Hydroxychloroquine Versus Placebo in Primary Sjögren's Syndrome

Primary Sjögren's Syndrome Clinical Trial

— JOQUER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00632866
• Other study ID #: P070125-AOM 07065
• Status: Completed
• Phase: Phase 3
• First received: February 29, 2008
• Last updated: July 1, 2012
• Start date: March 2008
• Est. completion date: May 2012

Study information

• Verified date: July 2012
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 2012
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Primary Sjögren's Syndrome
• Sjogren's Syndrome
• Syndrome

Intervention

Drug:
• Hydroxychloroquine
Hydroxychloroquine : 200mg / day since 24 weeks
• Placebo
Placebo : 2cp/ day since 24 weeks

Locations

Country	Name	City	State
France	Hopital Bicëtre	Le Kremlin Bicetre

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Sanofi

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No