A Trial of Rosiglitazone for Ulcerative Colitis

INCLUSION CRITERIA: Participants must meet the following criteria for inclusion in the trial: Must sign and date the informed consent form At least 18 years of age Documented diagnosis (endoscopic, surgical or x-ray) of ulcerative colitis (UC) Mild to moderate ulcerative colitis indicated by Disease Activity Index score of greater than or equal to 4 and less than or equal to 10 Unless the patient is intolerant of oral 5-ASA therapy, patient must be treated with a minimum of 2 gm daily of an oral 5-ASA agent for a minimum of 4 weeks during the current exacerbation of ulcerative colitis or immediately prior to study entry If treated with oral corticosteroids, dose must not exceed 20 mg per day of Prednisone or equivalent If treated with corticosteroids, dose must be stable for 4 weeks prior to study entry and remain on same dose throughout If treated with 6-mercaptopurine or azathioprine, must have been on medication for 4 months and a stable dose for 2 months prior to study entry If a female of childbearing age, the participant must have a negative serum pregnancy test and have been using a medically approved form of contraceptive birth control for 3 months prior to enrollment. Participants, both male and female, must also be willing to use medically approved contraceptive birth control (at least one barrier method) throughout the study If treated with rectal therapy, dose must be stable for 2 weeks prior to study entry and remain on same dose throughout EXCLUSION CRITERIA: Participants will be ineligible for participation in the trial if they meet any of the following criteria: Severe ulcerative colitis indicated by Disease Activity Index score of greater than 10 Class III or IV congestive heart failure by NYHA classification system Allergy to thiazolidinediones Presence of any medical condition with an expected survival of less than 1 year Participants receiving therapy with cyclosporin, anti-TNF therapy, or methotrexate within the last 2 months of screening Positive stool culture for enteric pathogens (salmonella, shigella, and campylobacter), positive C.difficile toxin, or positive stool ova and parasite exam Positive proteinuria by urine dipstick History of chronic liver disease or baseline liver chemistries greater than the upper limit of normal Diabetes mellitus requiring hypoglycemic agents Participation in study of experimental therapy within 2 months of first screening visit Has any of the following laboratory abnormalities: WBC < 3,000 per uL, Neutrophil < 1,000 cell/cu.mm, Platelets <75,000 per uL, INR > 1.2 Participant is female and is pregnant or currently breastfeeding