NCT01289730Unknown2 期
An Open-label Study of Etanercept (Enbrel) Efficacy in Undifferentiated Spondyloarthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)50 response
研究概览
简要总结
The study has the aim to investigate the efficacy and safety of etanercept in patients with active undifferentiated spondyloarthritis (uSpA) over the period of 520 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 to 65 years of age.
- •Proven undifferentiated spondyloarthritis according to the European Spondylarthropathy Study Group (ESSG) criteria who do not have ankylosing spondylitis, reactive arthritis, psoriasis and/or inflammatory bowel disease
- •Acute phase of disease with high disease activity the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4 or a pain score ≥ 4 on a Numeric Rating Scale (NRS) at two occasions in 2 weeks
- •Understand, sign and date the written informed consent at the screening visit.
- •Sexually active women participating in the study must use a medically acceptable form of contraception until 6 month after the last injection of study medication. Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception. Additionally, the use of condoms is suggested as an adjunct to the methods previously addressed to protect against sexually transmitted diseases and to provide additional protection against accidental pregnancy.
- •Sexually active men must agree to use a medically accepted form of contraception during the study until 6 month after the last injection of study medication.
- •Negative serum or urine pregnancy test taken at screen in all women except those surgically sterile or at least 1 year postmenopausal.
- •Able to self-administer injectable drug supplies or have a caregiver who will do so.
- •Able to store injectable test article at 2° to 8° C.
排除标准
- •Pregnancy/lactation
- •Previously exposure to murine or chimeric monoclonal antibodies
- •Receipt of any live (attenuated) vaccines within 4 weeks before screening visit
- •History of chronic or a recent serious infection
- •History of tuberculosis within the last 3 years
- •History of malignancy
- •Significant concurrent medical diseases including uncompensated congestive heart failure, myocardial infarction within 12 months, stable or unstable angina pectoris, uncontrolled hypertension, severe pulmonary disease, history of human immunodeficiency virus (HIV) infection, central nervous system demyelinating events suggestive of multiple sclerosis
- •Presence or history of confirmed blood dyscrasias
- •History of any viral hepatitis within 1 year prior screening or history of any drug-induced liver injury at any time prior to screening
- •Laboratory exclusions are: hemoglobin level < 8,5 mg/dl white blood cell count < 3.5 x 10^9/l platelet count < 125 x 10^9 /l creatinine level > 175 mcmol/l, liver enzymes > 1.5 times the upper limit of normal or alkaline phosphatase > 2 times the upper limit of normal.
- •Participation in trials of other investigational medications within 30 days of entering the study
- •Clinical examination showing significant abnormalities of clinical relevance
- •Concomitant medication with disease-modifying anti-rheumatic drugs (DMARDs) or corticosteroids
- •History or current evidence of abuse of "hard" drugs (eg., cocaine/heroine) or alcoholism
研究组 & 干预措施
Etanercept 25 mg
Experimental
Etanercept 25 mg subcutaneously twice a week
干预措施: Etanercept (Drug)
结局指标
主要结局
The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)50 response
时间窗: at week 12
Achievement of at least 50% improvement of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at week 12 as compared to baseline
次要结局
- Sustained response(every 3 months througout the study)
- Safety outcome(at 12 weeks, every 12 weeks thereafter)
- Magnetic resonance imaging (MRI) response(at week 24, 54, 102, 210, 308, 416, 514)
- X-ray progression(at week 54, 102, 210, 308, 514)
研究者
研究点 (2)
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