NL-OMON49310尚未招募4 期
Handscan optical measurements in Rheumatoid Arthritis: an inventory comparing serum levels of CRP, ESR, IL-6, clinical arthritis and reproducibility of DAS28. - HANDRAI
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 45
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
- •- Able and willing to give written informed consent
- •- Patients aged >= 18 years
- •- Recent (< 2 yr) diagnosis of Rheumatoid Arthritis (RA) according to the 2010
- •American College of Rheumatology/European League Against Rheumatism (EULAR/ACR)
- •classification criteria
- •- At least two swollen joints of wrists, PIP or MCP joints.
- •- No previous methotrexate and/or biologic treatment
- •- No systemic steroids within 6 weeks prior to baseline
排除标准
- •- Deformity of the hand or an allergy to light is an exclusion criteria for
- •valid use of the Handscan
- •- A recent (< 2 months) or planned carpal tunnel operation
- •- Female who is pregnant, breastfeeding, or is considering becoming pregnant
- •the study or a male planning to father a child.
- •- Any active or recurrent viral infection that, based on the Investigator's
- •assessment, makes the subject an unsuitable candidate for the study, including
- •hepatitis B virus (HBV) or hepatitis C virus (HCV), recurrent or disseminated
- •(even a single episode) herpes zoster, disseminated (even a single episode)
- •simplex, or human immunodeficiency virus (HIV).
- •- History of any malignancy within the last five years except for successfully
- •treated NMSC or localized carcinoma in situ of the cervix.
- •- Laboratory values meeting the following criteria within the Screening period
- •to the first dose of study drug:
- •Serum aspartate transaminase (AST) > 2 × ULN
- •Serum alanine transaminase (ALT) > 2 × ULN
- •Estimated glomerular filtration rate (GFR) by simplified 4-variable
- •Modification of Diet in Renal Disease (MDRD) formula < 40 mL/min/1.73 m2
- •Total white blood cell (WBC) count < 2,500/µL
- •Absolute neutrophil count (ANC) < 1,500/µL
- •Platelet count < 100,000/µL
- •Absolute lymphocyte count < 850/µL
- •Hemoglobin < 5.8 mmol/L
- •- Uncooperative patients, or any condition that could make the patient
- •potentially noncompliant to the study procedures
- •- Patients for whom Sarilumab is contra-indicated as described in the local
- •- Patients currently participating in any interventional clinical trials
- •- Previous experience with Sarilumab either through a clinical trial or
- •- Concomitant use of any biologic DMARDs or any tsDMARDs, including but not
- •limited to etanercept, adalimumab, infliximab, anakinra, rituximab, abatacept,
- •tociluzumab, certolizumab, golimumab, tofacitinib
研究者
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