CTRI/2019/01/017122进行中（未招募）4 期
A Phase IV Clinical Trial to evaluate safety and efficacy of Glenmark Aprezo�® (Apremilast) Tablets in subjects with Active Psoriatic Arthritis
Glenmark Pharmaceuticals Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •Patients who meet ALL the following criteria can be enrolled:
- •1.Males or females, aged ââ?°Â¥ 18 years and ââ?°Â¤ 65 years at time of informed consent.
- •2.Subjects having a diagnosis of Psoriatic Arthritis (PsA, by any criteria) for ââ?°Â¥ 6 months duration.
- •3.Subjects meeting the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria for PsA at time of screening.
- •4.May not have axial involvement alone
- •5.Treatment naÃ?¯ve patients or patients taking concurrent DMARDs at baseline could continue stable doses of methotrexate (ââ?°Â¤ 25 mg/week), leflunomide (ââ?°Â¤ 20 mg/day), sulfasalazine (ââ?°Â¤ 2 g/day)
- •6.Must have ââ?°Â¥ 3 swollen AND ââ?°Â¥ 3 tender joints.
- •7.Female subjects of child bearing potential must use medically accepted form of contraception
- •8.Patients on stable dose of NSAIDs, narcotics and low dose oral corticosteroids (prednisone ââ?°Â¤ 10 mg or equivalent) allowed.
- •9.Must have psoriasis of body surface area (BSA: ââ?°Â¥3%).
排除标准
- •Exclusion Criteria
- •Patients who meet AT LEAST one of the following exclusion criteria will be excluded:
- •1.Pregnant or lactating women or planning to become pregnant during the study period.
- •2.History of allergy to any component of the investigational product
- •3.Subjects with known positive human immunodeficiency virus (HIV), or have congenital or acquired immunodeficiency, hepatitis B or C
- •4.Therapeutic failure on > 3 agents for PsA or > 1 biologic tumour necrosis factor (TNF) blocker, IL-17 inhibitors discontinued within 3 months of screening.
- •5.History of significant or current evidence of chronic infectious disease, system disorder, organ disorder, or other medical condition that would place patient at undue risk by participation or could jeopardize the integrity of the study evaluations
- •6.Subjects with uncontrolled hypertension or recurrent hypotensive events considered as clinically relevant or documented orthostatic hypotension
- •7.Subjects with a history or known diagnosis of uncontrolled diabetes mellitus or requiring insulin treatment
- •8.Subjects with recent history or who are currently known to abuse alcohol or drugs
- •9.Subjects who have participated in another clinical study within past one month
研究者
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