Open label = Single dose administration of single dose Denosumab 120 mg subcutaneously

Crohn Disease

Denosumab

University of Manitoba

The Efficacy of Denosumab in Active Crohn's Disease

Denosumab (A Monoclonal Antibody to Receptor Activator of Nuclear Factor-Kappa B Ligand (RANKL) in Crohn's Disease

Decrease in CDAI to ≤150 points at 12 weeks.

In those with elevated fecal calprotectin at baseline, reduction in fecal calprotectin to <250 ug/g at week 12.

for those with increased CRP at baseline change in CRP to normal at week 12

For those who underwent endoscopy within 1 month of study enrollment as part of standard of care and who underwent a repeat endoscopy within 1 month of study completion as part of standard of care, improvement in endoscopy by Crohn's Disease Endoscopy Inflammation Score (CDEIS) between baseline and second endoscopy.

For those who underwent abdominal MRI within 1 month of study enrollment as part of standard of care and who underwent a repeat abdominal MRI within 1 month of study completion as part of standard of care then improvement in MRI findings by central reader (Dr H Greenberg) between baseline and second abdominal MRI.

Serum calcium will be assessed at 3 days post drug administration and every 4 weeks. There is a rare incidence of hypocalcemia with use of this drug. Osteonecrosis of the jaw will be assessed at every study visit. This drug is rarely associated with this outcome especially in cancer patients. Liver enzymes every 4 weeks will be assessed.

osteopetrosis/fatigue

The Efficacy of Denosumab in Active Crohn's Disease

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