EUCTR2016-005017-45-PL进行中（未招募）1 期
A Randomized, Placebo-Controlled, Double Blind, Multicenter Phase 2 Study to Explore Tolerability, Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Intravenous Multiple Infusions of NI-0101, an anti-Toll Like Receptor 4 Monoclonal Antibody in Patients with Rheumatoid Arthritis
ovImmune S.A.0 个研究点目标入组 81 人开始时间: 2017年6月19日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 81
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
- •- Male and female patients
- •- Age >= 18 years old
- •- BMI: < 30 and > 18
- •- Diagnosis of RA according to 2010 ACR/EULAR criteria and with a disease duration of at least 6 months since diagnosis
- •- Patient must present with active RA, characterized by at least 6 swollen joints out of 66 assessed and 6 tender jointsout of 68 assessed and by the presence of synovitis (measured by ultrasound) in at least one of the 6 swollen joints
- •- C-reactive protein (CRP) level > 0.7 mg/dL or if the CRP level is between 0.3 mg/dL and 0.7 mg/dL (included) then patient must also present an ESR > 30mm/hr
- •- Patients must have received MTX treatment for at least 3 months and have been on a stable dose of MTX for at least 6 weeks prior to start of screening
- •- ACPA-positive RA patients
- •- Women must be postmenopausal (> 12 months without menses) or surgically sterile or if considered of child bearing potential must be using at least a highly effective contraception method for at least for 4 weeks prior to the randomization date and agree to continue contraception for the duration of their participation in the study (until the end of follow up period).
- •- Sexually active male patients must use a barrier method of contraception during the course of the study (and until the end of the follow up period), in addition to their partner(s) using another highly effective method
- •- Patients must give written informed consent for study participation
- •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 41
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •- A documented history of an autoimmune disease other than RA by ACR classification, or Sjögren syndrome
- •- Administration of cytotoxic drugs and immune suppressants (other than MTX) within 3 months prior to screening
- •- Previous multiple administrations of any biological DMARD or targeted synthetic DMARD
- •- Known primary immunodeficiency
- •- Pregnant or breastfeeding women
- •- Suspicion of active or latent tuberculosis
- •- HIV, HCV, HBV infection
- •- Infection reported during screening not recovered 72h prior to first dose
- •- History of anaphylactic reactions to any protein therapeutics or excipients
- •- Any history of malignancy, excluding cured basal or squamous cell carcinoma of the skin, or cervical in situ carcinoma
- •- Clinically significant cardiac disease requiring medication, such as congestive heart failure, unstable angina, myocardial infarction within 6 months prior to randomization
- •- Moderate to severe renal insufficiency, clinically relevant liver function test abnormalities or pancytopenia
- •- Major psychiatric or neurological disorder
- •- Administration of anti-RANKL monoclonal antibody within 3 months
- •prior to screening.
研究者
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