EUCTR2018-002362-39-NL进行中（未招募）1 期
Comparing Methotrexate monotherapy with methotrexate Plus LEflunomide combination ThErapy in Psoriatic Arthritis: A pragmatic randomized placebo-controlled double-blind clinical trial. - Comparing methotrexate with methotrexate plus leflunomide in psoriatic arthritis
St Maartenskliniek0 个研究点目标入组 78 人开始时间: 2018年7月9日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 78
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Adult male or female
- •-Age =18 years
- •-Clinical diagnoses of PsA
- •-Evidence of active disease defined as =2 swollen joints, dactylitis counts as 1 swollen joint.
- •-Subjects that have used cDMARDs and/or bDMARDs before, must have discontinued this treatment for at least 6 months prior to baseline visit.
- •-Subjects who are already taking NSAIDs/COX-2 inhibitors may participate in the study but the dose has to be stable for at least one week prior to first dose of study drug
- •-Oral or injected corticosteroids (intramuscular, intravenous and intra-articular) have to be discontinued 8 weeks prior to first dose of study drug
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 70
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 8
排除标准
- •-Female subject who is pregnant, breastfeeding or is considering becoming pregnant during the study or for approximately 2 years after the last dose of study drug or up to 11 days after treatment when washout procedure is executed.
- •-Male subject who is considering fathering a child or donating sperm during the study or for approximately 2 years after the last dose of study drug or up to 11 days after treatment when washout procedure is executed.
- •-History of an inadequate response to MTX or LEF (prescribed by a rheumatologist for joint disease).
- •-Current severe infection including, but not limited to:
- •oActive human immunodeficiency virus (HIV)
- •-History of an allergic reaction or significant sensitivity to constituents of the study drugs (MTX/LEF)
- •-Current or history of liver insufficiency
- •-History of clinically significant (per Investigator's judgment) drug or alcohol abuse within the last 6 months prior to baseline visit.
- •-Current or recent history of a severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiovascular or neurologic disease.
- •-History of any fibromyalgia or diagnosis of inflammatory rheumatic disease other than PsA. Prior history of fibromyalgia is permitted if documentation of change in diagnosis to PsA or documentation that the diagnosis of fibromyalgia was made incorrectly.
- •-Abnormal laboratory values within 1 month prior to baseline visit:
- •oSerum alanine transaminase (ALT) > 1.5 × ULN;
- •oEstimated glomerular filtration rate (GFR) by simplified 4-variable Modification of Diet in Renal Disease (MDRD) formula < 40 mL/min/1.73m2;
- •oTotal white blood cell count (WBC) < 3,000/µL;
- •oPlatelet count < 100,000/µL;
- •oHemoglobin < 10 g/dL (6.3 mmol/L).
- •-Current persistent hypertension requiring start or change of treatment regimen
- •-Malignancy in the past 5 years except for non-melanoma skin cancer
研究者
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