EUCTR2012-002945-40-ES进行中（未招募）1 期
Efficacy, safety and immunogenicity of BI 695501 versus adalimumab in patients with active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or female participants, between 18 and 80 years of age, who
- •have a diagnosis of moderately to severely active RA for at least 6
- •months as defined by at least six swollen joints (66 joint count) and at
- •least six tender joints (68 joint count) at Screening and Baseline (Day
- •1), and either an ESR of >28 mm/hour OR a CRP level >1.0 mg/dL
- •(normal: <0.4 mg/dL) at Screening. Patients must currently be receiving
- •MTX therapy.
- •2. Current treatment for RA on an outpatient basis
- •3. For participants of reproductive potential (males and females), a
- •reliable means of contraception has to be used throughout trial
- •participation and for 5 months following completion or discontinuation
- •from the trial.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 450
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
排除标准
- •1)ACR functional Class IV or wheelchair/bed bound
- •2)Primary or secondary immunodeficiency (history of, or currently
- •3)Positive TB test without treatment for TB infection or
- •chemoprophylaxis for TB exposure.
- •4)Known clinically significant coronary artery disease or significant
- •cardiac arrhythmias or severe congestive heart failure
- •5)Previous treatment with any biologic agent
- •6)History of a severe allergic reaction or anaphylactic reaction to a
- •biological agent or history of hypersensitivity to adalimumab or any
- •component of the trial drug
- •7)History of cancer
- •8)Positive serological test for hepatitis B or for hepatitis C
- •9)Receipt of a live/attenuated vaccine within 12 weeks prior to
- •Screening Visit.
- •10)Patients with a significant disease other than RA and/or a significant
- •uncontrolled disease
- •11)History of, or current, inflammatory joint disease other than RA
- •12)Diagnosis of juvenile idiopathic arthritis, also known as juvenile RA,
- •and/or RA before age 16
- •13)Known active infection
- •14)Patients who are currently participating in another clinical trial or
- •who have been participating in another clinical trial with another
- •investigational drug within a minimum of 12 weeks or five half-lives
- •(whichever is longer) of the drug prior to Day 1. Patients who have
- •previously been randomized in this trial
研究者
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