NL-OMON51447尚未招募不适用
The effects of belimumab on synovial inflammation and composition of lymph nodes in SLE patients - Belimumab in SLE synovial inflammation and lymph nodes
Amsterdam UMC0 个研究点目标入组 15 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •SLE patients who:
- •1. fulfill ACR 1997 and/or SLICC and/or ACR/ EULAR 2019 criteria,
- •2. have active joint disease (arthritis) in wrist, knee or ankle joints.
- •3. have a SLEDAI-2K score >=6.
- •4. are aged between 18-75
- •5. start with belimumab
排除标准
- •Patients who are not able to give informed consent.
- •Severe renal impairment (eGFR <30ml/min/1.73m2)
- •Active nephritis
- •Present or previous treatment with any cell depleting therapies, including
- •anti-B-cell therapy or other investigational agents
- •Intravenous cyclophosphamide 90 days prior to belimumab
- •Any non-biologic investigational agent 30 Days Prior to belimumab (or 5
- •half-lives, whichever is greater)
- •Live vaccines within 30 days prior to baseline or concurrently with belimumab
- •Presence of any other disease for which study subjects need chronic or
- •intermittent immunosuppressive therapy (e.g. prednisolon for COPD).
- •History of malignancies neoplasm within the last 5 years except basal cell or
- •squamous cell carcinoma of the skin treated with local resection only or
- •carcinoma in situ of the uterine cervix treated locally and with no evidence of
- •metastatic disease for 3 years
- •Have any intercurrent significant medical or psychiatric illness that the
- •investigator considers would make the candidate unsuitable for the study,
- •including evidence of serious suicide risk including any history of suicidal
- •behaviour in the last 6 months and/or any suicidal ideation in the last 2
- •months or who in the investigator's judgment, poses a significant suicide risk
- •Have current drug or alcohol abuse or dependence, or a history of drug or
- •alcohol abuse or dependence within 365 days prior to Day 0
- •Have a historically positive HIV test or test positive at screening for HIV, or
- •other immunodeficiency
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