role of tofacitinib in patients with inflammatory bowel disease (ulcerative colitis)

INTERVENTION: Intervention1: Tofacitinib: 10 mg twice daily for 8 weeks (can be extended to 16 weeks in partial responders at 8 weeks (i.e. total Mayo clinic score declined by â?¥3 and at least 30% versus baseline, which must include a decrease in the score for rectal bleeding of at least 1 point, or an absolute score for rectal bleeding not exceeding 1, but total score is 2) followed by 5 mg twice daily till week 24. Control Intervention1: Corticosteroids: Prednisolone starting at 40 mg/day for 2‐4 weeks (depending on clinical response, defined as decrease in partial Mayo clinic score by 2) followed by tapering dose (taper by 5 mg per week till 20 mg/day and subsequent taper by 2.5 mg per week) and stopped over a period of 12‐16 weeks. CONDITION: Health Condition 1: K51‐ Ulcerative colitis PRIMARY OUTCOME: The proportion of subjects achieving clinical remission at week 8.Timepoint: Week 8 SECONDARY OUTCOME: The proportion of subjects in clinical remission at week 24.Timepoint: Week 24 INCLUSION CRITERIA: 1. Patients with active ulcerative colitis, moderately severe disease (Total Mayo clinic score between 6 and 9) 2. Stable dose (no change) of 5‐ASA and/or thiopurines in four (04) weeks prior to enrolment 3. Any disease extent : E1, E2 or E3 4. Diagnosis (endoscopic or radiographic and histological) of UC at least 6 months prior to entry into the study 5. Age â?¥ 18 years 6. Subjects who are willing and able to comply with treatment plan, laboratory tests, daily bowel movement diary call, and other study procedures 7. Subjects who are willing to provide a written informed consent