EMA Articulates Trial Designs for Crohn’s Disease, Ulcerative Colitis, TB

The EMA is mapping out trial designs for the development of therapies to treat Crohn’s disease, ulcerative colitis and mycobacterium tuberculosis.

With the revised guidelines for the three indications, the agency is focusing on areas such as patient selection, efficacy trials and safety. None of these documents have been updated since 2008.

Each of the documents also provides disease-specific recommendations. For instance, drugmakers developing treatment options for Crohn’s disease should enroll only those patients who have active swelling of the mucus membrane as documented via endoscope or small intestine imaging.