Clinical trial NCT00899678: The Use of Certolizumab Pegol for Treatment of Active Crohn's Disease in Children and Adolescents
Official 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Crohn's Disease
Keywords: Certolizumab Pegol
Cimzia ®
Crohn's Disease
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2009-05-12
Enrollment: 99
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

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

Primary outcomes:
measure: Percentage of Subjects in Clinical Remission at Week 62
timeFrame: Week 62
Secondary outcomes:
measure: Absolute Pediatric Crohn's Disease Activity Index (PCDAI) Scores at Week 62
timeFrame: Week 62
measure: Change in Pediatric Crohn's Disease Activity Index (PCDAI) Scores From Week 0 to the End of the Study (Week 62)
timeFrame: From Week 0 to Week 62
measure: Percentage of Subjects Achieving Clinical Response From Week 0 to the End of the Study (Week 62)
timeFrame: From Week 0 to Week 62
measure: C-Reactive Protein (CRP) Levels at Week 62
timeFrame: Week 62
measure: Change in C-Reactive Protein (CRP) Levels From Week 0 to the End of the Study (Week 62)
timeFrame: From Week 0 to Week 62
measure: Erythrocyte Sedimentation Rate (ESR) at Week 62
timeFrame: Week 62
measure: Change in Erythrocyte Sedimentation Rate (ESR) From Week 0 to the End of the Study (Week 62)
timeFrame: From Week 0 to Week 62
measure: Change in Growth Scores (Tanner Stage [Assessing Puberty]) From Week 0 to the End of the Study (Week 62)
timeFrame: From Week 0 to Week 62
measure: Percentage of Subjects Who Initiated Steroid Tapering
timeFrame: From Week 2 up to Week 8
measure: Percentage of Subjects in Corticosteroid-free Remission at the End of the Study
timeFrame: Last/Withdrawal Visit (up to Week 62)
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Los Angeles
country: United States
state: California
city: Orange
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Hartford
country: United States
state: Connecticut
city: Orlando
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Lexington
country: United States
state: Kentucky
city: Shreveport
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Rochester
country: United States
state: Minnesota
city: Morristown
country: United States
state: New Jersey
city: New Hyde Park
country: United States
state: New York
city: Cincinnati
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Seattle
country: United States
state: Washington
city: Milwaukee
country: United States
state: Wisconsin
city: Randwick
country: Australia
state: New South Wales
city: Herston
country: Australia
state: Queensland
city: Parkville
country: Australia
state: Victoria
city: Edmonton
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Halifax
country: Canada
state: Nova Scotia
city: Hamilton
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Grafton
country: New Zealand
state: Auckland
city: Christchurch
country: New Zealand
state: Canterbury
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: