NCT03618784已完成1 期
A Multi-center, Randomized, Double-blind, Parallel, Placebo-controlled Phase I/2a Clinical Trial to Evaluate the Efficacy and Safety of FURESTEM-RA Inj. for Moderate to Severe Rheumatoid Arthritis
Kang Stem Biotech Co., Ltd.7 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2018年7月11日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 7
- 主要终点
- Safety of FURESTEM-RA Inj. - number of adverse events
研究概览
简要总结
Safety and Efficacy of FURESTEM-RA Inj. in Patients With Moderate to Severe Rheumatoid arthritis
详细描述
Phase 1: Single center, open Phase 2a : Multi-center, randomized, double-blind, parallel, placebo Clinical Trial to Evaluate the Efficacy and Safety of FURESTEM-RA Inj. for Moderate to Severe Rheumatoid arthritis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •of either gender, 19-80years old
- •Subjects must be diagnosed according to the 2010 ACR/EULAR criteria for at least 12 weeks duration.
- •Subjects must be diagnosed with ACR functional class I. II, III
- •≥ 6 tender joints, swollen joints (68 joint count) at Screening
- •Subject who has moderate to severe disease activity (DAS28-ESR>3.2) on screening visit
- •History of treatment for one of conventional DMARDs or biologic DMARDs or JAK inhibitors AND people diagnosed with either (a) or (b) by a trained person, or people that have potential side effects thus not qualified from using biologic DMARDs.
- •people that have no effect with permitted dose taking for more than 3 months
- •people with a history of side effects of relevant treatment
- •Subjects must be taking cDMARDs(including methotrexate, sulfasalazine, hydroxychloroquine, leflunomide) or tacrolimus of stable dose More than 12 weeks before baseline visit and be willing to remain on stable dose throughout the study
- •If subject is currently administering steroids everyday, when steroid dose is converted into prednisolone oral dose, the subject should take a stable dose(≤10mg/day) over 4 weeks on screening visit
- •In case of taking NASAIDs, Tramadol patients with stable amount of medication at least 2 weeks before screening visit.
- •During screening visit , patients with an ESR result of 28mm/hr; patients with a 1.0mg/dL or greater in a CRP testing
- •Subject who understands and voluntarily sign an informed consent form
排除标准
- •Subjects who is diagnosed ACR function class IV Rheumatoid Arthritis
- •Patients who are judged by the PI(or Sub-I) to be unable to participate in clinical trials due to uncontrolled or unstable cardiovascular disease or severe blood disease
- •Subjects who has AIDS, other rheumatic disease(Crohn's disease, systemic lupus erythematosus, lyme disease, psoriatic arthritis, spondylarthropathy, infectious or reactive arthritis, reiter's syndrome, etc.)
- •Prior use of bDMARDs, within the following windows prior to baseline
- •24 weeks for Rituximab
- •10 weeks for Abatacept, Golimumab, Certolizumab pegol, Tocilizumab
- •7 weeks for Infliximab
- •4 weeks for Etanercept
- •3 weeks for Tofacitinib, Baricitinib
- •Subject who has history of hypersensitivity, heavy metal poisoning, etc. to drugs which is composed of similar components.
- •Subject who has treated intravenous, intramuscular steroid injection within 2 weeks before screening visit or intra-articular steroid injection within 4 weeks before screening visit
- •Subject who has administered ACTH(adrenocorticotropic hormone) agents within 4 weeks before screening visit
- •Subject who has undergone administration of any investigational drug within 30 days before screening visit.
- •Use of prohibited medication or inability to avoid the use of prohibited medication during the study
- •Pregnant, breast-feeding women
- •A female or male in their childbearing ages that is not willing to take proper contraceptive methods during a study
- •Subject who has sever dyshepatia (Serum creatinine level ≥ 1.7mg/dl)
- •Subject who has severe renal dysfunction (ALT/AST/bilirubin value ≥ 2 upper limit of the normal range at screening test)
- •Any other condition which the PI Judges would make patient unsuitable for study participation
研究组 & 干预措施
Placebo Comparator: Placebo
Placebo Comparator
干预措施: sterile saline (Other)
FURESTEM-RA Inj.
Experimental
干预措施: FURESTEM-RA Inj (Biological)
结局指标
主要结局
Safety of FURESTEM-RA Inj. - number of adverse events
时间窗: 4 weeks follow-up after treatment
Evaluate the number of adverse events Safety of FURESTEM-RA Inj.
次要结局
- Efficacy as measured by EULAR (European League Against Rheumatism)reaction rate(16 weeks follow-up after treatment)
- Efficacy as measured by ACR(American College of Rheumatology)20,50,70 reaction rate(16 weeks follow-up after treatment)
- Efficacy as measured by KHAQ(Korean Health assessment questionnaire)(16 weeks follow-up after treatment)
- Efficacy as measured by 100mm Pain VAS(Visual analogue scale)(16 weeks follow-up after treatment)
- Efficacy as measured by DAS(Disease activity scores)28-ESR(16 weeks follow-up after treatment)
- Efficacy as measured by CDAI (clinical disease activity index)(16 weeks follow-up after treatment)
- Total number of use and consumed amount of rescue medicine(16 weeks follow-up after treatment)
- Change in Cytokine(TNF-a, Interleukin (IL)-1b, IL-4,IL-6,IL-8,IL-10,IL-13,IL-17A,IL-21,IL-22)(16 weeks follow-up after treatment)
研究者
研究点 (7)
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