Comparing Subcutaneous Infliximab Alone or With Immunosuppressive Drugs for Moderate to Severe Crohns Disease

What this Trial Is About

This research aims to compare the effectiveness of subcutaneous infliximab IFX with and without immunosuppressive medications in adults with moderate to severe Crohns disease. The study is designed as a prospective, multicenter, randomized controlled trial to assess whether IFX alone is no worse than IFX combined with immunosuppressants in helping patients achieve corticosteroid-free clinical remission and significant improvement in intestinal inflammation by week 26. Participants will be randomly assigned to one of two groups one receiving IFX alone via subcutaneous injections and the other receiving IFX along with immunosuppressive drugs such as 6-mercaptopurine or methotrexate. The IFX dosing schedule starts with 240 mg at weeks 0 and 2, followed by 120 mg every two weeks. The combination group will restart immunosuppressive therapy after screening, while the monotherapy group will not receive additional immunosuppression. The treatment period lasts 26 weeks. During the study, patients will undergo assessments including clinical symptom scoring, endoscopy to evaluate intestinal healing, blood and stool tests for inflammation markers, quality of life questionnaires, and drug level monitoring. Researchers will track adverse events and immune responses to IFX. The main outcome is the proportion of patients achieving corticosteroid-free remission and endoscopic improvement at 26 weeks. Participants progress will be monitored throughout the study duration to evaluate treatment effects and safety.

InDuctIon TREatment with SubCuTaneous Infliximab for Crohn's Disease