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To study the effect of Tofacitinib along with corticosteroids in patients with acute severe ulcerative colitis.

A Prospective Placebo Controlled Randomized Clinical Study Of Tofacitinib As An Adjunct to corticosteroids in Acute Severe Ulcerative Colitis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/08/044613
Enrollment
100
Registered
2022-08-03
Start date
Unknown
Completion date
Unknown
Last updated
2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K519- Ulcerative colitis, unspecified

Interventions

Intervention1: Patients with acute severe ulcerative colitis: Group 1 : Intravenous hydrocortisone (300 mg per day in three divided doses) plus Tofacitinib (10 mg thrice daily) for 7 days Control Inte

Sponsors

Dr Ajit Sood
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with acute severe ulcerative colitis (defined by Truelove Witts Criteria) 2. Subject must be at least 18 years of age. 3. Subjects who are willing and able to comply with treatment plan, laboratory tests, daily bowel movement diary call, and other study procedures. 4. Subjects who are willing to provide a written informed consent.

Exclusion criteria

Exclusion criteria: 1. Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohnâ??s Disease. 2. Subjects displaying clinical signs of fulminant colitis or toxic megacolon 3. Subjects infected with human immunodeficiency virus (HIV) or hepatitis B or C viruses 4. 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 12 5. 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. 6. Subjects with current or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, neurological disease. 7. Pregnant females

Design outcomes

Primary

MeasureTime frame
The effectiveness of tofacitinib as adjunctive therapy to intravenous hydrocortisone in patients with ASUC will be evaluated. This will see the response of tofacitinib in achieving remission in patients with ASUCTimepoint: 7 days Drug or placebo therapy 14th day Follow up 8 weeks Follow up—

Secondary

MeasureTime frame
The effectiveness of Tofacitinib in patients with ASUC.Timepoint: After 8 weeks Follow up—

Countries

India

Contacts

Public ContactDr Manjeet Goyal

Dayanand medical college and hospital

ajitsood10@gmail.com9815400718

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026