Methotrexate in Induction and Maintenance of Steroid Free Remission in Ulcerative Colitis

Exclusion Criteria

• •Failure to respond to 40 mg of prednisone or higher/day in the last 2 weeks before inclusion
• •Concomitant use of azathioprine (AZA) or 6-mercaptopurine (6-MP) must be discontinued at least 2 weeks before inclusion into the study (Week 0 visit)
• •Anti-TNF therapy in the 2 weeks before the Week 0 visit
• •Failure of cyclosporine therapy in the previous 6 months prior to Screening visit
• •Patients with serum albumin \< 2.5 g/dl at baseline
• •Low serum folate defined as decrease of \>10% below normal range
• •Patients with WBC\< 3.0 x109th/L at baseline
• •Patients with platelet count \< 100 x109th/L
• •Patients with an underlying infection with C. difficile at Screening visit
• •Patients with pre-existing hepatic disease
• •Patients with known non-alcoholic fatty liver disease (NAFLD)
• •Patients with known Hepatitis B or Hepatitis C
• •Patients with pre-existing renal dysfunction (creatinine \>1.5 mg/dl).
• •Patients with a pre-existing chronic lung disease other than well controlled asthma
• •Patients with interstitial lung disease of unknown cause
• •Patients with a BMI \>35
• •Known previous or concurrent malignancy (other than that considered surgically cured, with no evidence for recurrence for 5 years - basal cell does not exclude)
• •Existing pregnancy, lactation, or planned pregnancy\* (men and women) within the next 12 months. (\*Methotrexate should not be used for at least 3 months before planned pregnancy for men and women and should not be used during pregnancy or breast feeding)
• •High alcohol consumption (more than seven drinks per week)
• •Non - steroidal inflammatory medications (NSAIDs) as long-term treatment, defined as use for at least 4 days a week each month
• •Continuous treatment with one of the following drugs:
• •Probenecid,
• •Trimethoprim/sulfamethoxazole
• •Sulfasalazine
• •Acitretin
• •Streptozocin
• •Non-use of appropriate contraceptives in females of childbearing potential (e.g. condoms, intrauterine device {IUD}, hormonal contraception, or other means considered adequate by the responsible investigator) or in males with a child-fathering potential (condoms, or other means considered adequate by the responsible investigator during treatment
• •Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial
• •Well-founded doubt about the patient's cooperation.