Using hydroxychloroquine to reduce steroid use in patients with extrapulmonary sarcoidosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of hydroxychloroquine as a steroid-sparing agent in patients with extrapulmonary sarcoidosis. The study aims to determine whether hydroxychloroquine can help manage symptoms and reduce the need for long-term corticosteroid treatment, which is associated with significant side effects. Participants will be randomly assigned to receive either hydroxychloroquine or a placebo, and their responses will be monitored over time. The trial focuses on patients with non-severe forms of sarcoidosis affecting various organs outside the lungs.

Why it matters

Who can join: the full rules

* 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)

Where it's running

• Service de Médecine Interne Infectiologie Aïgue Polyvalente- Hôpital Henri Duffaud
  Avignon, France Recruiting
• Service de médecine interne - Hôpital de la Croix Rousse
  Lyon, France Recruiting
• Service de médecine interne - Hôpital Lyon Sud
  Lyon, France Recruiting
• Service de Médecine Interne et maladies infectieuses - Hôpital Haut Lévêque
  Pessac, France Recruiting
• Service de Médecine Interne et Immunologie Clinique - Hôpital Sud
  Rennes, France Recruiting
• Service de médecine interne - Clinique Saint exupéry
  Toulouse, France Recruiting

Study contacts

• Study coordinator: Thomas El Jammal, Dr
• Email: thomas.el-jammal@chu-lyon.fr
• Phone: 04.26.73.26.29

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.