JPRN-jRCT2071220040进行中（未招募）2 期
A phase II investigator-initiated randomized, double blind, parallel-group clinical trialof 5-aminolevulinic acid hydrochloride/ sodium ferrous citrate (5-ALA-HCl/ SFC) for patients with adult-onset still's disease (AOSD) refractory to corticosteroids
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
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
- >= 16age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Patients who are 16 years of age or older at the time consent is obtained, any gender is acceptable
- •2) Patients who confirmed diagnosis of AOSD as per Yamaguchi criteria (Yamaguchi et al. 1992) with an onset of disease 16 years of age or older 3) Patients with a history of refractory to treatment with corticosteroids at a prednisolone equivalent of 0.4 mg/kg/day or more for at least 2 weeks
- •4) Patients with all of the following a-c disease activity during the screening period despite taking prednisolone equivalent of 10 mg/day or more at a fixed dose for at least one week prior to obtaining consent
- •a. Patients with fever> 38 degrees Celsius for even one day due to AOSD
- •b. Patients with an active joint count (tender (68 joints) or swollen (66 joints)) of 2 or more
- •c. Patients with ESR (Westergren method)> 20 mm/h or CRP> 1.0 mg/dL
- •5) Patients whose free will informed consent can be obtained in writing and who are able to comply with the requirements of the study protocol; for subjects under 18 years of age, written consent must be obtained from a surrogate and, in principle, from the patient him/herself
- •6) Females of childbearing potential or Males who are sexually active with females of childbearing potential who agree to use an effective contraceptive method (e.g., condom) for the duration of the study and until the day after the last dose of study drug
排除标准
- •1) Females who are lactating, pregnant, or intend to become pregnant during the study period
- •2) Patients with serious infections (including active tuberculosis)
- •3) Patients who received live vaccinations within 12 weeks prior to obtaining consent
- •4) Patients with HBV antibody, HCV antibody, or HIV antibody positive by screening test
- •Patients with a positive HBsAb or HBcAb test are eligible if HBV-DNA is negative
- •Patients with positive HCV antibodies are eligible only if the polymerase chain reaction (PCR) test is negative for HCV-RNA
- •5) Patients with complications or history of porphyria/ photosensitivity
- •6) Patients with hemochromatosis
- •7) Patients with known allergy or hypersensitivity or intolerance to aminolevulinic acid, sodium ferrous citrate, porphyrin, or their additives
- •8) Patients with a history of macrophage activation syndrome (MAS) or disseminated intravascular coagulation syndrome within 12 weeks prior to obtaining consent
- •9) Patients on dialysis
- •10) Patients with severe liver dysfunction (either AST or ALT exceeding 5 times the upper limit of the institutional reference value at the time of screening test)
- •11) Patients who used ALA-containing or iron-based drugs or supplements within 1 week prior to enrollment
- •12) Patients who used canakinumab, infliximab, or infliximab biosimilar within 12 weeks prior to enrollment
- •13) Patients who used golimumab, adalimumab, adalimumab biosimilar, certolizumab pegol, or abatacept within 8 weeks prior to enrollment
- •14) Patients who used tocilizumab or sarilumab within 4 weeks prior to enrollment
- •15) Patients who used etanercept or etanercept biosimilar within 2 weeks prior to enrollment
- •16) Patients who used any other biologic within either 12 weeks prior to enrollment or within 5 times the mean elimination half-life
- •17) Patients who used targeted synthetic DMARDs such as tofacitinib, baricitinib, peficitinib, upadacitinib, or filgotinib within 2 weeks prior to enrollment
- •18) Patients who used immunosuppressive drugs (oral) such as cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, or mizoribine within 2 weeks prior to enrollment
- •19) Patients who used intravenous cyclophosphamide or other immunosuppressive drugs (intravenous) within 4 weeks prior to enrollment
- •20) Patients who have changed doses of methotrexate or other disease-modifying anti-rheumatic drugs within 4 weeks prior to enrollment
- •21) Patients who are receiving another investigational drug or have not received their last dose for 30 days or 5 times the half-life of the investigational drug, whichever is longe
- •22) Patients with a serious complication for which the investigator or subinvestigator determines that they are not suitable for the clinical study
- •23) patients deemed inappropriate by the investigator or subinvestigator
研究者
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