Health Condition 1: K519- Ulcerative colitis, unspecified
Conditions
Interventions
Intervention1: Tofacitinib: Induction dose 10 mg PO BD x 8
weeks
• In case of partial response at 8
weeks, induction dosing can be
extended till 16 weeks.
• Maintenance dose 5 mg PO BD after
8 weeks f
Sponsors
All India Institute of Medical Sciences New Delhi Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with moderate to severe (as defined by SCCAI score >6 and UCEIS >3) 2. Patients who are on optimum dosage of oral (minimum 2.4 g per day) and topical 5-ASA agents, are steroid naïve, or steroid experienced (last dose >12 weeks prior) but not on steroids or azathioprine. 3. Anti-TNF/Anti-integrin naïve or experienced (intolerant or non-responder) but last dose =2 months back. 4. Concomitant therapy alloweda) Topical steroid and topical 5-ASA therapy (if stable for last 2 weeks) b) Budesonide up to 9 mg/day. Stable dose for at least 2 weeks prior to baseline period or Budesonide tapering 3 mg every 3 weekly. c) Patients on stable doses of oral 5- ASA (5-amino salicylic acid) for past 4 weeks. 5. Women of childbearing age should agree to avoid conception during the study period. 6. Patients giving written informed consent.
Exclusion criteria
Exclusion criteria: 1) Age 65 years 2) Patients with acute severe ulcerative colitis 3) Clinical signs of fulminant colitis or toxic megacolon 4) Patients with a steroid refractory disease. 5) Indeterminate, ischemic, infectious or Crohn’s colitis 6) Received no treatment for UC in past i.e., treatment-naïve 7) If the subject has received the following therapya. Intravenous corticosteroids within 2 weeks prior to baseline b. Anti-TNF therapy (e.g., infliximab, adalimumab, or certolizumab) within 8 weeks prior to baseline 8) Pregnancy and lactation 9) Concomitant Clostridioides difficile infection 10) Severe comorbid medical illness a. Cardiac: NYHA II or higher congestive heart failure b. Renal: Creatine clearance (Cockcroft Gault formula) c. Severe hepatic impairment d. Malignancies or a history of malignancies e. Significant trauma or major surgery within 4 weeks f. History of bowel surgery within 6 months 12) Contraindication to Tofacitinib including: a. Severe hepatic impairment c. Active Tuberculosis d. H/O deep venous thrombosis DVT or thrombotic disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome • The mean number of days required to achieve a decrease in SCCAI of > 3 pointsTimepoint: At 8 weeks (induction phase) and at 52 weeks (maintenance phase) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes 1. Clinical response and remission at 8 weeks, 24 weeks and 52 weeks defined as decline in SCCAI by > 3 points and SCCAI of 2. Endoscopic response and remission at 8 weeks and 52 weeks defined as decline in UCEIS by 2 points and UCEIS of 3. Deep remission at 8 weeks defined as a combination of clinical and endoscopic remission. 4. Biochemical remission at 8 and 52 weeks defined as fecal calprotectin stool 5. Histological remission at 24 and 52 weeks defined as Nancy score of 0. 6. Adverse events at 8, 24 and 52 weeks. 7. Relapse rate at 52 weeks among patients who had clinical response/remission at 8 weeks.Timepoint: At 8 weeks (induction phase) and at 52 weeks (maintenance phase) | — |
Countries
India
Contacts
Public ContactMridul Mahajan
All India Institute of Medical Sciences, New Delhi
Outcome results
None listed