TOFACITINIB vs TOFACITINIB WITH MESALAMINE IN ULCERATIVE COLITIS

Launched by POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH · Oct 2, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two different treatment approaches for people with ulcerative colitis (UC) who are in remission after being treated with a medication called tofacitinib and another drug called mesalamine. The main goal is to see if continuing treatment with just tofacitinib (without mesalamine) is as effective and safe as continuing both medications together in maintaining remission from UC. The researchers believe that stopping mesalamine while continuing tofacitinib may work just as well.

To participate in this study, individuals must have a confirmed diagnosis of UC and have been in remission for at least three months while taking both medications. The trial is not open for recruitment yet, but it will include adults aged 65 to 74, regardless of gender. Participants will need to meet specific health criteria and should not have certain other conditions or recent health issues that could affect their participation. This study could help determine the best approach to treatment for maintaining remission in people with UC.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Diagnosed cases of UC by endoscopy and biopsy
• • Patients in clinical remission for at least 3 months on Tofacitinib and mesalamine
• Exclusion Criteria:
• • Incomplete evaluation
• • Uncertain diagnosis
• • Active disease
• • Subjects with Crohn's disease, microscopic colitis and collegenous colitis or IBD-U
• • Unwilling to participate in study
• • Pregnant and lactating women or those who are planning pregnancy in the forthcoming 2 years
• • Patients with any suspected or proven malignancy
• • Subjects with severe comorbidities
• • Prior history of venous thromboembolism.
• • Subjects undergoing major surgery
• • Myocardial infarction within previous 3 months
• • Heart failure