Hydroxychloroquine Versus Placebo in Primary Sjögren's Syndrome (JOQUER)

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 3

Conditions: Primary Sjögren's Syndrome

Treatments: Drug: Hydroxychloroquine; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00632866

P070125-AOM 07065

Details and patient eligibility

About

Primary Sjögren's syndrome (SJp) affects 0.1% of the population. This systemic autoimmune disease systemic is characterized by disabling dryness, fatigue and pain, and systemic complications in 30% of patients. No treatment has proven effective in this disease. In open studies, some efficacy was observed with hydroxychloroquine but no RCT versus placebo has ever been done.

Thus, the primary purpose of this study is to evaluate the efficacy and safety of hydroxychloroquine (400mg/ day) on dryness, pain, and fatigue, assessed by the patient using visual analogical scales.

Full description

Primary Sjögren's syndrome (SJp) affects 0.1% of the population. This systemic autoimmune disease systemic is characterized by disabling dryness, fatigue and pain, and systemic complications in 30% of patients. No treatment has proven effective in this disease. In open studies, some efficacy was observed with hydroxychloroquine but no RCT versus placebo has ever been done.

Thus, the primary purpose of this study is to evaluate the efficacy and safety of hydroxychloroquine (400mg/ day) on dryness, pain, and fatigue, assessed by the patient using visual analogical scales (VAS).

Response is defined by the improvement of 30% or more of at least 2 out of 3 of the following VAS : most disabling dryness, fatigue, and pain.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients suffering from primary Sjögren's syndrome according to the European-American consensus group criteria
• Male and female aged of 18 or more
• Conducting a clinical examination beforehand.
• Having undergone less than 6 months before an ophthalmological examination, which did not counter-indicated hydroxychloroquine.
• Patient without heart conduction disturbance (PR>=0.2 sec and QRS>=0.08 sec).
• Patient with the ability to give informed, dated and signed consent before the beginning of any proceedings related to the trial
• Patients treated with corticosteroids and / or NSAIDs, and / or cyclosporine, and / or pilocarpine must have received stable doses of these treatments during the month preceding inclusion.

Exclusion criteria

• SJ associated with other autoimmune diseases
• Retinopathy /severe cataract/ monophthalmos
• Previous or ongoing treatment by hydroxychloroquine
• Treatment by another immunosuppressant not interrupted at least 4 weeks prior to inclusion, or 6 months prior to inclusion for cyclophosphamide or rituximab
• lymphoma or other severe SJp complications: vasculitis responsible for a documented renal, neurological, digestive or heart involvement, glomerular disease associated with hematuria and / or proteinuria > 0.5 g / d), CNS involvement, peripheral neurological involvement with motor deficiency scored at 3 or less on a scale of 5 , interstitial pneumonitis, recent symptomatic cryoglobulinemia with neurological, renal, or other systemic involvement, myositis with motor deficiency (isolated purpura is not an exclusion criteria)
• Chronic Alcoholism
• Hepato-cellular insufficiency
• Creatinine clearance <60 ml / min
• Risk of lost follow-up
• People younger than 18, major trusteeship and guardianship, or deprived of liberty
• Pregnancy /Breastfeeding
• Hypersensitivity to chloroquine or to hydroxychloroquine or any of the other constituents of Plaquenil
• Psoriasis or intermittent porphyria.
• G6PD deficiency, congenital galactosemia, malabsorption syndrome, glucose and galactose, or lactase deficiency.
• Non-membership in a social security system.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Active treatment : Hydroxychloroquine

Treatment:

Drug: Hydroxychloroquine

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo