Health Condition 1: M059- Rheumatoid arthritis with rheumatoid factor, unspecified
Conditions
Interventions
Intervention1: Tofacitinib Extended Release Tablets 11 mg: One tablet should be taken orally once daily with or without food from Day 1 to Day 84
Control Intervention1: NA: NA
Sponsors
Sun Pharmaceutical Industries Limited (SPIL)
Sun Pharmaceutical Industries Limited SPIL
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with TEAEsTimepoint: Proportion of patients with TEAEs | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients with PGA responseTimepoint: Day 28, 56 and 84 | — |
Countries
India
Contacts
Public ContactDr Rajiv Yadav
Sun Pharma Laboratories Limited
Outcome results
None listed