JOQUER: Hydroxychloroquine Versus Placebo in Primary Sjögren's Syndrome

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT00632866

Collaborator

Sanofi (Industry)

120

Enrollment

Location

Arms

Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Sjögren's Syndrome	Drug: Hydroxychloroquine Drug: Placebo	Phase 3

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Randomized, Double-blind, Placebo-controlled Trial of Hydroxychloroquine in Primary Sjögren's Syndrome

Study Start Date :

Mar 1, 2008

Actual Primary Completion Date :

May 1, 2011

Actual Study Completion Date :

May 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Active treatment : Hydroxychloroquine	Drug: Hydroxychloroquine Hydroxychloroquine : 200mg / day since 24 weeks Other Names: Plaquenil
Placebo Comparator: 2 Placebo	Drug: Placebo Placebo : 2cp/ day since 24 weeks

Arm

Intervention/Treatment

Experimental: 1

Active treatment : Hydroxychloroquine

Drug: Hydroxychloroquine

Hydroxychloroquine : 200mg / day since 24 weeks

Other Names:

Plaquenil

Placebo Comparator: 2

Placebo

Drug: Placebo

Placebo : 2cp/ day since 24 weeks

Outcome Measures

Primary Outcome Measures

Proportion of patients with an improvement of 30% or more of at least 2 out of the 3 following VAS: 1. the most disabling dryness 2. pain 3. fatigue [6 months]

Secondary Outcome Measures

SCHIRMER's test, van BIJSTERVELD score, salivary flow, disease systemic features, quality of life, interferon-inducible genes expression Association between clinical response and hydroxychloroquine blood level, interferon-inducible genes expression [6 mois]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.