CTRI/2024/07/071353
Recruiting
Post Marketing Surveillance
A Multi-Centric, Active Post Marketing Surveillance Study to Assess the Safety and Efficacy of Tofacitinib Extended Release Tablets 11 mg for the Treatment of Adult Patients with Rheumatoid Arthritis, Psoriatic Arthritis, and Ulcerative Colitis
Sun Pharmaceutical Industries Limited (SPIL)16 sites in 1 country268 target enrollmentStarted: August 2, 2024Last updated:
Overview
- Phase
- Post Marketing Surveillance
- Status
- Recruiting
- Sponsor
- Sun Pharmaceutical Industries Limited (SPIL)
- Enrollment
- 268
- Locations
- 16
- Primary Endpoint
- Proportion of patients with TEAEs
Overview
Brief Summary
This will be a multi-centric, active post marketing surveillance to assess the safety and efficacy of Tofacitinib Extended Release Tablets 11 mg for treatment of Rheumatoid Arthritis, Psoriatic Arthritis, and Ulcerative Colitis in Indian adults. Approximately, 268 adult patients will be enrolled in the surveillance. Treatment will be administered as per treating physician’s discretion based on prescribing information. Surveillance duration of all patients will be 12 weeks and surveillance data on safety and efficacy will be collected for a duration of 12 weeks.
Study Design
- Study Type
- Pms
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients of either gender, aged between greater than or equal to 18 years to lesser than or equal to 65 years
- •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)
- •Patients who are willing to provide informed consent to collect the surveillance data.
Exclusion Criteria
- •Patients with history of intolerance or hypersensitivity to any of the Tofacitinib including its components
- •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
- •Pregnant women and nursing mothers.
Outcomes
Primary Outcomes
Proportion of patients with TEAEs
Time Frame: Proportion of patients with TEAEs
Secondary Outcomes
- Percentage of patients with PGA response(Day 28, 56 and 84)
Investigators
Dr Pravin Ghadge
Sun Pharma Laboratories Limited
Study Sites (16)
Loading locations...
Similar Trials
Recruiting
Not Applicable
Evaluate the Safety and Effectiveness of Oral Suspension of Sodium Alginate IP 500 mg, Sodium Bicarbonate 213 mg and Calcium Carbonate IP 325 mg in Patients with Heartburn and Indigestion.CTRI/2024/12/077951Naxpar Pharma Pvt. Ltd,320
Recruiting
Not Applicable
To evaluate the safety of Needle Free Injection System when administered with various types of vaccine for healthy childrens age is 6 months to 24 monthsCTRI/2024/09/074054IntegriMedical Private Limited500
Completed
Not Applicable
A clinical study to evaluate the safety and effectiveness of Vilanterol and Fluticasone Furoate powder for inhalation in patients with asthma.CTRI/2025/04/085135Zydus Healthcare Limited190
Not yet recruiting
Not Applicable
Evaluate the Safety and Effectiveness of Oral Suspension of Sodium Alginate IP 1000 mg and Potassium hydrogen carbonate Ph EUR 200 mg in 320 Patients with Gastroesophageal Reflux Disease (GERD) or acidity.CTRI/2025/10/096431Ms Abbott India Limited320
Not yet recruiting
Not Applicable
A study to evaluate the safety of test drug to treat patients with relapsed or refractory diffuse large Bcell lymphoma (DLBCL) in IndiaCTRI/2025/12/099510Roche Products (India) Pvt. Ltd.45