Hydroxychloroquine as a Steroid-sparing Agent in Extrapulmonary Sarcoidosis (CAESAR)
Extra Pulmonary Sarcoidosis
About this trial
This is an interventional treatment trial for Extra Pulmonary Sarcoidosis focused on measuring Sarcoidosis, Hydroxychloroquine, steroid-sparing agent
Eligibility Criteria
Inclusion Criteria : at least 18 years of age pathologically proven sarcoidosis as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS)/World Association of Sarcoidosis and Other Granulomatous Disorders (WASOG) criteria non severe 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 non severe sarcoidosis-related hypercalcemia requiring systemic treatment non severe peripheral nervous system sarcoidosis requiring systemic treatment non severe sarcoidosis-related non-severe Ear, Nose and Throat (ENT) involvement requiring systemic treatment signed informed consent affiliated to National French social security system Exclusion Criteria : severe sarcoidosis involvement requiring another immunosuppressant or anti-TNF antibody or methylprednisolone i.v. pulses previous (<3 months before screening) or concurrent treatment with immunosuppressants previous treatment with antimalarial drugs (HCQ/CQ) treatment with citalopram, escitalopram, hydroxyzin, domperidone and piperaquine known hypersensitivity or intolerance to HCQ/CQ or 4-aminoquinoline derivatives and prednisone history of drug induced maculopathy heart rhythm disorders on EKG (QT prolongation) severe ophthalmological impairment or ophthalmological impairment that does not allow ophthalmic monitoring; previous history of maculopathy or retinopathy end-stage lung, liver, cardiac, or renal disease sarcoidosis with central nervous system involvement 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 persons under court protection women must not be pregnant, breastfeeding, or considering pregnancy during the study or within 30 days of the last study drug administration. (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)
Sites / Locations
- Service de Médecine Interne Infectiologie Aïgue Polyvalente- Hôpital Henri Duffaud
- Service de Médecine Interne et Immunologie Clinique - CHU Dijon Bourgogne
- Service de medecine interne - Hôpital Claude Huriez
- Service de medecine interne - Hôpital Duputryen
- Service de médecine interne - Hôpital de la Croix Rousse
- Service de médecine interne - Hôpital Lyon Sud
- Service de medecine interne - Hôpital Saint Eloi
- Service de medecine interne - Hôpital Hôtel Dieu
- Service de médecine interne - Hôpital Lariboisière
- Service de medecine interne 2- Hôpital de la Pitié-Salpétrière
- Service de Médecine Interne et maladies infectieuses - Hôpital Haut Lévêque
- Service de Médecine Interne et Immunologie Clinique - Hôpital Sud
- Service de medecine interne - Hôpital Nord
- Service de medecine interne - Hôpital de Hautepierre
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Hydroxychloroquine
Placebo arm
prednisone (scheduled protocol) + hydroxychloroquine (200-400 mg /day during a 12 months double blind placebo-controlled period, then according to the treating the physician for an additional open period of 12 months)
prednisone (scheduled protocol) + placebo (1-2 tablets/day during a 12 months double blind placebocontrolled period, then the treatment is left to the physician's discretion until M24)