NCT01284569已完成1 期
A Phase I/II, Randomised, Double-Blind, Placebo Controlled Study, Evaluating the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD) and Efficacy of Single and Multiple Intravenous Doses of ALX-0061 in Patients With RA
Ablynx, a Sanofi company7 个研究点 分布在 3 个国家目标入组 65 人开始时间: 2011年3月1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
- 65
- 试验地点
- 7
- 主要终点
- Safety: number of treatment emergent adverse events (TEAEs)
研究概览
简要总结
The purpose of this study is to determine whether the ALX-0061, a Nanobody targeting the receptor for interleukin 6 (IL6R), is safe and effective after single or multiple administrations to patients with rheumatoid arthritis (RA). Patients will receive different single or multiple doses of either placebo or ALX-0061.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index (BMI) <35.0 kg/m2
- •Diagnosed with rheumatoid arthritis (RA) according to the 2010 European League Against Rheumatism (EULAR)/ American College of Rheumatology (ACR) criteria for at least 6 months prior to randomisation
- •Treatment with methotrexate (MTX) for at least 12 weeks prior to screening, with at least 4 weeks before screening at a stable dose, that will remain stable throughout the study period. Inadequate response or or intolerance to disease modifying antirheumatic drugs (DMARDs) (including MTX, where a patient may remain on treatment with %TX at a lower dose for improved tolerance, but with reduced effectiveness)
- •For patients (men and women) of reproductive potential, use of an acceptable method of contraception for the duration of the study. Female patients must be willing to use appropriate birth control measures that would prevent pregnancy starting from the time of signing the informed consent until 90 days after the last dose of study drug is administered
- •For single dose part: Disease Activity Score using 28 joint counts (DAS28) score >= 2.4
- •For multiple dose part: DAS28 score >= 3.2
- •For multiple dose part: swollen joint count >= 3
排除标准
- •A documented history of an autoimmune disease other than RA (other than secondary Sjögren's syndrome)
- •Functional class IV by ACR classification
- •Any new/additional biologic DMARD therapy, cytotoxic drugs and immunosuppressants within four weeks prior to screening, and between screening and Day 1 with the exception of ALX-0061
- •Suspicion of active tuberculosis verified by quantiferon test and abnormal chest X-ray
- •Female patients who are pregnant during the study, or are breastfeeding
- •History of anaphylactic reactions to protein therapeutics
- •Participation in an investigational drug study within 60 days prior to drug administration except for the patients who participated in the single dose part of this study and who are eligible to participate in the multiple dose part
- •Donation of more than 300 mL of blood within 60 days prior to drug administration
- •Malignancy, or prior malignancy, with a disease free interval of <5 years after diagnosis and intervention except curative treatment for non-melanoma skin cancer or resected carcinoma in situ
- •Any current or recent (within 4 weeks prior to first dose) signs or symptoms of infection that requires parenteral antibiotic administration, any known active viral infection (hepatitis B virus [HBV], hepatitis C virus [HCV], human immunodeficiency virus [HIV]) that would impair the participation in the study
- •Major surgery (including joint surgery) within 8 weeks prior to screening and hospitalisation for a clinically relevant event within the 4 weeks prior to screening
- •Any other disease, metabolic dysfunction, physical examination finding, or clinically significant laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patient at high risk for treatment complications
- •Administration of a live, attenuated vaccine within 1 month before dosing with ALX-0061, or anticipation that such a live attenuated vaccine will be required during the study or within 60 days after the last dose
- •For multiple dose part: contraindication to MRIs or the use of contrast agents for MRI scanning
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Biological)
ALX-0061
Experimental
干预措施: ALX-0061 (Biological)
结局指标
主要结局
Safety: number of treatment emergent adverse events (TEAEs)
时间窗: From first study drug administration until last follow-up visit (i.e. 90 days after dosing for single dose part, 210 days after first dose for multiple dose part)
次要结局
- Pharmacokinetics (PK): serum concentration of ALX-0061(From first day prior to study drug administration until last follow-up visit (i.e. 90 days after dosing for single dose part, 210 days after first dose for multiple dose part))
- Biological efficacy: pharmacodynamic (PD) markers(From first day prior to study drug administration until last follow-up visit (i.e. 90 days after dosing for single dose part, 210 days after first dose for multiple dose part))
- Disease activity: RA-related assessments(From first day prior to study drug administration until last follow-up visit (i.e. 90 days after dosing for single dose part, 210 days after first dose for multiple dose part))
研究者
研究点 (7)
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