CTRI/2022/08/044613
Suspended
未知
A Prospective PlaceboControlled Randomized ClinicalStudy Of Tofacitinib As AnAdjunct to corticosteroids inAcute Severe Ulcerative Colitis
Dr Ajit Sood0 sites0 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: K519- Ulcerative colitis, unspecified
- Sponsor
- Dr Ajit Sood
- Status
- Suspended
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •1\. Presence of indeterminate colitis, microscopic colitis, ischemic
- •colitis, infectious colitis, or clinical findings suggestive of Crohnâ??s
- •2\. Subjects displaying clinical signs of fulminant colitis or toxic
- •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
- •5\. Subjects with malignancies or a history of malignancies, with the
- •exception of adequately treated or excised non\-metastatic basal cell
Outcomes
Primary Outcomes
Not specified
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