NCT02047604已完成2 期
A Randomized, Double-blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Escalating Doses of SAN-300 in Patients With Active Rheumatoid Arthritis With Inadequate Response to Disease-Modifying Anti-rheumatic Drug(s).
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 12
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Escalating Doses of SAN-300 in Patients with Active Rheumatoid Arthritis with Inadequate Response to Disease-Modifying Anti-rheumatic Drug(s).
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with RA for ≥ 6 months according to American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Classification Criteria 2010
- •18 to 75 years of age, inclusive, at the time of informed consent
- •Swollen joint count of ≥ 6 (66-joint count) and tender joint count of ≥ 6 (68-joint count) at Screening and randomization
- •Inadequate response to therapy or discontinuation of therapy because of unacceptable toxicity from at least one prior traditional or biologic disease-modifying anti-rheumatic drug (DMARD)
- •Stable dose of methotrexate (≥ 15 mg/week and ≤ 25 mg/week) for ≥ 6 weeks before randomization
排除标准
- •Functional Class IV as defined by ACR classification of functional status in RA
- •History of significant systemic involvement secondary to RA (e.g., vasculitis, pulmonary fibrosis, or Felty's syndrome)
- •History of malignancy or carcinoma in situ within the 5 years before Screening or any history of melanoma. Patients with history of excised or adequately treated non-melanoma skin cancer are eligible
- •Evidence of clinically significant uncontrolled concurrent diseases such as cardiovascular, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major diseases
- •History of recurrent clinically significant infections
- •Current active infection or serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia) within 3 months before randomization
- •History of severe allergic or anaphylactic reactions to other biologic agents
- •History of allergies to murine protein
- •Surgery within 3 months before randomization (other than minor cosmetic surgery or minor dental procedures) or plans for a surgical procedure during the Treatment Period or Follow-up Period
- •History of tuberculosis or latent infection currently undergoing treatment
- •History of malaria
- •Treatment regimen with prednisone that is either over 10 mg/day (or equivalent dose of another corticosteroid) or is not taken at a stable dose of ≤ 10 mg/day for at least 4 weeks before randomization
- •Intra-articular corticosteroid injection(s) within 4 weeks before randomization
- •Any live immunization/vaccination, including against Herpes zoster, within 4 weeks before randomization. Live vaccinations must also be avoided throughout the study
- •Abnormal laboratory value at Screening or Day -1 considered clinically significant
- •Positive for hepatitis C virus (HCV) antibody or hepatitis B surface antigen (HBsAg)
- •Positive for human immunodeficiency virus (HIV) antibody
- •History of tuberculosis or positive QuantiFERON®-TB Gold test (QFT)
研究组 & 干预措施
Cohort A - SAN-300 0.5 mg/kg QW
Experimental
SAN-300 0.5 mg/kg subcutaneous once weekly for six weeks
干预措施: SAN-300 0.5 mg/kg QW (Drug)
Cohort B - SAN-300 1.0 mg/kg QW
Experimental
SAN-300 1.0 mg/kg subcutaneous once weekly for six weeks
干预措施: SAN-300 1.0 mg/kg QW (Drug)
Cohort C - SAN-300 2.0 mg/kg QOW
Experimental
SAN-300 2.0 mg/kg subcutaneous every other week for six weeks
干预措施: SAN-300 2.0 mg/kg QOW (Drug)
Cohort D - SAN-300 4.0 mg/kg QOW
Experimental
SAN-300 4.0 mg/kg subcutaneous every other week for six weeks
干预措施: SAN-300 4.0 mg/kg QOW (Drug)
Cohort E - SAN-300 4.0 mg/kg QW
Experimental
SAN-300 4.0 mg/kg subcutaneous every other week for six weeks
干预措施: SAN-300 4.0 mg/kg QW (Drug)
Placebo
Placebo Comparator
Placebo dosing
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: 10 weeks
Adverse events data are collected during a 10-week period, which includes 6 weeks of treatment and 4 weeks of follow-up.
次要结局
- Number of Participants With American College of Rheumatology 20 (ACR20) Response.(End of Treatment Visit (Week 7))
- Change From Baseline in Disease Activity Score With 28-joint Count Using C-reactive Protein (DAS28-CRP)(Baseline, End of Treatment Visit (Week 7))
研究者
研究点 (12)
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