Tofacitinib Tablets in the Treatment of Rheumatoid Arthritis, Psoriatic Arthritis, and Ulcerative Colitis
- Conditions
- Health Condition 1: M059- Rheumatoid arthritis with rheumatoid factor, unspecified
- Registration Number
- CTRI/2024/07/071353
- Lead Sponsor
- Sun Pharmaceutical Industries Limited (SPIL)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Patients of either gender, aged between greater than or equal to 18 years to lesser than or equal to 65 years
2.Patient with moderately to severely active Rheumatoid Arthritis, OR active Psoriatic Arthritis, OR moderately to severely Ulcerative Colitis, as per the treating physician’s clinical judgment (Physician Global Assessment)
3.Patients who are willing to provide informed consent to collect the surveillance data
1.Patients with history of intolerance or hypersensitivity to any of the Tofacitinib including its components
2.Patient with any clinically significant disorder that, in the opinion of the treating physician would result in jeopardizing patient safety and his/ her inability to understand and comply with the requirements of the surveillance
3.Pregnant women and nursing mothers
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients with TEAEsTimepoint: Proportion of patients with TEAEs
- Secondary Outcome Measures
Name Time Method Percentage of patients with PGA responseTimepoint: Day 28, 56 and 84