Health Condition 1: null- Patients with Ulcerative colitis
Conditions
Interventions
Intervention1: Azathioprine: Oral (2 mg/kg/day) for 6 months
Control Intervention1: Methotrexate: Subcutaneous injection 25 mg/week for 6 months
Sponsors
Gastroenterology Research Education Society
Eligibility
Inclusion criteria
Inclusion criteria: Patients who are steroid dependent Ulcerative colitis defined as unable to reduce steroids below the equivalent of prednisolone 10 mg/day within 3 months of starting steroids, without recurrent active disease, or who have a relapse within 3 months of stopping steroids Patients of Ulcerative colitis who have required a second course of corticosteroid within 1 year. Patients will be included in the trial when the dose of oral corticosteroids will be at 20 mg/day.
Exclusion criteria
Exclusion criteria: Age > 75 years Patients with Ulcerative Colitis of duration less than 6 months Patients who are refractory to initial dose of corticosteroids defined as no improvement after 2 weeks on 40 mg prednisolone. Patients with proctitis defined as disease confined to the rectum(15 cms from the anal verge) Patients with pre-existing hepatic disease, renal dysfunction, clinically important lung disease, systemic infection Pregnancy or desire to become pregnant within the next 24 months Breast feeding History of cancer Indication for colectomy Alcohol consumption Patients infected with human immunodeficiency virus, hepatitis B virus, hepatitis C virus Obesity (defined by body mass index >30 kg/m2) Diabetes mellitus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Steroid-free remission at week 24 definedTimepoint: 1. Steroid-free remission at week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures 2. Steroid-free clinical remission at week 16 3. Endoscopic healing 4. Adverse events Timepoint: Week 16 and 24 | — |
Countries
India
Contacts
Public ContactDr Vineet Ahuja
Outcome results
None listed