Health Condition 1: K51- Ulcerative colitis
Conditions
Interventions
Intervention1: Tofacitinib: 10 mg twice daily for 8 weeks (can be extended to 16 weeks in partial responders at 8 weeks (i.e. total Mayo clinic score declined by �3 and at least 30% versus basel
Sponsors
Dayanand Medical College and Hospital Ludhiana
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with active ulcerative colitis, moderately severe disease (Total Mayo clinic score between 6 and 9) 2. Stable dose (no change) of 5-ASA and/or thiopurines in four (04) weeks prior to enrolment 3. Any disease extent : E1, E2 or E3 4. Diagnosis (endoscopic or radiographic and histological) of UC at least 6 months prior to entry into the study 5. Age � 18 years 6. Subjects who are willing and able to comply with treatment plan, laboratory tests, daily bowel movement diary call, and other study procedures 7. 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 Crohnââ?¬•s Disease. 2. Total mayo clinic score 9. 3. Subjects without previous treatment for UC (i.e. treatment-naÃ?¯ve) 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 megacolon 9. 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 viruses 11. 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. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects achieving clinical remission at week 8.Timepoint: Week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of subjects in clinical remission at week 24.Timepoint: Week 24 | — |
Countries
India
Contacts
Public ContactAjit Sood
Department of Gastroenterology, Third Floor, Dayanand Medical College and Hospital Ludhiana
Outcome results
None listed