临床试验/NCT01223911

NCT01223911已完成2 期

A Randomised, Double-blind, Placebo-controlled, Multiple Dose Trial of NNC 0151-0000-0000 in Subjects With Rheumatoid Arthritis

Novo Nordisk A/S1 个研究点分布在 1 个国家目标入组 34 人开始时间: 2011年1月最近更新: 2017年2月9日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: Novo Nordisk A/S
入组人数: 34
试验地点: 1
主要终点: Number of adverse events (AEs)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability and pharmacokinetics (at which rate the drug is eliminated from the body) of NNC 151-0000-0000 in subjects with rheumatoid arthritis (RA).

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: Double (Participant, Investigator)

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

•CZ: Age between 18 and 65 years (both inclusive)
•A diagnosis of rheumatoid arthritis of at least three months before entry in trial
•Active rheumatoid arthritis (RA)
•Subjects are on stable doses of methotrexate (up to and including 25 mg/week) for at least 4 weeks before trial drug administration

排除标准

•Known or suspected allergy to trial product or related products
•Body mass index (BMI) less than 18.0 or more than 38.0 kg/m2 (inclusive)

研究组 & 干预措施

A

Experimental

干预措施: NNC 0151-0000-0000 (Drug)

B

Placebo Comparator

干预措施: placebo (Drug)

结局指标

主要结局

Number of adverse events (AEs)

时间窗: at all scheduled visits (week 1 - week 11)

次要结局

Serum concentrations of NNC 151-0000-0000(at 48 hours after all dose administrations)

研究者

发起方

Novo Nordisk A/S

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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