Hydroxychloroquine as a Steroid-sparing Agent in Extrapulmonary Sarcoidosis

Launched by HOSPICES CIVILS DE LYON · Apr 24, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating whether hydroxychloroquine (HCQ), a medication often used to treat malaria and certain autoimmune diseases, can help people with extrapulmonary sarcoidosis while reducing the need for steroids. Sarcoidosis is a condition that can affect various parts of the body, not just the lungs, and while steroids are commonly used to manage it, they can have unwanted side effects if used for a long time. The researchers believe that adding HCQ to the treatment plan might allow patients to take less steroid medication, which could be beneficial for their overall health.

To be eligible for this trial, participants need to be at least 18 years old and have been diagnosed with a specific type of sarcoidosis that requires treatment but is not severe. They cannot have any serious complications from the disease or recent treatments that might interfere with the study. If someone joins the trial, they can expect to receive HCQ alongside their usual treatment and will be monitored closely for any side effects. It's important to note that women participating must not be pregnant or breastfeeding during the study. This trial is currently enrolling participants, and those interested may want to consult their healthcare provider for more information.

Gender

ALL

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
• • symptomatic hypercalciuria \>200 mg/24h (24 h urine) OR
• • - \> 20 mg/mmol creatinine on urine sample
• • - \> 180 mg/g creatinine on urine sample
• • 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 corticoid (patient weaned for 3 months before inclusion)
• • previous treatment with antimalarial drugs (HCQ/CQ) (patient must have been off plaquenil for at least 12 months)
• • treatment with citalopram, escitalopram, hydroxyzin, domperidone and piperaquine
• • known hypersensitivity or intolerance to HCQ/CQ or 4-aminoquinoline derivatives and prednisone
• • heart rhythm disorders on EKG (QT prolongation) (except atrial fibrillations)
• • 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
• • Use 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)