Study of Infliximab and Immunosuppressive Drugs for Treating Crohns Disease in Children Aged 6 to 18

What this Trial Is About

Researchers are evaluating the effectiveness and safety of infliximab alone compared to a combination of infliximab and immunosuppressive therapy in children with Crohns disease. This randomized controlled trial focuses on pediatric patients aged 6 to 18 years who have moderate to severe disease activity as measured by clinical and endoscopic scores. The study aims to provide important information about treatment options for pediatric Crohns disease. Participants receive infliximab infusions at 0, 2, and 6 weeks, followed by maintenance doses every 8 weeks. Those in the combination group also take immunomodulatory drugs such as azathioprine daily or methotrexate weekly at specified doses. The trial compares this combined therapy to infliximab alone over time to assess differences in outcomes. During the study, children will undergo regular assessments including clinical remission and endoscopic remission evaluations at week 54. Disease activity will be monitored frequently using the Pediatric Crohns Disease Activity Index at multiple time points throughout the trial. Safety and treatment response will be carefully observed under medical supervision from the start through the study completion.

Combined Immunosuppression for Pediatric Crohn's Disease