A Trial for Prevention of Loss of the Effect of Biological Drugs in Patients With Inflammatory Bowel Disease

Inclusion Criteria

• •1. Diagnosis of CD or UC according to validated criteria, with a Crohn's Disease Activity Score (CDAI) of 200-450 at inclusion.
• •2. Patients on a stable dose within the last 6 weeks of any type of anti TNF agent or any other biological agent
• •3. 5-ASA (mesalamine), and immunomodulatory, or immunosuppressive agent, and symptomatic relief (anti-diarrheals) for patients are allowed in a stable dose (6 weeks).
• •4. Non-smoking (by declaration) for a period of at least 6 months.
• •5. Females of childbearing potential must be non-pregnant (as determined by a serum pregnancy test at screening and again, prior to each dosing session) and agree to use adequate contraceptive means throughout the study.
• •6. No known history of significant neurological, renal, cardiovascular, respiratory (asthma), endocrinological, gastrointestinal, primary hematopoietic disease, neoplasm, or any other clinically significant medical disorder other than Crohn's disease and its complications, which in the investigator's judgment contraindicate administration of the study medications.
• •7. No history of drug or alcohol abuse.
• •8. Screening tests must meet the following criteria: HGB ≥8.5 g/dL, platelets ≥ 100,000/ mm³, WBC: 3500-12,000/mm³, serum albumin above 2.5 g/dL, amylase, lipase and total bilirubin within normal limits. ALT, AST, alkaline phosphatase up to 1.5 times normal limits.
• •9. No clinically significant abnormalities in screening physical exam.
• •10. Negative HIV, Hepatitis B and Hepatitis C serology tests within 2 years.
• •11. Patients must be able to adhere to the visit schedule and protocol requirements and be available to complete the study.
• •12. Patients must satisfy a medical examiner about their fitness to participate in the study.
• •13. Patients must provide written informed consent to participate in the study.