NL-OMON54653招募中4 期
A Stratification trial to determine key immunological factors predicting Tofacitinib efficacy in Psoriatic Arthritis (PsA). TOFA-PREDICT - TOFA-PREDICT
niversitair Medisch Centrum Utrecht0 个研究点目标入组 160 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Age 18-75 years old
- •Meets CASPAR criteria for psoriatic arthritis
- •Disease duration of at least 8 weeks
- •Evidence of active arthritis based upon >=2 swollen joints and >=2 tender joints
- •Subjects are to discontinue active psoriasis treatment prior to being
- •enrolled in the study.
- •Inclusion criteria arm 1:
- •o No history of csDMARD use or bDMARD therapy use
- •Inclusion criteria arm 2:
- •o Current use of methotrexate, sulfasalazine or leflunomide on the highest
- •tolerated dosage and on a stable dosage for at least 4 weeks prior to
- •randomization. Highest dosage accepted respectively are max <=25mg/wk, 20mg/day
- •and 3000mg/day.
- •o *History of use of max. 1 bDMARD prior to inclusion is allowed, except:
- •- Prior use of etanercept
- •- Primary failure (total non-response at start) on other TNFi (adalimumab,
- •golimumab, infliximab, certolizumab). Patients that have had a loss of response
- •on their first TNFi are allowed to participate.
- •o No history of tsDMARD therapy use (JAKi, abatacept)
排除标准
- •Currently have pustular psoriasis only
- •Participation in other studies involving investigational drug(s) (Phases 1-4)
- •within 4 weeks before the current study begins and/or during study
- •participation. Participation in any observational studies during study
- •participation.
- •Pregnant females, breastfeeding females, females of child-bearing potential
- •not using highly effective contraception or not agreeing to continue highly
- •effective contraception for at least one ovulatory cycle after last dose of
- •investigational product or females planning pregnancy. Women of childbearing
- •potential must test negative for pregnancy prior to enrolment in this study.
- •Current or recent history of a severe, progressive or uncontrolled renal,
- •hepatic, hematological, gastrointestinal, metabolic (including
- •hypercholersterolemia), endocrine, pulmonary, cardiovascular, or neurologic
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