A Double- Blind, Placebo Controlled Study Exploring the Safety, Tolerability, and Efficacy of a 28 Day Course Followed by an Additional 56 Day Course of Itacitinib in Subjects With Active Rheumatoid Arthritis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 106
- 主要终点
- Safety and tolerability of itacitinib as assessed by the changes in frequency and severity of adverse events, ECGs, vital signs, physical examinations, and clinical laboratory evaluations.
研究概览
简要总结
This is a study evaluating a 28-day course followed by a 56-day course of itacitinib in patients with active rheumatoid arthritis (RA). The study will evaluate safety and efficacy parameters of itacitinib.
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
- •Subjects with active RA aged 18 to 75 years of age and meet tender and swollen joint assessment expectations defined in the study protocol.
- •c-Reactive protein (CRP) or erythrocyte sedimentation rate (ESR) laboratory values meet minimal study protocol expectations.
排除标准
- •Females who are pregnant or breastfeeding.
- •Men and women who cannot comply with requirements to avoid fathering a child or becoming pregnant, respectively.
- •Subjects treated with a biologic agent within 12 weeks prior to first dose of study drug. (12 months in the case of rituximab.)
- •Subjects with a history or currently suspected inflammatory disease other than RA.
- •Subjects with a history of hematological disorders.
研究组 & 干预措施
Itacitinib 400 mg twice a day
Itacitinib 400 mg twice a day
干预措施: Itacitinib (Drug)
Itacitinib 400 mg placebo twice a day
Itacitinib 400 mg placebo twice a day
干预措施: Itacitinib Placebo (Drug)
Itacitinib 100 mg twice a day
This dose group will be studied twice during the study.
干预措施: Itacitinib (Drug)
Itacitinib 100 mg placebo twice a day
This dose group will be studied twice during the study.
干预措施: Itacitinib Placebo (Drug)
Itacitinib 100mg once a day
Itacitinib 100mg once a day
干预措施: Itacitinib (Drug)
Itacitinib 100 mg placebo once a day
Itacitinib 100 mg placebo once a day
干预措施: Itacitinib Placebo (Drug)
Itacitinib 200 mg twice a day
Itacitinib 200 mg twice a day
干预措施: Itacitinib (Drug)
Itacitinib 200 mg placebo twice a day
Itacitinib 200 mg placebo twice a day
干预措施: Itacitinib Placebo (Drug)
Itacitinib 300 mg once a day
Itacitinib 300 mg once a day
干预措施: Itacitinib (Drug)
Itacitinib 300 mg placebo once a day
Itacitinib 300 mg placebo once a day
干预措施: Itacitinib Placebo (Drug)
Itacitinib 600 mg once a day
Itacitinib 600 mg once a day
干预措施: Itacitinib (Drug)
Itacitinib 600 mg placebo once a day
Itacitinib 600 mg placebo once a day
干预措施: Itacitinib Placebo (Drug)
结局指标
主要结局
Safety and tolerability of itacitinib as assessed by the changes in frequency and severity of adverse events, ECGs, vital signs, physical examinations, and clinical laboratory evaluations.
时间窗: Approximately four months.
Preliminary efficacy as assessed by the percentage of patients achieving ACR20 improvement from baseline on the day 28 and day 84 visits.
时间窗: Approximately 84 days.
次要结局
- Preliminary Pharmacokinetic (PK) collections.(Following 15 days of therapy.)