effectiveness of tofacitinib in moderate to severe ulcerative colitis compared to steroid

To study the effectiveness of tofacitinib as a first line therapy for treatment of moderate to severe ulcerative colitis and compare it with prednisolone.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/09/057448

Enrollment

Registered

2023-09-11

Start date

Unknown

Completion date

Unknown

Last updated

2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K519- Ulcerative colitis, unspecified

Interventions

Intervention1: tofacitinib: tofacitinib 10 mg bd till remission , followed by 5 mg BD (a total duration of treatment 3 month) Control Intervention1: prednisolone: prednisolone 40 mg od to be tapered a

Eligibility

Inclusion criteria

Inclusion criteria: diagnosed cases of ulcerative colitis

Exclusion criteria

Exclusion criteria: ulcerative proctitis, severe commorbidity, c. difficile infection, toxic mega colon, any coagulopathy or hypercoaguable condition, thrombosis, pregnancy

Design outcomes

Primary

Measure	Time frame
to compare the remission rate in both steroid and tofacitinib groupTimepoint: at 4th week, 8th week and 12th week	—

Secondary

Measure	Time frame
to compare the safety profile and adverse events of the individual drugsTimepoint: 3 months	—

Countries

India

Contacts

Public ContactShankar Roy

Department of gastroenterology, Post graduate institute of Medical Education and Research (PGIMER)

sarojksinha@hotmail.com09914209614

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026