DRKS00000150已完成4 期
Effects of treatment with etanercept on fatigue, sleepiness, well being, sleep quality and selected immune parameters in patients with rheumatoid arthritis - Schlafprojekt
Charité - Universitätsmedizin BerlinMedizinische Klinik m.S. Rheumatologie / klinische Immunologie0 个研究点目标入组 36 人开始时间: 2009年6月19日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •Rheumatoid Arthritis according to ACR 1987 criteria;
- •age 18 - 70;
- •DAS28 geater or euqal to 3.2;
- •morning stiffness greater or equal to 30 minutes;
- •patients in etanercept group must fulfill DGRh criteria for initiation of biologic therapy;
- •patients may not have received prior biologic therapy;
- •NSAID, glucocorticoids must be at stable dosing 14 d prior to screening (gc dosing at a max of 10 mg/d prednisolon or equivalent);
- •able and willing to understand and sign informed consent;
- •able and willing to perform s.c injections themselves or having someone to do so;
- •females with reproductive potential must use adequate form of contraception
排除标准
- •Patients with history of severe disease including malignancies treated within 5 years of screening (except basal cell carcinoma of skin and squamous skin cell carcinoma and in situ carcinoma of the neck);
- •Patients with uncompensated heart insufficiency, myocardial infarction within 12 months of screening, instable angina pectoris,uncontrolled arterial hypertension, severe lung disease, history of HIV-infection, immunodeficiency syndromes, other rheumatologic disorders than RA, demyelinating CNS disease, multiple sklerosis or psychiatric disorders;
- •patients with other reasons for sleeping disorders (COLD, sleep apnea, allergic rhinitis etc.;
- •patients who received live vaccination within 4 weeks of screening;
- •patients receiving intraarticular injections with glucocorticoids within 4 weeks of screening
- •Patients receiving intramuscular or i.v. injections of glucocorticoids of euqual to or more of 10 mg/d prednisolone equivalent within 4 weeks of screening;
- •oral doses of more than 10 mg prednisolone equivalent ;
- •history of blood dyscrasias;
- •Patients with active infections or predisposing conditions for infection (e.g. leg ulcerations, untreated diabetes mellitus);
- •Patients with active Hepatitis A,B,C, Tuberculosis, chronic or latent TB, latent TB must have been adequately treated with Isoniazid 300 mg/d for 10 month starting at least 4 weeks prior to first etanercept application.
- •Renal disease or known cirrhosis or fibrosis of the liver,
- •Liver function parameters at more than 2 times of upper limit of normal range;
- •sleep associated respiratory disorder, ideopatic insomnia
- •AHI >10/h, PMLI > 5/h;
- •alcohol abuse;
- •brest feeding;
- •Patients incapable of giving informed consent
研究者
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