CHARMA Multi-Center Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Crohn's Disease

Date de début de l'étude : 1 juillet 2003

Inclusion: * Males and females between the ages of 18 and 75 who are diagnosed with moderate to severe Crohn's Disease defined by a CDAI score of \>= 220 and \<= 450, normal laboratory parameters, * are willing and able to give informed consent, and * are able to self-inject or have a designee or healthcare professional who can inject the study medication. Exclusion: * History of certain types of cancer, diagnosis of ulcerative colitis, * female or breast feeding subjects, * surgical bowel resection(s) with in the past 6 months, * history of listeria, * human immunodeficiency virus (HIV), * central nervous system demyelinating disease or untreated TB, * history of a poorly controlled medical condition, * unsuccessful response to infliximab or any anti-TNF agent use in the past.