The Use of Certolizumab Pegol for Treatment of Active Crohn's Disease in Children and Adolescents

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)

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.

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