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The purpose of this study is to see if the investigational use of abatacept is better than placebo (inactive substance) for the treatment of active ulcerative colitis. Abatacept was approved by the United States Food and Drug Administration (FDA) in December 2005 for the treatment of rheumatoid arthritis in the US and in June 2006 in Canada. A second purpose of this study is to evaluate the safety (possible side effects) of abatacept in patients with ulcerative colitis. The study will consist of three periods (Screening, Induction and maintenance) and an open-label extension phase. Studies with abatacept have been conducted in subjects with rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), lupus, psoriasis and multiple sclerosis (MS). In subjects who received abatacept, the most frequently reported side effects were: upper respiratory tract infections, nasopharyngitis (pain/ inflammation in the nose and throat), influenza, urinary tract infections, bronchitis, nausea, dyspepsia (abdominal discomfort), headache, dizziness, back pain, cough, and high blood pressure. Because abatacept suppresses the immune system, you may be more open to bacterial, viral and fungal infections

The study population will consist of men and
women, ages 18 and above, with active moderate to
severe ulcerative colitis for at least 3 months
prior to enrollment and who have had an inadequate
clinical response and/or intolerance to medical
therapy.

If eligible, you will be asked to come to Virginia
Mason Medical Center for a screening visit with
the study doctor. If after screening (blood draw,
Urinalysis, chest x-ray, and TB skin test) you are
still eligible, you will be randomized into the
treatment phase (Induction period which will be
double blinded, placebo controlled, for 12 weeks).
If you respond to the study drug during this phase
you will be re-randomized into the maintainance
period (double blinded, placebo controlled) where
you will continue to recieve the study drug for
12months. But if no response at induction period,
you will be re-randomized to the open label period
for at least 13months.

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