EUCTR2019-004961-42-BE进行中（未招募）1 期
SPondyloArthritis: inducing drug-free Remission by early TNF-Alpha bloCkade Under guidance of Single cell RNA sequencing and epigenetic profiling - SPARTACUS
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 112
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
- •-Subjects must be between 18 and 65 years of age.
- •-Subjects must have been diagnosed with peripheral spondyloarthritis by the treating rheumatologist.
- •-Subjects must meet the ASAS classification criteria for peripheral spondyloarthritis: subjects must have current arthritis (asymmetric or predominantly in the lower limbs) or current enthesitis (except for enthesitis only along the spine, sacroiliac joints and/or chest wall) or current dactylitis plus at least 1 SpA features
- •-Subjects must have had onset of peripheral SpA symptoms =12 months prior to the screening visit.
- •-Subjects must have active disease at screening defined by Patient Global Assessment of Disease Activity Numerical Rating Scale (NRS) = 4 and Patient Global Assessment of Pain NRS = 4. At the baseline visit patients will be clinically evaluated to exclude spontaneous clinical remission.
- •-In subjects with concurrent axial SpA symptoms, the peripheral SpA symptoms must be the predominant symptoms at study entry based on the Investigator’s clinical judgment.
- •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 75
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 37
排除标准
- •Medical history of inflammatory arthritis of a different etiology than peripheral spondyloarthritis (e.g. rheumatoid arthritis, systemic lupus erythematosus, gout, …).
- •Prior adequate treatment with methotrexate and/or sulphasalazine.
- •Prior exposure to any biologic therapy with a potential therapeutic impact on SpA.
- •Treatment with any investigational drug of chemical or biological nature within a minimum of 30 days or 5 half-lives of the drug (whichever is longer) prior to the Baseline Visit.
- •Infection(s) requiring treatment with intravenous (iv) anti-infective agents within 30 days prior to the Baseline visit or oral anti-infectives within 14 days prior to the baseline Visit.
- •Have a known hypersensitivity to human immunoglobulin proteins or other components of golimumab.
- •History of central nervous system (CNS) demyelinating disease or neurologic symptoms suggestive of CNS demyelinating disease.
- •History of listeriosis, histoplasmosis, chronic or active Hepatitis B infection, Hepatitis C infection, human immunodeficiency virus (HIV) infection, immunodeficiency syndrome, chronic recurring infections or active TB.
- •(History of) chronic heart failure, including medically controlled, asymptomatic CHF.
- •History of malignancy (including lymphoma and leukemia) other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix.
- •Have received any live virus or bacterial vaccination within 3 months prior to the first administration of study agent; patients who are expected to receive such vaccinations during the trial, or within 3 months after the last administration of study agent.
- •Positive serum pregnancy test at screening.
- •Female subjects who are breast-feeding.
- •Clinically significant abnormal screening laboratory results as evaluated by the Investigator.
- •Positive anti-cyclic citrullinated peptide (anti-CCP) antibody at screening if the titers are crossing 3 times the upper limit of normal.
- •Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
- •Subject with current symptoms of fibromyalgia that would confound evaluation of the patient.
研究者
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