2022-502155-65-00招募中3 期
HydroxyChloroquine as steroid-sparing Agent in Extra-pulmonary SARcoidosis. A multicenter, prospective, placebo-controlled, randomized trial. CAESAR
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 15
- 主要终点
- The primary endpoint is the percentage of patients in remission and off prednisone at month 9, without relapse until month 12. The primary endpoint will thus be assessed at M12.
研究概览
简要总结
Evaluate the steroid-sparing effect of hydroxychloroquine as an add-on therapy in patients with non severe extra-pulmonary sarcoidosis requiring a systemic treatment.
研究设计
- 分配方式
- Randomized
- 主要目的
- HydroxyChloroquine / Placebo
- 盲法
- Double (Subject, Monitor, Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •at least 18 years of age
- •non severe sarcoidosis-related hypercalcemia requiring systemic treatment
- •non severe peripheral nervous system sarcoidosis requiring systemic treatment
- •Symptomatic hypercalciuria >200 mg/24h (24 h urine) OR - > 20 mg/mmol creatinine on urine sample - > 180 mg/g creatinine on urine sample
- •non severe sarcoidosis-related non-severe ENT involvement requiring systemic treatment
- •pathologically proven sarcoidosis as defined by the ATS/ERS/WASOG criteria (the non-severe / severe criteria are defined in Appendix 9 of the protocol)
- •patient able to give free, informed and written consent
- •affiliated to National French social security system
- •nons evere ocular sarcoidosis requiring systemic treatment
- •non severe skin sarcoidosis requiring systemic treatment
- •non severe osseous sarcoidosis requiring systemic treatment
- •non severe sarcoidosis with joint involvement requiring systemic treatment
排除标准
- •severe sarcoidosis involvement requiring another immunosuppressant or anti-TNF antibody or methylprednisolone i.v. pulses
- •end-stage lung, liver, cardiac, or renal disease
- •sarcoidosis with central nervous system involvement
- •Provision of effective contraception for the duration of the study (Contraception is considered effective when it consists of one of the following: use of a male condom during all sexual activity and/or efficient oral hormonal contraception (better considered combined contraception) and/or an intrauterine device (IUD) and/or hormone-releasing intrauterine system (IUS) and/or history of bilateral tubal ligation and/or history of vasectomy, provided the male partner is the trial participant's only sexual partner and/or sexual abstinence)
- •cardiac sarcoidosis
- •clinical evidence of active infection (including infection with herpes virus and varicella-zoster virus) or severe/unstabilized comorbidity (e.g. moderate to severe heart failure) or unstabilized psychosis
- •chronic viral (HIV or HBV) infection
- •untreated latent/active tuberculosis
- •pregnancy or lactation (βHCG will be test by blood analysis at inclusion)
- •concurrent vaccination with live vaccines during therapy
- •inability to understand information about the protocol and to sign informed consent or not suitable candidate to comply with the requirements of this study
- •patient participating in other interventional research
- •Previous treatment with cortocoids (patient must have been weaned for 3 months)
- •persons under court protection
- •previous (<3 months before screening) or concurrent treatment with immunosuppressants
- •previous treatment with antimalarial drugs (HCQ/CQ) (the patient must have been off plaquenil for at least 12 months)
- •treatment with citalopram, escitalopram, hydroxyzin, domperidone and piperaquine
- •known hypersensitivity or intoloerance to HCQ/CQ or 4-aminoquinoline derivatives and prednisone
- •heart rhythm disorders on EKG (QT prolongation) (except atrial fibrillation)
- •severe ophthalmological impairment or ophthalmological impairment that does not allow ophthalmic monitoring; previous history of maculopathy or retinopathy
结局指标
主要结局
The primary endpoint is the percentage of patients in remission and off prednisone at month 9, without relapse until month 12. The primary endpoint will thus be assessed at M12.
The primary endpoint is the percentage of patients in remission and off prednisone at month 9, without relapse until month 12. The primary endpoint will thus be assessed at M12.
次要结局
- Organ-specific response assessed by calculation of the extrapulmonary Physician Organ Severity Tool (ePOST, previously validated in sarcoidosis RCT) at M0, M1, M3, M6, M12, M18, and M24
- Global clinical response assessed by the physician as complete, partial, stable, or relapse (or progression) at M0, M1, M3, M6, M12, M18, and M24
- Type, frequency and dosage of local steroid treatments, allowing cumulative doses calculation at M0, M1, M3, M6, M12, M18 and M24
- Relapse rate until M24. Remission is defined by either complete or partial response. Relapse is defined as the persistence, or recurrence of existing manifestations and/or the occurrence of new sarcoidosis manifestations requiring substantial treatment modification
- Frequencies of steroid-associated side-effects monitored clinically and biologically (BMI calculation, blood pressure measurement for arterial hypertension, dosages of glycaemia and HbA1c for diabetes mellitus, dosages of lipids, dosages of bone turnover markers for osteoporosis and clinical evaluation for infections) and Glucocorticoid Toxicity Index (GTI) will be calculated at M0, M1, M3, M6, M12, M18, and M24.
- HCQ safety will be assessed through initial and annual eye evaluation: electroretinogram or autofluorescence or OCT, and monitoring of eventual AEs. EKG will be performed before study initiation and at M1, M3, M6, M12, M18, and M24. An AE will be considered as serious if it leads to HCQ cessation, hospitalization, or death. Patients’ adherence will be controlled by patient notebooks, pharmacy count of unused tablets and serial dosages of blood HCQ levels (M6 and M12
- Quality of life will be assessed by the SF36 questionnaire (Annex 16.1) HADS and FAS at M0, M1, M3, M6, M12, M18, and M24
研究者
Dr Jamilloux
Scientific
Hospices Civils De Lyon
研究点 (15)
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