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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 Crohns disease. 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 Crohns disease. 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 Crohns disease 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 maintenance
period (double blinded, placebo controlled) where
you will continue to receive 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

Study Summary:

Detailed Study Description:

Study Design: Interventional
Phase of Study: n/a
Study Type: Interventional
Condition or Study Focus: Crohn's Disease
Intervention Type: Drug
Intervention Name: Abatacept
Gender: Male and Female
Age group: Interventional
Sponsor: Bristol Myers Squibb