National Study to Assess the Effectiveness and Safety of Granulocyte and Monocyte Apheresis GMA Using Adacolumn in Adults with Ulcerative Colitis or Crohns Disease in Real-World Practice

What this Trial Is About

Inflammatory bowel disease IBD, including ulcerative colitis UC and Crohns disease CD, involves chronic inflammation affecting the digestive tract with periods of flare-ups. This study evaluates the real-world effectiveness and safety of granulocytapheresis GMA using the Adacolumn device in adult patients with UC or CD. GMA selectively removes inflammatory cells from the blood to reduce inflammation and is considered as an alternative or complementary treatment to corticosteroids and biological therapies in IBD management. Participants will receive GMA treatment with Adacolumn, typically following the standard regimen of one session per week for five weeks. In some cases, induction regimens with two sessions per week or maintenance regimens with one to two sessions per month may be used. The study is noninterventional and conducted across about 30 sites, aiming to enroll approximately 350 patients. Treatment use and regimens will be observed according to routine clinical practice without interfering with patient care. Patients will be followed through up to four visits baseline, and follow-ups at about 1 month, 6 months, and 12 months after the last induction session. Data collection includes clinical remission rates, steroid use, adverse events, quality of life assessments, and biomarker changes. All assessments coincide with routine care visits. The primary outcome is the proportion of patients achieving steroid-free remission at six months, with additional secondary outcomes evaluating remission rates, treatment regimens, safety, and quality of life over 12 months.

National GMA Post-market Clinical Follow-up Study (GRACE)