Budesonide 9 mg Capsules in Active UC

Inclusion Criteria: * Signed informed consent, * Men or women aged 18 to 75 years, * Active ulcerative colitis, except proctitis limited to 15 cm ab ano, confirmed by endoscopy and histology, * Established disease, Exclusion Criteria: * Crohn's disease, indeterminate colitis, ischaemic colitis, radiation colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis, incomplete microscopic colitis), diverticular disease associated colitis, * Toxic megacolon or fulminant colitis, * Colon resection, * Evidence of infectious colitis (e.g., pathogenic bacteria or Clostridium difficile toxin in stool culture at screening), * Malabsorption syndromes, * Celiac disease, * Bleeding hemorrhoids, * Active peptic ulcer disease * Other inflammatory or bleeding disorders of the colon and intestine, or diseases that may cause diarrhea or gastrointestinal bleeding, * Hypertension, diabetes mellitus, osteoporosis, peptic ulcer disease, glaucoma, cataract, or infection if careful medical monitoring is not ensured, * Any severe infectious disease (e.g., tuberculosis, AIDS), * Severe co-morbidity substantially reducing life expectancy, * History of colorectal cancer, * History of cancer (other than colorectal) in the last 5 years, except for basal cell carcinoma