To study the effect of Tofacitinib along with corticosteroids in patients with acute severe ulcerative colitis.
- Conditions
- Health Condition 1: K519- Ulcerative colitis, unspecified
- Registration Number
- CTRI/2022/08/044613
- Lead Sponsor
- Dr Ajit Sood
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 0
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The effectiveness of tofacitinib as adjunctive <br/ ><br>therapy to intravenous hydrocortisone in patients with ASUC will be evaluated. <br/ ><br>This will see the response of tofacitinib in achieving remission in patients with ASUCTimepoint: 7 days Drug or placebo therapy <br/ ><br>14th day Follow up <br/ ><br>8 weeks Follow up
- Secondary Outcome Measures
Name Time Method The effectiveness of Tofacitinib in patients with ASUC.Timepoint: <br/ ><br>After 8 weeks Follow up