2024-510903-12-00
尚未招募
4 期
A stratification trial to determine key immunological factors predicting Tofacitinib efficacy in Psoriatic Arthritis (PsA); TOFA-PREDICT
Universitair Medisch Centrum Utrecht6 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2024年6月24日最近更新:
概览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- Universitair Medisch Centrum Utrecht
- 入组人数
- 160
- 试验地点
- 6
- 主要终点
- Minimal Disease Activity (MDA) at week 16
概览
简要总结
Identify pre-treatment profiles with integrated clinical, transcriptomic, metabolomic, proteomic, flow cytometric, and imaging data that predict response to treatment with tofacitinib, in DMARD-naïve and DMARD non-responsive PsA patients
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years old
- •Inclusion criteria for the csDMARD-IR group (Arm 2): • Current use of methotrexate, sulfasalazine or leflunomide on the highest tolerated 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. • “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. • No history of tsDMARD therapy use (JAKi, abatacept)
- •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 for the csDMARD-naïve group (Arm 1): • No history of csDMARD use or bDMARD therapy use
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 enrollment 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 disease.
结局指标
主要结局
Minimal Disease Activity (MDA) at week 16
Minimal Disease Activity (MDA) at week 16
Baseline molecular network profile (based on the composite systems medicine analysis)
Baseline molecular network profile (based on the composite systems medicine analysis)
次要结局
- change (50%) in the molecular network before treatment as compared to after (week 4 and 16) treatment
- change in composite clinical disease activity scores (MDA, ACR(20,50,70) response, DAS28) at week 16
- change in individual clinical parameters that make up the composite scores (i.e. PASI score (reduction of 50%, 75%, 90%), joint count, CRP, ESR, QOL-measures) at week 16
研究者
dr. S.Mastbergen
Scientific
Universitair Medisch Centrum Utrecht
研究点 (6)
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