JPRN-jRCTs071190045招募中4 期
Glucocorticoid-tapering aimed maintenance therapy in patients with systemic lupus erythematosus
Tanaka Yoshiya0 个研究点目标入组 100 人开始时间: 2020年2月14日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Patients diagnosed with systemic lupus erythematosus (SLE) under the 1997 American College of Rheumatology (ACR) criteria and has active disease with SELENA-SLEDAI score less than 5
- •2) Patients aged over 18 years (all gender)
- •3) Patients who have administered glucocorticoid with constant dosage (10mg/day or less in prednisolone) for 30 days or more before informed consent
- •4) Patients who have been treated with hydroxychloroquine and/or immunosuppressive drugs for systemic lupus erythematosus and whose dosage is constant for 30 days or more before informed consent
- •5) Patients have negative urine pregnancy test. (Female patients of childbearing potential)
- •6) Patients prevent pregnancy during the study.
- •7) Written informed consent for participation of this study by the patient himself if the patient is over 20 years old (the patients himself/herself and a signer if the patient is under 20 years old)
排除标准
- •1) Patients with a history of anaphylaxis to contrast media or biological agents
- •2) Periods from last dose date of B cell targeted drugs (Rituximab and Belimumab and no limited to these) to informed consent date is within 1 year
- •3) Last dose date of Abatacept to informed consent date is within 1 year
- •4) Period from the last dose date of anti-TNF therapy, IL-1 receptor antagonist and immunoglobulin intravenous is within 3 months to informed consent date
- •5) Period from last dose date of cyclophosphamide intravenous is within 6 months to informed consent date
- •6) Patients who have not reached 30 days or 5 times their half-life, whichever is longer, from last administration date of a non-biological product in a trial phase to informed consent date
- •7) Period from last administration date of a biological product in a trial phase to informed consent date is within 1 year
- •8) Period from last administration date of high dose glucocorticoid (10mg/day or more in prednisolone) or plasma exchange to informed consent date is within 6 months
- •9) Patients who have received raw vaccine 30 days or less before informed consent date
- •10) Patients who underwent an operation of major organ transplant (heart, kidneys, lungs, liver) or a hematopoietic stem cell/ bone marrow transplant
- •11) Patients with complications of malignancy or a history of malignancy within the past 5 years (within 5 years prior to obtaining consent)
- •Excluding the following
- •(1) Basal cell carcinoma and spinous cell carcinoma treated by local resection alone with no evidence of metastasis for 3 years
- •(2) Intraepithelial carcinoma of the cervix treated by local treatment only, with no evidence of metastasis for 3 years
- •12) Patient with a history of self harm within 6 months before informed consent date
- •13) Patients who have Type 4 or 5 of Suicide Idea under Columbia Suicide Severity Rating Scale(C-SSRS) at screening
- •14) Patients with a history of drug or alcohol abuse or dependence within one year prior to informed consent
- •15) Patients with a history of primary immunodeficiency
- •16) Patients with a past or present history of infection
- •Patients who have received parenteral antibacterial, antiviral, antifungal, or antiparasitic drugs within 60 days prior to enrollment
- •Currently receiving anti-infection therapy for chronic infections (such as uberculosis, pneumocystis pneumonia, cytomegalovirus, herpes simplex virus, shingles and atypical mycobacterial infections)
- •Hospitalized for treatment of infection prior to within 60 days before administration of Belimumab
- •Patients with history of HIV test positive
- •17) Patients with a past or present history of hepatitis
- •HBs antigen or HBc antibody positive
- •Hepatitis C antibody positive (HCV antibody, HCV-RNA quantification, etc.)
- •18) Patients with serious IgG deficiency (IgG concentration<400 mg/dL at screening)
- •19) Patients with IgA deficiency (IgA concentration<10 mg/dL at screening)
- •20) Patients who are lactating and unable to stop
- •21) Patients who are not inappropriate to participate in this study for any reason by the judgement of investigators
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