CTRI/2024/07/071353招募中Unknown
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 个研究点 分布在 1 个国家目标入组 268 人开始时间: 2024年8月2日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 268
- 试验地点
- 16
- 主要终点
- Proportion of patients with TEAEs
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Proportion of patients with TEAEs
时间窗: Proportion of patients with TEAEs
次要结局
- Percentage of patients with PGA response(Day 28, 56 and 84)
研究者
Dr Pravin Ghadge
Sun Pharma Laboratories Limited
研究点 (16)
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