JPRN-UMIN000016928招募中未知
Targeted Ultrasound in Rheumatoid Arthritis - TURA
eeds University0 个研究点目标入组 400 人开始时间: 2015年3月26日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •General 1. Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 12 months following randomisation. 2. Any persons that are committed to a psychiatric institution or in prison will be excluded from participation in this study. Study Specific 3. Patients with a secondary, non-inflammatory musculoskeletal condition (e.g., osteoarthritis or fibromyalgia) that in the Investigator's opinion is symptomatic 4. enough to interfere with evaluation of the effect of study drug or the patient's primary diagnosis of RA. 5. Patients with a diagnosis of any other inflammatory arthritis (e.g., psoriatic arthritis or ankylosing spondylitis) or connective tissue diseases, e.g. primary Sjogren's syndrome, systemic sclerosis, systemic lupus erythematosus, polymyositis. 6. Patients not on a stable dose of methotrexate within 8 weeks of screening, intolerance or contraindications (as per clinician judgment) 7. Intramuscular, intra-articular or change in oral corticosteroid within 8 weeks of screening visit. 8. Oral Prednisolone dose > 5 mg within 8 weeks of screening 9. Unable to attend 12-weekly clinical assessments 10. Female patients who are breastfeeding, pregnant, or plan to become pregnant during the trial or within twelve weeks following completion of the study. 11. Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol. Excluded Previous or Concomitant Therapy: 12. Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) of screening. 13. Patients who have previously received any biological therapy for RA. 14. Immunisation with a live/attenuated vaccine within 4 weeks prior to baseline. 15. Any previous treatment with alkylating agents such as chlorambucil, or with total lymphoid irradiation.
研究者
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