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HydroxyChloroquine as steroid-sparing Agent in Extra-pulmonary SARcoidosis. A multicenter, prospective, placebo-controlled, randomized trial. CAESAR
EU CTIS ID: 2022-502155-65-00
What this study is testing
Evaluate the steroid-sparing effect of hydroxychloroquine as an add-on therapy in patients with non severe extra-pulmonary sarcoidosis requiring a systemic treatment.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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)
You likely can't join if
- 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
See the full eligibility criteria
Who can join
- 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
What rules you out
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.