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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00899678




Registration number
NCT00899678
Ethics application status
Date submitted
29/04/2009
Date registered
8/05/2009
Date last updated
10/07/2018

Titles & IDs
Public title
The Use of Certolizumab Pegol for Treatment of Active Crohn's Disease in Children and Adolescents
Scientific title
A Phase 2, Open-label, Multicenter Study to Assess the Safety and Efficacy of Certolizumab Pegol in Children and Adolescents With Active Crohn's Disease (NURTURE Study)
Secondary ID [1] 0 0
2014-004381-24
Secondary ID [2] 0 0
C87035
Universal Trial Number (UTN)
Trial acronym
NURTURE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Certolizumab Pegol
Treatment: Drugs - Certolizumab Pegol

Active Comparator: Maintenance High-Dose - Maintenance High-Dose group: 400 mg Certolizumab Pegol for subjects = 40 kg or 200 mg Certolizumab Pegol for subjects 20 to < 40 kg

Active Comparator: Maintenance Low-Dose - Maintenance Low-Dose group: 200 mg Certolizumab Pegol for subjects = 40 kg or 100 mg Certolizumab Pegol for subjects 20 to < 40 kg


Treatment: Drugs: Certolizumab Pegol
400 mg administered subcutaneously at once every 4 weeks for subjects = 40 kg or 200 mg for subjects 20 to < 40 kg
*prior to this dosing regimen, subjects will undergo 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

Treatment: Drugs: Certolizumab Pegol
200 mg administered subcutaneously at once every 4 weeks for subjects = 40 kg or 200 mg for subjects 20 to < 40 kg
*prior to this dosing regimen, subjects will undergo 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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Subjects in Clinical Remission at Week 62 - 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.
Timepoint [1] 0 0
Week 62
Secondary outcome [1] 0 0
Absolute Pediatric Crohn's Disease Activity Index (PCDAI) Scores at Week 62 - 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.
Timepoint [1] 0 0
Week 62
Secondary outcome [2] 0 0
Change in Pediatric Crohn's Disease Activity Index (PCDAI) Scores From Week 0 to the End of the Study (Week 62) - 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.
Timepoint [2] 0 0
From Week 0 to Week 62
Secondary outcome [3] 0 0
Percentage of Subjects Achieving Clinical Response From Week 0 to the End of the Study (Week 62) - 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.
Timepoint [3] 0 0
From Week 0 to Week 62
Secondary outcome [4] 0 0
C-Reactive Protein (CRP) Levels at Week 62 - The C-Reactive Protein (CRP) is a considered marker of inflammation in subjects with Crohn's Disease (CD)
Timepoint [4] 0 0
Week 62
Secondary outcome [5] 0 0
Change in C-Reactive Protein (CRP) Levels From Week 0 to the End of the Study (Week 62) - 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.
Timepoint [5] 0 0
From Week 0 to Week 62
Secondary outcome [6] 0 0
Erythrocyte Sedimentation Rate (ESR) at Week 62 - The Erythrocyte Sedimentation Rate (ESR) is a considered biomarker of inflammation in subjects with Crohn's Disease (CD).
Timepoint [6] 0 0
Week 62
Secondary outcome [7] 0 0
Change in Erythrocyte Sedimentation Rate (ESR) From Week 0 to the End of the Study (Week 62) - 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.
Timepoint [7] 0 0
From Week 0 to Week 62
Secondary outcome [8] 0 0
Change in Growth Scores (Tanner Stage [Assessing Puberty]) From Week 0 to the End of the Study (Week 62) - 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.
Timepoint [8] 0 0
From Week 0 to Week 62
Secondary outcome [9] 0 0
Percentage of Subjects Who Initiated Steroid Tapering - 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.
Timepoint [9] 0 0
From Week 2 up to Week 8
Secondary outcome [10] 0 0
Percentage of Subjects in Corticosteroid-free Remission at the End of the Study - 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.
Timepoint [10] 0 0
Last/Withdrawal Visit (up to Week 62)

Eligibility
Key inclusion criteria
- Subjects with active Crohn's Disease (CD) confirmed 3 months prior to Screening

- Subjects with a Pediatric Crohn's Disease Activity Index (PCDAI) score of > 30 at Week
0

- Subjects between the ages of 6 and 17, inclusive, prior to baseline dosing

- Subjects must weigh > 20 kg (44 lbs)

- Subjects must have normal Electrocardiogram (ECG) or no medically relevant
abnormalities as assessed by the investigator

- Subjects must meet Tuberculosis (TB) screening criteria

- Subjects taking corticosteroids, antibiotics and analgesics must have stable dosing,
as defined, for one week
Minimum age
6 Years
Maximum age
17 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Subjects who score > 5 on the perirectal disease item of the PCDAI at Baseline

- Subjects who have had an active enterocutaneous fistulae within 3 months prior to
Baseline

- Subjects with non-enterocutaneous fistulae, signs or symptoms of bowel obstruction or
short bowel syndrome

- Subjects with a functional colostomy or ileostomy

- Subjects who have had surgical bowel resection within 6 months prior to Baseline or
who may be planning any resection while enrolled in the study

- Subjects with clinical suspicion of intraabdominal abscesses

- Subjects with a positive stool result for enteric pathogens and/or parasites

- Subject has received any investigational biological therapies (within or outside a
clinical trial) within 12 weeks prior to Screening or has been dosed in any clinical
trial using non biological therapies within 4 weeks prior to Screening

- Subjects who have lost response to another Tumor Necrosis Factor (TNF) agent

- Subjects may not use another TNF agent within 12 weeks of Screening Visit

- Subjects with any prior exposure to natalizumab

- Subjects who have received mycophenolate or thalidomide within 4 weeks prior to
Screening

- Subjects who have received cyclosporin or tacrolimus within 6 months prior to
Screening

- Subjects who have received parenteral corticosteroids within 2 weeks prior to
Screening

- Subjects who have received corticosteroids or corticotrophins for indications other
than CD within 2 weeks of Screening

- Subject has a current or recent history (within 6 months prior to Screening) of
significant and severe renal, hepatic, hematological, gastrointestinal (other than
CD), endocrine, pulmonary, cardiac, neurological, or cerebral disease including blood
dyscrasia (eg, pancytopenia, aplastic anemia), demyelinating disease (eg, multiple
sclerosis, myelitis, optic neuritis), or ischemic heart disease

- Subjects with a current sign or symptom indicating recent or chronic infections
(including herpes zoster)

- Subject has negative test for Immunoglobulin G (IgG) against Varicella zoster (chicken
pox)

- Subjects who have not completed their primary vaccination series, or are planning to
have a live vaccine administered during the study period or up to 3 months after last
dose of study drug

- Subject has a history of TB or a positive chest x-ray suggestive of TB

- Subjects with known concurrent viral hepatitis or Acquired Immune Deficiency Syndrome
(AIDS) or known Human Immunodeficiency Virus (HIV) infection

- Subjects with concurrent malignancy or history of malignancy, excluding treated
squamous cell carcinoma of the skin

- Subject has concurrent bowel dysplasia or a history of bowel dysplasia in the 5 years
prior to Screening

- Subjects with a history lymphoproliferative disorder including lymphoma or signs and
symptoms suggestive of lymphoma at any time

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
- Randwick
Recruitment hospital [2] 0 0
- Herston
Recruitment hospital [3] 0 0
- Parkville
Recruitment postcode(s) [1] 0 0
- Randwick
Recruitment postcode(s) [2] 0 0
- Herston
Recruitment postcode(s) [3] 0 0
- Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Louisiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
State/province [13] 0 0
Minnesota
Country [14] 0 0
United States of America
State/province [14] 0 0
New Jersey
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
Tennessee
Country [19] 0 0
United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Washington
Country [21] 0 0
United States of America
State/province [21] 0 0
Wisconsin
Country [22] 0 0
Canada
State/province [22] 0 0
Alberta
Country [23] 0 0
Canada
State/province [23] 0 0
British Columbia
Country [24] 0 0
Canada
State/province [24] 0 0
Nova Scotia
Country [25] 0 0
Canada
State/province [25] 0 0
Ontario
Country [26] 0 0
New Zealand
State/province [26] 0 0
Auckland
Country [27] 0 0
New Zealand
State/province [27] 0 0
Canterbury

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
UCB Celltech
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics, and
immunogenicity of certolizumab pegol treatment in pediatric subjects, aged 6 to 17, with
moderately to severely active Crohn's disease. The target enrollment is 160 subjects.
Trial website
https://clinicaltrials.gov/show/NCT00899678
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
UCB Clinical Trial Call Center
Address 0 0
+1 877 822 9493 (UCB)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00899678