Efficacy of Infliximab in the Treatment of Patients Affected by Corticodependent Crohn's Disease (P02732)

Exclusion Criteria

• •Patients with abscesses or active perianal diseases.
• •Clinically symptomatic and/or with retrodilatation intestinal stenosis.
• •Patients previously treated with infliximab.
• •Patients with history of allergy to murine proteins.
• •Treatment with immunosuppressant such as AZA, 6-mercaptopurine, methotrexate and cyclosporine A during the previous 3 months.
• •Positive feces exams for intestinal pathogens, parasitic or toxin of clostridium difficilis.
• •Tuberculosis (TBC) both active and inactive, evaluated by means of a detailed description (personal history of tuberculosis or possible previous contact with a source of TBC infection), and appropriate screening tests, Thorax Rx, tuberculin test.
• •Ongoing infections due to CMV, pneumocystis carinii, atypical mycobacterium. Proved HIV infection, presence of ARC or AIDS.
• •Necessity during the study of elective or emergency surgical operation.
• •Altered hepatic function: total bilirubin \>=1.5 times the upper limit of the normal ranges (UNL), AST (SGOT) \>=2 UNL, phosphatase alkaline \>=2.5 UNL, or PTT - INR \>=1.5 UNL.
• •Altered renal function: creatinine \>=1.5 mg.
• •Presence of serious concomitant illnesses (cardiac, pulmonary, neurological diseases).
• •History of pathology in charge of the haemopoietic system and of lymphoproliferative diseases such as lymphoma, lymphadenopathies of unusual localisation (i.e. at the nape, epitochlear or periaortic) or splenomegaly.
• •Presence of neoplastic or pre-neoplastic lesions, or history of neoplasm in the past 5 years.
• •Presence or history of drug or alcohol abuse.
• •Pregnant or lactating women.
• •Women of childbearing potential without adequate contraception except in case of surgical menopause. These methods of birth control should also be used during the 6 months after the last infusion.
• •Contraindications for AZA (i.e. lymphoproliferative diseases, leukopenia) and prednisolone (i.e. peptic ulcer, systemic fungal infections) as laid out in the summary of product characteristics.
• •Hyperamylasemia \>=1.5 times the upper limit of the normal ranges.