Trial Details

Recruiting
Basic Information
Clinical ID c2349
Identifier CTRI/2021/10/037641
Trial Title An open label study to compare the efficacy and safety of tofacitinib compared to corticosteroids for inducing remission in moderately severe active ulcerative colitis
Trial URL Visit Original Page
Study Information
Study Results

No results available

Conditions Disease.2. Total mayo clinic score <6 or >9. 3. Subjects without previous treatment for UC (i.e. treatment-naïve)4. Active or latent or inadequately treated infections (including Clostridiodes difficile, Cytomegalovirus, Mycobacterium tuberculosis, etc.)5. Subjects receiving any of these therapies during the study period:a. Anti-TNF-alpha therapy (e.g., infliximab, adalimumab or certolizumab) within 8 weeks prior to baseline;b. Cyclosporine, mycophenolate mofetil/mycophenolic acid, or tacrolimus within 4 weeks prior to baseline;c. Interferon therapy within 8 weeks prior to baseline;d. Intravenous corticosteroids within 2 weeks prior to baseline;8. Subjects displaying clinical signs of fulminant colitis or toxic megacolon9. Subjects with a history of more than one episode of herpes zoster, a history of disseminated herpes zoster or disseminated herpes simplex.10. Subjects infected with human immunodeficiency virus (HIV) or hepatitis B or C viruses11. 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 medication12. 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.13. Subjects with current or recent history of severe, progressive, or uncontrolled renal, hepatic, haematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, neurological disease.14. Pregnant females
Interventions Health Condition 1: K51- Ulcerative colitis
Participant Information
Sponsor Dayanand Medical College and Hospital Ludhiana
City -
Country/Region India
Enrollment Criteria
Sex Requirement NOT SPECIFIED
Age Requirement -
Study Design
Study Type Interventional
Phase PHASE4
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date -