Health Condition 1: K519- Ulcerative colitis, unspecified
Conditions
Interventions
Intervention1: Tofacitinib and Budesonide MMX: Patients will receive oral Tofacitinib 10 mg twice daily for 12 weeks along with oral Budesonide MMX 9 mg once daily for a duration of 8 weeks. Oral 5-AS
Sponsors
Postgraduate Institute of Medical Education and Research
Eligibility
Inclusion criteria
Inclusion criteria: Patients aged more than 18 years with moderate to severe ulcerative colitis, diagnosed by clinical, endoscopic and histologic criteria.
Exclusion criteria
Exclusion criteria: 1. Patients in remission, 2. Patients with ASUC defined as per the Truelove and Witt’s Criteria 3. Patients with disease limited to 15 cm from anal verge (proctitis only) 4. Patients with toxic megacolon 5. Patients with any serious infection, defined as any infection that requires hospitalization or change in the treatment plan 6. Patients with Indeterminate colitis or Crohn’s disease 7. Patients with prior history of exposure to tofacitinib 8. Patients with prior use of steroids in the last 3 months 9. Lactating and pregnant females 10. Patients with suspected or proven malignancy 11. Patients with dyslipidemia precluding the use of tofacitinib 12. Patients with severe comorbidities 13. Patients with diagnosed case of liver cirrhosis 14. Patients with latent tuberculosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical remissionTimepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Mucosal healing 2) Clinical response 3) Rate of infection 4) Rate of cardiovascular eventsTimepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactProf Dr Saroj Kant Sinha
Postgraduate Institute of Medical Education and Research
Outcome results
None listed