ACTRN12621001657819招募中1 期
A Randomised, Double-Blind, Placebo-Controlled, Parallel Dose Comparison Study Evaluating Safety and Efficacy of SVT-6A4710 in Adults with active Rheumatoid Arthritis.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Servatus Ltd
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •1.Male and female Participants aged 18 to 80 years, capable of providing verbal informed consent and able to attend the clinic as required for the study;
- •2.Participants must have active Rheumatoid Arthritis meeting classification criteria according to the 2010 ACR/EULAR guidelines with a score equal to or greater than 6/10;
- •3.Participants must have a Clinical Disease Activity Index (CDAI) Score greater than 10;
- •4.Participants may or may not be taking conventional DMARD therapies;
- •5.If taking DMARD therapy, they must have been taking it continuously for at least 3 months prior to the first dose of study drug and be on a stable weekly dose for at least 4 weeks prior to the first dose of study drug and be maintained for the study duration, as:
- •a.Sulfasalazine less than or equal to 2000 mg/day
- •b.Hydroxychloroquine less than or equal to 200 mg/day
- •c.Leflunomide less than or equal to 20 mg/day
- •d.Azathioprine less than or equal to 4 mg/kg per day
- •e. Methotrexate less than or equal to 25 mg/week
- •6.If taking low dose prednisone, they must be taking it continuously for 3 months and be on a stable dose of less than 7.7 mg/day for 4 weeks prior to the first dose of the study drug. Tapering or removing prednisone from treatment plan will be based on disease activity assessed at each clinic visit;
- •7.Must have normal differential white cell counts within reference range at screening:
- •a.Lymphocytes (1.1 - 4.0 x 10^9 per L)
- •b.Neutrophils (2.0 - 7.5 x 10^9 per L)
- •c.Monocytes (0.2 - 1.0 x 10^9 per L)
- •d.Eosinophils (0.04 - 0.4 x 10^9 per L)
- •e.Basophils (0 - 0.21 x 10^9 per L)
- •8.Participant has discontinued all disallowed concomitant medications for the required time prior to the first dose of study drug and is taking only those concomitant medications in doses and frequency allowed by the protocol;
- •9.Females of childbearing potential (FOCBP) must test negative for pregnancy prior to enrolment in the study;
- •10.Sexually active FOCBP and men, whose partners are FOCBP and who are not using adequate contraceptive methods, are required to use adequate contraceptive methods during participation in this trial.
排除标准
- •Participants fulfilling any of the following criteria are not eligible for inclusion in this study.
- •1.History of any other rheumatic autoimmune disease, other than Sjogren’s syndrome;
- •2.Current or previous exposure to biological DMARDs within 3 months, or Infliximab within 6 months prior to the first dose of the study drug;
- •3.Use of high potency opioid analgesics (e.g., methadone, hydromorphone, morphine);
- •4.Use of oral antimicrobial drugs within 4 weeks prior to the first dose of the study drug;
- •5.Use of probiotic supplements within 2 weeks prior to the first dose of the study drug;
- •6.History of hypersensitivity to the study drug or its excipients or to drugs of similar classes, probiotics or any antibiotics commonly used to treat bacterial infections;
- •7.History of any infection requiring hospitalisation, parental antimicrobial therapy, or as otherwise judged clinically significant, within the 3 months prior to screening;
- •8.History of septicaemia or bacteraemia;
- •9.Use of any investigational drug and/or device within 4 weeks before randomisation or a period of 5 half-lives of the investigational drug, whichever is longer. Patients cannot participate in studies of other investigational compounds at any time during their participation in this study;
- •10.Current or recent history of uncontrolled clinically significant renal, hepatic, haematological, gastrointestinal, endocrine, metabolic (including uncontrolled clinically significant hypercholesterolemia), pulmonary, cardiac, or neurological disease;
- •11.History of, or signs and symptoms suggestive of any current, lymphoproliferative disease or lymphatic disorder, or history of malignancy of any known malignancy of any organ system with the past 5 years (except for basal cell carcinoma or actinic keratoses that have been treated with no evidence of recurrence in the past 3 months, carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed);
- •12.Those with known or suspected history of immunodeficiency;
- •13.Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study;
- •14.Any planned surgical procedure during the treatment period, other than that deemed by the Study Coordinator to be minor and unlikely to impact on the study and will not require the use of antibiotics;
- •15.Females who are pregnant or breastfeeding or planning on becoming pregnant for the study period (treatment and follow-up periods);
- •16.History of alcohol or drug abuse with less than 6 months of abstinence prior to first dose of study drug;
- •17.Screening 12-lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect patient safety;
- •18.Inability or unwillingness to undergo repeated venepuncture (e.g., because of poor tolerability or lack of access to veins);
- •19.Inability or unwillingness to complete repeated stool collections.
研究者
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