The purpose of this study is to evaluate the safety, tolerance and efficacy of subcutaneous SCH 52000 (rHuIL-10) in steroid-dependent Crohn's Disease subjects. Efficacy will be defined as the ability to wean off steroids by Week 16 and to maintain clinical remission (CDAI<150) at the end of 28 weeks of treatment without the need for additional significant CD management. Crohn's disease is a chronic inflammatory bowel disease (IBD) that can affect any segment of the GIT. Currently used anti-inflammatory drugs include the use of corticosteroids which inhibit synthesis of almost all cytokines. ALthough corticosteroids are highly effetive in improving symptoms, steroid weaning may be difficult without relapses. Past studies have shown that at least 20% of all Crohn's Disease subjects are cortico-dependent. Interleukin-10 (IL-10) can down-regulate both the secretion and gene transcription of IL-1B and TNF (proinflammatory cytokines) and can hence be used in Crohn's disease for its anti-inflammatory effects. Several human studies have shown that SCH 52000 administration to be safe and well tolerated in a large population of subjects with Crohn's disease. This is a Phase II/III randomized, multicenter, double-blind, placebo-controlled study. Subjects will be randomized (1:1:1) to receive 4.0 or 8 mcg/kg of SCH 52000 or placebo. the randomization will be stratified based on concomitant use of immunosuppressive therapy. SCH 52000 or placebo will be administered via SC injection QD for 2 weeks followed by TIW for 26 weeks. The follow-up phase will be 8 weeks. Subjects will undergo a steroid taper according to protocol and must be weaned off by Week 16. This study will require 9 office visits, 2 scheduled phonecalls from the study coordinator and one solely for blood tests. During the screening visit, informed consent, history and physical examination will be undertaken. In addition, blood, urine and stool tests will be done. An electrocardiogram (EKG) and Chest X-ray (CXR) will also be done unless there were normal within the previous 6 months. For the other visits, the same procedure will be undertaken except no further EKG or CXR will be done. A Quality of life questionnaire will be asked for.
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