Health Condition 1: K51- Ulcerative colitis
Conditions
Interventions
Intervention1: tofacitinib 30 mg per day: Tofacitinib 10 mg thrice daily + Corticosteroids arm (Group 1): Patients randomized to receive tofacitinib 3o mg in addition to the standard treatment of acut
Sponsors
Research and Development Center
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects hospitalized with ASUC, as defined by Truelove Witts criteria 2. Subjects who are willing and able to comply with treatment plan, laboratory tests, daily bowel movement diary call, and other study procedures. 3. Subjects who are willing to provide a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients hospitalized with severe UC but did not fulfil the Truelove Witts criteria 2. Prior exposure to intravenous corticosteroids or tofacitinib within 4 weeks before hospitalization 3. Active enteric or extra-intestinal infection (including Clostridioides difficile, tuberculosis, etc.) 4. Crohnâ??s colitis 5. Toxic megacolon, intestinal perforation, or massive haemorrhage requiring emergency colectomy 6. Pregnancy/lactation 7. Current or prior history of thromboembolic disease 8. Subjects infected with human immunodeficiency virus (HIV) or hepatitis B or C viruses 9. Subjects who have been vaccinated with live or attenuated vaccine within 6 weeks of baseline or scheduled to receive these vaccines during study period or within 6 weeks after last dose of study medication 10. Subjects with malignancies or a history of malignancies, with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin. 11. Subjects with current or recent history of severe, progressive, or uncontrolled renal, hepatic, haematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, neurological disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects responding to treatment by day 7.Timepoint: day 7. | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of patients requiring initiation of infliximab/cyclosporine or undergoing colectomy after discharge but within 90 days following randomization. Timepoint: day 90;The proportion of patients requiring medical (infliximab/cyclosporine) or surgical (colectomy) rescue therapy by day 7. Timepoint: day 7 | — |
Countries
India
Contacts
Public ContactAjit Sood
Outcome results
None listed