Proactive infliximab optimization using a pharmacokinetic dashboard versus standard of care in patients with Crohn s disease: The OPTIMIZE Trial

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Crohn's Disease
  • Age: Between 16 Year(s) - 80 Year(s)
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Diagnosis of Crohn’s disease (CD) prior to screening using standard endoscopic, histologic, or radiologic criteria
    2. Moderately to severely active Crohn’s disease (CD)
    3. Physician intends to prescribe infliximab as part of the usual care of the participant.
    4. No previous use of infliximab
    5. Able to participate fully in all aspects of this clinical trial
    6. Written informed consent must be obtained and documented

You may not be eligible for this study if the following are true:

    1. Participants with any of the following CD-related complications:
      • Abdominal or pelvic abscess, including perianal
      • Presence of stoma or ostomy
      • Isolated perianal disease
      • Obstructive disease, such as obstructive stricture
      • Short gut syndrome
      • Toxic megacolon or any other complications that might require surgery, or any other manifestation that precludes or confounds the assessment of disease activity (CDAI or SES-CD)
      • Total colectomy
    2. History or current diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, colonic mucosal dysplasia, or untreated bile acid malabsorption
    3. Current bacterial or parasitic pathogenic enteric infection, according to SOC assessments, including: Clostridioides difficile; tuberculosis; known infection with hepatitis B or C virus; known infection with HIV; sepsis; abscesses
    4. Has any malignancy or lymphoproliferative disorder other than nonmelanoma cutaneous malignancies or cervical carcinoma in situ that has been treated with no evidence of recurrence within the last 5 years
    5. Known primary or secondary immunodeficiency
    6. PNR to adalimumab
    7. Participants with failure to a prior biologic, defined as PNR, SLR, or intolerance
    8. Concomitant use of oral CS therapy exceeding prednisone 40 mg/day, budesonide 9 mg/day, or equivalent
    9. Presence of any medical condition or use of any medication that is a contraindication for IFX use
    10. A concurrent clinically significant, serious, unstable, or uncontrolled underlying cardiovascular, pulmonary, hepatic, renal, gastronintestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder that, in the opinion of the investigator, might confound the study results, pose additional risk to the participant, or interfere with the participant’s ability to participate fully in the study
    11. Pregnant or lactating women
    12. Known intolerance or hypersensitivity to infliximab or other murine proteins

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