The Use of Certolizumab Pegol for Treatment of Active Crohn's Disease in Children and Adolescents
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: Certolizumab Pegol; Certolizumab Pegol
Intervention description: 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; 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 MeSH terms: Certolizumab Pegol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 99.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Certolizumab Pegol; Cimzia ®; Crohn's Disease

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