Health Condition 1: K518- Other ulcerative colitis
Conditions
Interventions
Intervention1: Tofacitinib along with Fecal microbiota transplantation (FMT): Tofacitinib 10 mg BD for 8 weeks
and FMT at 0, 2 & 6 weeks
Control Intervention1: Tofacitinib along with sham transplantat
Sponsors
AIIMS funding
Eligibility
Inclusion criteria
Inclusion criteria: 1)Patients with moderate to severe (as defined by SCCAI score >6) endoscopically active UC (UCEIS >1) 2)Patients giving written informed consent 3)Patients who are steroid dependent or refractory 4)Patients who are thiopurine failure or intolerant 5)Anti-TNF naïve or experienced (intolerant or non-responder) but last dose >=2 months back 6)Anti-integrin naïve or experienced (intolerant or non-responder) but last dose >=2 months back 7)Concomitant therapy allowed- a.Topical steroid and topical 5-ASA therapy (if stable for last 2 weeks) b.Oral corticosteroids (Prednisone equivalent up to 20 mg/day; budesonide up to 9 mg/day. Stable dose for at least 2 weeks prior to baseline period. Budesonide tapering 3mg every 3weekly and prednisolone tapering 5mg every 2 weekly), c.Patients on stable doses of 5-ASA (5-amino salicylic acid) for past 4 weeks 8)Women of childbearing age should agree to avoid conception during the study period
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)Indeterminate, ischemic, infectious or Crohnâ??s colitis 5)UC limited to distal 15 cm of colon 6)Received no treatment for UC in past i.e., treatment-naïve 7)Patients who are steroid naïve 8)If subject have received the following therapy- a.Intravenous corticosteroids within 2 weeks prior to baseline b.Anti-TNF therapy (e.g., infliximab, adalimumab, or certolizumab) within 8 weeks prior to baseline 9)Pregnancy and lactation 10)Concomitant Clostridioides Difficile infection 11)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: b.Hepatitis B, C c.Active TB d.H/O DVT or thrombotic disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Clinical remission at 8 weeks defined as SCCAI less than or equal to 2 and rectal bleeding sub score of 0 2.Endoscopic remission at 8 weeks defined as UCEIS less than or equal to 1 Timepoint: 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Clinical response at 8 weeks defined as decline in SCCAI by greater than or equal to 3 points. 2.Endoscopic response at 8 weeks defined as decline in UCEIS by 2 points 3.Deep remission at 8 weeks defined as a combination of clinical and endoscopic remission. 4.Biochemical remission at 8 weeks defined as fecal calprotectin less than 150 μg/g of stool 5.Histological remission at 8 weeks defined as Nancy index grade 0 6.Adverse events at 8 weeks 7.Relapse rate at 48 weeks among patients who had clinical response or remission at 8 weeks Timepoint: 8 weeks | — |
Countries
India
Contacts
Public ContactDr Rohit Kumar Garg
All India Institute of Medical Sciences,New Delhi
Outcome results
None listed