Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Crohn's Disease

Inclusion Criteria

• Subjects between the ages of 6 and 17, inclusive, prior to baseline dosing.
• Subjects with a diagnosis of Crohn's disease for greater than 12 weeks prior to screening, confirmed by endoscopy or radiologic evaluation.
• PCDAI > 30 despite concurrent treatment with an oral corticosteroid, and/or azathioprine (AZA) or 6-mercaptopurine (6-MP) or methotrexate (MTX) as defined below:
• Oral corticosteroid - Prednisone of ≥ 10 mg/day or equivalent, but not exceeding 40 mg, with a stable dose for at least two weeks prior to Baseline.
• Azathioprine or 6-MP - AZA dose of ≥ 1.5 mg/kg/day or 6-MP dose of ≥ 1 mg/kg/day rounded to the nearest available tablet formulation, or a dose that is the highest tolerated for the subject, in the opinion of the investigator (for example due to leukopenia, elevated liver enzymes, nausea, etc.) for at least 8 weeks prior to Baseline with a stable dose for at least 4 weeks prior to Baseline.
• MTX dose of ≥ 5 mg once weekly, either subcutaneously (SC), intramuscularly (IM), or orally for subjects whose body weight is ≥ 20 kg, or a dose that is the highest tolerated for the subject, in the opinion of the investigator (for example due to leukopenia, elevated liver enzymes, nausea, etc.) for at least 8 weeks prior to Baseline with a stable dose for at least 4 weeks prior to Baseline.
• MTX dose of 0.2 mg/kg, up to 5 mg, once weekly, either SC, IM, or orally for subjects whose body weight is 1.75 x the upper limit of the reference range;
• Total bilirubin ≥ 3 mg/dL;
• Serum creatinine > 1.6 mg/dL;
• Subjects on AZA, 6-MP, or MTX who had not been on these medications for at least 8 weeks prior to Baseline and on stable doses of these medications for at least 4 weeks prior to Baseline. Subjects who had been on AZA, 6-MP, or MTX who had discontinued these medications within 8 weeks of Baseline.
• Subjects on aminosalicylates, or Crohn's-related antibiotics (fluoroquinolones such as ciprofloxacin or nitroimidazole derivatives such as metronidazole) that had not been on stable doses of these medications for at least 4 weeks prior to Baseline. In addition, subjects on aminosalicylates or Crohn's-related antibiotic treatments who had discontinued these medications within four weeks of Baseline.
• Subjects on prednisone > 40 mg/day (or equivalent) or subjects on 9 mg/day and subjects who were not on stable doses for at least 2 weeks prior to Baseline. In addition, subjects who discontinued budesonide within 2 weeks of Baseline.
• Subjects who were currently taking both budesonide and prednisone (or equivalent).
• Subjects who had undergone therapeutic enemas within two weeks prior to Baseline.
• Subjects who had been on cyclosporine (intravenous [IV], oral), tacrolimus (any form), or mycophenolate mofetil within 28 days of Baseline.
• Subjects who had been on Kineret® (anakinra) must discontinue use 2 days prior to Baseline.
• Subjects with any prior exposure to Tysabri (natalizumab).
• Subjects with known hypersensitivity to the excipients of adalimumab as stated in the label.
• Subjects with a previous history of dysplasia of the gastrointestinal tract.
• Subjects who weighed < 17 kg at Screening.
• Subject not in compliance with prior and concomitant medications.