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| Name | Class |
|---|---|
| All India Institute of Medical Sciences | OTHER |
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This randomised trial plans to compare oral tofacitinib with intravenous cyclosporine in patients with acute severe ulcerative colitis who have failed to respond to intravenous steroids
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | Group A: Intravenous Cyclosporine 2 mg/kg continuous infusion for 5-7 days and then shifted to oral cyclosporine 4 mg/kg/day in two divided doses for 12 weeks |
|
| Group B | Experimental | Oral Tofacitinib 10 mg TDS for 3 days, and then 10 mg BD to complete 8 weeks followed by 5 mg BD till follow-up (14 weeks) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tofacitinib | Drug | For the tofacitinib the dose of 10 mg BD will be administered for 8 weeks (10 mg TDS for initial three days) and then reduced to 5 mg BD for the period of study |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment failure | I) At Day 7 Absence of clinical response at day 7 (as defined by Partial Mayo of > 3) II) By Day 98
| 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response | Partial Mayo <4 | 7 days |
| Absence of steroid free remission | Mayo score of more than 2 with endoscopic sub-score of more than 1 |
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Inclusion Criteria:
Patients admitted with Acute severe ulcerative colitis as defined by Modified Truelove and Witts Criteria WITH Failure to respond to intravenous steroids (Hydrocortisone 100 mg IV QID OR IV Methylprednisolone 60 mg IV OD) as defined by
Exclusion Criteria:
Age <18, Age > 65 years
E1 disease (involvement distal to rectosigmoid junction only)
Crohn's disease
Contraindication to intravenous cyclosporine or oral tofacitinib
Patient wants treatment with intravenous infliximab or wants surgery
Underlying sepsis or active infection (Enteric infections, Clostridium difficile, active hepatitis B or C, Tuberculosis, zoster, CMV disease)
Toxic megacolon, previous dysplasia or any indication of immediate surgery
Known malignancy
Pregnancy or Lactation
Unwilling to provide consent or for follow-up
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vishal Sharma | Contact | +917087008099 | docvishalsharma@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Vishal Sharma | PGIMER Chandigarh | Principal Investigator |
| Vineet Ahuja | AIIMS Delhi | Principal Investigator |
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The anonymised participant data may be shared on reasonable request
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C479163 | tofacitinib |
| D016572 | Cyclosporine |
| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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| Cyclosporine | Drug | : Intravenous Cyclosporine 2 mg/kg continuous infusion for 5-7 days and then shifted to oral cyclosporine 4 mg/kg/day in two divided doses for 12 weeks.Those who respond with intravenous cyclosporine will be shifted to oral cyclosporine 4 mg/kg for 12 weeks while the thiopurine dose is adjusted to the patient's weight |
|
| day 98 |
| Colectomy free survival | No need for colectomy | 98 days |
| Time to clinical response | Partial Mayo of 3 or less | 98 days |
| Endoscopic healing | Mayo endoscopic sub-score of 1 or less | Day 98 |
| Serious adverse effects | requiring hospitalization, cessation of treatment and events like cardiovascular events, pulmonary embolism, venous thrombosis, any infection, malignancy, gastrointestinal perforation | 98 days |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D010455 |
| Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |