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Summary of Clinical Trial Findings
Background
Regulatory guidance for Crohn’s disease trials suggests using coprimary efficacy end points to evaluate symptoms and mucosal inflammation. This study aimed to assess the effectiveness of commonly used disease activity assessments alone and in combination.
Methods
- Endoscopic and clinical data from 129 participants in the Study of Biologic and Immunomodulator Naïve Patients in Crohn’s Disease trial were analyzed.
- Readers scored the Simple Endoscopic Score for Crohn’s Disease and the Crohn’s Disease Endoscopic Index of Severity using standardized conventions.
- Index reliability was determined using intraclass correlation coefficients, and index responsiveness was assessed based on treatment assignment.
Results
- When used as continuous measures, the Simple Endoscopic Score for Crohn’s Disease and Crohn’s Disease Endoscopic Index of Severity showed substantial inter-rater reliability.
- Composite outcomes including endoscopy were found to improve sensitivity to treatment effect.
Conclusion
The study concluded that endoscopic indices were more reliable as continuous measures, and composite outcomes including endoscopy improved sensitivity to treatment effect.
For full clinical trial report, click here.
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