Study Comparing Weekly vs. Bi-Weekly Subcutaneous Infliximab After Intravenous Dose Optimization for Adults with Inflammatory Bowel Diseases

What this Trial Is About

The trial investigates treatment options for adults with inflammatory bowel diseases IBD, including Crohns disease and ulcerative colitis, focusing on patients who were previously treated with an optimized dose of intravenous infliximab. The study aims to compare if switching to weekly subcutaneous infliximab leads to better clinical and biological remission outcomes than the standard bi-weekly subcutaneous administration. It also compares patients willing to switch to subcutaneous treatment with those continuing intravenous therapy. Participants who switch from intravenous infliximab will be randomly assigned to receive either 120 mg of subcutaneous infliximab weekly or every other week. Those not willing to switch will continue their existing intravenous dosing schedule. The study is conducted nationally with multiple centers, involving screening and follow-up visits over one year, with physical exams, clinical scoring, blood and stool analyses, and questionnaires about quality of life and treatment satisfaction. During the study, participants will have four visits with their gastroenterologist throughout one year, where clinical remission scores, lab tests, and medication use are assessed. Those on subcutaneous infliximab will keep a diary of at-home injections and complete satisfaction questionnaires. The primary measurement is the proportion of patients maintaining steroid-free clinical and biological remission without treatment changes at week 52. Researchers will also monitor treatment optimization, discontinuation, relapse timing, and patient experiences.

Subcutaneous Infliximab After A Previous Intravenous Dose Optimization