safety and immunogenicity of a tnfa kinoid in patients with crohn's disease

Conditions: Crohn's Disease

Summary: evaluation of the safety and the immune response induced by active immunization through a tnfa kinoid in patients with crohn's disease.


Eligibility criteria:
inclusion criteria: * subjects must have active crohn's disease, as defined by a crohn's disease activity index (cdai) score of \>220 but ≤400, with active crohn's disease of ileum and/or colon (other areas may be involved if ileum and/or colon are also involved)based upon either endoscopic, histologic and/or radiographic evidence * patients with active disease despite treatment with 5-asas or sulfasalazine, corticosteroids (prednisone, budesonide, other), aza or 6-mp or cyclosporine or mtx or tacrolimus, ; or intolerant of 5-asas or sulfasalazine; or intolerant of antibiotics; or intolerant of corticosteroids (prednisone, budesonide, other); or intolerant of aza or 6-mp or cyclosporine or mtx or tacrolimus * patients might have previously responded to any prior anti-tnf agents and then lost response or might be intolerant of any prior anti-tnf agents * positive skin reaction to challenge with candida antigens * written informed consent exclusion criteria: * prior history of tuberculosis or positive chest x ray or positive purified protein derivative skin test or positive interferon gamma tb assay * signs or symptoms of clinically significant stricture of bowel. * total parenteral nutrition or elemental diet required for treatment of disease or support of short bowel syndrome * presence of an enteric stoma * imminent or urgent surgery required for infection, abscess, bleeding or any other cause relating to their crohn's disease or other condition * history of malignancy. however, subjects with basal call carcinomas or less than 3 squamous cell carcinomas are allowed * history of asthma or serious allergic condition (including history of seafood allergy) * serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia) within the 3 months prior to the first dose of study drug * history of opportunistic infection excluding oral candidiasis on steroids * enteric infection as evidenced by positive stool c\&s, o\&p and c. difficile obtained during screening * any significant or decompensated cardiac, neurologic, liver, pulmonary or renal disease * history of lymphoproliferative disorders * clinically significant abnormal hematology values, as determined by the investigator, for hematocrit, hemoglobin, white blood cell count or platelets * clinically significant abnormal blood chemistry values as determined by the investigator * current significant drug or alcohol abuse as determined by the investigator * positive for hepatitis c antibody or positive for hepatitis b surface antigen (hbsag) or hiv infection * surgery within the previous 3 months (other than minor cosmetic surgery or minor dental procedures) * participation in a clinical study (including previous participation in this study) within the previous 4 months * had a primary non-response to any prior anti-tnf agents as defined by the investigator or received any prior anti-tnf agents within the past 8 weeks prior to study entry * pregnancy and lactation

Keywords: anti-tnfa immunization kinoid crohn's disease