Efficacyand tolerability of Azathioprine and Methotrexate in treatment of ulcerative colitis

Not Applicable

Conditions: Health Condition 1: null- Patients with Ulcerative colitis

Registration Number: CTRI/2017/01/007629

Lead Sponsor: Gastroenterology Research Education Society

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 50

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Steroid-free remission at week 24 definedTimepoint: 1. Steroid-free remission at week 24

Secondary Outcome Measures

Name	Time	Method
Secondary outcome measures <br/ ><br>2. Steroid-free clinical remission at week 16 <br/ ><br>3. Endoscopic healing <br/ ><br>4. Adverse events <br/ ><br>Timepoint: Week 16 and 24