A Pharmacokinetic-pharmacodynamic Modeling and Simulation Study of Subcutaneous Infliximab in Patients With Inflammatory Bowel Disease

Inclusion criteria

• Patients with Crohns disease with a score on the Crohn's disease activity index between 220 and 450.
• Patients with active Ulcerative colitis as defined by a total Mayo score between 6 and 12 points (Part 2 only)

Exclusion criteria

• Patients who have previously received a biological agent for the treatment of CD and UC and/or a tumor necrosis factor-alpha (TNFa)-inhibitor for the treatment of other diseases.
• Patients who have allergies to any of the excipients of infliximab or any other murine and/or human proteins or patients with a hypersensitivity to immunoglobulin products.
• Patients who have a current or past history of infection with HIV, hepatitis B or C (carriers of hepatitis B and C are not permitted to enrol into the study, but past hepatitis B resolved can be enrolled).
• Patients who have acute infections requiring oral antibiotics within 2 weeks or parenteral injection of antibiotics within 4 weeks prior to the first administration of the study drug, other serious infection within 6 months prior to the first administration of the study drug or recurrent herpes zoster or other chronic or recurrent infection within 6 weeks prior to the first administration of the study drug.
• Patient who have an indeterminate result for interferon-y release assay (IGRA) or latent tuberculosis (TB) at Screening. For part 2, if IGRA result is indeterminate at the Screening, one retest will be possible during the screening. If the repeated IGRA result is negative, the patient can be included in the study.