IT IS AN AUTONOMOUS BODY UNDER MINISTRY OF SKILL DEVELOPMENT, ENTREPRENEURSHIP, YOUTH AFFAIRS AND SPORTS, GOVERNMENT OF INDIA. IT IS ACCREDITED BY NATIONAL ACCREDITATION BOARD FOR TESTING & CALIBRATION LABORATORIES NDTL AT A GLANCE QUALITY POLICY
Study D9422C00002 was an open-label, un-comparative study designed to evaluate Entocort 6 mg once daily as maintenance treatment in 50 pediatric patients (children and adolescents aged 5 to 17 years) with a diagnosis of mild to moderate Crohn's disease of the ileum and/or ascending colon who were in clinical remission (PCDAI ≤10). Treatment consisted of a 12-week maintenance treatment phase of 6 mg once daily, a 2-week taper phase to 3 mg once daily. The median duration of treatment exposure of Entocort was days (range: 11 days to 135 days). Most patients remained in the clinical remission stage, as there were no major changes in the mean PCDAI composite score or IMPACT 3 score. Mean (SD) PCDAI was () at baseline and () after 12 weeks of maintenance treatment with Entocort 6 mg daily. At the same points in time the mean IMPACT3 score was () and (), respectively. AEs were observed at a similar frequency and severity as seen in adults, and were mostly related to Crohn's disease, puberty and possible GCS related side effects.