
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) population. At the start of the Maintenance Period, the FAS had 37 subjects in the Low-Dose group and 35 subjects in the High- Dose group. However, at Week 62, there were only 12 subjects in the Low-Dose group and 7 subjects in the High-Dose group with a valid Erythrocyte Sedimentation Rate (ESR).
Arm/Group Title Maintenance Low-Dose Maintenance High-Dose
Hide Arm/Group Description:

Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg

*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg

Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg

*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg

Overall Number of Participants Analyzed 12 7
Geometric Mean (95% Confidence Interval)
Unit of Measure: mm/h
20.9
(11.8 to 37.2)
25.2
(12.3 to 51.7)
8.Secondary Outcome
Title Change in Erythrocyte Sedimentation Rate (ESR) From Week 0 to the End of the Study (Week 62)
Hide Description

The Erythrocyte Sedimentation Rate (ESR) is a considered biomarker of inflammation in subjects with Crohn's Disease (CD).

Changes from Baseline in CRP levels are expressed as a ratio with the value measured at baseline as the denominator.

Time Frame From Week 0 to Week 62
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) population. At the start of the Maintenance Period, the FAS had 37 subjects in the Low-Dose group and 35 subjects in the High- Dose group. However, at Week 62, there were only 12 subjects in the Low-Dose group and 7 subjects in the High-Dose group with a valid Erythrocyte Sedimentation Rate (ESR).
Arm/Group Title Maintenance Low-Dose Maintenance High-Dose
Hide Arm/Group Description:

Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg

*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg

Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg

*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg

Overall Number of Participants Analyzed 12 7
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio
0.57
(0.31 to 1.04)
1.08
(0.39 to 3.02)
9.Secondary Outcome
Title Change in Growth Scores (Tanner Stage [Assessing Puberty]) From Week 0 to the End of the Study (Week 62)
Hide Description The Tanner stage is an assessment of developmental stage on external genitalia and pubic hair (boys), and on breast and pubic hair (girls). Values range from 1 to 5 where a higher number indicates more development.
Time Frame From Week 0 to Week 62
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Analysis (FAS) population. At the start of the Maintenance Period, the FAS had 37 subjects in the Low-Dose group and 35 subjects in the High- Dose group. However, at Week 62, there were only 10 subjects in the Low-Dose group and 7 subjects in the High-Dose group with valid Growth scores.
Arm/Group Title Maintenance Low-Dose Maintenance High-Dose
Hide Arm/Group Description:

Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg

*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg

Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg

*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg

Overall Number of Participants Analyzed 10 7
Measure Type: Number
Unit of Measure: participants
Increase from Stage I to Stage II 2 0
Increase from Stage I to Stage III 1 1
Increase from Stage II to Stage III 0 1
Increase from Stage III to Stage IV 2 0
Increase from Stage IV to Stage V 0 1
Decrease from Stage IV to Stage III 1 1
Subjects remained in Stage I 0 1
Subjects remained in Stage III 0 2
Subjects remained in Stage IV 1 0
Subjects remained in Stage V 3 0
10.Secondary Outcome
Title Percentage of Subjects Who Initiated Steroid Tapering
Hide Description Subjects receiving corticosteroids at Screening may start a defined tapering schedule between Weeks 2 and 8. Corticosteroid tapering must start at the latest by Week 8. Corticosteroid doses are tapered at different rates depending on the subject's dose.
Time Frame From Week 2 up to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) population. There were only 21 subjects in the Low-Dose group and 20 subjects in the High-Dose group who took steroids during the Maintenance Period.
Arm/Group Title Maintenance Low-Dose Maintenance High-Dose
Hide Arm/Group Description:

Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg

*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg

Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg

*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg

Overall Number of Participants Analyzed 21 20
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
71.4
(52.1 to 90.8)
65.0
(44.1 to 85.9)
11.Secondary Outcome
Title Percentage of Subjects in Corticosteroid-free Remission at the End of the Study
Hide Description Corticosteroid use at end of study is defined as 84 days past the last dose of study medication. Remission is assessed at the last visit where Pediatric Crohn's Disease Activity index (PCDAI) data is available.
Time Frame Last/Withdrawal Visit (up to Week 62)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) population. There were only 21 subjects in the Low-Dose group and 20 subjects in the High-Dose group who took steroids during the Maintenance Period.
Arm/Group Title Maintenance Low-Dose Maintenance High-Dose
Hide Arm/Group Description:

Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg

*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg

Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg

*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg

Overall Number of Participants Analyzed 21 20
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of paticipants
23.8
(5.6 to 42.0)
15.0
(0.0 to 30.6)
Time Frame Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Event Reporting Description Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
 
Arm/Group Title Induction Period Maintenance Low-Dose Maintenance High-Dose Overall Study
Hide Arm/Group Description

Induction Only is the period between the Week 0 dose and prior to first maintenance dose (Week 8). Induction Only includes all subjects who received a dose during the Induction Period but did not receive any treatment during the Maintenance Period. During the Induction Period (Weeks 0 to 6), subjects were administered Certolizumab Pegol (CZP) subcutaneously every 2 weeks (Q2W) (for a total of 3 administrations of drug) at a dose of either:

  • 400 mg for subjects ≥ 40 kg
  • 200 mg for subjects 20 to < 40 kg

Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg

*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg

Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg

*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg

Overall Study comprises Induction Period and Maintenance Period (Week -6 to Week 62).
All-Cause Mortality
Induction Period Maintenance Low-Dose Maintenance High-Dose Overall Study
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Induction Period Maintenance Low-Dose Maintenance High-Dose Overall Study
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/99 (6.06%)      4/37 (10.81%)      4/35 (11.43%)      14/99 (14.14%)    
Blood and lymphatic system disorders         
Anaemia * 1  1/99 (1.01%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0 1/99 (1.01%)  1
Gastrointestinal disorders         
Abdominal Pain * 1  0/99 (0.00%)  0 0/37 (0.00%)  0 1/35 (2.86%)  1 1/99 (1.01%)  1
Anal fistula * 1  0/99 (0.00%)  0 1/37 (2.70%)  1 0/35 (0.00%)  0 1/99 (1.01%)  1
Crohn's disease * 1  1/99 (1.01%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0 1/99 (1.01%)  1
Diarrhoea * 1  0/99 (0.00%)  0 1/37 (2.70%)  1 0/35 (0.00%)  0 1/99 (1.01%)  1
Haematochezia * 1  1/99 (1.01%)  1 0/37 (0.00%)  0 1/35 (2.86%)  1 2/99 (2.02%)  2
Vomiting * 1  1/99 (1.01%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0 1/99 (1.01%)  1
General disorders         
Pyrexia * 1  0/99 (0.00%)  0 1/37 (2.70%)  1 0/35 (0.00%)  0 1/99 (1.01%)  1
Infections and infestations         
Candidiasis * 1  0/99 (0.00%)  0 1/37 (2.70%)  1 0/35 (0.00%)  0 1/99 (1.01%)  1
Gastroenteritis * 1  0/99 (0.00%)  0 0/37 (0.00%)  0 1/35 (2.86%)  1 1/99 (1.01%)  1
Gastroenteritis viral * 1  2/99 (2.02%)  2 0/37 (0.00%)  0 0/35 (0.00%)  0 2/99 (2.02%)  2
Oral herpes * 1  0/99 (0.00%)  0 1/37 (2.70%)  1 0/35 (0.00%)  0 1/99 (1.01%)  1
Salmonellosis * 1  1/99 (1.01%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0 1/99 (1.01%)  1
Viral infection * 1  0/99 (0.00%)  0 0/37 (0.00%)  0 1/35 (2.86%)  1 1/99 (1.01%)  1
Perineal abscess * 1  0/99 (0.00%)  0 1/37 (2.70%)  1 0/35 (0.00%)  0 1/99 (1.01%)  1
Investigations         
Weight decreased * 1  0/99 (0.00%)  0 0/37 (0.00%)  0 1/35 (2.86%)  1 1/99 (1.01%)  1
Metabolism and nutrition disorders         
Dehydration * 1  1/99 (1.01%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0 1/99 (1.01%)  1
Psychiatric disorders         
Depression * 1  0/99 (0.00%)  0 1/37 (2.70%)  1 0/35 (0.00%)  0 1/99 (1.01%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Induction Period Maintenance Low-Dose Maintenance High-Dose Overall Study
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   59/99 (59.60%)      28/37 (75.68%)      27/35 (77.14%)      78/99 (78.79%)    
Gastrointestinal disorders         
Abdominal pain * 1  4/99 (4.04%)  4 3/37 (8.11%)  4 4/35 (11.43%)  4 10/99 (10.10%)  12
Abdominal pain upper * 1  4/99 (4.04%)  4 5/37 (13.51%)  5 2/35 (5.71%)  3 9/99 (9.09%)  12
Anal inflammation * 1  0/99 (0.00%)  0 0/37 (0.00%)  0 2/35 (5.71%)  2 2/99 (2.02%)  2
Constipation * 1  3/99 (3.03%)  3 3/37 (8.11%)  3 1/35 (2.86%)  1 7/99 (7.07%)  7
Crohn's disease * 1  0/99 (0.00%)  0 5/37 (13.51%)  7 7/35 (20.00%)  8 12/99 (12.12%)  15
Diarrhoea * 1  7/99 (7.07%)  7 3/37 (8.11%)  5 3/35 (8.57%)  7 12/99 (12.12%)  19
Gastrooesophageal reflux disease * 1  2/99 (2.02%)  2 2/37 (5.41%)  2 2/35 (5.71%)  2 5/99 (5.05%)  6
Mouth ulceration * 1  2/99 (2.02%)  2 3/37 (8.11%)  3 3/35 (8.57%)  3 8/99 (8.08%)  8
Nausea * 1  6/99 (6.06%)  8 3/37 (8.11%)  3 2/35 (5.71%)  2 10/99 (10.10%)  13
Stomatitis * 1  2/99 (2.02%)  3 1/37 (2.70%)  1 2/35 (5.71%)  2 5/99 (5.05%)  6
Toothache * 1  1/99 (1.01%)  1 3/37 (8.11%)  3 0/35 (0.00%)  0 3/99 (3.03%)  4
Vomiting * 1  6/99 (6.06%)  7 3/37 (8.11%)  3 6/35 (17.14%)  10 13/99 (13.13%)  20
General disorders         
Fatigue * 1  3/99 (3.03%)  3 3/37 (8.11%)  4 0/35 (0.00%)  0 6/99 (6.06%)  7
Injection site pain * 1  22/99 (22.22%)  55 4/37 (10.81%)  17 6/35 (17.14%)  36 22/99 (22.22%)  108
Pyrexia * 1  9/99 (9.09%)  15 6/37 (16.22%)  7 9/35 (25.71%)  9 20/99 (20.20%)  31
Infections and infestations         
Ear infection * 1  1/99 (1.01%)  1 2/37 (5.41%)  2 1/35 (2.86%)  1 4/99 (4.04%)  4
Influenza * 1  1/99 (1.01%)  1 3/37 (8.11%)  3 2/35 (5.71%)  3 6/99 (6.06%)  7
Nasopharyngitis * 1  5/99 (5.05%)  5 1/37 (2.70%)  1 2/35 (5.71%)  2 8/99 (8.08%)  8
Pharyngitis * 1  1/99 (1.01%)  1 2/37 (5.41%)  2 0/35 (0.00%)  0 3/99 (3.03%)  3
Sinusitis * 1  2/99 (2.02%)  2 3/37 (8.11%)  3 1/35 (2.86%)  1 5/99 (5.05%)  6
Upper respiratory tract infection * 1  0/99 (0.00%)  0 8/37 (21.62%)  9 2/35 (5.71%)  2 10/99 (10.10%)  11
Urinary tract infection * 1  0/99 (0.00%)  0 0/37 (0.00%)  0 2/35 (5.71%)  2 2/99 (2.02%)  2
Viral infection * 1  2/99 (2.02%)  3 4/37 (10.81%)  4 3/35 (8.57%)  5 9/99 (9.09%)  12
Injury, poisoning and procedural complications         
Contusion * 1  0/99 (0.00%)  0 2/37 (5.41%)  2 0/35 (0.00%)  0 2/99 (2.02%)  2
Ligament sprain * 1  0/99 (0.00%)  0 2/37 (5.41%)  2 0/35 (0.00%)  0 2/99 (2.02%)  2
Investigations         
C-reactive protein increased * 1  0/99 (0.00%)  0 0/37 (0.00%)  0 2/35 (5.71%)  2 2/99 (2.02%)  2
Weight decreased * 1  2/99 (2.02%)  2 2/37 (5.41%)  2 1/35 (2.86%)  3 4/99 (4.04%)  7
Metabolism and nutrition disorders         
Decreased appetite * 1  4/99 (4.04%)  4 3/37 (8.11%)  3 1/35 (2.86%)  1 8/99 (8.08%)  8
Musculoskeletal and connective tissue disorders         
Arthralgia * 1  6/99 (6.06%)  7 4/37 (10.81%)  4 2/35 (5.71%)  2 12/99 (12.12%)  13
Myalgia * 1  0/99 (0.00%)  0 2/37 (5.41%)  2 0/35 (0.00%)  0 2/99 (2.02%)  2
Nervous system disorders         
Headache * 1  9/99 (9.09%)  12 4/37 (10.81%)  10 3/35 (8.57%)  4 12/99 (12.12%)  26
Respiratory, thoracic and mediastinal disorders         
Cough * 1  5/99 (5.05%)  5 3/37 (8.11%)  3 2/35 (5.71%)  5 8/99 (8.08%)  13
Oropharyngeal pain * 1  5/99 (5.05%)  5 2/37 (5.41%)  2 2/35 (5.71%)  2 8/99 (8.08%)  9
Rhinorrhoea * 1  0/99 (0.00%)  0 1/37 (2.70%)  1 2/35 (5.71%)  2 3/99 (3.03%)  3
Skin and subcutaneous tissue disorders         
Acne * 1  3/99 (3.03%)  3 1/37 (2.70%)  1 1/35 (2.86%)  1 5/99 (5.05%)  5
Rash * 1  2/99 (2.02%)  2 3/37 (8.11%)  6 0/35 (0.00%)  0 5/99 (5.05%)  8
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.0
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB Clinical Trial Call Center
Organization: UCB
Phone: +1 877 822 9493
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB Celltech )
ClinicalTrials.gov Identifier: NCT00899678    
Other Study ID Numbers: C87035
2014-004381-24 ( EudraCT Number )
First Submitted: April 29, 2009
First Posted: May 12, 2009
Results First Submitted: June 28, 2013
Results First Posted: November 21, 2013
Last Update Posted: August 7, 2018