Cure8 trial brief
Perianal fistulas are a common, disabling complication of Crohn's disease; a trial focused on fistulizing disease tests whether ustekinumab can achieve clinical and MRI-based healing, which is directly relevant to patients with perianal disease.
Adults with Crohn's disease and perianal fistulas, clinicians managing complex perianal Crohn's disease, and researchers studying biologic treatments or biomarkers of fistula healing.
The trial enrolled adults with moderate–severe Crohn's disease and at least one active perianal fistula, including both anti-TNF–naïve and anti-TNF–refractory patients. Patients were randomized to receive intravenous ustekinumab induction (6 mg/kg) followed by subcutaneous maintenance (90 mg every 8 weeks) or matched placebo.
The primary outcome was combined clinical and radiologic remission at week 12 (no external drainage from fistula openings plus no collections >2 cm on central MRI).
Secondary outcomes included clinical response, radiologic remission at multiple time points, quality-of-life measures, and correlation of response with ustekinumab trough levels and anti-drug antibodies.
What this record does not say: This ClinicalTrials.gov record is a trial registration and summary of the study design, endpoints, and eligibility; it does not report the trial results or safety findings here.
For efficacy and safety outcomes, consult the full posted results on ClinicalTrials.gov, peer-reviewed publications, or regulatory communications if available.
This entry is a ClinicalTrials.gov trial record (Phase IV, completed) describing study design, endpoints, and planned biomarker assessments (trough levels and anti-drug antibodies). The record does not include outcome data in the supplied text; look for posted results or publications for findings.
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
Perianal fistulas are a serious complication of Crohn’s disease with limited high-quality trial evidence. This randomized trial suggests ustekinumab may increase the chance of combined clinical and MRI remission at 12...
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