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Trial record 1 of 1 for:    NCT01190410
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Extension Study to Assess Long Term Safety in Children and Adolescents With Crohn's Disease Receiving Certolizumab Pegol

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ClinicalTrials.gov Identifier: NCT01190410
Recruitment Status : Completed
First Posted : August 27, 2010
Results First Posted : March 26, 2019
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Crohn's Disease
Intervention Drug: certolizumab pegol
Enrollment 16
Recruitment Details The study started to enroll patients in August 2010 and concluded in November 2017.
Pre-assignment Details The study included an Open Label treatment period, having 16 subjects enrolled in the Safety Set (SS) shown in the Participant Flow.
Arm/Group Title Certolizumab Pegol: Low-dose Group (Weight Adjusted) Certolizumab Pegol: High-dose Group (Weight Adjusted)
Hide Arm/Group Description 200 mg administered subcutaneously every 4 weeks for subjects >= 40 kg or 100 mg for subjects 20 to < 40 kg. Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study. 400 mg administered subcutaneously every 4 weeks for subjects >= 40 kg or 200 mg for subjects 20 to < 40 kg. Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.
Period Title: Overall Study
Started [1] 4 12
Re-Induction 0 2
Completed [2] 3 3
Not Completed 1 9
Reason Not Completed
Adverse Event             0             3
Lack of Efficacy             0             2
Withdrawal by Subject             0             2
Administrative decision             1             0
PI discretion             0             2
[1]
16
[2]
6
Arm/Group Title Certolizumab Pegol: Low-dose Group (Weight Adjusted) Certolizumab Pegol: High-dose Group (Weight Adjusted) Total Title
Hide Arm/Group Description 200 mg administered subcutaneously every 4 weeks for subjects >= 40 kg or 100 mg for subjects 20 to < 40 kg. Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study. 400 mg administered subcutaneously every 4 weeks for subjects >= 40 kg or 200 mg for subjects 20 to < 40 kg. Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study. [Not Specified]
Overall Number of Baseline Participants 4 12 16
Hide Baseline Analysis Population Description
Baseline Characteristics refer to the Safety Set which included all subjects enrolled in the study.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 12 participants 16 participants
<=18 years
4
 100.0%
11
  91.7%
15
  93.8%
Between 18 and 65 years
0
   0.0%
1
   8.3%
1
   6.3%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 12 participants 16 participants
13.5  (2.4) 13.9  (2.9) 13.8  (2.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 12 participants 16 participants
Female
2
  50.0%
6
  50.0%
8
  50.0%
Male
2
  50.0%
6
  50.0%
8
  50.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 12 participants 16 participants
Black
0
   0.0%
3
  25.0%
3
  18.8%
White
4
 100.0%
9
  75.0%
13
  81.3%
1.Primary Outcome
Title Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE) During Study Treatment (up to 303 Weeks)
Hide Description Treatment-Emergent Adverse Events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.
Time Frame During study treatment (up to 303 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.
Arm/Group Title Certolizumab Pegol: Low-dose Group (Weight Adjusted) – (SS) Certolizumab Pegol: High-dose Group (Weight Adjusted) – (SS) Certolizumab Pegol: Re-Induction Group – (SS)
Hide Arm/Group Description:
200 mg administered subcutaneously every 4 weeks for subjects >= 40 kg or 100 mg for subjects 20 to < 40 kg. Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.
400 mg administered subcutaneously every 4 weeks for subjects >= 40 kg or 200 mg for subjects 20 to < 40 kg. Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.
If a subject had not been previously reinduced in C87035, the subject is eligible for 1 reinduction due to loss of response in CR0012. Reinduction Week 0 (first reinduction dose) is followed by Reinduction Week 2 (second dose, 2 weeks after first dose), and Reinduction Week 4 (third dose, 2 weeks after second dose). The reinduction dose was adjusted to the subject’s weight: 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg subcutaneously Q2W for a total of 3 doses. After reinduction was complete participants continued dosing with CZP administered subcutaneously Q4W as 400 mg for subjects ≥ 40 kg or 200mg for subjects 20 to < 40 kg, regardless of the subject’s previous randomized dose group). Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.
Overall Number of Participants Analyzed 4 10 2
Measure Type: Count of Participants
Unit of Measure: Participants
Subjects
2
  50.0%
6
  60.0%
2
 100.0%
2.Secondary Outcome
Title Number of Subjects Discontinuing Treatment Due to a Treatment-Emergent Adverse Event (TEAE)
Hide Description Treatment-Emergent Adverse Events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.
Time Frame During study treatment (up to 303 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.
Arm/Group Title Certolizumab Pegol: Low-dose Group (Weight Adjusted) – (SS) Certolizumab Pegol: High-dose Group (Weight Adjusted) – (SS) Certolizumab Pegol: Re-Induction Group – (SS)
Hide Arm/Group Description:
200 mg administered subcutaneously every 4 weeks for subjects >= 40 kg or 100 mg for subjects 20 to < 40 kg. Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.
400 mg administered subcutaneously every 4 weeks for subjects >= 40 kg or 200 mg for subjects 20 to < 40 kg. Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.
If a subject had not been previously reinduced in C87035, the subject is eligible for 1 reinduction due to loss of response in CR0012. Reinduction Week 0 (first reinduction dose) is followed by Reinduction Week 2 (second dose, 2 weeks after first dose), and Reinduction Week 4 (third dose, 2 weeks after second dose). The reinduction dose was adjusted to the subject’s weight: 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg subcutaneously Q2W for a total of 3 doses. After reinduction was complete participants continued dosing with CZP administered subcutaneously Q4W as 400 mg for subjects ≥ 40 kg or 200mg for subjects 20 to < 40 kg, regardless of the subject’s previous randomized dose group). Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.
Overall Number of Participants Analyzed 4 10 2
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2
  20.0%
0
   0.0%
3.Secondary Outcome
Title Number of Subjects Who Develop Anti-nuclear Antibodies During the Study
Hide Description Anti-nuclear antibodies (ANA) are autoantibodies. ANA titers will be determined every 12 weeks starting at Week 14, and at the Completion/Early Termination and Safety Follow-Up (SFU) Visits.
Time Frame At the time of completion or termination visit (up to 298 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The Intention-to-Treat (ITT) Population included all subjects irrespective of any protocol deviations who received at least 1 injection of the study treatment and who had at least 1 efficacy measurement after the first injection of this study.
Arm/Group Title Certolizumab Pegol: Low-dose Group (Weight Adjusted) – (ITT) Certolizumab Pegol: High-dose Group (Weight Adjusted) – (ITT)
Hide Arm/Group Description:
200 mg administered subcutaneously every 4 weeks for subjects >= 40 kg or 100 mg for subjects 20 to &lt; 40 kg. Part of the Intention-to-Treat (ITT) Population included all subjects irrespective of any protocol deviations who received at least 1 injection of the study treatment and who had at least 1 efficacy measurement after the first injection of this study.
400 mg administered subcutaneously every 4 weeks for subjects >= 40 kg or 200 mg for subjects 20 to &lt; 40 kg. Part of the Intention-to-Treat (ITT) Population included all subjects irrespective of any protocol deviations who received at least 1 injection of the study treatment and who had at least 1 efficacy measurement after the first injection of this study.
Overall Number of Participants Analyzed 3 10
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
3
  30.0%
4.Secondary Outcome
Title Number of Subjects Who Develop Double-stranded Deoxyribonucleic Acid (dsDNA) Antibodies During the Study
Hide Description Anti-dsDNA are autoantibodies. Anti-dsDNA titers will be determined every 12 weeks starting at Week 14, and at the Completion/Early Termination and Safety Follow-Up (SFU) Visits.
Time Frame At the time of completion or termination visit (up to 298 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The Intention-to-Treat (ITT) Population included all subjects irrespective of any protocol deviations who received at least 1 injection of the study treatment and who had at least 1 efficacy measurement after the first injection of this study.
Arm/Group Title Certolizumab Pegol: Low-dose Group (Weight Adjusted) – (ITT) Certolizumab Pegol: High-dose Group (Weight Adjusted) – (ITT)
Hide Arm/Group Description:
200 mg administered subcutaneously every 4 weeks for subjects >= 40 kg or 100 mg for subjects 20 to &lt; 40 kg. Part of the Intention-to-Treat (ITT) Population included all subjects irrespective of any protocol deviations who received at least 1 injection of the study treatment and who had at least 1 efficacy measurement after the first injection of this study.
400 mg administered subcutaneously every 4 weeks for subjects >= 40 kg or 200 mg for subjects 20 to &lt; 40 kg. Part of the Intention-to-Treat (ITT) Population included all subjects irrespective of any protocol deviations who received at least 1 injection of the study treatment and who had at least 1 efficacy measurement after the first injection of this study.
Overall Number of Participants Analyzed 3 10
Measure Type: Count of Participants
Unit of Measure: Participants
Subjects
0
   0.0%
0
   0.0%
5.Secondary Outcome
Title Percentage of Subjects in Clinical Remission
Hide Description Percentage of subjects in clinical remission (clinical remission is defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score ≤ 10)
Time Frame At the time of completion or termination visit (up to 298 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The Intention-to-Treat (ITT) Population included all subjects irrespective of any protocol deviations who received at least 1 injection of study treatment in this study and who had at least 1 efficacy measurement after the first injection of this study.
Arm/Group Title Certolizumab Pegol: Low-dose Group (Weight Adjusted) – (ITT) Certolizumab Pegol: High-dose Group (Weight Adjusted) – (ITT)
Hide Arm/Group Description:
200 mg administered subcutaneously every 4 weeks for subjects >= 40 kg or 100 mg for subjects 20 to < 40 kg. Part of the Intention-to-Treat (ITT) Population included all subjects irrespective of any protocol deviations who received at least 1 injection of the study treatment and who had at least 1 efficacy measurement after the first injection of this study.
400 mg administered subcutaneously every 4 weeks for subjects >= 40 kg or 200 mg for subjects 20 to < 40 kg. Part of the Intention-to-Treat (ITT) Population included all subjects irrespective of any protocol deviations who received at least 1 injection of the study treatment and who had at least 1 efficacy measurement after the first injection of this study.
Overall Number of Participants Analyzed 3 9
Measure Type: Number
Unit of Measure: Percentage of particpiants
100 44.4
Time Frame During study treatment (up to 303 weeks)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Certolizumab Pegol: Low-dose Group (Weight Adjusted) – (SS) Certolizumab Pegol: High-dose Group (Weight Adjusted) – (SS) Certolizumab Pegol: Re-Induction Group – (SS)
Hide Arm/Group Description 200 mg administered subcutaneously every 4 weeks for subjects >= 40 kg or 100 mg for subjects 20 to < 40 kg. Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study. 400 mg administered subcutaneously every 4 weeks for subjects >= 40 kg or 200 mg for subjects 20 to < 40 kg. Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study. If a subject had not been previously reinduced in C87035, the subject is eligible for 1 reinduction due to loss of response in CR0012. Reinduction Week 0 (first reinduction dose) is followed by Reinduction Week 2 (second dose, 2 weeks after first dose), and Reinduction Week 4 (third dose, 2 weeks after second dose). The reinduction dose was adjusted to the subject’s weight: 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg subcutaneously Q2W for a total of 3 doses. After reinduction was complete participants continued dosing with CZP administered subcutaneously Q4W as 400 mg for subjects ≥ 40 kg or 200mg for subjects 20 to < 40 kg, regardless of the subject’s previous randomized dose group). Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.
All-Cause Mortality
Certolizumab Pegol: Low-dose Group (Weight Adjusted) – (SS) Certolizumab Pegol: High-dose Group (Weight Adjusted) – (SS) Certolizumab Pegol: Re-Induction Group – (SS)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)      0/10 (0.00%)      0/2 (0.00%)    
Hide Serious Adverse Events
Certolizumab Pegol: Low-dose Group (Weight Adjusted) – (SS) Certolizumab Pegol: High-dose Group (Weight Adjusted) – (SS) Certolizumab Pegol: Re-Induction Group – (SS)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/4 (0.00%)      4/10 (40.00%)      1/2 (50.00%)    
Gastrointestinal disorders       
Crohn's disease * 1  0/4 (0.00%)  0 1/10 (10.00%)  1 1/2 (50.00%)  1
Small intestinal obstruction * 1  0/4 (0.00%)  0 1/10 (10.00%)  1 0/2 (0.00%)  0
Infections and infestations       
Anal abscess * 1  0/4 (0.00%)  0 0/10 (0.00%)  0 1/2 (50.00%)  1
Gastritis viral * 1  0/4 (0.00%)  0 1/10 (10.00%)  1 0/2 (0.00%)  0
Pancreatitis viral * 1  0/4 (0.00%)  0 1/10 (10.00%)  1 0/2 (0.00%)  0
Psychiatric disorders       
Suicide attempt * 1  0/4 (0.00%)  0 1/10 (10.00%)  1 0/2 (0.00%)  0
1
Term from vocabulary, MedDRA20.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Certolizumab Pegol: Low-dose Group (Weight Adjusted) – (SS) Certolizumab Pegol: High-dose Group (Weight Adjusted) – (SS) Certolizumab Pegol: Re-Induction Group – (SS)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/4 (50.00%)      5/10 (50.00%)      2/2 (100.00%)    
Blood and lymphatic system disorders       
Iron deficiency anaemia * 1  0/4 (0.00%)  0 1/10 (10.00%)  1 0/2 (0.00%)  0
Gastrointestinal disorders       
Abdominal pain upper * 1  0/4 (0.00%)  0 4/10 (40.00%)  5 0/2 (0.00%)  0
Nausea * 1  0/4 (0.00%)  0 2/10 (20.00%)  2 0/2 (0.00%)  0
Stomatitis * 1  0/4 (0.00%)  0 1/10 (10.00%)  1 1/2 (50.00%)  1
Abdominal tenderness * 1  0/4 (0.00%)  0 1/10 (10.00%)  1 0/2 (0.00%)  0
Anal fissure * 1  0/4 (0.00%)  0 0/10 (0.00%)  0 1/2 (50.00%)  1
Crohn's disease * 1  0/4 (0.00%)  0 0/10 (0.00%)  0 1/2 (50.00%)  1
Diarrhoea * 1  0/4 (0.00%)  0 1/10 (10.00%)  1 0/2 (0.00%)  0
Dyspepsia * 1  0/4 (0.00%)  0 1/10 (10.00%)  1 0/2 (0.00%)  0
Gastritis * 1  0/4 (0.00%)  0 1/10 (10.00%)  1 0/2 (0.00%)  0
Oesophagitis * 1  1/4 (25.00%)  1 0/10 (0.00%)  0 0/2 (0.00%)  0
Tooth impacted * 1  0/4 (0.00%)  0 1/10 (10.00%)  1 0/2 (0.00%)  0
Vomiting * 1  0/4 (0.00%)  0 1/10 (10.00%)  2 0/2 (0.00%)  0
General disorders       
Chest pain * 1  0/4 (0.00%)  0 1/10 (10.00%)  1 0/2 (0.00%)  0
Chills * 1  0/4 (0.00%)  0 1/10 (10.00%)  1 0/2 (0.00%)  0
Fatigue * 1  0/4 (0.00%)  0 1/10 (10.00%)  1 0/2 (0.00%)  0
Pain * 1  0/4 (0.00%)  0 1/10 (10.00%)  2 0/2 (0.00%)  0
Pyrexia * 1  0/4 (0.00%)  0 1/10 (10.00%)  1 0/2 (0.00%)  0
Infections and infestations       
Nasopharyngitis * 1  0/4 (0.00%)  0 2/10 (20.00%)  2 0/2 (0.00%)  0
Ear infection * 1  0/4 (0.00%)  0 1/10 (10.00%)  2 0/2 (0.00%)  0
Furuncle * 1  0/4 (0.00%)  0 0/10 (0.00%)  0 1/2 (50.00%)  1
Localised infection * 1  0/4 (0.00%)  0 1/10 (10.00%)  1 0/2 (0.00%)  0
Pharyngitis streptococcal * 1  0/4 (0.00%)  0 1/10 (10.00%)  1 0/2 (0.00%)  0
Upper respiratory tract infection * 1  0/4 (0.00%)  0 1/10 (10.00%)  1 0/2 (0.00%)  0
Injury, poisoning and procedural complications       
Abdominal injury * 1  0/4 (0.00%)  0 0/10 (0.00%)  0 1/2 (50.00%)  1
Procedural pain * 1  0/4 (0.00%)  0 1/10 (10.00%)  1 0/2 (0.00%)  0
Investigations       
C-reactive protein increased * 1  0/4 (0.00%)  0 0/10 (0.00%)  0 1/2 (50.00%)  1
Haemoglobin decreased * 1  0/4 (0.00%)  0 0/10 (0.00%)  0 1/2 (50.00%)  1
Ultrasound abdomen * 1  0/4 (0.00%)  0 1/10 (10.00%)  1 0/2 (0.00%)  0
Vitamin D decreased * 1  0/4 (0.00%)  0 1/10 (10.00%)  1 0/2 (0.00%)  0
Metabolism and nutrition disorders       
Vitamin D deficiency * 1  0/4 (0.00%)  0 1/10 (10.00%)  2 0/2 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Pain in extremity * 1  0/4 (0.00%)  0 2/10 (20.00%)  2 0/2 (0.00%)  0
Arthralgia * 1  0/4 (0.00%)  0 1/10 (10.00%)  5 0/2 (0.00%)  0
Back pain * 1  0/4 (0.00%)  0 1/10 (10.00%)  1 0/2 (0.00%)  0
Joint stiffness * 1  0/4 (0.00%)  0 1/10 (10.00%)  2 0/2 (0.00%)  0
Nervous system disorders       
Dizziness * 1  1/4 (25.00%)  1 1/10 (10.00%)  2 0/2 (0.00%)  0
Headache * 1  0/4 (0.00%)  0 1/10 (10.00%)  3 0/2 (0.00%)  0
Psychiatric disorders       
Enuresis * 1  0/4 (0.00%)  0 0/10 (0.00%)  0 1/2 (50.00%)  1
Respiratory, thoracic and mediastinal disorders       
Dysmenorrhoea * 1  1/4 (25.00%)  1 0/10 (0.00%)  0 0/2 (0.00%)  0
Cough * 1  1/4 (25.00%)  1 1/10 (10.00%)  6 0/2 (0.00%)  0
Asthma exercise induced * 1  1/4 (25.00%)  1 0/10 (0.00%)  0 0/2 (0.00%)  0
Epistaxis * 1  0/4 (0.00%)  0 1/10 (10.00%)  1 0/2 (0.00%)  0
Nasal congestion * 1  0/4 (0.00%)  0 1/10 (10.00%)  1 0/2 (0.00%)  0
Oropharyngeal pain * 1  0/4 (0.00%)  0 1/10 (10.00%)  1 0/2 (0.00%)  0
Rhinorrhoea * 1  0/4 (0.00%)  0 1/10 (10.00%)  2 0/2 (0.00%)  0
Skin and subcutaneous tissue disorders       
Ingrowing nail * 1  0/4 (0.00%)  0 1/10 (10.00%)  2 0/2 (0.00%)  0
1
Term from vocabulary, MedDRA20.1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB
Organization: Cares
Phone: +1844599 ext 2273
EMail: UCBCares@ucb.com
Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01190410    
Other Study ID Numbers: CR0012
First Submitted: August 25, 2010
First Posted: August 27, 2010
Results First Submitted: November 27, 2018
Results First Posted: March 26, 2019
Last Update Posted: March 26, 2019