Induction Optimization with Stelara for Crohn s Disease

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 18 years - 70 years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. History of Crohn’s disease for at least 3 months confirmed by colonoscopy and/or cross sectional imaging reviewed by the PI
    2. Moderate to Severe Crohn’s disease
    3. Either a C-reactive protein (CRP)>8mg/L or a fecal calprotectin > 250ug/g within 4 weeks of starting ustekinumab
    4. Stable Concomitant medications (prior to first dose of ustekinumab):
      • Stable dose of 6-MP, azathioprine, or methotrexate for at least 4 weeks
      • Stable dose of oral mesalamine for at least 2 weeks
      • Stable dose of prednisone of 20mg or less or budesonide 9mg daily for at least 2 weeks
    5. Female participants must be postmenopausal
    6. Must use highly effective method of birth control
    7. Must not be pregnant

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

    1. Past Stelara or anti-IL 23 use
    2. Active infection
    3. Has any known malignancy or has a history of malignancy
    4. Indeterminate colitis
    5. Active perianal fistula as the primary symptom
    6. Fibrostenotic disease with primarily obstructive symptoms
    7. Hospitalization within the past 2 weeks
    8. Bowel resection within the past 4 weeks
    9. Subtotal colectomy
    10. Permanent Ileostomy
    11. Is infected with human immunodeficiency virus (HIV; positive serology for HIV antibody)
    12. Has a concomitant diagnosis or any history of congestive heart failure or demyelinating disease
    13. Has current signs or symptoms, or a history of severe, progressive, or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic, systemic lupus erythematosus, or psychiatric diseases.
    14. Has a transplanted organ
    15. Has a history of lymphoproliferative disease
    16. Has previously undergone allergy immunotherapy for prevention of anaphylactic reactions
    17. Is unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access to veins
    18. Has known allergies, hypersensitivity, or intolerance to ustekinumab or excipients
    19. Has a clinically significant substance abuse problem
    20. Any biologic or small molecule therapy within 4 weeks of start of ustekinumab
    21. Positive quantiferon gold that is not being treated and followed by Infectious Disease
    22. Tests positive for HBV surface antigen (HBsAg)
    23. Have immune deficiency syndrome
    24. Is seropositive for antibodies to hepatitis C (HCV)

If you are registered as a volunteer, please log in to contact the study team/express interest in this study.