Phase
Condition
Sarcoidosis
Treatment
Hydroxychloroquine
Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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)
Study Design
Connect with a study center
Service de Médecine Interne Infectiologie Aïgue Polyvalente- Hôpital Henri Duffaud
Avignon, 84 000
FranceActive - Recruiting
Service de Pneumologie - Hôpital Avicenne
Bobigny, 93000
FranceSite Not Available
Service de medecine interne - Hôpital Henri Mondor
Créteil, 94000
FranceSite Not Available
Service de Médecine Interne et Immunologie Clinique - CHU Dijon Bourgogne
Dijon, 21 079
FranceSite Not Available
Service de medecine interne - Hôpital Claude Huriez
Lille, 59 000
FranceSite Not Available
Service de medecine interne - Hôpital Duputryen
Limoges, 87 042
FranceSite Not Available
Service de médecine interne - Centre Hospitalier Saint Joseph Saint Luc
Lyon, 69007
FranceSite Not Available
Service de médecine interne - Hôpital Edouard Herriot
Lyon, 69004
FranceSite Not Available
Service de médecine interne - Hôpital Lyon Sud
Lyon, 69004
FranceSite Not Available
Service de médecine interne - Hôpital de la Croix Rousse
Lyon, 69004
FranceActive - Recruiting
Service de medecine interne - Hôpital Saint Eloi
Montpellier, 34 295
FranceSite Not Available
Service de medecine interne - Hôpital Hôtel Dieu
Nantes, 44000
FranceSite Not Available
Hôpital Cochin - Médecine interne
Paris,
FranceSite Not Available
Hôpitaux Saint Joseph et Marie LANNELONGUE
Paris,
FranceSite Not Available
Service de medecine interne 2- Hôpital de la Pitié-Salpétrière
Paris, 75013
FranceSite Not Available
Service de médecine interne - Hôpital Lariboisière
Paris, 75010
FranceSite Not Available
Service de Médecine Interne et maladies infectieuses - Hôpital Haut Lévêque
Pessac, 33 604
FranceSite Not Available
Service de Médecine Interne et Immunologie Clinique - Hôpital Sud
Rennes, 35 2000
FranceActive - Recruiting
Service de medecine interne - Hôpital Nord
Saint-Étienne, 42 055
FranceSite Not Available
Service de medecine interne - Hôpital de Hautepierre
Strasbourg, 67 200
FranceSite Not Available
Service de médecine interne - Clinique Saint exupéry
Toulouse, 31077
FranceActive - Recruiting
CHU Tours - Médecine interne
Tours,
FranceSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.