CTRI/2025/07/091428招募中4 期
A Phase IV, Multicenter, Non Comparative, Open Label Study Evaluating the Safety and Efficacy of Guselkumab Administered Subcutaneously in the Treatment of Indian Patients with Psoriatic Arthritis
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 9
- 主要终点
- Number of Participants With Adverse Events (AEs)
研究概览
简要总结
The purpose of this study is to evaluate the safety and how well guselkumab treatment works (efficacy) in participants with psoriatic arthritis (PsA; a chronic, autoimmune form of arthritis that causes joint inflammation) who had inadequate response to standard therapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants who have definite diagnosis of active psoriatic arthritis (PsA) (according to the Classification criteria for Psoriatic Arthritis [CASPAR]) prior to the first administration of study drug and have at least 1 of the PsA.
- •subsets: distal interphalangeal joint arthritis, polyarticular arthritis with the absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis.
- •Participants who are negative for rheumatoid factors
- •Participants having inadequate response (defined by presence of active arthritis [presence of any swollen or any tender joint]) to standard therapies for 3 months at the highest recommended dose (e.g., conventional disease-modifying antirheumatic drugs [DMARDs] including methotrexate, apremilast, or nonsteroidal anti-inflammatory drugs [NSAIDs]), including biologics naïve patient or have failed, or were intolerant to one or more biological treatments [anti-TNF/IL-17i]
- •Participants are considered eligible per the following Tuberculosis (TB) screening criteria: 4a.
- •Have no history of TB prior to screening AND 4b.
- •Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination AND 4c.
- •Have had no recent close contact with a person with active TB, or if there has been such contact, will be referred to a physician specializing in TB to undergo additional evaluation and, if warranted, receive appropriate treatment for latent TB prior to or simultaneously with the first administration of study drug AND 4d.
- •Within 6 weeks prior to the first administration of study drug, have a negative QuantiFERON- TB Gold and a negative tuberculin skin test result, OR have a newly identified positive QuantiFERON-TB Gold or tuberculin skin test result during screening in which active TB has been ruled out and for which appropriate treatment for latent TB has been initiated either prior to or simultaneously with the first administration of study drug AND 4e.
- •Have a chest radiograph (both posterior-anterior and lateral views), taken within 3 months prior to the first administration of study drug and read by a qualified radiologist, with no evidence of current active TB or old inactive TB
- •Medically stable on the basis of physical examination, medical history, vital signs, and 12-lead ECG 6.
排除标准
- •History of latent or active granulomatous infection prior to screening
- •Have a known clinically significant hypersensitivity to guselkumab or to any of the excipients
- •Have had a serious infection, or have been hospitalized for an infection, or have been treated with intravenous (IV) antibiotics for an infection within 2 months prior to first administration of study intervention
- •Has any known malignancy or has a history of malignancy, or a history of lymphoproliferative disease
- •Have received, or are expected to receive, any live virus or bacterial vaccination within 3 months before the first administration of study intervention, during the study, or within 6 months after the last administration of study intervention.
结局指标
主要结局
Number of Participants With Adverse Events (AEs)
时间窗: Up to 32 weeks
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily
时间窗: Up to 32 weeks
have a causal relationship with the pharmaceutical/biological agent under study.
时间窗: Up to 32 weeks
2. Number of Participants With Serious Adverse Events (SAEs)
时间窗: Up to 32 weeks
A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient
时间窗: Up to 32 weeks
hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is
时间窗: Up to 32 weeks
a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.
时间窗: Up to 32 weeks
次要结局
- Percentage of Participants Who Achieve an American College of Rheumatology (ACR) 20 Response at Week 12.(Week 12)
- Percentage of Participants Who Achieve an ACR 20 Response at Week 24(Week 24)
- Change From Baseline in Analytic Marker of Inflammation (CRP Levels) at Weeks 12 and 24. CRP levels that is the analytic markers of inflammation will be assessed.(Week 12 and Week 24)
研究者
Dr Sanish Davis
Johnson and Johnson Pvt Ltd
研究点 (9)
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